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Sample records for parent consent form

  1. Informed consent and the readability of the written consent form.

    Science.gov (United States)

    Sivanadarajah, N; El-Daly, I; Mamarelis, G; Sohail, M Z; Bates, P

    2017-11-01

    Introduction The aim of this study was to objectively ascertain the level of readability of standardised consent forms for orthopaedic procedures. Methods Standardised consent forms (both in summary and detailed formats) endorsed by the British Orthopaedic Association (BOA) were retrieved from orthoconsent.com and assessed for readability. This involved using an online tool to calculate the validated Flesch reading ease score (FRES). This was compared with the FRES for the National Health Service (NHS) Consent Form 1. Data were analysed and interpreted according to the FRES grading table. Results The FRES for Consent Form 1 was 55.6, relating to the literacy expected of an A level student. The mean FRES for the BOA summary consent forms (n=27) was 63.6 (95% confidence interval [CI]: 61.2-66.0) while for the detailed consent forms (n=32), it was 68.9 (95% CI: 67.7-70.0). All BOA detailed forms scored >60, correlating to the literacy expected of a 13-15-year-old. The detailed forms had a higher FRES than the summary forms (p<0.001). Conclusions This study demonstrates that the BOA endorsed standardised consent forms are much easier to read and understand than the NHS Consent Form 1, with the detailed BOA forms being the easiest to read. Despite this, owing to varying literacy levels, a significant proportion of patients may struggle to give informed consent based on the written information provided to them.

  2. [Pediatric autopsy and informed parental consent].

    Science.gov (United States)

    Rambaud, C; Guilleminault, C

    2005-10-01

    In French legal terminology, the definition of autopsy is "organs'withholding". This phrase is ambiguous, meaning both removing the organs for their macroscopic exam and their retention for subsequent histology. The autopsy of a child requires an informed consent from both parents. The issue is that the pathologist who performs the autopsy is not the one who delivers the information and gets the parents' consent: therefore, he does not know what they were told and what they actually agreed upon. A questionnaire was sent to 3 groups of paediatricians (N=891) to approach their knowledge regarding autopsy. Among 362 paediatricians who answered the questionnaire, 57.2% never attended an autopsy and procedures were badly known. They did not know whether or not organs, were systematically sampled especially brain. Regarding the possibility of conservation of organs, a majority thought that one should not solely answer to parents'queries (63.8%) but rather that one should point out every possibility, without giving the ins and outs (60.8%). The majority favoured organs retention and use for research. We make 3 suggestions: to register autopsy in the Natioanal Securite Sociale nomenclature, to establish information and consent forms for organs'removal, retention and disposal, and to offer parents the possibility of an interview with the pathologist before and/or after the autopsy, in association with the paediatrician.

  3. Readability of Invasive Procedure Consent Forms.

    Science.gov (United States)

    Eltorai, Adam E M; Naqvi, Syed S; Ghanian, Soha; Eberson, Craig P; Weiss, Arnold-Peter C; Born, Christopher T; Daniels, Alan H

    2015-12-01

    Informed consent is a pillar of ethical medicine which requires patients to fully comprehend relevant issues including the risks, benefits, and alternatives of an intervention. Given the average reading skill of US adults is at the 8th grade level, the American Medical Association (AMA) and the National Institutes of Health (NIH) recommend patient information materials should not exceed a 6th grade reading level. We hypothesized that text provided in invasive procedure consent forms would exceed recommended readability guidelines for medical information. To test this hypothesis, we gathered procedure consent forms from all surgical inpatient hospitals in the state of Rhode Island. For each consent form, readability analysis was measured with the following measures: Flesch Reading Ease Formula, Flesch-Kincaid Grade Level, Fog Scale, SMOG Index, Coleman-Liau Index, Automated Readability Index, and Linsear Write Formula. These readability scores were used to calculate a composite Text Readability Consensus Grade Level. Invasive procedure consent forms were found to be written at an average of 15th grade level (i.e., third year of college), which is significantly higher than the average US adult reading level of 8th grade (p readability guidelines for patient materials of 6th grade (p readability levels which makes comprehension difficult or impossible for many patients. Efforts to improve the readability of procedural consent forms should improve patient understanding regarding their healthcare decisions. © 2015 Wiley Periodicals, Inc.

  4. Parental And Clinician Views Of Consent In Neonatal Research

    LENUS (Irish Health Repository)

    O’Shea, N

    2018-03-01

    Informed consent is an obligatory requirement for research participation1. The process of informed consent states that certain measures must be followed to ensure a research participant has made an informed decision about their participation in a research study2,3. Consent for research should be voluntary, informed, and understood by the consenting individual who must also be competent to do so. In the case of neonatal research informed consent is acquired from parent(s)\\/guardian(s) of a patient.

  5. Developing a simplified consent form for biobanking.

    Science.gov (United States)

    Beskow, Laura M; Friedman, Joëlle Y; Hardy, N Chantelle; Lin, Li; Weinfurt, Kevin P

    2010-10-08

    Consent forms have lengthened over time and become harder for participants to understand. We sought to demonstrate the feasibility of creating a simplified consent form for biobanking that comprises the minimum information necessary to meet ethical and regulatory requirements. We then gathered preliminary data concerning its content from hypothetical biobank participants. We followed basic principles of plain-language writing and incorporated into a 2-page form (not including the signature page) those elements of information required by federal regulations and recommended by best practice guidelines for biobanking. We then recruited diabetes patients from community-based practices and randomized half (n = 56) to read the 2-page form, first on paper and then a second time on a tablet computer. Participants were encouraged to use "More information" buttons on the electronic version whenever they had questions or desired further information. These buttons led to a series of "Frequently Asked Questions" (FAQs) that contained additional detailed information. Participants were asked to identify specific sentences in the FAQs they thought would be important if they were considering taking part in a biorepository. On average, participants identified 7 FAQ sentences as important (mean 6.6, SD 14.7, range: 0-71). No one sentence was highlighted by a majority of participants; further, 34 (60.7%) participants did not highlight any FAQ sentences. Our preliminary findings suggest that our 2-page form contains the information that most prospective participants identify as important. Combining simplified forms with supplemental material for those participants who desire more information could help minimize consent form length and complexity, allowing the most substantively material information to be better highlighted and enabling potential participants to read the form and ask questions more effectively.

  6. Parents, adolescents, and consent for research participation.

    Science.gov (United States)

    Iltis, Ana S

    2013-06-01

    Decisions concerning children in the health care setting have engendered significant controversy and sparked ethics policies and statements, legal action, and guidelines regarding who ought to make decisions involving children and how such decisions ought to be made. Traditionally, parents have been the default decision-makers for children not only with regard to health care but with regard to other matters, such as religious practice and education. In recent decades, there has been a steady trend away from the view that parents are in authority over their children and toward the view that children are rights-bearers who should be granted greater authority over themselves. The mature minor doctrine refers to the decision to grant mature minors the authority to make decisions traditionally reserved for their parents. This essay (1) documents the trend towards expanding the understanding of some minors as "mature" and hence as having the right and authority to give informed consent, (2) examines the reasons for which some commentators have a special interest in expanding the mature minor doctrine to the research setting and allowing minors to enroll in research without parental permission, and (3) defends the view that the mature minor doctrine, regardless of its application to clinical health care decisions, ought to be set aside in the research setting in favor of greater parental involvement.

  7. Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy

    Directory of Open Access Journals (Sweden)

    Borello Alessandro

    2016-01-01

    Full Text Available Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion.

  8. Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy

    OpenAIRE

    Borello Alessandro; Ferrarese Alessia; Passera Roberto; Surace Alessandra; Marola Silvia; Buccelli Claudio; Niola Massimo; Di Lorenzo Pierpaolo; Amato Maurizio; Di Domenico Lorenza; Solej Mario; Martino Valter

    2016-01-01

    Abstract Background Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. Methods This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a grap...

  9. Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy.

    Science.gov (United States)

    Borello, Alessandro; Ferrarese, Alessia; Passera, Roberto; Surace, Alessandra; Marola, Silvia; Buccelli, Claudio; Niola, Massimo; Di Lorenzo, Pierpaolo; Amato, Maurizio; Di Domenico, Lorenza; Solej, Mario; Martino, Valter

    2016-01-01

    Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed. Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension. Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding.

  10. 42 CFR 50.205 - Consent form requirements.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Consent form requirements. 50.205 Section 50.205 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.205 Consent form...

  11. Opt-Out Parental Consent in Online Surveys: Ethical Considerations.

    Science.gov (United States)

    Harris, Jane; Porcellato, Lorna

    2018-07-01

    This article aims to foster discussion and debate around seeking parental consent from young people recruited online. The growth of social media, particularly for young people, has led to increased interest in young people's online activities as both a research topic and recruitment setting. In a health-related study, which sought to recruit young people aged 13 to 18 years old from YouTuber fan communities to an online survey, the question arose of how parental consent could be sought from young people below 16 when no link existed between researcher and parents/guardians. A practical strategy is proposed which combines novel communication methods for participant information, opt-out online consent and age verification to address this issue. Strengths and limitations of these approaches are discussed.

  12. 16 CFR 312.5 - Parental consent.

    Science.gov (United States)

    2010-01-01

    ..., to the extent reasonably necessary: (i) To protect the security or integrity of its website or online... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... online contact information of a parent or child to be used for the sole purpose of obtaining parental...

  13. Readability and comprehensibility of informed consent forms for clinical trials

    Directory of Open Access Journals (Sweden)

    Anvita Pandiya

    2010-01-01

    A shortened Informed Consent Form, with information that a reasonable person would want to understand along with specific information that the person wants in particular would be a good option to improve understanding or comprehensibility. Additional informational meetings with a qualified person like a counselor could help in comprehension. Questionnaires designed to test comprehension of patient, peer review, patient writing the salient features could help evaluate the comprehensibility of the Informed Consent Form.

  14. Remote preenrollment checking of consent forms to reduce nonconformity.

    Science.gov (United States)

    Journot, Valérie; Pérusat-Villetorte, Sophie; Bouyssou, Caroline; Couffin-Cadiergues, Sandrine; Tall, Aminata; Chêne, Geneviève

    2013-01-01

    In biomedical research, the signed consent form must be checked for compliance with regulatory requirements. Checking usually is performed on site, most frequently after a participant's final enrollment. We piloted a procedure for remote preenrollment consent forms checking. We applied it in five trials and assessed its efficiency to reduce form nonconformity before participant enrollment. Our clinical trials unit (CTU) routinely uses a consent form with an additional copy that contains a pattern that partially masks the participant's name and signature. After completion and signatures by the participant and investigator, this masked copy is faxed to the CTU for checking. In case of detected nonconformity, the CTU suspends the participant's enrollment until the form is brought into compliance. We checked nonconformities of consent forms both remotely before enrollment and on site in five trials conducted in our CTU. We tabulated the number and nature of nonconformities by location of detection: at the CTU or on site. We used these data for a pseudo before-and-after analysis and estimated the efficiency of this remote checking procedure in terms of reduction of nonconformities before enrollment as compared to the standard on-site checking procedure. We searched for nonconformity determinants among characteristics of trials, consent forms, investigator sites, and participants through multivariate logistic regression so as to identify opportunities for improvement in our procedure. Five trials, starting sequentially but running concurrently, with remote preenrollment and on-site checking of consent forms from 415 participants screened in 2006-2009 led to 518 consent forms checked; 94 nonconformities were detected in 75 forms, 75 (80%) remotely and 19 more (20%) on site. Nonconformities infrequently concerned dates of signatures (7%) and information about participants (12%). Most nonconformities dealt with investigator information (76%), primarily contact information

  15. Emerging issues in paediatric health research consent forms in Canada: working towards best practices.

    Science.gov (United States)

    Dove, Edward S; Avard, Denise; Black, Lee; Knoppers, Bartha M

    2013-01-30

    Obtaining a research participant's voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements. Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008-2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child's assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child's psychological and social perspective; (3) whether a child's ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child's perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed. The review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study. The analysis provides valuable insight and evidence into

  16. Emerging issues in paediatric health research consent forms in Canada: working towards best practices

    Directory of Open Access Journals (Sweden)

    Dove Edward S

    2013-01-01

    Full Text Available Abstract Background Obtaining a research participant’s voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements. Methods Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008–2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1 whether the scope of parental consent allows for a child’s assent, dissent, or future consent; (2 whether the concepts of risk and benefit incorporate the child’s psychological and social perspective; (3 whether a child’s ability to withdraw is respected and to what extent withdrawal is permitted; (4 whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5 whether privacy and confidentiality concerns adequately address the child’s perspective and whether standard data and/or sample identifiability nomenclature is used; and (6 whether retention of and access to paediatric biological samples and associated medical data are addressed. Results The review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad, and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the

  17. Parental comprehension and satisfaction in informed consent in paediatric clinical trials: a prospective study on childhood leukaemia.

    Science.gov (United States)

    Chappuy, H; Baruchel, A; Leverger, G; Oudot, C; Brethon, B; Haouy, S; Auvrignon, A; Davous, D; Doz, F; Tréluyer, J M

    2010-10-01

    To evaluate the extent to which parents are satisfied with and understand the information they are given when their consent is sought for their child to participate in a phase III randomised clinical trial and the reasons for their decision. The authors carried out a prospective study. The authors included all parents whose consent was sought for their child to participate in the FRALLE 2000A protocol (acute lymphoblastic leukaemia) at two centres. The parents were questioned twice by a qualified psychologist using a semidirected interview, 1 and 6 months after consent was sought. 43 first interviews were carried out. All the parents declared they were satisfied with the explanations provided by the physician. 35 (81%) parents felt that the information provided with the request for consent was appropriate. Eight (19%) parents did not realise that their child had been included in a research protocol. 16 (39%) parents did not understand the concept of randomisation. Half the parents could explain neither the aim of the clinical trial nor the potential benefit of inclusion to their child. Only one third of the parents were aware that they had an alternative. The principal factor underlying their decision, as stated by 29 parents (67%), was confidence in the medical team. The parents signed consent forms without having fully understood all the elements specific to the experimental protocol. Rather, the parents based their decision on their confidence in the medical team, even when their child's life was at risk.

  18. 42 CFR Appendix to Subpart B of... - Required Consent Form

    Science.gov (United States)

    2010-10-01

    ... final paragraphs: Use the first paragraph below except in the case of premature delivery or emergency... information about sterilization from _______ (doctor or clinic). When I first asked for the information, I was... signature on the consent form. In those cases, the second paragraph below must be used. Cross out the...

  19. Patient Recall of Informed Consent at 4 Weeks After Total Hip Replacement With Standardized Versus Procedure-Specific Consent Forms.

    Science.gov (United States)

    Pomeroy, Eoghan; Shaarani, Shahril; Kenyon, Robert; Cashman, James

    2017-08-25

    Informed consent plays a pivotal role in the operative process, and surgeons have an ethical and legal obligation to provide patients with information to allow for shared decision-making. Unfortunately, patient recall after the consent process is frequently poor. This study aims to evaluate the effect of procedure-specific consent forms on patient's recall four weeks after total hip replacement (THR). This is a prospective study using a posttest-only control group design. Sixty adult patients undergoing total hip replacement were allocated to be consented using either the generic or the surgery-specific consent form. Four weeks after surgery, a phone interview was conducted to assess patient's recall of risk of surgical complications. Patient demographic characteristics and educational attainment were similar in both groups. There was a statistically significant increase in the mean number of risks recalled in the study group at 1.43 compared with 0.67 in the control group (P = 0.0131). Consent is a complex process, and obtaining informed consent is far from straightforward. A statistically significant improvement in patient's recall with the use of procedure-specific consent forms was identified, and based on this, we would advocate their use. However, overall patient recall in both groups was poor. We believe that improving the quality of informed consent may require the sum of small gains, and the use of procedure-specific consent forms may aid in this regard.

  20. Assessing usefulness and researcher satisfaction with consent form templates.

    Science.gov (United States)

    Larson, Elaine L; Teller, Alan; Aguirre, Alejandra N; Jackson, Jhia; Meyer, Dodi

    2017-08-01

    We aimed to improve the research consenting process by developing and evaluating simplified consent forms. Four templates written at the eighth-tenth grade reading level were developed and trialed by a group of experts in clinical research, health literacy, national regulatory requirements, and end users. Researchers from protocols which had received expedited review were surveyed at 2 time points regarding their use and assessment of the templates. At baseline 18/86 (20.9%) responding researchers had heard of the templates and 5 (5.8%) reported that they had used them; 2 years later, 54.2% (32/59) had heard of the templates and 87.5% (28/32) had used them ( p Consent form templates may be one mechanism to improve patient comprehension of research protocols as well as efficiency of the review process, but require considerable time for development and implementation, and one key to their success is involvement and support from the IRB and technical staff.

  1. Undergraduate Consent Form Reading in Relation to Conscientiousness, Procrastination, and the Point-of-Time Effect.

    Science.gov (United States)

    Theiss, Justin D; Hobbs, William B; Giordano, Peter J; Brunson, Olivia M

    2014-07-01

    Informed consent is central to conducting ethical research with human participants. The present study investigated differences in consent form reading in relation to conscientiousness, procrastination, and the point-of-time (PT) effect among undergraduate participants at a U.S. university. As hypothesized, conscientious participants and those who signed up to participate in a research study more days in advance and for earlier sessions (PT effect) read the consent form more thoroughly. However, procrastination was not related to consent form reading. Most importantly, consent form reading in general was poor, with 80% of participants demonstrating that they had not read the consent form. Conscientious participants were more likely to self-report reading the consent form, irrespective of their measured consent form reading. The article closes with suggestions to improve the process of obtaining informed consent with undergraduate participants. © The Author(s) 2014.

  2. Readability of informed consent forms in vascular and interventional radiology

    International Nuclear Information System (INIS)

    Pinto, I.; Vigil, D.

    1998-01-01

    To evaluate the readability of the informed consent forms prepared for vascular and interventional radiology. The 18 informed consent forms were analyzed using the Gramatica tool employed in Microsoft Word 97 For Windows which combines the statistics on legibility in terms of three sections: scores, averages and legibility (Flech index, passive voice, sentence complexity and vocabulary complexity). For each, the integrated readability index was also manually calculated. All the documents present a Flesch index of over 10; the sentence complexity indexes are less than or equal to 20, demonstrating that the sentences are not long or complicated in structure. Finally, the integrated readability index of all of them is well over 70. The forms posses acceptable legibility indexes, but their evaluation should be completed by an opinion poll of the patients for whom they are written. Moreover, it must be kept in mind that these documents, like the procedures performed, are changing continually. Thus, it is necessary to update and modify the information to be provided to the patients. (Author) 11 refs

  3. Parental perspectives on consent for participation in large-scale, non-biological data repositories.

    Science.gov (United States)

    Manhas, Kiran Pohar; Page, Stacey; Dodd, Shawn X; Letourneau, Nicole; Ambrose, Aleta; Cui, Xinjie; Tough, Suzanne C

    2016-01-01

    Data sharing presents several challenges to the informed consent process. Unique challenges emerge when sharing pediatric or pregnancy-related data. Here, parent preferences for sharing non-biological data are examined. Groups (n = 4 groups, 18 participants) and individual interviews (n = 19 participants) were conducted with participants from two provincial, longitudinal pregnancy cohorts (AOB and APrON). Qualitative content analysis was applied to transcripts of semi-structured interviews. Participants were supportive of a broad, one-time consent model or a tiered consent model. These preferences were grounded in the perceived obligations for reciprocity and accuracy. Parents want reciprocity among participants, repositories and researchers regarding respect and trust. Furthermore, parents' worry about the interrelationships between the validity of the consent processes and secondary data use. Though parent participants agree that their research data should be made available for secondary use, they believe their consent is still required. Given their understanding that obtaining and informed consent can be challenging in the case of secondary use, parents agreed that a broad, one-time consent model was acceptable, reducing the logistical burden while maintaining respect for their contribution. This broad model also maintained participant trust in the research and secondary use of their data. The broad, one-time model also reflected parents' perspectives surrounding child involvement in the consent process. The majority of parents felt decision made during childhood were the parents responsibility and should remain in parental purview until the child reaches the age of majority.

  4. Reading Level and Length of Written Research Consent Forms

    Science.gov (United States)

    Foe, Gabriella; Lally, Rachel

    2015-01-01

    Abstract In 100 Institutional Review Board approved consent forms (CFs), we assessed pages, reading levels, and whether they included essential elements. CF page numbers ranged from 3 to 28 (mean, 10.3) and readability ranged from grades 5.6 to 28.9 (mean, 11.6). The CF mean score for including essential elements was 90.8% (range: 63.5–100%). There were no significant differences by specialty in number of pages (p = 0.053), but surgical specialties had the highest readability (mean, 13.1), and pediatrics the lowest (10.5), p = 0.008. While approved CFs generally included the Office for Human Research Protections recommended essential elements, they were very long, and even pediatric forms, which had the lowest reading levels, were written on average at a tenth grade level. Researchers need guidance to resolve pressure between regulatory mandates and guidelines and “keeping it simple and clear.” PMID:25580939

  5. A semi-qualitative study of attitudes to vaccinating adolescents against human papillomavirus without parental consent

    Directory of Open Access Journals (Sweden)

    Kitchener Henry C

    2007-02-01

    Full Text Available Abstract Background The first vaccine to prevent human papillomavirus (HPV and cervical cancer has been licensed, and in future, vaccination may be routinely offered to 10–14 year old girls. HPV is a sexually transmitted virus and some parents may refuse consent for vaccination. Under-16s in the UK have a right to confidential sexual health care without parental consent. We investigated parents' views on making available HPV vaccination to adolescent minors at sexual health clinics without parental consent. Methods This was a semi-qualitative analysis of views of parents of 11–12 year old school children collected as part of a population-based survey of parental attitudes to HPV vaccination in Manchester. Parents were firstly asked if they agreed that a well-informed child should be able to request vaccination at a sexual health clinic without parental consent, and secondly, to provide a reason for this answer. Ethical perspectives on adolescent autonomy provided the framework for descriptive analysis. Results 307 parents answered the question, and of these, 244 (80% explained their views. Parents with views consistent with support for adolescent autonomy (n = 99 wanted to encourage responsible behaviour, protect children from ill-informed or bigoted parents, and respected confidentiality and individual rights. In contrast, 97 parents insisted on being involved in decision-making. They emphasised adult responsibility for a child's health and guidance, erosion of parental rights, and respect for cultural and moral values. Other parents (n = 48 wanted clearer legal definitions governing parental rights and responsibilities or hoped for joint decision-making. Parents resistant to adolescent autonomy would be less likely to consent to future HPV vaccination, (67% than parents supporting this principle (89%; p Conclusion In the UK, the principle of adolescent autonomy is recognised and logically should include the right to HPV vaccination, but

  6. Factors that influence parental decisions to participate in clinical research: consenters vs nonconsenters.

    Science.gov (United States)

    Hoberman, Alejandro; Shaikh, Nader; Bhatnagar, Sonika; Haralam, Mary Ann; Kearney, Diana H; Colborn, D Kathleen; Kienholz, Michelle L; Wang, Li; Bunker, Clareann H; Keren, Ron; Carpenter, Myra A; Greenfield, Saul P; Pohl, Hans G; Mathews, Ranjiv; Moxey-Mims, Marva; Chesney, Russell W

    2013-06-01

    A child's health, positive perceptions of the research team and consent process, and altruistic motives play significant roles in the decision-making process for parents who consent for their child to enroll in clinical research. This study identified that nonconsenting parents were better educated, had private insurance, showed lower levels of altruism, and less understanding of study design. To determine the factors associated with parental consent for their child's participation in a randomized, placebo-controlled trial. Cross-sectional survey conducted from July 2008 to May 2011. The survey was an ancillary study to the Randomized Intervention for Children with VesicoUreteral Reflux Study. Seven children's hospitals participating in a randomized trial evaluating management of children with vesicoureteral reflux. Parents asked to provide consent for their child's participation in the randomized trial were invited to complete an anonymous online survey about factors influencing their decision. A total of 120 of the 271 (44%) invited completed the survey; 58 of 125 (46%) who had provided consent and 62 of 144 (43%) who had declined consent completed the survey. A 60-question survey examining child, parent, and study characteristics; parental perception of the study; understanding of the design; external influences; and decision-making process. RESULTS Having graduated from college and private health insurance were associated with a lower likelihood of providing consent. Parents who perceived the trial as having a low degree of risk, resulting in greater benefit to their child and other children, causing little interference with standard care, or exhibiting potential for enhanced care, or who perceived the researcher as professional were significantly more likely to consent to participate. Higher levels of understanding of the randomization process, blinding, and right to withdraw were significantly positively associated with consent to participate. CONCLUSIONS AND

  7. How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study.

    Science.gov (United States)

    Woolfall, Kerry; Frith, Lucy; Gamble, Carrol; Gilbert, Ruth; Mok, Quen; Young, Bridget

    2015-09-18

    Alternatives to prospective informed consent to enable children with life-threatening conditions to be entered into trials of emergency treatments are needed. Across Europe, a process called deferred consent has been developed as an alternative. Little is known about the views and experiences of those with first-hand experience of this controversial consent process. To inform how consent is sought for future paediatric critical care trials, we explored the views and experiences of parents and practitioners involved in the CATheter infections in CHildren (CATCH) trial, which allowed for deferred consent in certain circumstances. Mixed method survey, interview and focus group study. 275 parents completed a questionnaire; 20 families participated in an interview (18 mothers, 5 fathers). 17 CATCH practitioners participated in one of four focus groups (10 nurses, 3 doctors and 4 clinical trial unit staff). 12 UK children's hospitals. Some parents were momentarily shocked or angered to discover that their child had or could have been entered into CATCH without their prior consent. Although these feelings resolved after the reasons why consent needed to be deferred were explained and that the CATCH interventions were already used in clinical care. Prior to seeking deferred consent for the first few times, CATCH practitioners were apprehensive, although their feelings abated with experience of talking to parents about CATCH. Parents reported that their decisions about their child's participation in the trial had been voluntary. However, mistiming the deferred consent discussion had caused distress for some. Practitioners and parents supported the use of deferred consent in CATCH and in future trials of interventions already used in clinical care. Our study provides evidence to support the use of deferred consent in paediatric emergency medicine; it also indicates the crucial importance of practitioner communication and appropriate timing of deferred consent discussions

  8. How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study

    Science.gov (United States)

    Woolfall, Kerry; Frith, Lucy; Gamble, Carrol; Gilbert, Ruth; Mok, Quen; Young, Bridget

    2015-01-01

    Objective Alternatives to prospective informed consent to enable children with life-threatening conditions to be entered into trials of emergency treatments are needed. Across Europe, a process called deferred consent has been developed as an alternative. Little is known about the views and experiences of those with first-hand experience of this controversial consent process. To inform how consent is sought for future paediatric critical care trials, we explored the views and experiences of parents and practitioners involved in the CATheter infections in CHildren (CATCH) trial, which allowed for deferred consent in certain circumstances. Design Mixed method survey, interview and focus group study. Participants 275 parents completed a questionnaire; 20 families participated in an interview (18 mothers, 5 fathers). 17 CATCH practitioners participated in one of four focus groups (10 nurses, 3 doctors and 4 clinical trial unit staff). Setting 12 UK children's hospitals. Results Some parents were momentarily shocked or angered to discover that their child had or could have been entered into CATCH without their prior consent. Although these feelings resolved after the reasons why consent needed to be deferred were explained and that the CATCH interventions were already used in clinical care. Prior to seeking deferred consent for the first few times, CATCH practitioners were apprehensive, although their feelings abated with experience of talking to parents about CATCH. Parents reported that their decisions about their child's participation in the trial had been voluntary. However, mistiming the deferred consent discussion had caused distress for some. Practitioners and parents supported the use of deferred consent in CATCH and in future trials of interventions already used in clinical care. Conclusions Our study provides evidence to support the use of deferred consent in paediatric emergency medicine; it also indicates the crucial importance of practitioner communication

  9. Readability and Content Assessment of Informed Consent Forms for Medical Procedures in Croatia.

    Science.gov (United States)

    Vučemilo, Luka; Borovečki, Ana

    2015-01-01

    High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia. 52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content. The averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10-19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%. Readability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation.

  10. Work efficiency improvement of >90% after implementation of an annual inpatient blood products administration consent form.

    Science.gov (United States)

    Lindsay, Holly; Bhar, Saleh; Bonifant, Challice; Sartain, Sarah; Whittle, Sarah B; Lee-Kim, Youngna; Shah, Mona D

    2018-01-01

    Paediatric haematology, oncology and bone marrow transplant (BMT) patients frequently require transfusion of blood products. Our institution required a new transfusion consent be obtained every admission. The objectives of this project were to: revise inpatient blood products consent form to be valid for 1 year, decrease provider time spent consenting from 15 to improve provider frustration with the consent process. Over 6 months, we determined the average number of hospitalisations requiring transfusions in a random sampling of haematology/oncology/BMT inpatients. We surveyed nurses and providers regarding frustration levels and contact required regarding consents. Four and 12 months after implementation of the annual consent, providers and nurses were resurveyed, and new inpatient cohorts were assessed. Comparison of preintervention and postintervention time data allowed calculation of provider time reduction, a surrogate measure of improved work efficiency. Prior to the annual consent, >33 hours were spent over 6 months obtaining consent on 40 patients, with >19 hours spent obtaining consent when no transfusions were administered during admission. Twelve months after annual consent implementation, 97.5% (39/40) of analysed patients had a completed annual blood products transfusion consent and provider work efficiency had improved by 94.6% (>30 hours). Although several surveyed variables improved following annual consent implementation, provider frustration with consent process remained 6 out of a max score of 10, the same level as prior to the intervention. Development of an annual inpatient blood products consent form decreased provider time from 15 to 90%.

  11. Ethics in clinical research: need for assessing comprehension of informed consent form?

    Science.gov (United States)

    Shafiq, Nusrat; Malhotra, Samir

    2011-03-01

    Comprehension of informed consent form has not achieved the attention it deserves. We made a 24-item questionnaire to assess clinical research participants' comprehension of informed consent form (Contemp Clin Trials 2009;30:427-30). Due to repeated requests by clinical researchers in our country and abroad, we are publishing the questionnaire in this article. Copyright © 2010 Elsevier Inc. All rights reserved.

  12. An audit cycle of consent form completion: A useful tool to improve junior doctor training.

    Science.gov (United States)

    Leng, Catherine; Sharma, Kavita

    2016-01-01

    Consent for surgical procedures is an essential part of the patient's pathway. Junior doctors are often expected to do this, especially in the emergency setting. As a result, the aim of our audit was to assess our practice in consenting and institute changes within our department to maintain best medical practice. An audit of consent form completion was conducted in March 2013. Standards were taken from Good Surgical Practice (2008) and General Medical Council guidelines. Inclusion of consent teaching at a formal consultant delivered orientation programme was then instituted. A re-audit was completed to reassess compliance. Thirty-seven consent forms were analysed. The re-audit demonstrated an improvement in documentation of benefits (91-100%) and additional procedures (0-7.5%). Additional areas for improvement such as offering a copy of the consent form to the patient and confirmation of consent if a delay occurred between consenting and the procedure were identified. The re-audit demonstrated an improvement in the consent process. It also identified new areas of emphasis that were addressed in formal teaching sessions. The audit cycle can be a useful tool in monitoring, assessing and improving clinical practice to ensure the provision of best patient care.

  13. UMTRA consent form acquisition: a survey of nonrespondents

    International Nuclear Information System (INIS)

    Gonsalves, L.L.; Carpenter, D.; Borak, T.B.; Kearney, P.

    1986-01-01

    The Radiological Survey Activities group of the Health and Safety Research Division at Oak Ridge National Laboratory is the Inclusion Survey Contractor (ISC) for the Uranium Mill Tailings Remedial Action (UMTRA) project in Grand Junction, Colorado. The ISC is responsible for performing any required radiological surveys and data analyses for the recommendation of inclusion or exclusion of designated properties in the UMTRA project. One of the responsibilities of the ISC is to obtain consent from the property owners to conduct radiological surveys. In Grand Junction, Colorado 30-40% of the owners of designated properties have not responded to the consent-for-access requests sent by certified mail. A questionnaire was designed to identify and study this nonresponse through personal interviews with 100 randomly selected nonrespondents. A profile of the population of nonrespondents, reasons for nonresponse, as well as suggestions to encourage response were identified and analyzed

  14. UMTRA consent form acquisition: a survey of nonrespondents

    International Nuclear Information System (INIS)

    Gonsalves, L.L.; Borak, T.B.; Kearney, P.; Carpenter, D.

    1986-01-01

    The Radiological Survey Activities group of the Health and Safety Research Division at Oak Ridge National Laboratory is the Inclusion Survey Contractor (ISC) for the Uranium Mill Tailings Remedial Action (UMTRA) project in Grand Junction, Colorado. The ISC is responsible for performing any required radiological surveys and data analyses for the recommendation of inclusion or exclusion of designated properties in the UMTRA project. One of the responsibilities of the ISC is to obtain consent from the property owners to conduct radiological surveys. In Grand Junction, Colorado 30 to 40% of the owners of designated properties have not responded to the consent-for-access requests sent by certified mail. A questionnaire was designed to identify and study this nonresponse through personal interviews with 100 randomly selected nonrespondents. A profile of the population of nonrespondents, reasons for nonresponse, as well as suggestions to encourage response were identified and analyzed

  15. Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond

    Directory of Open Access Journals (Sweden)

    Go Yoshizawa

    2017-07-01

    Full Text Available The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs for genomic research formulated by four selected research programs and institutes in East Asia – the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in

  16. Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond.

    Science.gov (United States)

    Yoshizawa, Go; Sasongko, Teguh H; Ho, Chih-Hsing; Kato, Kazuto

    2017-01-01

    The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia - the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More

  17. A qualitative study to assess school nurses' views on vaccinating 12-13 year old school girls against human papillomavirus without parental consent.

    Science.gov (United States)

    Stretch, Rebecca; McCann, Rosemary; Roberts, Stephen A; Elton, Peter; Baxter, David; Brabin, Loretta

    2009-07-21

    In the UK, parental consent for the routine vaccination of 12-13 year olds schoolgirls against human papillomavirus (HPV) is recommended, although legally girls may be able to consent themselves. As part of a vaccine study conducted ahead of the National HPV Vaccine Programme we sought the views of school nurses on vaccinating girls who did not have parental consent. HPV vaccination was offered to all 12 year old girls attending schools in two Primary Care Trusts in Greater Manchester. At the end of the study semi-structured, tape-recorded interviews were conducted with school nurses who had delivered the vaccine (Cervarix). The interview template was based on concepts derived from the Theory of Planned Behaviour. Transcripts were analysed thematically in order to understand school nurses' intentions to implement vaccination based on an assessment of Gillick competency. School nurses knew how to assess the competency of under-16s but were still unwilling to vaccinate if parents had refused permission. If parents had not returned the consent form, school nurses were willing to contact parents, and also to negotiate with parents who had refused consent. They seemed unaware that parental involvement required the child's consent to avoid breaking confidentiality. Nurses' attitudes were influenced by the young appearance and age of the school year group rather than an individual's level of maturity. They were also confused about the legal guidelines governing consent. School nurses acknowledged the child's right to vaccination and strongly supported prevention of HPV infection but ultimately believed that it was the parents' right to give consent. Most were themselves parents and shared other parents' concerns about the vaccine's novelty and unknown long-term side effects. Rather than vaccinate without parental consent, school nurses would defer vaccination. Health providers have a duty of care to girls for whom no parental consent for HPV vaccination has been given

  18. A qualitative study to assess school nurses' views on vaccinating 12–13 year old school girls against human papillomavirus without parental consent

    Directory of Open Access Journals (Sweden)

    Baxter David

    2009-07-01

    Full Text Available Abstract Background In the UK, parental consent for the routine vaccination of 12–13 year olds schoolgirls against human papillomavirus (HPV is recommended, although legally girls may be able to consent themselves. As part of a vaccine study conducted ahead of the National HPV Vaccine Programme we sought the views of school nurses on vaccinating girls who did not have parental consent. Methods HPV vaccination was offered to all 12 year old girls attending schools in two Primary Care Trusts in Greater Manchester. At the end of the study semi-structured, tape-recorded interviews were conducted with school nurses who had delivered the vaccine (Cervarix™. The interview template was based on concepts derived from the Theory of Planned Behaviour. Transcripts were analysed thematically in order to understand school nurses' intentions to implement vaccination based on an assessment of Gillick competency. Results School nurses knew how to assess the competency of under-16s but were still unwilling to vaccinate if parents had refused permission. If parents had not returned the consent form, school nurses were willing to contact parents, and also to negotiate with parents who had refused consent. They seemed unaware that parental involvement required the child's consent to avoid breaking confidentiality. Nurses' attitudes were influenced by the young appearance and age of the school year group rather than an individual's level of maturity. They were also confused about the legal guidelines governing consent. School nurses acknowledged the child's right to vaccination and strongly supported prevention of HPV infection but ultimately believed that it was the parents' right to give consent. Most were themselves parents and shared other parents' concerns about the vaccine's novelty and unknown long-term side effects. Rather than vaccinate without parental consent, school nurses would defer vaccination. Conclusion Health providers have a duty of care to

  19. Customizable pre-printed consent forms: a solution in light of the Montgomery ruling.

    Science.gov (United States)

    Owen, Deborah; Aresti, Nick; Mulligan, Alex; Kosuge, Dennis

    2018-02-02

    This article presents an audit cycle supported quality improvement project addressing best practice in the consent process for lower limb arthroplasty which takes into account the new standard in surgical consent and the importance of material risks. 50 consecutive total hip and total knee replacement consent forms over a 3-month period were reviewed for legibility and completeness. Following the introduction of a new, pre-printed but customizable consent form the review process was repeated. The introduction of a customizable, pre-printed consent form that can be adjusted to reflect the individualized material risks of each patient increased legibility, reduced inappropriate human error variation and abolished the use of abbreviations and medical jargon. When used as part of an extended consent process, the authors feel that the use of pre-printed but customizable consent forms improves legibility, completeness and consistency and also provides the ability to highlight those complications that are of particular importance for that patient to satisfy the new accepted standard in surgical consent.

  20. [The impact of a verbal consent form on the participation rate in a telephone survey].

    Science.gov (United States)

    Jacques, Christian; Ladouceur, Robert; Fournier, Patricia-Maude; Baillargeon, Lucie

    2009-03-01

    To assess the impact of a consent form on the participation rate in a telephone survey about gambling and money. Four different consent forms were tested. The first consent form globally met the academic ethics committee requirements, while the second and third forms excluded some elements. Finally, the fourth form was similar to the introduction generally used by private survey firms. Even when the consent form required by academic ethics committees was shortened, the private firm introduction led to the best participation rate. However, participants who received the private firm introduction indicated that they wished they had been better informed before the interview started. The discussion highlights the delicate situation of academic research wishing to meet ethics requirements as well as conduct valid and representative research.

  1. Readability and Content Assessment of Informed Consent Forms for Medical Procedures in Croatia

    Science.gov (United States)

    Vučemilo, Luka; Borovečki, Ana

    2015-01-01

    Background High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia. Methods 52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content. Results The averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10–19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%. Conclusions Readability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation. PMID:26376183

  2. Informed consent for clinical trials: a comparative study of standard versus simplified forms.

    Science.gov (United States)

    Davis, T C; Holcombe, R F; Berkel, H J; Pramanik, S; Divers, S G

    1998-05-06

    A high level of reading skill and comprehension is necessary to understand and complete most consent forms that are required for participation in clinical research studies. This study was conducted to test the hypothesis that a simplified consent form would be less intimidating and more easily understood by individuals with low-to-marginal reading skills. During July 1996, 183 adults (53 patients with cancer or another medical condition and 130 apparently healthy participants) were tested for reading ability and then asked to read either the standard Southwestern Oncology Group (SWOG) consent form (16th grade level) or a simplified form (7th grade level) developed at Louisiana State University Medical Center-Shreveport (LSU). Participants were interviewed to assess their attitudes toward and comprehension of the form read. Then they were given the alternate consent form and asked which one they preferred and why. Overall, participants preferred the LSU form (62%; 95% confidence interval [CI] = 54.8%-69.2%) over the SWOG form (38%; 95% CI = 30.8%-45.2%) (P = .0033). Nearly all participants thought that the LSU form was easier to read (97%; 95% CI = 93.1%-99.9%) than the SWOG form (75%; 95% CI = 65.1%-85.7%) (Pinformed consent documents for the substantial proportion of Americans with low-to-marginal literacy skills.

  3. Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure

    NARCIS (Netherlands)

    Jansen-van der Weide, Marijke C.; Caldwell, Patrina H. Y.; Young, Bridget; de Vries, Martine C.; Willems, Dick L.; van't Hoff, William; Woolfall, Kerry; van der Lee, Johanna H.; Offringa, Martin

    2015-01-01

    Treatments and interventions used to care for children in emergencies should be based on strong evidence. Well-designed clinical trials investigating these interventions for children are therefore indispensable. Parental informed consent is a key ethical requirement for the enrollment of children in

  4. A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol

    OpenAIRE

    Berry, Jesia G; Ryan, Philip; Braunack-Mayer, Annette J; Duszynski, Katherine M; Xafis, Vicki; Gold, Michael S

    2011-01-01

    Abstract Background The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Methods...

  5. Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial.

    Science.gov (United States)

    Natale, Joanne E; Lebet, Ruth; Joseph, Jill G; Ulysse, Christine; Ascenzi, Judith; Wypij, David; Curley, Martha A Q

    2017-05-01

    To evaluate whether race or ethnicity was independently associated with parental refusal of consent for their child's participation in a multisite pediatric critical care clinical trial. We performed a secondary analyses of data from Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a 31-center cluster randomized trial of sedation management in critically ill children with acute respiratory failure supported on mechanical ventilation. Multivariable logistic regression modeling estimated associations between patient race and ethnicity and parental refusal of study consent. Among the 3438 children meeting enrollment criteria and approached for consent, 2954 had documented race/ethnicity of non-Hispanic White (White), non-Hispanic Black (Black), or Hispanic of any race. Inability to approach for consent was more common for parents of Black (19.5%) compared with White (11.7%) or Hispanic children (13.2%). Among those offered consent, parents of Black (29.5%) and Hispanic children (25.9%) more frequently refused consent than parents of White children (18.2%, P refuse consent. Parents of children offered participation in the intervention arm were more likely to refuse consent than parents in the control arm (OR 2.15, 95% CI 1.37-3.36, P care clinical trial. Ameliorating this racial disparity may improve the validity and generalizability of study findings. ClinicalTrials.gov: NCT00814099. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Reading Level and Comprehension of Research Consent Forms: An Integrative Review.

    Science.gov (United States)

    Foe, Gabriella; Larson, Elaine L

    2016-02-01

    Consent forms continue to be at a higher reading level than the recommended sixth to eighth grade, making it difficult for participants to comprehend information before enrolling in research. To assess and address the extent of the problem regarding the level of literacy of consent forms and update previously published reports, we conducted an integrative literature review of English language research published between January 1, 2000, and December 31, 2013; 35 descriptive and eight intervention studies met inclusion criteria. Results confirmed that developing forms at eighth-grade level was attainable though not practiced. It was found that risks of participation was the section most poorly understood. There was also a lack of consensus regarding the most effective method to increase comprehension. Further research using standardized tools is needed to determine the best approach for improving consent forms and processes. © The Author(s) 2016.

  7. Why parents and children consent to become involved in medical student teaching.

    Science.gov (United States)

    Pinnock, Ralph; Weller, Jennifer; Shulruf, Boaz; Jones, Rhys; Reed, Peter; Mizutani, Satomi

    2011-04-01

    Clinical experience in paediatrics is essential for medical undergraduates. This is the first study, of which we are aware, to examine why children of different ages admitted acutely to hospital and their parents agree to become involved in medical student teaching. We wanted to establish whether they considered that they needed to give consent before seeing medical students, whether this was routinely sought and what influenced their decisions. Data were collected using questionnaires and semi-structured interviews of parents and children. Questionnaires were completed by 105 parents of children less than 6 years old, and 34 children between 10 years and 15 years old and their parents. Interviews were conducted with 32 children between the ages of 6 and 10 years and their parents. Most parents and children consider that they have a responsibility to teaching but must always be asked for consent. They were motivated by altruism, but fear of emotional distress or pain can lead them to refuse. Younger children may not be able to give reasons for not wanting to see a medical student but sometimes have firm views, which must be respected. Having seen a medical student previously did influence children's or parents' opinions. Most children who have seen a medical student were prepared to see students again. Medical students can be reassured that parents and children admitted acutely to a children's hospital have a positive attitude to student involvement and are prepared to help them learn clinical skills, but consent must always be obtained and the child's perspective must always be considered. © 2011 The Authors. Journal of Paediatrics and Child Health © 2011 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

  8. A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol

    Directory of Open Access Journals (Sweden)

    Duszynski Katherine M

    2011-01-01

    Full Text Available Abstract Background The Vaccine Assessment using Linked Data (VALiD trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Methods/Design Single-centre, single-blind, randomised controlled trial (RCT stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response. A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. Discussion The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12610000332022

  9. A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol.

    Science.gov (United States)

    Berry, Jesia G; Ryan, Philip; Braunack-Mayer, Annette J; Duszynski, Katherine M; Xafis, Vicki; Gold, Michael S

    2011-01-04

    The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Single-centre, single-blind, randomised controlled trial (RCT) stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response). A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. Australian New Zealand Clinical Trials Registry ACTRN12610000332022.

  10. 17 CFR 249.507 - Form 7-M, consent to service of process by an individual nonresident broker-dealer.

    Science.gov (United States)

    2010-04-01

    ... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Form 7-M, consent to service of process by an individual nonresident broker-dealer. 249.507 Section 249.507 Commodity and... Forms for Statements Made in Connection With Exempt Tender Offers § 249.507 Form 7-M, consent to service...

  11. 17 CFR 249.509 - Form 9-M, consent to service of process by a partnership nonresident broker-dealer.

    Science.gov (United States)

    2010-04-01

    ... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Form 9-M, consent to service of process by a partnership nonresident broker-dealer. 249.509 Section 249.509 Commodity and... Forms for Statements Made in Connection With Exempt Tender Offers § 249.509 Form 9-M, consent to service...

  12. Physician counseling, informed consent and parental decision making for infants with hypoplastic left-heart syndrome.

    Science.gov (United States)

    Paris, J J; Moore, M P; Schreiber, M D

    2012-10-01

    Until the development in 1980 by William Norwood of a staged palliative surgical procedure for hypoplastic left heart syndrome (HPLHS), there was no treatment for that condition. With medical developments in the 1980s, parents had the option of the Norwood procedure, transplantation or comfort care for a child born with HPLHS. With an improvement in the survival rate for the Norwood procedure from an initial 30% to now better than 80%, some physicians believe that comfort care should no longer be an option. If, however, medically sophisticated parents, who know the neurological and motor skills impairments that accompany HPLHS, object to the surgery, they are allowed to opt for comfort care. This two-pronged approach to medical treatment seems to violate the norms on equity and fairness in the care of the patient. Parents need to be informed about long-term neurological and motor skill development as well as survival rates to give informed consent.

  13. What constitutes consent when parents and daughters have different views about having the HPV vaccine: qualitative interviews with stakeholders.

    Science.gov (United States)

    Wood, Fiona; Morris, Lucy; Davies, Myfanwy; Elwyn, Glyn

    2011-08-01

    The UK Human Papillomavirus (HPV) vaccine programme commenced in the autumn of 2008 for year 8 (age 12-13 years) schoolgirls. We examine whether the vaccine should be given when there is a difference of opinion between daughters and parents or guardians. Qualitative study using semi-structured interviews. A sample of 25 stakeholders: 14 professionals involved in the development of the HPV vaccination programme and 11 professionals involved in its implementation. Overriding the parents' wishes was perceived as problematic and could damage the relationship between school and parents. A number of practical problems were raised in relation to establishing whether parents were genuinely against their daughter receiving the vaccine. Although many respondents recognised that the Gillick guidelines were relevant in establishing whether a girl could provide consent herself, they still felt that there were significant problems in establishing whether girls could be assessed as Gillick competent. In some areas school nurses had been advised not to give the vaccine in the absence of parental consent. None of the respondents suggested that a girl should be vaccinated against her consent even if her parents wanted her to have the vaccine. While the Gillick guidelines provide a legal framework to help professionals make judgements about adolescents consenting to medical treatment, in practice there appears to be variable and confused interpretation of this guidance. Improved legal structures, management procedures and professional advice are needed to support those who are assessing competence and establishing consent to vaccinate adolescents in a school setting.

  14. Readability of informed consent forms in clinical trials conducted in a skin research center

    Science.gov (United States)

    Samadi, Aniseh; Asghari, Fariba

    2016-01-01

    Obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. In order for the consent to be informed, the patient must receive and comprehend the information appropriately. Complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. The objective of this study was to assess the readability of different templates of informed consent forms (ICFs) used in clinical trials in the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran, Iran. This study was conducted on ICFs of 45 clinical trials of the CRTSDL affiliated with Tehran University of Medical Sciences. ICFs were tested for reading difficulty, using the readability assessments formula adjusted for the Persian language including the Flesch–Kincaid reading ease score, Flesch–Kincaid grade level, and Gunning fog index. Mean readability score of the whole text of ICFs as well as their 7 main information parts were calculated. The mean ± SD Flesch Reading Ease score for all ICFs was 31.96 ± 5.62 that is in the difficult range. The mean ± SD grade level was calculated as 10.71 ± 1.8 (8.23–14.09) using the Flesch–Kincaid formula and 14.64 ± 1.22 (12.67–18.27) using the Gunning fog index. These results indicate that the text is expected to be understandable for an average student in the 11th grade, while the ethics committee recommend grade level 8 as the standard readability level for ICFs. The results showed that the readability scores of ICFs assessed in our study were not in the acceptable range. This means they were too complex to be understood by the general population. Ethics committees must examine the simplicity and readability of ICFs used in clinical trials. PMID:27471590

  15. How do clinical genetics consent forms address the familial approach to confidentiality and incidental findings? A mixed-methods study.

    Science.gov (United States)

    Dheensa, Sandi; Crawford, Gillian; Salter, Claire; Parker, Michael; Fenwick, Angela; Lucassen, Anneke

    2018-01-01

    Genetic test results can be relevant to patients and their relatives. Questions thus arise around whether clinicians regard genetic information as confidential to individuals or to families, and about how they broach this and other issues, including the potential for incidental findings, in consent (forms) for genetic testing. We conducted a content analysis of UK-wide genetic testing consent forms and interviewed 128 clinicians/laboratory scientists. We found that almost all genetic services offered patients multiple, sometimes unworkable, choices on forms, including an option to veto the use of familial genetic information to benefit relatives. Participants worried that documented choices were overriding professional judgement and cautioned against any future forms dictating practice around incidental findings. We conclude that 'tick-box' forms, which do little to enhance autonomy, are masking valid consent processes in clinical practice. As genome-wide testing becomes commonplace, we must re-consider consent processes, so that they protects patients'-and relatives'-interests.

  16. GCP compliance and readability of informed consent forms from an emerging hub for clinical trials

    Directory of Open Access Journals (Sweden)

    Satish Chandrasekhar Nair

    2015-01-01

    Full Text Available Background: The rapid expansion of trials in emerging regions has raised valid concerns about research subject protection, particularly related to informed consent. The purpose of this study is to assess informed consent form (ICF compliance with Good Clinical Practice (GCP guidelines and the readability easeof the ICFs in Abu Dhabi, a potential destination for clinical trials in the UAE. Materials and Methods: A multicenter retrospective cross-sectional analysis of 140 ICFs from industry sponsored and non-sponsored studies was conducted by comparing against a local standard ICF. Flesch-Kincaid Reading Scale was used to assess the readability ease of the forms. Results: Non-sponsored studies had signifi cantly lower overall GCP compliance of 55.8% when compared to 79.5% for industry sponsored studies. Only 33% of sponsored and 16% of non-sponsored studies included basic information on the participants′ rights and responsibilities. Flesch-Kincaid Reading ease score for the informed consent forms from industry sponsored studies was signifi cantly higher 48.9 ± 4.8 as compared to 38.5 ± 8.0 for non-sponsored studies, though both were more complex than recommended. Reading Grade Level score was also higher than expected, but scores for the ICFs from the industry sponsored studies were 9.7 ± 0.7, signifi cantly lower as compared to 12.2 ± 1.3 for non-sponsored studies. Conclusion: In spite of the undisputed benefits of conducting research in emerging markets readability, comprehension issues and the lack of basic essential information call for improvements in the ICFs to protect the rights of future research subjects enrolled in clinical trials in the UAE.

  17. Obtaining waivers of parental consent: A strategy endorsed by gay, bisexual, and queer adolescent males for health prevention research.

    Science.gov (United States)

    Flores, Dalmacio; McKinney, Ross; Arscott, Joyell; Barroso, Julie

    Requiring parental consent in studies with sexual minority youth (SMY) can sometimes be problematic as participants may have yet to disclose their sexual orientation, may not feel comfortable asking parents' permission, and may promote a self-selection bias. We discuss rationale for waiving parental consent, strategies to secure waivers from review boards, and present participants' feedback on research without parents' permission. We share our institutional review board proposal in which we made a case that excluding SMY from research violates ethical research principles, does not recognize their autonomy, and limits collection of sexuality data. Standard consent policies may inadvertently exclude youth who are at high risk for negative health outcomes or may potentially put them at risk because of forced disclosure of sexual orientation. Securing a waiver addresses these concerns and allows for rich data, which is critical for providers to have a deeper understanding of their unique sexual health needs. To properly safeguard and encourage research informed by SMY, parental consent waivers may be necessary. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Obtaining active parental consent for school-based research: a guide for researchers.

    Science.gov (United States)

    Wolfenden, Luke; Kypri, Kypros; Freund, Megan; Hodder, Rebecca

    2009-06-01

    Schools increasingly require researchers to obtain active parental consent for students to participate in health research. We sought to identify effective strategies for the recruitment of child research participants through schools. A search of Medline, PsycINFO, Educational Resources Information Center, ProQuest 5000 and the Cochrane Library electronic databases was conducted for the period 1988 to 2008. The review found evidence that the following strategies may be effective in enhancing participation rates: 1) promotion of the research to school principals, teachers, parents and students; 2) dissemination of study information using methods allowing direct contact with parents (i.e. telephone or face-to-face); 3) provision of incentives to teachers, students and at a class level; 4) making reminder contacts; and 5) having a member of the research team co-ordinate and closely monitor the recruitment process. Application of these strategies should reduce the risk of non-response and other biases that result from selective non-participation. Further randomised controlled trials of these and other strategies are required to strengthen the evidence base.

  19. When Can the Child Speak for Herself? The Limits of Parental Consent in Data Protection Law for Health Research.

    Science.gov (United States)

    Taylor, Mark J; Dove, Edward S; Laurie, Graeme; Townend, David

    2017-11-13

    Draft regulatory guidance suggests that if the processing of a child's personal data begins with the consent of a parent, then there is a need to find and defend an enduring consent through the child's growing capacity and on to their maturity. We consider the implications for health research of the UK Information Commissioner's Office's (ICO) suggestion that the relevant test for maturity is the Gillick test, originally developed in the context of medical treatment. Noting the significance of the welfare principle to this test, we examine the implications for the responsibilities of a parent to act as proxy for their child. We argue, contrary to draft ICO guidance, that a data controller might legitimately continue to rely upon parental consent as a legal basis for processing after a child is old enough to provide her own consent. Nevertheless, we conclude that data controllers should develop strategies to seek fresh consent from children as soon as practicable after the data controller has reason to believe they are mature enough to consent independently. Techniques for effective communication, recommended to address challenges associated with Big Data analytics, might have a role here in addressing the dynamic relationship between data subject and processing. Ultimately, we suggest that fair and lawful processing of a child's data will be dependent upon data controllers taking seriously the truism that consent is ongoing, rather than a one-time event: the core associated responsibility is to continue to communicate with a data subject regarding the processing of personal data. © The Author 2017. Published by Oxford University Press.

  20. Understanding of Technical Terms and Contents of Informed Consent Forms for Sedative Gastrointestinal Endoscopy Procedures

    Directory of Open Access Journals (Sweden)

    Ihnsook Jeong, RN, PhD

    2013-03-01

    Conclusion: The understanding of the terms and knowledge about the procedures were disappointing. Therefore, sufficient explanations should be provided to the patients. While the informed consent was taken by doctors, the level of understanding should be monitored by nurses. In particular, subjects who did not have any previous experience with endoscopy procedures showed relatively lower level of understanding. We recommend that medical terms should be replaced with more common and nontechnical words in consent forms.

  1. The radiology informed consent form: recommendations from the European Society of Cardiology position paper.

    Science.gov (United States)

    Carpeggiani, Clara; Picano, Eugenio

    2016-06-01

    Every radiological and nuclear medicine examination confers a definite long-term risk of cancer, but most patients undergoing such examinations receive no or inaccurate information about radiation dose and corresponding risk related to the dose received. Informed consent is a procedure to support (not substitute) the physician/patient dialogue and relationship, facilitating a free, informed and aware expression of the patient's will in the principle of patient autonomy. Physicians are responsible for providing patients with all the information on risks, benefits and alternatives useful to the patient to make the decision. In current radiological practice the information on the radiation dose and long-term cancer risks is difficult to find and not easy to understand. The form using plain language should spell-out the type of examination, the effective dose (mSv), the effective dose expressed in number of chest radiographs and the risk of cancer. The current practice clashes against the guidelines and the law.

  2. [Global analysis of the readability of the informed consent forms used in public hospitals of Spain].

    Science.gov (United States)

    Mariscal-Crespo, M I; Coronado-Vázquez, M V; Ramirez-Durán, M V

    To analyse the readability of informed consent forms (ICF) used in Public Hospitals throughout Spain, with the aim of checking their function of providing comprehensive information to people who are making any health decision no matter where they are in Spain. A descriptive study was performed on a total of 11,339 ICF received from all over Spanish territory, of which 1617 ICF were collected from 4 web pages of Health Portal and the rest (9722) were received through email and/or telephone contact from March 2012 to February 2013. The readability level was studied using the Inflesz tool. A total of 372 ICF were selected and analysed using simple random sampling. The Inflesz scale and the Flesch-Szigriszt index were used to analyse the readability. The readability results showed that 62.4% of the ICF were rated as a "little difficult", the 23.4% as "normal", and the 13.4% were rated as "very difficult". The highest readability means using the Flesch index were scored in Andalusia with a mean of 56.99 (95% CI; 55.42-58.57) and Valencia with a mean of 51.93 (95% CI; 48.4-55.52). The lowest readability means were in Galicia with a mean of 40.77 (95% CI; 9.83-71.71) and Melilla, mean=41.82 (95% CI; 35.5-48.14). The readability level of Spanish informed consent forms must be improved because their scores using readability tools could not be classified in normal scales. Furthermore, there was very wide variability among Spanish ICF, which showed a lack of equity in information access among Spanish citizens. Copyright © 2017 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  3. [Informed consent and parental refusal for medical treatment in childhood. The threshold of medical and social tolerance. Part II].

    Science.gov (United States)

    Guadarrama-Orozco, Jessica H; Garduño Espinosa, Juan; Vargas López, Guillermo; Viesca Treviño, Carlos

    Medical care in pediatric patients is conditional to parental consent. Parents decide the time and type of treatment they want their children to receive when they are ill. The physician should request parental consent before carrying out the most appropriate therapy. When parents refuse the treatment offered, the physician should seek alternative therapies that may be better accepted by parents and find the most beneficial treatment for children and their families. If physicians and parents are unable to agree on the best therapeutic methods, then the physician becomes involved in an ethical conflict related to the best interests of the child and parental choices. From the above posture, the following questions arise: What should the physician do when faced with this situation? Should the physician use legal measures to force parents to accept treatment? Under what conditions is it justified to force parents and when should the decision be tolerated? What is the role of the Hospital Bioethics Committee concerning this issue? This second part focuses on proposing four practical criteria to be used by the physician and Hospital Bioethics Committee when all alternative therapies and conciliatory options have been exhausted with parents and they continue to refuse treatment. The physician then has to make a decision because the child is placed at risk of harm. This decision focuses on whether there is danger to the minor arising from the decisions of parents and if such harm is avoidable. Copyright © 2015 Hospital Infantil de México Federico Gómez. Publicado por Masson Doyma México S.A. All rights reserved.

  4. Informed consent, parental awareness, and reasons for participating in a randomised controlled study

    NARCIS (Netherlands)

    M. van Stuijvenberg (Margriet); M.H. Suur (Marja); S. de Vos (Sandra); G.C.H. Tjiang (Gilbert); E.W. Steyerberg (Ewout); G. Derksen-Lubsen (Gerarda); H.A. Moll (Henriëtte)

    1998-01-01

    textabstractBACKGROUND: The informed consent procedure plays a central role in randomised controlled trials but has only been explored in a few studies on children. AIM: To assess the quality of the informed consent process in a paediatric setting. METHODS: A

  5. Improving biobank consent comprehension: a national randomized survey to assess the effect of a simplified form and review/retest intervention

    OpenAIRE

    Beskow, Laura M.; Lin, Li; Dombeck, Carrie B.; Gao, Emily; Weinfurt, Kevin P.

    2016-01-01

    Purpose: To determine the individual and combined effects of a simplified form and a review/retest intervention on biobanking consent comprehension. Methods: We conducted a national online survey in which participants were randomized within four educational strata to review a simplified or traditional consent form. Participants then completed a comprehension quiz; for each item answered incorrectly, they reviewed the corresponding consent form section and answered another quiz item on that to...

  6. Is free, prior and informed consent a form of corporate social responsibility?

    NARCIS (Netherlands)

    Rodhouse, Toyah; Vanclay, Frank

    2016-01-01

    International organizations are increasingly including Indigenous peoples' rights and the concept of Free, Prior and Informed Consent (FPIC) in their guidance documents, codes of conduct, and performance standards. Leading companies are adjusting their Corporate Social Responsibility (CSR) and

  7. Parental perceptions and predictors of consent for school-located influenza vaccination in urban elementary school children in the United States.

    Science.gov (United States)

    Cheung, Susan; Wang, Hai-Lin; Mascola, Laurene; El Amin, Alvin Nelson; Pannaraj, Pia S

    2015-09-01

    School-located influenza vaccination (SLV) programs have the potential to mass-vaccinate all enrolled children, but parental consent is required. To examine parental attitudes and determine predictors of parental consent for vaccination of schoolchildren through SLV programs. Surveys were distributed to parents of 4517 children during 2009-2010 (year 1) and 4414 children during 2010-2011 (year 2) in eight elementary schools in conjunction with a SLV program. Participants included 1259 (27·9%) parents in year 1 and 1496 (33·9%) in year 2. Parental consent for 2009 H1N1, 2009 seasonal, and 2010 seasonal influenza vaccines was obtained from 738 (70·8%), 673 (64·5%), and 1151 (77·2%) respondents, respectively. During the 2009 pandemic, respondents concerned about influenza severity were twice as likely to consent for the 2009 H1N1 vaccination compared to unconcerned respondents (OR 2·04, 95% CI:1·19-3·51). During year 2, factors that predicted parental consent were the perception of high susceptibility to influenza infection (OR 2·19, 95% CI:1·50-3·19) and high benefit of vaccine (OR 2·23, 95% CI:1·47-3·40). In both years, college-educated parents were more likely to perceive vaccine risks (year 1: 83·6 versus 61·5%, P college-educated parents. Parents who appreciate the risks of influenza and benefits of vaccination are more likely to consent for SLV. More research is needed to determine how to address heightened safety concerns among college-educated parents. © 2015 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.

  8. Informed consent and stimulant medication: adolescents' and parents' ability to understand information about benefits and risks of stimulant medication for the treatment of attention-deficit/hyperactivity disorder.

    Science.gov (United States)

    Schachter, Debbie; Tharmalingam, Sukirtha; Kleinman, Irwin

    2011-04-01

    This study of informed consent examines understanding of information needed to consent to stimulant treatment for attention-deficit/hyperactivity disorder (ADHD). The understanding of adolescents with ADHD, their parents, control adolescents, and their parents is compared. Fifty-eight ADHD and 64 control adolescents between the ages of 12 and 16 and their parents were studied. Baseline understanding of information was determined. Subjects received information relevant to informed consent for stimulation medication and afterward were evaluated on their recall understanding and their final understanding. Knowledge was increased after the information session for all subjects. There was no significant difference between unadjusted baseline, recall, and final knowledge of control adolescents and parents. Although unadjusted baseline, recall, and final knowledge of ADHD adolescents is significantly less than that of parents, 78% of ADHD adolescents had final understanding scores within 2 standard deviations of parents' scores. After controlling for baseline understanding and cognitive variables, there was no significant difference between understanding of ADHD adolescents and ADHD parents, whereas control adolescents understanding scores were higher than that of their parents. Understanding was highly associated with mathematics achievement in all groups. The majority of adolescents with ADHD, both with and without a history of stimulant medication treatment, have understanding that is similar to their parents and their inclusion in the informed consent process should be encouraged. Extra care should be afforded to those adolescents with low numeracy or literacy to ensure their understanding.

  9. 17 CFR 249.510 - Form 10-M, consent to service of process by a nonresident general partner of a broker-dealer firm.

    Science.gov (United States)

    2010-04-01

    ..., consent to service of process by a nonresident general partner of a broker-dealer firm. This form shall be... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Form 10-M, consent to service of process by a nonresident general partner of a broker-dealer firm. 249.510 Section 249.510...

  10. [Informed consent and parental refusal to medical treatment in childhood. The threshold of medical and social tolerance. Part I].

    Science.gov (United States)

    Guadarrama-Orozco, Jessica H; Garduño Espinosa, Juan; Vargas López, Guillermo; Viesca Treviño, Carlos

    Informed consent is a right of all individuals and no one can force anyone to receive treatment against their wishes. The right to accept or refuse treatment persists in individuals who are incompetent from a legal point of view; this is exercised on their behalf by a third party. Children are considered incompetent to make medical decisions about their own health and their parents or legal guardians are empowered to make those decisions. However, parental authority is not absolute and there are situations where their decisions are not the best, sometimes leading to jeopardizing the well-being and even the lives of their children, forcing the state to intervene on behalf of the best interests of the child. This is the reason why it is necessary to ask the following questions: is it really the child's best interest that moves us to legally intervene when a parent refuses to accept the proposed medical treatment or is the damage done to make this decision? What kind of parental decisions are those that should not be tolerated? After a review of the theme, we conclude that if the decision of the parents regarding a medical decision is considered to be made with maleficence that is harmful to the child, it is justified that the State intervenes. Finally, we exposed four criteria that can be used in making decisions in complex cases where parents refuse treatment for their children. Copyright © 2015. Publicado por Masson Doyma México S.A.

  11. From the Form to the Face to Face: IRBs, Ethnographic Researchers, and Human Subjects Translate Consent

    Science.gov (United States)

    Metro, Rosalie

    2014-01-01

    Based on my fieldwork with Burmese teachers in Thailand, I describe the drawbacks of using IRB-mandated written consent procedures in my cross-cultural collaborative ethnographic research on education. Drawing on theories of intersubjectivity (Mikhail Bakhtin), ethics (Emmanuel Levinas), and translation (Naoki Sakai), I describe face-to-face…

  12. What parents of children who have received emergency care think about deferring consent in randomised trials of emergency treatments: postal survey.

    Directory of Open Access Journals (Sweden)

    Carrol Gamble

    Full Text Available To investigate parents' views about deferred consent to inform management of trial disclosure after a child's death.A postal questionnaire survey was sent to members of the Meningitis Research Foundation UK charity, whose child had suffered from bacterial meningitis or meningococcal septicaemia within the previous 5 years. Main outcome measures were acceptability of deferred consent; timing of requesting consent; and the management of disclosure of the trial after a child's death.220 families were sent questionnaires of whom 63 (29% were bereaved. 68 families responded (31%, of whom 19 (28% were bereaved. The majority (67% was willing for their child to be involved in the trial without the trial being explained to them beforehand; 70% wanted to be informed about the trial as soon as their child's condition had stabilised. In the event of a child's death before the trial could be discussed the majority of bereaved parents (66% 12/18 anticipated wanting to be told about the trial at some time. This compared with 37% (18/49 of non-bereaved families (p = 0.06. Parents' free text responses indicated that the word 'trial' held strongly negative connotations. A few parents regarded gaps in the evidence base about emergency treatments as indicating staff lacked expertise to care for a critically ill child. Bereaved parents' free text responses indicated the importance of individualised management of disclosure about a trial following a child's death.Deferred consent is acceptable to the majority of respondents. Parents whose children had recovered differed in their views compared to bereaved parents. Most bereaved parents would want to be informed about the trial in the aftermath of a child's death, although a minority strongly opposed such disclosure. Distinction should be drawn between the views of bereaved and non-bereaved parents when considering the acceptability of different consent processes.

  13. Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China.

    Science.gov (United States)

    Wen, Gaiyan; Liu, Xinchun; Huang, Lihua; Shu, Jingxian; Xu, Nana; Chen, Ruifang; Huang, Zhijun; Yang, Guoping; Wang, Xiaomin; Xiang, Yuxia; Lu, Yao; Yuan, Hong

    2016-01-01

    To explore the readability and content integrity of informed consent forms (ICFs) used in China and to compare the quality of Chinese local ICFs with that of international ICFs. The length, readability and content of 155 consent documents from phase II-IV drug clinical trials from the Third Xiangya Hospital Ethics Committee from November 2009 to January 2015 were evaluated. Reading difficulty was tested using a readability formula adapted for the Chinese language. An ICF checklist containing 27 required elements was successfully constructed to evaluate content integrity. The description of alternatives to participation was assessed. The quality of ICFs from different sponsorships were also compared. Among the 155 evaluable trials, the ICFs had a median length of 5286 words, corresponding to 7 pages. The median readability score was 4.31 (4.02-4.41), with 63.9% at the 2nd level and 36.1% at the 3rd level. Five of the 27 elements were frequently neglected. The average score for the description of alternatives to participation was 1.06, and 27.7% of the ICFs did not mention any alternatives. Compared with Chinese local ICFs, international ICFs were longer, more readable and contained more of the required elements (P readability and content integrity than Chinese local ICFs. More efforts should thus be made to improve the quality of consent documents in China.

  14. Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

    Science.gov (United States)

    Koonrungsesomboon, Nut; Tharavanij, Thipaporn; Phiphatpatthamaamphan, Kittichet; Vilaichone, Ratha-Korn; Manuwong, Sudsayam; Curry, Parichat; Siramolpiwat, Sith; Punchaipornpon, Thanachai; Kanitnate, Supakit; Tammachote, Nattapol; Yamprasert, Rodsarin; Chanvimalueng, Waipoj; Kaewkumpai, Ruchirat; Netanong, Soiphet; Kitipawong, Peerapong; Sritipsukho, Paskorn; Karbwang, Juntra

    2017-02-01

    This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

  15. Improving biobank consent comprehension: a national randomized survey to assess the effect of a simplified form and review/retest intervention

    Science.gov (United States)

    Beskow, Laura M.; Lin, Li; Dombeck, Carrie B.; Gao, Emily; Weinfurt, Kevin P.

    2017-01-01

    Purpose: To determine the individual and combined effects of a simplified form and a review/retest intervention on biobanking consent comprehension. Methods: We conducted a national online survey in which participants were randomized within four educational strata to review a simplified or traditional consent form. Participants then completed a comprehension quiz; for each item answered incorrectly, they reviewed the corresponding consent form section and answered another quiz item on that topic. Results: Consistent with our first hypothesis, comprehension among those who received the simplified form was not inferior to that among those who received the traditional form. Contrary to expectations, receipt of the simplified form did not result in significantly better comprehension compared with the traditional form among those in the lowest educational group. The review/retest procedure significantly improved quiz scores in every combination of consent form and education level. Although improved, comprehension remained a challenge in the lowest-education group. Higher quiz scores were significantly associated with willingness to participate. Conclusion: Ensuring consent comprehension remains a challenge, but simplified forms have virtues independent of their impact on understanding. A review/retest intervention may have a significant effect, but assessing comprehension raises complex questions about setting thresholds for understanding and consequences of not meeting them. Genet Med advance online publication 13 October 2016 PMID:27735922

  16. Naming it 'nano': Expert views on 'nano' terminology in informed consent forms of first-in-human nanomedicine trials.

    Science.gov (United States)

    Satalkar, Priya; Elger, Bernice Simone; Shaw, David

    2016-04-01

    Obtaining valid informed consent (IC) can be challenging in first-in-human (FIH) trials in nanomedicine due to the complex interventions, the hype and hope concerning potential benefits, and fear of harms attributed to 'nano' particles. We describe and analyze the opinions of expert stakeholders involved in translational nanomedicine regarding explicit use of 'nano' terminology in IC documents. We draw on content analysis of 46 in-depth interviews with European and North American stakeholders. We received a spectrum of responses (reluctance, ambivalence, absolute insistence) on explicit mention of 'nano' in IC forms with underlying reasons. We conclude that consistent, clear and honest communication regarding the 'nano' dimension of investigational product is critical in IC forms of FIH trials.

  17. Parental consent for bone marrow transplantation in the case of genetic disorders.

    Science.gov (United States)

    Prows, C A; McCain, G C

    1997-01-01

    To describe the responses of mothers and fathers who were offered bone marrow transplantation (BMT) for their children with genetic disorders. Qualitative. Private hospital rooms/offices. Six mothers and 4 fathers of children with genetic disorders. The basic social-psychological problem confronting the parents was the conflicting alternatives of life versus death for their children. It was certain that these children would die from their genetic disorders but without having to endure the pain and suffering of a BMT. The BMT would be difficult, possibly resulting in death, but with a chance of survival. Parents believed that BMT was the only chance of survival for their children, leaving them no choice except to pursue the BMT treatment.

  18. Parental consent requirements and privacy rights of minors: the contraceptive controversy.

    Science.gov (United States)

    1975-03-01

    That the adult zone of privacy recognized by the Supreme Court during the past decade embraces access to contraceptives is suggested. 2 further questions are examined: 1) whether the right of children to have access to contraceptives is fundamental and 2) whether countervailing interests of parents and state should outweigh whatever interest the child has in obtaining contraceptives. More fundamentally, 3 complex issues relative to an analysis of minors' rights to obtain contraceptives are discussed: 1) the scope of the constitutional right of adults to obtain contraceptives remains uncertain; 2) courts have not yet articulated the special factors that determine how existing frameworks for analyzing the rights of adults are to be applied to minors; and 3) the question of minors' access to contraceptive involves a particularly complex mixture of the interests of minors, parents, and the state.

  19. CTEPP DATA COLLECTION FORM 04: PARENT PRE-MONITORING QUESTIONNAIRE

    Science.gov (United States)

    This data collection form is used to identify the activity patterns of the preschool children and possible sources and routes of exposure. The parent is asked questions on their child's activities indoors and outdoors at the home. These include questions on their child's frequenc...

  20. 17 CFR 249.508 - Form 8-M, consent to service of process by a corporation which is a nonresident broker-dealer.

    Science.gov (United States)

    2010-04-01

    ... to service of process by a corporation which is a nonresident broker-dealer. This form shall be filed... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Form 8-M, consent to service of process by a corporation which is a nonresident broker-dealer. 249.508 Section 249.508 Commodity...

  1. An analysis of the readability of patient information and consent forms used in research studies in anaesthesia in Australia and New Zealand.

    Science.gov (United States)

    Taylor, H E; Bramley, D E P

    2012-11-01

    The provision of written information is a component of the informed consent process for research participants. We conducted a readability analysis to test the hypothesis that the language used in patient information and consent forms in anaesthesia research in Australia and New Zealand does not meet the readability standards or expectations of the Good Clinical Practice Guidelines, the National Health and Medical Research Council in Australia and the Health Research Council of New Zealand. We calculated readability scores for 40 patient information and consent forms using the Simple Measure of Gobbledygook and Flesch-Kincaid formulas. The mean grade level of patient information and consent forms when using the Simple Measure of Gobbledygook and Flesch-Kincaid readability formulas was 12.9 (standard deviation of 0.8, 95% confidence interval 12.6 to 13.1) and 11.9 (standard deviation 1.1, 95% confidence interval 11.6 to 12.3), respectively. This exceeds the average literacy and comprehension of the general population in Australia and New Zealand. Complex language decreases readability and negatively impacts on the informed consent process. Care should be exercised when providing written information to research participants to ensure language and readability is appropriate for the audience.

  2. Recall and decay of consent information among parents of infants participating in a randomized controlled clinical trial using an audio-visual tool in The Gambia.

    Science.gov (United States)

    Mboizi, Robert B; Afolabi, Muhammed O; Okoye, Michael; Kampmann, Beate; Roca, Anna; Idoko, Olubukola T

    2017-09-02

    Communicating essential research information to low literacy research participants in Africa is highly challenging, since this population is vulnerable to poor comprehension of consent information. Several supportive materials have been developed to aid participant comprehension in these settings. Within the framework of a pneumococcal vaccine trial in The Gambia, we evaluated the recall and decay of consent information during the trial which used an audio-visual tool called 'Speaking Book', to foster comprehension among parents of participating infants. The Speaking Book was developed in the 2 most widely spoken local languages. Four-hundred and 9 parents of trial infants gave consent to participate in this nested study and were included in the baseline assessment of their knowledge about trial participation. An additional assessment was conducted approximately 90 d later, following completion of the clinical trial protocol. All parents received a Speaking Book at the start of the trial. Trial knowledge was already high at the baseline assessment with no differences related to socio-economic status or education. Knowledge of key trial information was retained at the completion of the study follow-up. The Speaking Book (SB) was well received by the study participants. We hypothesize that the SB may have contributed to the retention of information over the trial follow-up. Further studies evaluating the impact of this innovative tool are thus warranted.

  3. Black Hawk Down?: Establishing Helicopter Parenting as a Distinct Construct from Other Forms of Parental Control during Emerging Adulthood

    Science.gov (United States)

    Padilla-Walker, Laura M.; Nelson, Larry J.

    2012-01-01

    The purpose of the current study was to establish a measure of helicopter parenting that was distinct from other forms of parental control, and to examine parental and behavioral correlates of helicopter parenting. Participants included 438 undergraduate students from four universities in the United States (M[subscript age] = 19.65, SD = 2.00,…

  4. Voluntary Informed Consent in Paediatric Oncology Research.

    Science.gov (United States)

    Dekking, Sara A S; Van Der Graaf, Rieke; Van Delden, Johannes J M

    2016-07-01

    In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised in these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context. © 2015 John Wiley & Sons Ltd.

  5. How Does the Patient React After Reading the Informed Consent Form of a Gynecological Surgery? A Qualitative Study.

    Science.gov (United States)

    Amorim, Andrea Cristina; Santos, Luis Guilherme Teixeira Dos; Poli-Neto, Omero Benedicto; Brito, Luiz Gustavo Oliveira

    2018-02-01

     To analyze the reaction of women after reading the Informed Consent Form (ICF) before undergoing elective gynecological/urogynecological surgeries.  A qualitative study with 53 women was conducted between September 2014 and May 2015. The analysis of the content was conducted after a scripted interview was made in a reserved room and transcribed verbatim. We read the ICF once more in front of the patient, and then she was interviewed according to a script of questions about emotions and reactions that occurred about the procedure and her expectations about the intra- and postoperative period.  The women had a mean age of 52 years, they were multiparous, and most had only a few years of schooling (54.7%). The majority (60.4%) of them had undergone urogynecological surgeries. Hysterectomy and colpoperineoplasty were the most frequent procedures. Ten women had not undergone any previous abdominal surgery. Fear (34.6%) was the feeling that emerged most frequently from the interviews after reading the ICF, followed by indifference (30.8%) and resignation (13.5%). Nine women considered their reaction unexpected after reading the ICF. Three patients did not consider the information contained in the ICF to be sufficient, and 3 had questions about the surgery after reading the document.  Reading the ICF generates fear in most women; however, they believe this feeling did not interfere in their decision-making process. Thieme Revinter Publicações Ltda Rio de Janeiro, Brazil.

  6. [Information and consent forms for hematopoietic stem cell transplantation donors and recipients: Guidelines from the Franchophone society of bone marrow transplantation and cellular therapy (SFGM-TC)].

    Science.gov (United States)

    Bruno, Bénédicte; Thibert, Jean-Baptiste; Bancillon, Nelly; Desbos, Anna; Fawaz, Abir; Fournier, Isabelle; Genty, Carole; Issarni, Dominique; Leveille, Sandrine; Premel, Christelle; Polomeni, Alice; Renault, Myriam; Tarillon, Sylvie; Wallart, Anne; Yakoub-Agha, Ibrahim; Bordessoule, Dominique

    2016-11-01

    Within the context of the SFGM-TC's 6th workshop series on the harmonization of clinical practices, our workshop proposes a standardization of the informed consent process for hematopoietic stem cell donors and recipients leading up to an autologous or allogenic transplantation. All informed consent was for bone marrow or peripheral stem cell donors, and mononuclear/lymphocyte donors according to usual procedures. The informed consent for autologous and allogenic related or unrelated adults and pediatric transplantation patients have been included. A first step has been conducted for collecting in advance the informed consent forms used routinely in all francophone transplantation centers. In a second step, a comprehensive version has been re-written by a multidisciplinary team. For the purposes of understanding the risks and advantages, language has been carefully considered and streamlined. In the third step, texts were sent to stem cell transplantation experts, experts at the French biomedical agency (agence de la biomédecine [ABM]), law specialists, members of the ethical committee of the French society of hematology and several transplant recipients to be edited and proofread. Copyright © 2016 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

  7. Developing the Scale for Quality of Life in Pediatric Oncology Patients Aged 13-18: Adolescent Form and Parent Form.

    Science.gov (United States)

    Bektas, Murat; Akdeniz Kudubes, Aslı; Ugur, Ozlem; Vergin, Canan; Demirag, Bengü

    2016-06-01

    This study aimed to develop the Scale for Quality of Life in Pediatric Oncology Patients Aged 13-18: Adolescent Form and Parent Form. We used the child and parent information form, Visual Quality of Life Scale, and our own scale, the Scale for Quality of Life in Pediatric Oncology Patients Aged 13-18: Adolescent Form and Parent Form. We finalized the 35-item scale to determine the items, received opinions from 14 specialists on the scale, and pilot-tested the scale in 25 children and their parents. We used Pearson correlation analysis, Cronbach α coefficient, factor analysis and receiver operating characteristics analysis to analyze the data. The total Cronbach α of the parent form was .97, the total factor load was .60-.97 and the total variance was 80.4%. The cutoff point of the parent form was 85.50. The total Cronbach α of the adolescent form was .98, the total factor load was .62-.96, and the total variance explained was 83.4%. The cutoff point of the adolescent form was 75.50. As a result of the parent form factor analysis, we determined the Kaiser-Meyer-Olkin coefficient as .83, the Barlett test χ(2) as 12,615.92; the factor coefficients of all items of the parent form ranged from .63 to .98. The factor coefficients of all items of the adolescent form ranged from .34 to .99. As a result of the adolescent form factor analysis, we determined the KMO as .79, and the Barlett test χ(2) as 13,970.62. Conclusively, we found that the adolescent form and the parent form were valid and reliable in assessing the children's quality of life. Copyright © 2016. Published by Elsevier B.V.

  8. Informed consent - a survey of doctors' practices in South Africa ...

    African Journals Online (AJOL)

    Informed consent - a survey of doctors' practices in South Africa. ... whether informed consent as envisioned by the law exists in reality. Cross-cultural research is needed to clarify patients' and parents' expectations of informed consent ...

  9. Adolescents and consent to treatment.

    Science.gov (United States)

    Dickens, B M; Cook, R J

    2005-05-01

    Adolescents, defined by WHO as 10 to 19 years old, can give independent consent for reproductive health services if their capacities for understanding have sufficiently evolved. The international Convention on the Rights of the Child, almost universally ratified, limits parental powers, and duties, by adolescents' "evolving capacities" for self-determination. Legal systems may recognize "mature minors" as enjoying adult rights of medical consent, even when consent to sexual relations does not absolve partners of criminal liability; their consent does not make the adolescents offenders. There is usually no chronological "age of consent" for medical care, but a condition of consent, meaning capacity for understanding. Like adults, mature minors enjoy confidentiality and the right to treatment according to their wishes rather than their best interests. Minors incapable of self-determination may grant or deny assent to treatment for which guardians provide consent. Emancipated minors' self-determination may also be recognized, for instance on marriage or default of adults' guardianship.

  10. Informed consent recall and comprehension in orthodontics: traditional vs improved readability and processability methods.

    Science.gov (United States)

    Kang, Edith Y; Fields, Henry W; Kiyak, Asuman; Beck, F Michael; Firestone, Allen R

    2009-10-01

    Low general and health literacy in the United States means informed consent documents are not well understood by most adults. Methods to improve recall and comprehension of informed consent have not been tested in orthodontics. The purposes of this study were to evaluate (1) recall and comprehension among patients and parents by using the American Association of Orthodontists' (AAO) informed consent form and new forms incorporating improved readability and processability; (2) the association between reading ability, anxiety, and sociodemographic variables and recall and comprehension; and (3) how various domains (treatment, risk, and responsibility) of information are affected by the forms. Three treatment groups (30 patient-parent pairs in each) received an orthodontic case presentation and either the AAO form, an improved readability form (MIC), or an improved readability and processability (pairing audio and visual cues) form (MIC + SS). Structured interviews were transcribed and coded to evaluate recall and comprehension. Significant relationships among patient-related variables and recall and comprehension explained little of the variance. The MIC + SS form significantly improved patient recall and parent recall and comprehension. Recall was better than comprehension, and parents performed better than patients. The MIC + SS form significantly improved patient treatment comprehension and risk recall and parent treatment recall and comprehension. Patients and parents both overestimated their understanding of the materials. Improving the readability of consent materials made little difference, but combining improved readability and processability benefited both patients' recall and parents' recall and comprehension compared with the AAO form.

  11. 'The words will pass with the blowing wind': staff and parent views of the deferred consent process, with prior assent, used in an emergency fluids trial in two African hospitals.

    Directory of Open Access Journals (Sweden)

    Sassy Molyneux

    Full Text Available To document and explore the views and experiences of key stakeholders regarding the consent procedures of an emergency research clinical trial examining immediate fluid resuscitation strategies, and to discuss the implications for similar trials in future.A social science sub-study of the FEAST (Fluid Expansion As Supportive Therapy trial. Interviews were held with trial team members (n = 30, health workers (n = 15 and parents (n = 51 from two purposively selected hospitals in Soroti, Uganda, and Kilifi, Kenya.Overall, deferred consent with prior assent was seen by staff and parents as having the potential to protect the interests of both patients and researchers, and to avoid delays in starting treatment. An important challenge is that the validity of verbal assent is undermined when inadequate initial information is poorly understood. This concern needs to be balanced against the possibility that full prior consent on admission potentially causes harm through introducing delays. Full prior consent also potentially imposes worries on parents that clinicians are uncertain about how to proceed and that clinicians want to absolve themselves of any responsibility for the child's outcome (some parents' interpretation of the need for signed consent. Voluntariness is clearly compromised for both verbal assent and full prior consent in a context of such vulnerability and stress. Further challenges in obtaining verbal assent were: what to do in the absence of the household decision-maker (often the father; and how medical staff handle parents not giving a clear agreement or refusal.While the challenges identified are faced in all research in low-income settings, they are magnified for emergency trials by the urgency of decision making and treatment needs. Consent options will need to be tailored to particular studies and settings, and might best be informed by consultation with staff members and community representatives using a deliberative

  12. Black Hawk down? Establishing helicopter parenting as a distinct construct from other forms of parental control during emerging adulthood.

    Science.gov (United States)

    Padilla-Walker, Laura M; Nelson, Larry J

    2012-10-01

    The purpose of the current study was to establish a measure of helicopter parenting that was distinct from other forms of parental control, and to examine parental and behavioral correlates of helicopter parenting. Participants included 438 undergraduate students from four universities in the United States (M(age) = 19.65, SD = 2.00, range = 18-29; 320 women, 118 men), and at least one of their parents. Analyses revealed that helicopter parenting loaded on a separate factor from both behavioral and psychological control, and that helicopter parenting was positively associated with behavioral and psychological control, but not at levels suggesting complete overlap. Results also revealed that helicopter parenting was positively associated with parental involvement and with other positive aspects of the parent-child relationship; but negatively associated with parental autonomy granting and school engagement. Discussion focuses on the implications of helicopter parenting for healthy development during emerging adulthood. Copyright © 2012 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

  13. Making the Difference with Active Parenting; Forming Educational Partnerships between Parents and Schools

    Science.gov (United States)

    Oostdam, Ron; Hooge, Edith

    2013-01-01

    Although parental involvement is often a priority on the quality agenda of schools for primary and secondary education, it is still not usual to involve parents as an educational partner in the actual learning process of their child. Rather than adopting an open approach, teachers tend to tell parents what they should do or keep them at a safe…

  14. What constitutes consent when parents and daughters have different views about having the HPV vaccine: qualitative interviews with stakeholders

    NARCIS (Netherlands)

    Wood, F.; Morris, L.; Davies, M.; Elwyn, G.

    2011-01-01

    OBJECTIVE: The UK Human Papillomavirus (HPV) vaccine programme commenced in the autumn of 2008 for year 8 (age 12-13 years) schoolgirls. We examine whether the vaccine should be given when there is a difference of opinion between daughters and parents or guardians. DESIGN: Qualitative study

  15. Parental Grief Following the Brain Death of a Child: Does Consent or Refusal to Organ Donation Affect Their Grief?

    Science.gov (United States)

    Bellali, Thalia; Papadatou, Danai

    2006-01-01

    The purpose of this study was to investigate the grieving process of parents who were faced with the dilemma of donating organs and tissues of their underage brain dead child, and to explore the impact of their decision on their grief process. A grounded theory methodology was adopted and a semi-structured interview was conducted with 11 bereaved…

  16. Parents' Views of Video Games: Habitus Forms in the Context of Parental Mediation

    Science.gov (United States)

    Friedrichs, Henrike; von Gross, Friederike; Herde, Katharina; Sander, Uwe

    2015-01-01

    This research project was conducted to explore parental attitudes towards and their mediation of video games. Qualitative, semi-structured interviews with 28 parents (14 couples) assessed their media-related habitus, their media-educational habitus and the interaction between the habitus. The results show that the media-related habitus has a…

  17. Como tornar os termos de consentimento mais fáceis de ler? How to make consent forms easier to read?

    Directory of Open Access Journals (Sweden)

    Diego Vinicius Pacheco de Araujo

    2010-01-01

    Full Text Available OBJETIVO: Reconhecer o nível de alfabetismo funcional de usuários do ambulatório do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCMFUSP com a finalidade de identificar recomendações para adequar a redação do TCLE ao nível de alfabetismo dos usuários, pois estes podem vir a ser sujeitos de pesquisa. MÉTODOS: Estudo transversal quantitativo com 399 sujeitos. A amostra foi intencional, selecionada entre usuários dos ambulatórios do HCFMUSP. A coleta de dados utilizou instrumento que continha um texto em prosa compatível para a avaliação das habilidades de leitura necessárias para a compreensão de um TCLE. RESULTADOS: Mais de 46,6% dos entrevistados foram classificados como analfabetos funcionais. Desses, 12,7% sequer foram capazes de entender a tarefa proposta no texto lido. Apesar disto, quase 50% dos entrevistados declararam ter ao menos iniciado o ensino médio. CONCLUSÃO: Os resultados e as orientações para a redação de texto centrada no leitor permitiu que elaborássemos recomendações para tornar os termos de consentimento mais fáceis de ler. Recomendamos que o pesquisador elabore o TCLE como um texto em estrutura narrativa, dirigido ao leitor, usando palavras e termos familiares, ou seja, termos comuns à linguagem dos sujeitos e à linguagem médica. Além de contribuir para melhorar a relação entre o sujeito e o pesquisador, acredita-se que estas recomendações possam contribuir para a diminuição do tempo de tramitação de projetos de pesquisa. Já que os problemas na redação do TCLE motivam boa parte das pendências que retardam este andamento.OBJECTIVE: Define the literacy level of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCMFUSP outpatients, for the purpose of identifying recommendations to adapt writing of the informed consent form to the outpatients literacy level, since these can become the subject of research. METHODS

  18. Informed consent

    International Nuclear Information System (INIS)

    Bundy, A.L.

    1988-01-01

    Numerous articles on informed consent have appeared in medical and legal journals over the past few years. Many of these have been in the radiological literature. This chapter presents an overview of the legal principles behind this controversial topic. Recent articles are reviewed and specific suggestions are made where applicable. The doctrine of informed consent is both a product of and the basis for the physician-patient relationship. Their communications to each other establish the relationship, but once established, heightened degrees of expectations on the patient's part have dictated the need for a more sophisticated level of communication. Since patients and physicians often expect different things of each other, it is imperative that the relationship leads to effective and respectful conversation

  19. Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients' case notes, consent forms, and research records and by interview.

    Science.gov (United States)

    Smith, T; Moore, E J; Tunstall-Pedoe, H

    1997-05-31

    To monitor the conduct of medical research projects that have already been approved by the local medical research ethics committee. Follow up study of ethically approved studies (randomly selected from all the studies approved in the previous year) by examination of patients' case notes, consent forms, and research records and by interview of the researchers at their workplace. Tayside, Scotland (mixed rural and urban population). 30 research projects approved by Tayside local medical research ethics committee. Adherence to the agreed protocol, particularly for recruitment (obtaining and recording informed consent) and for specific requirements of the ethics committee, including notification of changes to the protocol and of adverse events. In one project only oral consent had been obtained, and in a quarter of the studies one or more consent forms were incorrectly completed. Inadequate filing of case notes in five studies and of consent forms in six made them unavailable for scrutiny. Adverse events were reported, but there was a general failure to report the abandoning or non-starting of projects in two studies the investigators failed to notify a change in the responsible researcher. Monitoring of medical research by local medical research ethics committees promotes and preserves ethical standards, protects subjects and researchers, discourages fraud, and has the support of investigators. We recommend that 10% of projects should undergo on-site review, with all others monitored by questionnaire. This would require about six person hours of time and a salary bill of 120 pounds per study monitored.

  20. Do Multiple Forms of Social Capital Mediate the Relationship Between Parental Violence and Children's Maladaptive Behaviors?

    Science.gov (United States)

    Kim, Sangwon; Lee, Yanghee

    2018-03-01

    Many things can harm children's well-being. Among them, exposure to parental violence makes children vulnerable and often leads to aggression and/or depression. However, not all children who have suffered parental violence show aggressive behavior or depressive mood. Social capital, defined as resources accruing from interpersonal relationships, was proposed to significantly mediate the relationships among adverse experiences and their negative impacts. In previous studies, social capital accrued from parents played a positive role for children in violent situations, but children exposed to parental violence need alternative sources of social capital. This study targeted fourth-grade Korean children and aimed to identify and test the role of various forms of social capital to help children overcome negative consequences from parental violence. Siblings, friends, teachers, neighbors, and online acquaintances were sources of social capital, and the results showed that social capital from siblings, teachers, neighbors, or online acquaintances mediated in the relationships between parental violence and aggressive behavior. In addition, social capital from siblings and online acquaintances mediated in the relationships between parental violence and depressive mood. The findings have implications in terms of intervention. It is suggested that multiple forms of social capital from children's immediate environments are helpful in their adaptation from exposure to parental violence, and thus, relationship-based interventions are recommended.

  1. Impact of verbal explanation and modified consent materials on orthodontic informed consent.

    Science.gov (United States)

    Carr, Kelly M; Fields, Henry W; Beck, F Michael; Kang, Edith Y; Kiyak, H Asuman; Pawlak, Caroline E; Firestone, Allen R

    2012-02-01

    Comprehension of informed consent information has been problematic. The purposes of this study were to evaluate the effectiveness of a shortened explanation of an established consent method and whether customized slide shows improve the understanding of the risks and limitations of orthodontic treatment. Slide shows for each of the 80 subject-parent pairs included the most common core elements, up to 4 patient-specific custom elements, and other general elements. Group A heard a presentation of the treatment plan and the informed consent. Group B did not hear the presentation of the informed consent. All subjects read the consent form, viewed the customized slide show, and completed an interview with structured questions, 2 literacy tests, and a questionnaire. The interviews were scored for the percentages of correct recall and comprehension responses. Three informed consent domains were examined: treatment, risk, and responsibility. These groups were compared with a previous study group, group C, which received the modified consent and the standard slide show. No significant differences existed between groups A, B, and C for any sociodemographic variables. Children in group A scored significantly higher than did those in group B on risk recall and in group C on overall comprehension, risk recall and comprehension, and general risks and limitations questions. Children in group B scored significantly higher than did those in group C on overall comprehension, treatment recall, and risk recall. Elements presented first in the slide show scored better than those presented later. This study suggested little advantage of a verbal review of the consent (except for patients for risk) when other means of review such as the customized slide show were included. Regression analysis suggested that patients understood best the elements presented first in the informed consent slide show. Consequently, the most important information should be presented first to patients, and any

  2. Domestic Property Violence: A Distinct and Damaging Form of Parent Abuse.

    Science.gov (United States)

    Murphy-Edwards, Latesha; van Heugten, Kate

    2018-02-01

    This article reports on the qualitative phase of mixed method research conducted in a medium-size city in New Zealand, which examined 14 parents' experiences of child- and youth-perpetrated domestic property violence (DPV). The research used semi-structured interviews and interpretative phenomenological analysis, enabling parents' perceptions of the causes and impacts of this form of family violence to be explored in depth. Three superordinate themes were identified in the analysis: damage done, the various impacts of DPV; staying safe and sane; and making sense of DPV, parents' perspectives. An ecological meaning-making theory emerged from the data and provided an overarching interpretative framework for considering the themes both separately and together. The findings showed that DPV is a distinct form of parent abuse and one that can have serious impacts of a financial, emotional, and relational nature. The theoretical and practical implications of the findings are discussed along with ideas for further research into this problem.

  3. From "a Fair Game" to "a Form of Covert Research": Research Ethics Committee Members' Differing Notions of Consent and Potential Risk to Participants Within Social Media Research.

    Science.gov (United States)

    Hibbin, R A; Samuel, G; Derrick, G E

    2018-04-01

    Social media (SM) research presents new challenges for research ethics committees (RECs) who must balance familiar ethical principles with new notions of public availability. This article qualitatively examines how U.K. REC members view this balance in terms of risk and consent. While it found significant variance overall, there were discernible experience-based trends. REC members with less experience of reviewing SM held inflexible notions of consent and risk that could be categorized as either relying on traditional notions of requiring direct consent, or viewing publicly available data as "fair game." More experienced REC members took a more nuanced approach to data use and consent. We conclude that the more nuanced approach should be best practice during ethical review of SM research.

  4. [Parental Alienation (Syndrome) - A serious form of child psychological abuse].

    Science.gov (United States)

    von Boch-Galhau, Wilfrid

    2018-04-13

    Induced parental alienation is a specific form of psychological child abuse, which is listed in DSM-5, the current Diagnostic and Statistical Manual of the American Psychiatric Association (APA), under diagnostic code V 995.51 "child psychological abuse". Untreated induced parental alienation can lead to long-term traumatic psychological and physical effects in the children concerned. This fact is still not given sufficient attention in family court cases. The article gives a condensed overview of parental alienation, summarising its definition, the symptoms and the various levels of severity. It also describes some major alienation techniques and possible psychosomatic and psychiatric effects of induced parental alienation. Finally, attention is drawn to programmes of prevention and intervention now used and evaluated in some countries. The article concludes with two real-life examples from psychiatric practice, and a comprehensive list of international references.

  5. [Informed consent].

    Science.gov (United States)

    López-Sáez, Asunción; López, de Teruel; Siso Martín, Juan

    2003-11-01

    Once the stage of health paternalism, exercised so many times under the pretext of the principle of benevolence, has been overcome, treatment relationships level off, they become symmetrical and balanced and in this climate of a "therapeutic alliance", both parties, the patient and the health professional, have to merge their capabilities and their limitations. The health professional can not impose general character operational methods to follow to a patient nor interventions, even though clinically correct, against a patient's will; but neither does a patient have the right to obtain treatment in accordance with his desires if these are found to be in disagreement with concrete clinical recommendations for the case dealt with according to the health professional's criteria. We can summarize what has just been stated in two basic principles: 1. The health professional is not obliged to follow the requests of a patient if he/she does not consider these clinically appropriate, but in order to follow a different treatment method, the health professional must have the consent of the patient. 2. In any case, if a patient opposes a treatment being applied to him/her, except in the few legally recognized exceptions, the health professional can try to persuade a patient to accept recommended treatment, but never can carry out treatment against the patient's will.

  6. 75 FR 24706 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2010-05-05

    ... parent consent 214 1 10/60 form. Child Clinic Visit--Case 107 1 1.5 children packet. Parent Clinic Visit...] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention...; (4) a telephone interview focusing on pregnancy-related events and early life history (biological...

  7. Interactive informed consent: randomized comparison with paper consents.

    Directory of Open Access Journals (Sweden)

    Michael C Rowbotham

    Full Text Available Informed consent is the cornerstone of human research subject protection. Many subjects sign consent documents without understanding the study purpose, procedures, risks, benefits, and their rights. Proof of comprehension is not required and rarely obtained. Understanding might improve by using an interactive system with multiple options for hearing, viewing and reading about the study and the consent form at the subject's own pace with testing and immediate feedback. This prospective randomized study compared the IRB-approved paper ICF for an actual clinical research study with an interactive presentation of the same study and its associated consent form using an iPad device in two populations: clinical research professionals, and patients drawn from a variety of outpatient practice settings. Of the 90 participants, 69 completed the online test and survey questions the day after the session (maximum 36 hours post-session. Among research professionals (n = 14, there was a trend (p = .07 in the direction of iPad subjects testing better on the online test (mean correct  =  77% compared with paper subjects (mean correct = 57%. Among patients (n = 55, iPad subjects had significantly higher test scores than standard paper consent subjects (mean correct = 75% vs 58%, p < .001. For all subjects, the total time spent reviewing the paper consent was 13.2 minutes, significantly less than the average of 22.7 minutes total on the three components to be reviewed using the iPad (introductory video, consent form, interactive quiz. Overall satisfaction and overall enjoyment slightly favored the interactive iPad presentation. This study demonstrates that combining an introductory video, standard consent language, and an interactive quiz on a tablet-based system improves comprehension of research study procedures and risks.

  8. Reliability and Validity Of The DSM-5 Level 2 Depression Scale- Turkish Version (Child Form for 11-17 years and Parent Form for 6-17 Years

    Directory of Open Access Journals (Sweden)

    Sermin Yalin-Sapmaz

    2017-04-01

    Results: In reliability analyses, Cronbach alpha internal consistency coefficient was found to be very high for child and parent forms (0.965/0.952. Item- total score correlation coefficients are high and very high, respectively and were found to be consistent with the original structure of the scale (0.725 and 0.864 for child form- 0.644 and 0.839 for parent form As for concurrent validity, child form had a high correlation with the Children’s Depression Inventory while parent form had a significant correlation with Strengths and Difficulties Questionnaire- Parent Form (r=0.853 p [JCBPR 2017; 6(1.000: 15-21

  9. Reasons of Aggressive Behaviour Against School Fellows, Its Frequency, Forms: Reaction of Schoolchildren, Teachers and Parents

    Directory of Open Access Journals (Sweden)

    Valdas Pruskus

    2011-12-01

    Full Text Available The present article, which is based on conducted research data, analyzes an attitude of schoolchildren, teachers and parents towards the reasons of schoolchildren’s aggressive behaviour, its frequency and forms. Different factors and motives that stimulate the aggressiveness of schoolchildren, who go to the city, village and different professional (arts and technology schools are examined. Schoolchildren’s approach towards violence against school fellows and themselves is being discussed, as well as reaction of teachers and parents to this phenomenon. The article reveals opinion of schoolchildren, teachers, and parents about the means used to prevent violence towards schoolchildren and existing ways that can be used to make preventive means to be more effective.

  10. Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients' case notes, consent forms, and research records and by interview.

    OpenAIRE

    Smith, T.; Moore, E. J.; Tunstall-Pedoe, H.

    1997-01-01

    OBJECTIVE: To monitor the conduct of medical research projects that have already been approved by the local medical research ethics committee. DESIGN: Follow up study of ethically approved studies (randomly selected from all the studies approved in the previous year) by examination of patients' case notes, consent forms, and research records and by interview of the researchers at their workplace. SETTING: Tayside, Scotland (mixed rural and urban population). SUBJECTS: 30 research projects app...

  11. Enhancing informed consent for research and treatment.

    Science.gov (United States)

    Dunn, L B; Jeste, D V

    2001-06-01

    Increased scrutiny of informed consent calls for further research into decision making by patients who may be at risk for impairments. We review interventions designed to improve patient understanding of informed consent. A number of studies, within as well as outside psychiatry, have evaluated the effectiveness of specific interventions, as well as possible "predictors" of understanding of consent, such as subject characteristics, psychiatric symptoms, and cognitive impairment. Deficits in patients' understanding of informed consent may be partially related to poorly conceived, written, or organized informed consent materials; these deficits may be remediable with educational interventions. We find that effective interventions include corrected feedback, multiple learning trials, and more organized or simplified consent forms. Educational levels of patients generally correlate with levels of understanding. Even among individuals with psychiatric illness or cognitive impairment, deficits in understanding can be remedied with certain educational interventions. A variety of interventions can enhance understanding of informed consent.

  12. Associations of Extroversion and Parental Overprotection with Forming Relationships with Peers among Adolescents with and without Visual Impairments

    Science.gov (United States)

    Pinquart, Martin; Pfeiffer, Jens P.

    2011-01-01

    This paper reports a study that focused on three risk factors that may be relevant for forming relationships with peers, namely, level of vision loss, low extroversion (high introversion), and parental overprotection. The authors analyzed the role of parental overprotection and extroversion in forming relationships with peers among 158 adolescents…

  13. Parenting

    Science.gov (United States)

    ... parents, people are always ready to offer advice. Parenting tips, parents' survival guides, dos, don'ts, shoulds ... right" way to be a good parent. Good parenting includes Keeping your child safe Showing affection and ...

  14. Use of informed consent with therapeutic paradox.

    Science.gov (United States)

    Farkas, M M

    1992-01-01

    Debate persists in the literature and among clinicians about the ethical appropriateness of paradoxical interventions. It has been suggested that informed consent with therapeutic paradox would alleviate ethical concerns of deception, manipulation, harm to the client, and withholding of information from the client in therapy. The purpose of this study was to explore health care consumer reactions to the benefits and risks of therapeutic paradox as stated in a consent for treatment form. The study explored the responses of 32 medical patients to a hypothetical consent for treatment form for therapeutic paradox. Data were collected in a brief semistructured interview after subjects read the hypothetical consent form. Utilizing a case study, the investigator then offered an example of a successful paradoxical intervention and additional subject comments were solicited. Content analysis of the responses was made. Health care consumers had mixed responses to the consent form. While the consent form served as an obstacle for some consumers, many were willing to sign the consent form and accept treatment even though they had internal reservations and questions. Appropriateness of the consent form format is discussed.

  15. Arp 202: a TDG formed in a parent's extended dark matter halo?

    Science.gov (United States)

    Scott, T. C.; Lagos, P.; Ramya, S.; Sengupta, C.; Paudel, S.; Sahu, D. K.; Misra, K.; Woo, J.-H.; Sohn, B. W.

    2018-03-01

    We report on H α + [N II] imaging of the Arp 202 interacting pair and its tidal dwarf galaxy (TDG) candidate as well as a GMOS long slit spectrum from the TDG candidate, observed with the Gemini North telescope. Our H α + [N II] imaging reveals the TDG to have an elongated structure, ˜ 1.9 kpc in length with the two principal star-forming knots at either end. Our observations also show the TDG candidate has a recessional VH α ˜ 3032 km s-1, within 100 km s-1 of the parent pair's mean velocity and an oxygen abundance of 12+log(O/H) = 8.10±0.41. The TDG's oxygen abundance is in good agreement with that of a star-forming region in NGC 2719A, one of the parent galaxies, which has an estimated oxygen abundance of 12+log(O/H) = 8.05 ± 0.41. The TDG's VH α and oxygen abundance confirm previous results validating the candidate as a TDG. The absence of detectable emission from the TDG in Spitzer 3.6 and 4.5 μm images together with the lack of absorption lines and weak continuum in the spectrum is consistent with absence the of an old population (≳0.5 Gyr). The location of the TDG within the interaction debris and the absence of indicators of an old stellar population in the TDG is consistent with a scenario in which the TDG is formed from H I stripped from the parent galaxies and within the extended dark matter halo of one of the parents as proposed by Bournaud et al. and Duc et al.

  16. Legal protection of informed consent of minors.

    Science.gov (United States)

    Osuna, Eduardo

    2010-06-01

    One of the pillars of healthcare provision is respect for the autonomy of the patient's wishes, which is given substance by the process of obtaining informed consent. Minors deserve special protection, entitled to basic rights and increasingly autonomous as they develop. In certain situations, minors are deemed matures and able to consent to treatment without the involvement of a parent or guardian. The assessment of competence would be based on the child's functional ability, not on age or outcome of the decision. This manuscript includes a brief analysis of legal perspectives on informed consent of minors, and minors' capacities to make medical decisions. Remaining questions of how to evaluate capacity and balance parental and minor autonomy are explored. Considerations on informed consent in different situations as refusing treatment and termination of pregnancy by female children are analyzed.

  17. From Informed Consent to Negotiated Consent.

    Science.gov (United States)

    Moody, Harry R.

    1988-01-01

    Considers informed consent standard inadequate for insuring autonomy in long term care. Argues for complex standard of "negotiated consent." Illuminates philosophical argument by qualitative data from interviews with physicians, nurses, and social workers in nursing homes, which demonstrated continuum of interventions ranging from…

  18. Informed Consent and Routinisation

    DEFF Research Database (Denmark)

    Ploug, Thomas; Holm, Søren

    2013-01-01

    provide evidence of the routinisation of informed consent in various types of interaction on the internet; among these, the routinisation of consent to the exchange of health related information. We also provide evidence that the extent of the routinisation of informed consent is dependent...

  19. Value of informed consent in surgical orthodontics

    NARCIS (Netherlands)

    Brons, S.; Becking, A.G.; Tuinzing, D.B.

    2009-01-01

    PURPOSE: Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation,

  20. Value of informed consent in surgical orthodontics

    NARCIS (Netherlands)

    Brons, S.; Becking, A.G.; Tuinzing, D.B.

    2009-01-01

    Purpose: Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation,

  1. Value of informed consent in surgical orthodontics.

    NARCIS (Netherlands)

    Brons, S.; Becking, A.G.; Tuinzing, D.B.

    2009-01-01

    PURPOSE: Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation,

  2. Value of informed consent in surgical orthodontics

    NARCIS (Netherlands)

    Brons, Sander; Becking, Alfred G.; Tuinzing, D. Bram

    2009-01-01

    Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation, attention was

  3. Where no consent = death.

    Science.gov (United States)

    1977-01-01

    Men must be made to understand the value of family planning - particularly in societies where men hold the power of decision in the family. Dr. Kotha Pannikar, chairman of the Kedah Family Planning Association (FPA) in Malaysia, illustrated this point in discussion which followed the Consultation of Medical and Communication Fieldworkers conference in Kuala Lumpur in August, with a story about 1 of her own patients. When the girl, who had a rheumatic heart, was 16, Dr. Pannikar advised the parents that she needed cardiac surgery if she were to be a healthy wife and mother. But the parents lived some distance from Dr. Pannikar's surgery and did not heed the advice. The girl was married to a carpenter from a traditional Chinese family, in which "the man is lord and master." Her new home had no piped water, and in additional to normal domestic tasks she had to carry water from a source 1 1/2 miles agay. In the 7th month of her 1st pregnancy, she went into cardiac failure. After the 3rd pregnancy and a 3rd cardiac failure, Dr. Pannikar tried to arrange a sterilization "but we could not get consent - her husband refused to turn up at the hospital." When the girl was admitted to hospital 6 months into her 4th pregnancy, Dr. Pannikar got hold of her patient's mother-in-law. "I told her if she wanted a servant in the house, it was easy to get one. But no servant would look after her grandchildren the way their mother would. I told her if she wanted to save the girl's life she had better speak to her son." During the 4th delivery, the girl went into cardiac arrest and spent 2 weeks in intensive care. The mother-in-law prevailed upon her son to at least consent, and the girl was sterilized before she left hospital. But "it was a very near thing," Dr. Pannikar recalls "and it wouldn't have happened if the husband had felt he was responsible in parenthood." The Kedah FPA makes special efforts to reach men. Dr. Pannikar herself talks to men's organizations like the Lions and

  4. Relationship of soil potassium forms with maize potassium contents in soils derived from different parent materials

    Directory of Open Access Journals (Sweden)

    Rashid Mehmood Butt

    2017-06-01

    Full Text Available Understanding of soil potassium (K dynamics is essential for sustainable crop production. Bioavailability of K depends on forms and distribution within the soil profile. The objectives of this research were to determine which soil K forms control the maize (Zea mays K contents and compare the extracting capability of sodium tetraphenylborate (NaTPB with ammonium acetate (NH4OAc method. Nine soils representing three different parent materials, i.e. loess, sandstone and shale were sampled at three surface genetic horizons. Within each parent material, three soils at varying level of development were selected. Besides basic soil parameters, K was fractioned into water soluble K, exchangeable K, non-exchangeable K, and NaTPB-extracted K. The maize was sown in pots having 2 kg soil from each genetic horizon. Crop was harvested at seven weeks and plant was analysed for K contents. Results show that NaTPB-extracted K gave best correlation as compared to NH4OAc method. This conveys that a non-exchangeable K portion that becomes available to plants can be better estimated by NaTPB method than NH4OAc extraction.

  5. Informed Consent in Dentistry.

    Science.gov (United States)

    Reid, Kevin I

    2017-03-01

    A review of literature regarding informed consent in dentistry reveals a paucity of information and minimal scholarship devoted to this subject. But this begs the question about informed consent somehow being different for dentistry than for medicine or other healthcare delivery. My account draws distinctions where appropriate but is rooted in the premise that informed consent is an ethical construct applicable to vulnerable people as patients independent of what type of treatment or body part being considered. This paper highlights the crucial importance of the process of informed consent and refusal in dentistry, underscoring its important place in oral healthcare. This paper will not address the unique circumstances involving consent in those without capacity or focus on informed consent in the research setting; our focus will be on those patients with full decisionmaking capacity in the clinical setting. I will emphasize the importance of disclosure of treatment options and highlight the benefits of shared-decision-making in the informed consent process.

  6. The accompanying adult: authority to give consent in the UK.

    Science.gov (United States)

    Lal, Seema Madhur Lata; Parekh, Susan; Mason, Carol; Roberts, Graham

    2007-05-01

    Children may be accompanied by various people when attending for dental treatment. Before treatment is started, there is a legal requirement that the operator obtain informed consent for the proposed procedure. In the case of minors, the person authorized to give consent (parental responsibility) is usually a parent. To ascertain if accompanying persons of children attending the Department of Paediatric Dentistry at the Eastman Dental Hospital, London were empowered to give consent for the child's dental treatment. A total of 250 accompanying persons of children attending were selected, over a 6-month period. A questionnaire was used to establish whether the accompanying person(s) were authorized to give consent. The study showed that 12% of accompanying persons had no legal authority to give consent for the child's dental treatment. Clinicians need to be aware of the status of persons accompanying children to ensure valid consent is obtained.

  7. Sirenomelia (mermaid syndrome): an infant from parents who used a special form of snuff.

    Science.gov (United States)

    Taghavi, M M; Jafari Naveh, H R; Shariati, M; Morteza Zade, F

    2009-05-01

    We report the first case of a fetus with sirenomelia or mermaid syndrome, whose Afghanian parents were heavy user of a special form of snuff. The case was diagnosed as a mermaid syndrome but some of the features were common to both symmelia dipus and symmelia apus, for example, the single lower extremity had the normal femur, tibia and fibula, but the single foot was rotated medially. The digestive tube ended to a massive closed saclike structure and the anus was absence. The external genital organs were rudiment and the normal testes were undescended. Aorta was divided to branches, such that the external iliac arteries were very small in comparison to the internal iliac arteries. Inferior Vena cava was placed on to the left side of the aorta and unlike the majority of reported mermaid syndrome, the bladder was present. So, the researchers believe that the present case is a rare variant of the mermaid syndrome.

  8. 34 CFR 300.9 - Consent.

    Science.gov (United States)

    2010-07-01

    ... SERVICES, DEPARTMENT OF EDUCATION ASSISTANCE TO STATES FOR THE EDUCATION OF CHILDREN WITH DISABILITIES... parent revokes consent in writing for their child's receipt of special education services after the child... amend the child's education records to remove any references to the child's receipt of special education...

  9. Testing Whether and when Parent Alcoholism Uniquely Affects Various Forms of Adolescent Substance Use

    Science.gov (United States)

    Hussong, Andrea M.; Huang, Wenjing; Serrano, Daniel; Curran, Patrick J.; Chassin, Laurie

    2012-01-01

    The current study examined the distal, proximal, and time-varying effects of parents' alcohol-related consequences on adolescents' substance use. Previous studies show that having a parent with a lifetime diagnosis of alcoholism is a clear risk factor for adolescents' own substance use. Less clear is whether the timing of a parent's…

  10. The Newborn Behavioral Observations (NBO) System as a Form of Intervention and Support for New Parents

    Science.gov (United States)

    Nugent, J. Kevin

    2015-01-01

    The period covering the first 3 months of life consists of a series of pivotal, life-changing transitions for the infant, for the parents, and for the emerging parent-child relationship. The Newborn Behavioral Observations (NBO) system is a relationship-based tool that offers individualized information to parents about their baby's communication…

  11. A survey on surgeons' perceived quality of the informed consent process in a Swiss paediatric surgery unit.

    Science.gov (United States)

    Guinand, Julie; Gapany, Christophe; Simon, Jeanne-Pascale; Wasserfallen, Jean-Blaise; Joseph, Jean-Marc

    2015-01-01

    To evaluate the levels of satisfaction and opinions on the usefulness of the informed consent form currently in use in our Paediatric Surgery Department. Qualitative study carried out via interviews of senior paediatric surgeons, based on a questionnaire built up from reference criteria in the literature and public health law. Physicians with between 2 and 35 years experience of paediatric surgery, with a participation rate of 92 %, agreed on the definition of an informed consent form, were satisfied with the form in use and did not wish to modify its structure. The study revealed that signing the form was viewed as mandatory, but meant different things to different participants, who diverged over whom that signature protected. Finally, all respondents were in agreement over what information was necessary for parents of children requiring surgery. Paediatric surgeons seemed to be satisfied with the informed consent form in use. Most of them did not identify that the first aim of the informed consent form is to give the patient adequate information to allow him to base his consent, which is a legal obligation, the protection of physicians by the formalisation and proof of the informed consent being secondary. Few surgeons brought up the fact that the foremost stakeholder in paediatric surgery are the children themselves and that their opinions are not always sought. In the future, moving from informed consent process to shared decision-making, a more active bidirectional exchange may be strongly considered. Involving children in such vital decisions should become the norm while keeping in mind their level of maturity.

  12. Parent Management

    DEFF Research Database (Denmark)

    Knudsen, Hanne

    2007-01-01

    and parents say given these assumptions? Which management responsibility is addressed through such training of the difficult conversation?  My conclusions are, briefly, that the difficult conversation is more correctly to be called an impossible conversation. It is an asking for the parent's consent...

  13. A primary microcephaly protein complex forms a ring around parental centrioles.

    Science.gov (United States)

    Sir, Joo-Hee; Barr, Alexis R; Nicholas, Adeline K; Carvalho, Ofelia P; Khurshid, Maryam; Sossick, Alex; Reichelt, Stefanie; D'Santos, Clive; Woods, C Geoffrey; Gergely, Fanni

    2011-10-09

    Autosomal recessive primary microcephaly (MCPH) is characterized by a substantial reduction in prenatal human brain growth without alteration of the cerebral architecture and is caused by biallelic mutations in genes coding for a subset of centrosomal proteins. Although at least three of these proteins have been implicated in centrosome duplication, the nature of the centrosome dysfunction that underlies the neurodevelopmental defect in MCPH is unclear. Here we report a homozygous MCPH-causing mutation in human CEP63. CEP63 forms a complex with another MCPH protein, CEP152, a conserved centrosome duplication factor. Together, these two proteins are essential for maintaining normal centrosome numbers in cells. Using super-resolution microscopy, we found that CEP63 and CEP152 co-localize in a discrete ring around the proximal end of the parental centriole, a pattern specifically disrupted in CEP63-deficient cells derived from patients with MCPH. This work suggests that the CEP152-CEP63 ring-like structure ensures normal neurodevelopment and that its impairment particularly affects human cerebral cortex growth.

  14. Differentiating pedogenesis from diagenesis in early terrestrial paleoweathering surfaces formed on granitic composition parent materials

    Science.gov (United States)

    Driese, S.G.; Medaris, L.G.; Ren, M.; Runkel, Anthony C.; Langford, R.P.

    2007-01-01

    Unconformable surfaces separating Precambrian crystalline basement and overlying Proterozoic to Cambrian sedimentary rocks provide an exceptional opportunity to examine the role of primitive soil ecosystems in weathering and resultant formation of saprolite (weathered rock retaining rock structure) and regolith (weathered rock without rock structure), but many appear to have been affected by burial diagenesis and hydrothermal fluid flow, leading some researchers to discount their suitability for such studies. We examine one modern weathering profile (Cecil series), four Cambrian paleoweathering profiles from the North American craton (Squaw Creek, Franklin Mountains, Core SQ-8, and Core 4), one Neoproterozoic profile (Sheigra), and one late Paleoproterozoic profile (Baraboo), to test the hypothesis that these paleoweathering profiles do provide evidence of primitive terrestrial weathering despite their diagenetic and hydrothermal overprinting, especially additions of potassium. We employ an integrated approach using (1) detailed thin-section investigations to identify characteristic pedogenic features associated with saprolitization and formation of well-drained regoliths, (2) electron microprobe analysis to identify specific weathered and new mineral phases, and (3) geochemical mass balance techniques to characterize volume changes during weathering and elemental gains and losses of major and minor elements relative to the inferred parent materials. There is strong pedogenic evidence of paleoweathering, such as clay illuviation, sepic-plasmic fabrics, redoximorphic features, and dissolution and alteration of feldspars and mafic minerals to kaolinite, gibbsite, and Fe oxides, as well as geochemical evidence, such as whole-rock losses of Na, Ca, Mg, Si, Sr, Fe, and Mn greater than in modern profiles. Evidence of diagenesis includes net additions of K, Ba, and Rb determined through geochemical mass balance, K-feldspar overgrowths in overlying sandstone sections, and

  15. Consent for pediatric anesthesia: an observational study.

    Science.gov (United States)

    Lagana, Zoe; Foster, Andrew; Bibbo, Adriana; Dowling, Kate; Cyna, Allan M

    2012-08-01

    Informed consent prior to anesthesia is an important part of the pediatric pre-anesthetic consultation. This study aimed to observe and identify the number and nature of the anesthesia risks considered and communicated to parents/guardians and children during the pediatric informed consent process on the day of elective surgery. A convenience sample of anesthetists had their pre-anesthesia consultations voice recorded, prior to elective surgery, during a 4-month period at the largest tertiary referral centre for pediatric care in South Australia. A data collection form was used to note baseline demographic data, and voice recording transcripts were independently documented by two researchers and subsequently compared for accuracy regarding the number and nature of risks discussed. Of the 96 voice recordings, 91 (92%) were suitable for the analysis. The five most commonly discussed risks were as follows: nausea and vomiting (36%); sore throat (35%); allergy (29%); hypoxia (25%); and emergence delirium (19%). Twenty-seven pre-anesthetic consultations (30%) were found to have had no discussion of anesthetic risk at all while a further 23 consultations (26%) incorporated general statements inferring that anesthesia carried risks, but with no elaboration about their nature, ramifications or incidence. The median number of risks (IQR) specifically mentioned per consultation was higher, 3 (1) vs 1 (1), P anesthesia experience odds ratio 0.34, 95% CI [0.13, 0.87], P = 0.025. The pediatric anesthesia risk discussion is very variable. Trainees tend to discuss more specific risks than consultants and a patient's previous experience of anesthesia was associated with a more limited discussion of anesthesia risk. © 2011 Blackwell Publishing Ltd.

  16. Satisfying the needs of Japanese cancer patients: a comparative study of detailed and standard informed consent documents.

    Science.gov (United States)

    Sato, Keiko; Watanabe, Toru; Katsumata, Noriyuki; Sato, Tosiya; Ohashi, Yasuo

    2014-02-01

    Simplified informed consent forms have been successful in improving patient satisfaction and decreasing patient anxiety. However, unsolved problems remain about whether these documents improve comprehension and satisfaction of patients with standard literacy skills. s To investigate whether a detailed consent form explaining the key elements of informed consent, in comparison to a standard consent form, would increase the comprehension and satisfaction of adult cancer patients. Patients who were eligible for the National Surgical Adjuvant Study of Breast Cancer (protocol 01(N-SAS/BC-01)) were randomly selected to receive one of the following four versions: detailed document with graphics, detailed document without graphics, standard document with graphics, and standard document without graphics. The forms were written in plain language from the patients' point of view. A total of 85 patients were administered questionnaires via interview to assess levels of comprehension, satisfaction, and anxiety. Patients demonstrated a strong understanding of information regarding treatment and research. Patient comprehension did not differ significantly between the detailed document arms and the standard document arms. Patient satisfaction level increased according to the amount of information presented in the consent form; most patients preferred the detailed document with graphics. Anxiety and accrual rates in the parent study were not affected by informed consent procedures. Findings were limited to adults who had standard literacy skills and may not be generalizable to a population with lower literacy. Informed consent can be a significant experience for a population with standard literacy skills, as long as the document is easily comprehensible. Such information should be provided in a format that corresponds with patient needs, education levels, and preferences.

  17. Forms of Capital and Teachers' Views of Collaboration and Threat Relations with Parents in Israeli Schools

    Science.gov (United States)

    Addi-Raccah, Audrey; Grinshtain, Yael

    2017-01-01

    Neo-liberal ideologies have given parents influence over education. This requires teachers to find ways to engage with parents and use resources for dealing with them. Following Bourdieu's notion of field, in which different groups struggle over resources to maintain their social position, we examine the relations between teachers' attitudes…

  18. Briefs for Parents in Ready-To-Copy Form: English and Spanish. 1993 Compilation.

    Science.gov (United States)

    Howley, Craig; Cahape, Pat

    This document contains English and Spanish versions of six one-page reports for parents. Each brief provides background, suggestions, and sources of further information on educational and child-rearing topics of common interest to parents. Titles are: "The Best and Worst of Times: Support Groups Help" ("Los tiempos mejores y peores: Los grupos…

  19. Informing the Uninformed: Optimizing the Consent Message Using a Fractional Factorial Design

    Science.gov (United States)

    Tait, Alan R.; Voepel-Lewis, Terri; Nair, Vijayan N.; Narisetty, Naveen N.; Fagerlin, Angela

    2013-01-01

    Objective Research information should be presented in a manner that promotes understanding. However, many parents and research subjects have difficulty understanding and making informed decisions. This study was designed to examine the effect of different communication strategies on parental understanding of research information. Participants 640 parents of children scheduled for elective surgery Design Observational study using a fractional factorial design Setting Large tertiary care children's hospital Interventions Parents were randomized to receive information about a hypothetical pain trial presented in one of 16 consent documents containing different combinations of 5 selected communication strategies (i.e., length, readability, processability [formatting], graphical display, and supplemental verbal disclosure). Main outcome measures Parents were interviewed to determine their understanding of the study elements (e.g., protocol, alternatives etc.) and their gist (main point) and verbatim (actual) understanding of the risks and benefits. Results Main effects for understanding were found for processability, readability, message length, use of graphics, and verbal discussion. Consent documents with high processability, 8th grade reading level, and graphics resulted in significantly greater gist and verbatim understanding compared with forms without these attributes (mean difference, 95% CI = 0.57, 0.26–0.88, correct responses out of 7 and 0.54, 0.20–0.88 correct responses out of 4 for gist and verbatim, respectively). Conclusions Results identified several communication strategy combinations that improved parents' understanding of research information. Adoption of these active strategies by investigators, clinicians, IRBs, and study sponsors represents a simple, practical, and inexpensive means to optimize the consent message and enhance parental, participant, and patient understanding. PMID:23700028

  20. Obtaining subjects' consent to publish identifying personal information: current practices and identifying potential issues.

    Science.gov (United States)

    Yoshida, Akiko; Dowa, Yuri; Murakami, Hiromi; Kosugi, Shinji

    2013-11-25

    In studies publishing identifying personal information, obtaining consent is regarded as necessary, as it is impossible to ensure complete anonymity. However, current journal practices around specific points to consider when obtaining consent, the contents of consent forms and how consent forms are managed have not yet been fully examined. This study was conducted to identify potential issues surrounding consent to publish identifying personal information. Content analysis was carried out on instructions for authors and consent forms developed by academic journals in four fields (as classified by Journal Citation Reports): medicine general and internal, genetics and heredity, pediatrics, and psychiatry. An online questionnaire survey of editors working for journals that require the submission of consent forms was also conducted. Instructions for authors were reviewed for 491 academic journals (132 for medicine general and internal, 147 for genetics and heredity, 100 for pediatrics, and 112 for psychiatry). Approximately 40% (203: 74 for medicine general and internal, 31 for genetics and heredity, 58 for pediatrics, and 40 for psychiatry) stated that subject consent was necessary. The submission of consent forms was required by 30% (154) of the journals studied, and 10% (50) provided their own consent forms for authors to use. Two journals mentioned that the possible effects of publication on subjects should be considered. Many journal consent forms mentioned the difficulties in ensuring complete anonymity of subjects, but few addressed the study objective, the subjects' right to refuse consent and the withdrawal of consent. The main reason for requiring the submission of consent forms was to confirm that consent had been obtained. Approximately 40% of journals required subject consent to be obtained. However, differences were observed depending on the fields. Specific considerations were not always documented. There is a need to address issues around the study

  1. Obtaining subjects’ consent to publish identifying personal information: current practices and identifying potential issues

    Science.gov (United States)

    2013-01-01

    Background In studies publishing identifying personal information, obtaining consent is regarded as necessary, as it is impossible to ensure complete anonymity. However, current journal practices around specific points to consider when obtaining consent, the contents of consent forms and how consent forms are managed have not yet been fully examined. This study was conducted to identify potential issues surrounding consent to publish identifying personal information. Methods Content analysis was carried out on instructions for authors and consent forms developed by academic journals in four fields (as classified by Journal Citation Reports): medicine general and internal, genetics and heredity, pediatrics, and psychiatry. An online questionnaire survey of editors working for journals that require the submission of consent forms was also conducted. Results Instructions for authors were reviewed for 491 academic journals (132 for medicine general and internal, 147 for genetics and heredity, 100 for pediatrics, and 112 for psychiatry). Approximately 40% (203: 74 for medicine general and internal, 31 for genetics and heredity, 58 for pediatrics, and 40 for psychiatry) stated that subject consent was necessary. The submission of consent forms was required by 30% (154) of the journals studied, and 10% (50) provided their own consent forms for authors to use. Two journals mentioned that the possible effects of publication on subjects should be considered. Many journal consent forms mentioned the difficulties in ensuring complete anonymity of subjects, but few addressed the study objective, the subjects’ right to refuse consent and the withdrawal of consent. The main reason for requiring the submission of consent forms was to confirm that consent had been obtained. Conclusion Approximately 40% of journals required subject consent to be obtained. However, differences were observed depending on the fields. Specific considerations were not always documented. There is a need

  2. Modulation of repetitive genes in the parent forms of heterozygous corn hybrids

    International Nuclear Information System (INIS)

    Gilyazetdinov, S.Ya.; Zimnitskii, A.N.; Yakhin, I.A.; Bikbaeva, E.S.

    1987-01-01

    The number of copies of the genes of high-molecular-weight rRNA, 5 S r RNA, and certain other families of repetitive sequences of DNA in the genome of different forms of corn is not coordinated but is stably inherited in the same strains. The authors present the results of their investigations into the repetition of the genes of tRNA, 5 S rRNA, histones, and the controlling element Ds of corn for the highly heterozygous hybrid Slava (VIR 44 x VIR 38), the medium-heterozygous hybrid Svetoch (VIR 40 x VIR 43), the low heterozygous hybrid Iskra (VIR 26 x VIR 27), and their parent strains. The relative content of these sequences was studied by the molecular hybridization of DNA immobilized on nitrocellulose filters with [ 125 I]tRNA labeled in vitro, 5 S rRNA, histone DNA of Drosophila, and the Ds-element of corn. The DNA preparations were isolated from the zones of the meristem (1.5-2mm), elongation (4-5mm), differentiation of the roots (3 cm), of 3-4 day seedlings, and from isolated embryos of 4 h and 24 h seedlings. The DNA of the embryos immobilized on the filters was preliminarily incubated with unlabeled high-molecular-weight rRNA in the experiments with tRNA and 5 S rRNA, while when histone DNA and the Ds element of corn were used in the hybridization reaction, it was preliminary incubated with plasmid DNA

  3. [Schizophrenia and informed consent to research].

    Science.gov (United States)

    Fovet, T; Amad, A; Thomas, P; Jardri, R

    2015-10-01

    Informed consent to research remains a complex issue, while sometimes staying difficult to obtain, even in the general population. This problem may be maximized with patients suffering from schizophrenia. This paper summarizes available data in the literature about informed consent for research involving patients suffering from schizophrenia. Medline and Google Scholar searches were conducted using the following MESH terms: schizophrenia, informed consent and research. Studies using dedicated standardized scales (e.g. MacCAT-CR) revealed a decrease in the capacity to consent of patients with schizophrenia when compared with healthy individuals. Keeping in mind that schizophrenia is an heterogeneous disorder, patients with the lowest insight as well as those with the most severe cognitive symptoms appeared more impaired in their capacity to consent. Such a poor capacity to understand and consent to trials was shown linked with alterations in decision-making. For these specific patients, interventions may be set up to increase their capacity to consent. Various strategies were proposed: enhanced consent forms, extended discussion, test/feedback method or multimedia interventions. Among them, interventions relying on communication and the growing field of information technologies (e.g. web-based tools) seem promising. Finally, associations grouping families and patients (like the French Association UNAFAM) may facilitate the involvement of patients in research programs with safer conditions. Patients suffering from schizophrenia appear able to consent to research programs when suitable interventions are proposed. Further studies are now needed to optimize and individualize such interventions. Copyright © 2014 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

  4. Simplifying informed consent for biorepositories: stakeholder perspectives.

    Science.gov (United States)

    Beskow, Laura M; Friedman, Joëlle Y; Hardy, N Chantelle; Lin, Li; Weinfurt, Kevin P

    2010-09-01

    Complex and sometimes controversial information must be conveyed during the consent process for participation in biorepositories, and studies suggest that consent documents in general are growing in length and complexity. As a first step toward creating a simplified biorepository consent form, we gathered data from multiple stakeholders about what information was most important for prospective participants to know when making a decision about taking part in a biorepository. We recruited 52 research participants, 12 researchers, and 20 institutional review board representatives from Durham and Kannapolis, NC. These subjects were asked to read a model biorepository consent form and highlight sentences they deemed most important. On average, institutional review board representatives identified 72.3% of the sentences as important; researchers selected 53.0%, and participants 40.4% (P = 0.0004). Participants most often selected sentences about the kinds of individual research results that might be offered, privacy risks, and large-scale data sharing. Researchers highlighted sentences about the biorepository's purpose, privacy protections, costs, and participant access to individual results. Institutional review board representatives highlighted sentences about collection of basic personal information, medical record access, and duration of storage. The differing mandates of these three groups can translate into widely divergent opinions about what information is important and appropriate to include a consent form. These differences could frustrate efforts to move simplified forms--for biobanking as well as for other kinds of research--into actual use, despite continued calls for such forms.

  5. Informed consent: using a structured interview changes patients' attitudes towards informed consent.

    Science.gov (United States)

    Dawes, P J; O'Keefe, L; Adcock, S

    1993-09-01

    Patients want to know more about their condition and its proposed treatment. Gaining patients' confidence before treatment reduces the changes of their seeking legal redress for an unexpected outcome. As part of a prospective study of informed consent for surgery we have assessed the attitudes of patients towards informed consent when different types of consent interview are used. We found that most patients are happy to do as their doctor advises but think the informal consent interview is important because it gives them information; they also want to know about most, but not all, complications of the procedure. One quarter worried about the anaesthetic, about one eighth worried about 'not waking up' and similar proportions worried about complications and other things such as pain and nausea. Most patients think that the consent form is a legal document. In addition patients who had an informal interview felt obliged to sign the consent form and thought it had medicolegal implications. In contrast those who had a structured interview felt less obliged to sign the consent form and more involved in the decision to operate.

  6. Consent ain't anything

    DEFF Research Database (Denmark)

    Di Nucci, Ezio

    2016-01-01

    I argue against various versions of the 'attitude' view of consent and of the 'action' view of consent: I show that neither an attitude nor an action is either necessary or sufficient for consent. I then put forward a different view of consent based on the idea that, given a legitimate epistemic ...

  7. Parents.

    Science.gov (United States)

    Hurst, Hunter, Ed.; And Others

    1986-01-01

    This document contains the fifth volume of "Today's Delinquent," an annual publication of the National Center for Juvenile Justice. This volume deals with the issue of the family and delinquency, examining the impact of parental behavior on the production of delinquent behavior. "Parents: Neglectful and Neglected" (Laurence D. Steinberg) posits…

  8. Qualitative evaluation of a deferred consent process in paediatric emergency research: a PREDICT study

    OpenAIRE

    Furyk, Jeremy; McBain-Rigg, Kristin; Watt, Kerrianne; Emeto, Theophilus I; Franklin, Richard C; Franklin, Donna; Schibler, Andreas; Dalziel, Stuart R; Babl, Franz E; Wilson, Catherine; Phillips, Natalie; Ray, Robin

    2017-01-01

    Background A challenge of conducting research in critically ill children is that the therapeutic window for the intervention may be too short to seek informed consent prior to enrolment. In specific circumstances, most international ethical guidelines allow for children to be enrolled in research with informed consent obtained later, termed deferred consent (DC) or retrospective consent. There is a paucity of data on the attitudes of parents to this method of enrolment in paediatric emergency...

  9. Informed consent in psychotherapy.

    Science.gov (United States)

    Beahrs, J O; Gutheil, T G

    2001-01-01

    The authors sought a rational approach to implementing informed consent within the practice of psychotherapy. The history of informed consent in psychotherapy was reviewed to define a common synthesis that maximizes the potential benefits and minimizes the potential hazards. The benefits of informed consent in psychotherapy include fostering a positive treatment outcome through enhancing patient autonomy, responsibility, and self-therapeutic activity; lessening the risks of regressive effects and therapist liability; and helping the practice of psychotherapy extend beyond particular parochialisms by providing checks and balances on therapist judgments. The hazards include the unpredictability of interactional outcomes and the possibilities of replacing positive expectancy with negative suggestion, replacing a therapeutic alliance with a legalistic stance, and misimplying that patients are passive recipients. Practical implementation of informed consent in psychotherapy must balance such tensions in service of optimal treatment. As a guiding principle, the authors recommend that psychotherapists convey to a prospective patient information that is material to the particular patient's decision. The level of detail needed in informed consent discussions varies directly with the cost and risks of the proposed treatment, the presence of viable alternatives and their relative grounding in scientific data and professional acceptance, and the presence of significant controversy. Unresolved is the question of how to address problematic or controversial psychotherapeutic trends that temporarily enjoy wide professional support.

  10. ANALYSIS OF THE FORMS OF PLACEMENT OF THE ORPHANS AND DEPRIVED OF PARENTAL CARE CHILDREN AND ITS EFFECTIVENESS IN UKRAINE

    Directory of Open Access Journals (Sweden)

    Svitlana Mykoluk

    2015-11-01

    Full Text Available The purpose. This article is devoted to the systems analysis of theoretical and practical aspects of forming of social security system of orphans and children deprived of parental care. Methodology. Covered a topical issue – placement of the orphans and deprived of parental care children. Characterized each form of the children placement emphasizing their fundamental difference and problem questions, consequences and lacks of such determination, are lighted up. Results. Offered a new approach to the forms of the children placement. Modern realities of the state development need considerable rethinking of essence of social security of children, and accordingly raising of new tasks which this system is called to decide, and mechanisms of realization of social security of children, which must be adequate to the markets conditions. Essence and functions of population social security of orphans and children deprived of parental care, are analyzed in the article. Practical meaning. Analysis of management activity in the field of social arrangement of children tells that the main its result is the arrangement of orphans and children deprived of parental care into the different forms of arrangements (adoption, guardianship (trusteeship, foster home, orphanage of family type, care home. We offer to consider the process of quality estimating with help of indicators of efficiency in depends on the priority in arrangement form of child (efficiency of management activity in the questions of adoption (Ead, efficiency of management activity in the questions of guardianship (trusteeship (Eg, efficiency of management activity in the questions of foster homes creation (Efh, efficiency of management activity in the questions of creation family type orphanage, (Ecfto efficiency of management activity in the questions of care homes creation (Echcand general efficiency of management activity in the field of social arrangement of children (Earr. Value

  11. Challenges to obtaining parental permission for child participation in a school-based waterpipe tobacco smoking prevention intervention in Qatar.

    Science.gov (United States)

    Nakkash, Rima T; Al Mulla, Ahmad; Torossian, Lena; Karhily, Roubina; Shuayb, Lama; Mahfoud, Ziyad R; Janahi, Ibrahim; Al Ansari, Al Anoud; Afifi, Rema A

    2014-09-30

    Involving children in research studies requires obtaining parental permission. A school-based intervention to delay/prevent waterpipe use for 7th and 8th graders in Qatar was developed, and parental permission requested. Fifty three percent (2308/4314) of the parents returned permission forms; of those 19.5% of the total (840/4314) granted permission. This paper describes the challenges to obtaining parental permission. No research to date has described such challenges in the Arab world. A random sample of 40 schools in Doha, Qatar was selected for inclusion in the original intervention. Permission forms were distributed to parents for approval of their child's participation. The permission forms requested that parents indicate their reasons for non-permission if they declined. These were categorized into themes. In order to understand reasons for non-permission, interviews with parents were conducted. Phone numbers of parents were requested from the school administration; 12 of the 40 schools (30%) agreed to provide the contact information. A random sample of 28 parents from 12 schools was interviewed to reach data saturation. Thematic analysis was used to analyze their responses. Reasons for non-permission documented in both the forms and interviews included: poor timing; lack of interest; the child not wanting to participate; and the child living in a smoke-free environment. Interviews provided information on important topics to include in the consent forms, parents' decision-making processes regarding their child's participation, and considerations for communicating with parents. Many parents also indicated that this was the first time they had been asked to give an informed consent for their child's participation in a study. Results indicate that more attention needs to be given to the informed parental consent process. Researchers should consider enhancing both the methods of communicating information as well the specific information provided. Before

  12. Gamma induced chromosomal aberrations in meristem cells of cotton hybrids and their parental forms

    International Nuclear Information System (INIS)

    Kraevoj, S.Ya.; Akhmedova, M.M.; Amirkulov, D.

    1977-01-01

    The effect of gamma quanta on the first mitoses in the small roots of cotton hybrids and their parents results in different frequency of chromosome rearrangements in them. It has been proved that the frequency of chromosome aberrations is different in hybrids and different varieties of cotton. With increase in irradiation doses (from 10 to 30 kR) the frequency of chromosome aberrations goes up in all varieties and hybrids studies. The type of chromosome rearrangements in hybrids and their parents depends on the irradiation dose

  13. A descriptive study of consent documentation.

    LENUS (Irish Health Repository)

    Murphy, K

    2011-09-01

    The aim of this study was to observe the error rate in the consent process of a university hospital and to illicit the opinions of the consenting doctors on the process. A prospective observational review of theatre consent forms was performed along with an anonymous survey of non-consultant hospital doctors (NCHD\\'s). No potential risks were documented in 95.3% of the 64 scrutinized consents and late alterations were required in 9%. Respondents to the NCHD survey estimated that they were unsure of the procedure or risks involved in an average of 29% of occasions. Interns admitted to being unsure of the details of the procedure in almost a third (32%) of cases, making them less well informed than their senior colleagues (p=0.024). This study highlights the difficulties encountered by consenting doctors, an issue which may lead to patient dissatisfaction, threaten the efficient running of a surgical unit and potentially expose its staff to avoidable litigation. It also recommends the use of multimedia adjuncts to facilitate both patient and doctor education in the consent process.

  14. [The informed consent in international clinical trials including developing countries].

    Science.gov (United States)

    Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

    2008-01-01

    The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.

  15. Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level.

    Science.gov (United States)

    Kim, Eun Jin; Kim, Su Hyun

    2015-06-01

    This study evaluated the effect of a simplified informed consent form for clinical trials on the understanding and efficacy of informed consent information across health literacy levels. A total of 150 participants were randomly assigned to one of two groups and provided with either standard or simplified consent forms for a cancer clinical trial. The features of the simplified informed consent form included plain language, short sentences, diagrams, pictures, and bullet points. Levels of objective and subjective understanding were significantly higher in participants provided with simplified informed consent forms relative to those provided with standard informed consent forms. The interaction effects between type of consent form and health literacy level on objective and subjective understanding were nonsignificant. Simplified informed consent was effective in enhancing participant's subjective and objective understanding regardless of health literacy. © The Author(s) 2015.

  16. Validity and Reliability of the Turkish Version for DSM-5 Level 2 Anger Scale (Child Form for Children Aged 11-17 Years and Parent Form for Children Aged 6-17 Years).

    Science.gov (United States)

    Yalin Sapmaz, Şermin; Özek Erkuran, Handan; Yalin, Nefize; Önen, Özlem; Öztekin, Siğnem; Kavurma, Canem; Köroğlu, Ertuğrul; Aydemir, Ömer

    2017-12-01

    This study aimed to assess the validity and reliability of the Turkish version of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Level 2 Anger Scale. The scale was prepared by translation and back translation of DSM-5 Level 2 Anger Scale. Study groups consisted of a clinical sample of cases diagnosed with depressive disorder and treated in a child and adolescent psychiatry unit and a community sample. The study was continued with 218 children and 160 parents. In the assessment process, child and parent forms of DSM-5 Level 2 Anger Scale and Children's Depression Inventory and Strengths and Difficulties Questionnaire-Parent Form were used. In the reliability analyses, the Cronbach alpha internal consistency coefficient values were found very high regarding child and parent forms. Item-total score correlation coefficients were high and very high, respectively, for child and parent forms indicating a statistical significance. As for construct validity, one factor was maintained for each form and was found to be consistent with the original form of the scale. As for concurrent validity, the child form of the scale showed significant correlation with Children's Depression Inventory, while the parent form showed significant correlation with Strengths and Difficulties Questionnaire-Parent Form. It was found that the Turkish version of DSM-5 Level 2 Anger Scale could be utilized as a valid and reliable tool both in clinical practice and for research purposes.

  17. CTEPP-OH DATA COLLECTED ON FORM 04: PARENT PRE-MONITORING QUESTIONNAIRE

    Science.gov (United States)

    This data set contains data concerning the individuals living in the home and the possible sources and routes of exposure, and the activity patterns of the preschool children for CTEPP-OH. The parent was asked questions related to the age of their home; frequency of cleaning carp...

  18. CTEPP NC DATA COLLECTED ON FORM 04: PARENT PRE-MONITORING QUESTIONNAIRE

    Science.gov (United States)

    This data set contains data concerning the individuals living in the home and the possible sources and routes of exposure, and the activity patterns of the preschool children. The parent was asked questions related to the age of their home; frequency of cleaning carpets, rugs, an...

  19. Informed consent comprehension in African research settings.

    Science.gov (United States)

    Afolabi, Muhammed O; Okebe, Joseph U; McGrath, Nuala; Larson, Heidi J; Bojang, Kalifa; Chandramohan, Daniel

    2014-06-01

    Previous reviews on participants' comprehension of informed consent information have focused on developed countries. Experience has shown that ethical standards developed on Western values may not be appropriate for African settings where research concepts are unfamiliar. We undertook this review to describe how informed consent comprehension is defined and measured in African research settings. We conducted a comprehensive search involving five electronic databases: Medline, Embase, Global Health, EthxWeb and Bioethics Literature Database (BELIT). We also examined African Index Medicus and Google Scholar for relevant publications on informed consent comprehension in clinical studies conducted in sub-Saharan Africa. 29 studies satisfied the inclusion criteria; meta-analysis was possible in 21 studies. We further conducted a direct comparison of participants' comprehension on domains of informed consent in all eligible studies. Comprehension of key concepts of informed consent varies considerably from country to country and depends on the nature and complexity of the study. Meta-analysis showed that 47% of a total of 1633 participants across four studies demonstrated comprehension about randomisation (95% CI 13.9-80.9%). Similarly, 48% of 3946 participants in six studies had understanding about placebo (95% CI 19.0-77.5%), while only 30% of 753 participants in five studies understood the concept of therapeutic misconception (95% CI 4.6-66.7%). Measurement tools for informed consent comprehension were developed with little or no validation. Assessment of comprehension was carried out at variable times after disclosure of study information. No uniform definition of informed consent comprehension exists to form the basis for development of an appropriate tool to measure comprehension in African participants. Comprehension of key concepts of informed consent is poor among study participants across Africa. There is a vital need to develop a uniform definition for

  20. Click here to consent forever: Expiry dates for informed consent

    Directory of Open Access Journals (Sweden)

    Bart Custers

    2016-01-01

    Full Text Available The legal basis for processing personal data and some other types of Big Data is often the informed consent of the data subject involved. Many data controllers, such as social network sites, offer terms and conditions, privacy policies or similar documents to which a user can consent when registering as a user. There are many issues with such informed consent: people get too many consent requests to read everything, policy documents are often very long and difficult to understand and users feel they do not have a real choice anyway. Furthermore, in the context of Big Data refusing consent may not prevent predicting missing data. Finally, consent is usually asked for when registering, but rarely is consent renewed. As a result, consenting once often implies consent forever. At the same time, given the rapid changes in Big Data and data analysis, consent may easily get outdated (when earlier consent no longer reflects a user’s preferences. This paper suggests expiry dates for consent, not to settle questions, but to put them on the table as a start for further discussion on this topic. Although such expiry dates may not solve all the issues of informed consent, they may be a useful tool in some situations.

  1. Nest site selection and nutritional provision through excreta: a form of parental care in a tropical endogeic earthworm

    Directory of Open Access Journals (Sweden)

    Angel I. Ortiz-Ceballos

    2016-05-01

    Full Text Available Nest construction is a common form of parental care in soil organisms. However, it is unknown whether the tropical earthworm Pontoscolex corethrurus produces nests in soils with low nutritional quality habitats. Here we studied the reproductive behaviour and nest site selection of P. corethrurus, and tested the hypothesis whether P. corethrurus produces more cocoons in habitats with low nutritional quality. In bidimensional terrariums we evaluated the combined effect of the nutritional quality of habitat: (Poor Quality Habitat = PQH, Medium Quality Habitat = MQH, High Quality Habitat = HQH and soil depth (Shallow, Intermediate, Deep in a factorial 32 design. The number and biomass of cocoons, progeny and the production of internal and external excreta were evaluated. The quality habitat and depth of soil and their interaction had a significant effect on nest site construction and the deposition of internal excreta. Pontoscolex corethrurus built a higher amount of nests in the PQH-Intermediate and MQH-Intermediate treatments while more internal excreta were found in the HQH-Intermediate treatment. Offspring biomass was positively associated with internal excreta in the PQH (soil only and MQH (soil + grass treatments, suggesting that this could be a form of parental care. Since P. corethrurus produces more cocoons in low and medium quality habitats, while produces more internal excreta at high quality habitats, there does not seem to be an association between number of offspring and parental care. We suggest P. corethrurus could have two reproductive strategies that act as diversified bet-hedging (do not put all cocoons in one basket behavior in unpredictable environment, and thus build a higher amount of nests in low and medium quality habitats; and another where they produce more internal excreta as a form of parental care in high quality habitats. Parental care in the form of internal excreta may be particularly important in poor and medium

  2. A randomized controlled trial of an electronic informed consent process.

    Science.gov (United States)

    Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

    2014-12-01

    A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

  3. The Role of Social Status of Parental Family in Forming the Background of Antisocial and Prosocial Behavior of a Person

    Directory of Open Access Journals (Sweden)

    Antonov Georgiy Vyacheslavovich

    2014-09-01

    Full Text Available Some results of the man complex research are presented in this article. Genetic, biophysical, biochemical, physiological, psychological and sociological methods of scientific information obtaining were used. This research reveals the ratio of genetic and psychosocial personality components. These components determine the forming of antisocial and prosocial human behavior. An individual set of phenotypic and genetic characteristics is defined in interrelation with sustainable symptoms of complex behaviors and predisposition to it. Methodic recommendations on revealing predisposition to deviant behavior, including aggressive one, written in the obtained results basis. It described the relationship of standard indicators of parental social status of the family in terms of students exhibiting signs of antisocial and prosocial behavior. To identify human predisposition to a certain type of social behavior, depending on the socio-economic status of the parents and family of origin as a whole was analyzed relations numerical values of a number of empirical indicators of social behavior and social status parameters parent families. Revealed that the level of education and activity of parents, as well as the birthplace of the person have a statistically significant effect on his social behavior.

  4. 34 CFR 300.300 - Parental consent.

    Science.gov (United States)

    2010-07-01

    ...; and (iii) Is not required to convene an IEP Team meeting or develop an IEP under §§ 300.320 and 300... related services; and (iv) Is not required to convene an IEP Team meeting or develop an IEP under §§ 300...

  5. Parental smoking and related behaviours influence adolescent tobacco smoking: results from the 2001 New Zealand national survey of 4th form students.

    Science.gov (United States)

    Scragg, Robert; Laugesen, Murray; Robinson, Elizabeth

    2003-12-12

    To investigate whether parental smoking and other parental behaviours are risk factors for smoking in 14- and 15-year-old children. National cross-sectional survey of 14 930 female and 14 341 male 4th form students who answered an anonymous, self-administered questionnaire in November 2001. The effect of both parents smoking on the risk of daily smoking by students varied significantly (p pocket money amount and living in a home where people smoked. Two thirds of daily smoking could be explained by the combined exposure to one or more of the following factors: parental smoking, pocket money >5 dollars per week, and smoking in the house. Parental behaviour is a key determinant of smoking by New Zealand adolescents. Efforts that target the role of parents should be pursued, such as health promotion strategies that advise parents about the possible benefits of banning smoking in the home, limiting pocket money, and not providing cigarettes to their children.

  6. Relationship between Multiple Forms of Maltreatment by a Parent or Guardian and Adolescent Alcohol Use.

    Science.gov (United States)

    Shin, Sunny Hyucksun; Edwards, Erika; Heeren, Timothy; Amodeo, Maryann

    2009-01-01

    This study examined the effect of the co-occurrence of multiple categories of maltreatment on adolescent alcohol use. Data were from the National Longitudinal Study of Adolescent Health which used a nationally representative sample of adolescents (n = 14,078). Among those reporting any maltreatment, over one-third had experienced more than one type of maltreatment. Logistic regression models found that all types or combinations of types of maltreatment except physical-abuse-only were strongly associated with adolescent alcohol use, controlling for age, gender, race, and parental alcoholism. These results add to accumulating evidence that child maltreatment has a deleterious impact on adolescent alcohol use.

  7. Informed consent for braces.

    Science.gov (United States)

    Jharwal, Vikas; Trehan, Mridula; Rathore, Nidhi; Rathee, Pooja; Agarwal, Deepesh; Mathur, Nikunj

    2014-05-01

    The influence of law on the orthodontic profession has greatly increased in the last few decades. Dental law has emerged today as a full-fedged specialty dealing with a variety of areas, like professional negligence, doctor-patient contracts, consumer protection laws, ethics, general and special health legislations and practice regulatory mechanisms. This article highlights the concept of informed consent which is based on the premise that each individual has a right to make decisions concerning his health, disease and treatment. How to cite this article: Jharwal V, Trehan M, Rathore N, Rathee P, Agarwal D, Mathur N. Informed Consent for Braces. Int J Clin Pediatr Dent 2014;7(2):105-108.

  8. Nudging and informed consent.

    Science.gov (United States)

    Cohen, Shlomo

    2013-01-01

    Libertarian paternalism's notion of "nudging" refers to steering individual decision making so as to make choosers better off without breaching their free choice. If successful, this may offer an ideal synthesis between the duty to respect patient autonomy and that of beneficence, which at times favors paternalistic influence. A growing body of literature attempts to assess the merits of nudging in health care. However, this literature deals almost exclusively with health policy, while the question of the potential benefit of nudging for the practice of informed consent has escaped systematic analysis. This article focuses on this question. While it concedes that nudging could amount to improper exploitation of cognitive weaknesses, it defends the practice of nudging in a wide range of other conditions. The conclusion is that, when ethically legitimate, nudging offers an important new paradigm for informed consent, with a special potential to overcome the classical dilemma between paternalistic beneficence and respect for autonomy.

  9. Parental Expressed Emotion During Two Forms of Family-Based Treatment for Adolescent Anorexia Nervosa.

    Science.gov (United States)

    Allan, Erica; Le Grange, Daniel; Sawyer, Susan M; McLean, Louise A; Hughes, Elizabeth K

    2018-01-01

    High parental expressed emotion (EE), reflected by criticism or emotional over-involvement, has been related to poorer outcome in family-based treatment (FBT) for adolescent anorexia nervosa. This study assessed EE in 89 mothers and 64 fathers at baseline and end of treatment in a randomised trial comparing conjoint FBT to parent-focused FBT (PFT). Compared with conjoint FBT, PFT was associated with a decrease in maternal criticism, regardless of adolescent remission. Furthermore, an increase in maternal criticism was more likely to be observed in conjoint FBT (80%) than PFT (20%, p = 0.001). Adolescents of mothers who demonstrated an increase in EE, or remained high in EE, were less likely to remit compared with adolescents for whom EE decreased or remained low (33% and 0% vs. 43% and 50%, p = 0.03). There were no significant effects for paternal EE. The results highlight the importance of considering EE when implementing FBT for adolescents with anorexia nervosa. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association.

  10. Consent in escrow.

    Science.gov (United States)

    Van der Loos, Kiah I; Longstaff, Holly; Virani, Alice; Illes, Judy

    2015-02-01

    Disasters such as flash flooding, mass shootings, and train and airplane accidents involving large numbers of victims produce significant opportunity for research in the biosciences. This opportunity exists in the extreme tails of life events, however, during which decisions about life and death, valuing and foregoing, speed and patience, trust and distrust, are tested simultaneously and abundantly. The press and urgency of these scenarios may also challenge the ability of researchers to comprehensively deliver information about the purposes of a study, risks, benefits, and alternatives. Under these circumstances, we argue that acquiring consent for the immediate use of data that are not time sensitive represents a gap in the protection of human study participants. In response, we offer a two-tiered model of consent that allows for data collected in real-time to be held in escrow until the acute post-disaster window has closed. Such a model not only respects the fundamental tenet of consent in research, but also enables such research to take place in an ethically defensible manner.

  11. Practice variation across consent templates for biobank research. A survey of German biobanks

    Directory of Open Access Journals (Sweden)

    Irene eHirschberg

    2013-11-01

    Full Text Available Introduction: Informed, voluntary, and valid consent from biomaterial donors is a precondi-tion for biobank research. Valid consent protects donors’ rights and helps maintain public trust in biobank research. Harmonisation of consent procedures in biobank research is needed, because of the widely shared vision on national and international networking of biobanks in-cluding data and sample sharing. So far, no study has assessed and compared the content of current consent forms for biobank research. The objective of this study was to perform a con-tent analysis of consent forms in German biobanks. Methods: Based on 10 guidelines for biomedical research, we developed an assessment ma-trix with 41 content issues that are potentially relevant for consent forms in biobank research. This assessment matrix was applied in a thematic text analysis to 30 consent documents of German biobanks identified via the German Biobank Registry in July 2012. Results: Coverage of the 41 items in the assessed consent forms varied widely. For example, the items Right to withdraw consent (without disadvantage, Policy for genetic infor-mation / consent to genetic analyses and International cooperation / transborder use were addressed in 97%, 40% and 23% of all 30 consent forms respectively. The number of items covered by a single consent form ranged from 9 to 36 (22% to 88% out of 41 items.Discussion: Our findings serve as a starting point to reflect upon the spectrum of consent is-sues that must be addressed in biobank research. The findings show that the majority of con-sent forms for German biobanks, if not all, should be improved and harmonised to better sup-port an informed and balanced choice of potential donors and to facilitate networking of bi-obanks. Best practice models for consent forms in biobank research should be developed and biobank operators need to be more aware of relevant consent issues.

  12. Value of informed consent in surgical orthodontics.

    Science.gov (United States)

    Brons, Sander; Becking, Alfred G; Tuinzing, D Bram

    2009-05-01

    Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation, attention was given to all aspects of the treatment. However, because of "insurance-related factors," the need for treatment because of functional reasons was stressed over esthetics. The recall of information given during an informed consent interview before orthognathic surgery was measured using a questionnaire. Patients with a mandibular deficiency with a low mandibular plane angle were questioned after an informed consent interview regarding surgical orthodontic treatment. Esthetics were more frequently and functional problems were less frequently recalled as the reason for operation than was expected. The risk of a change in the sensation of the lower lip by surgery was frequently recalled as a reason to refrain from the operation. The overall recall rate of the possible risks and complications of orthodontic surgery was 40%. No reports were found of comparable research on the preoperative recall after consultation before surgical orthodontic surgery. The aspects of communication that can improve recall must be clarified. A recall rate of 100% seems a utopia, although an arbitrary line is needed to determine the quality of an informed consent interview.

  13. Psychometric qualities of the short form of the self-efficacy for parenting tasks index-toddler scale

    NARCIS (Netherlands)

    Van Rijen, E. H M; Gasanova, N.; Boonstra, A. M.; Huijding, J.

    2014-01-01

    Parental self-efficacy (PSE; parental self-perceived competence in parenting) is known to have considerable impact on parenting quality. Although PSE is particularly under pressure during the turbulent period of toddlerhood, most studies so far have focused on PSE in parents of older children. The

  14. Testing an alternate informed consent process.

    Science.gov (United States)

    Yates, Bernice C; Dodendorf, Diane; Lane, Judy; LaFramboise, Louise; Pozehl, Bunny; Duncan, Kathleen; Knodel, Kendra

    2009-01-01

    One of the main problems in conducting clinical trials is low participation rate due to potential participants' misunderstanding of the rationale for the clinical trial or perceptions of loss of control over treatment decisions. The objective of this study was to test an alternate informed consent process in cardiac rehabilitation participants that involved the use of a multimedia flip chart to describe a future randomized clinical trial and then asked, hypothetically, if they would participate in the future trial. An attractive and inviting visual presentation of the study was created in the form of a 23-page flip chart that included 24 color photographs displaying information about the purpose of the study, similarities and differences between the two treatment groups, and the data collection process. We tested the flip chart in 35 cardiac rehabilitation participants. Participants were asked if they would participate in this future study on two occasions: immediately after the description of the flip chart and 24 hours later, after reading through the informed consent document. Participants were also asked their perceptions of the flip chart and consent process. Of the 35 participants surveyed, 19 (54%) indicated that they would participate in the future study. No participant changed his or her decision 24 hours later after reading the full consent form. The participation rate improved 145% over that of an earlier feasibility study where the recruitment rate was 22%. Most participants stated that the flip chart was helpful and informative and that the photographs were effective in communicating the purpose of the study. Participation rates could be enhanced in future clinical trials by using a visual presentation to explain and describe the study as part of the informed consent process. More research is needed to test alternate methods of obtaining informed consent.

  15. An Alternative Consent Process for Minimal Risk Research in the ICU.

    Science.gov (United States)

    Terry, Melissa A; Freedberg, Daniel E; Morris, Marilyn C

    2017-09-01

    Seeking consent for minimal risk research in the ICU poses challenges, especially when the research is time-sensitive. Our aim was to determine the extent to which ICU patients or surrogates support a deferred consent process for a minimal risk study without the potential for direct benefit. Prospective cohort study. Five ICUs within a tertiary care hospital. Newly admitted ICU patients 18 years old or older. We administered an eight-item verbal survey to patients or surrogates approached for consent to participate in a minimal risk, ICU-based study. The parent study involved noninvasive collection of biosamples and clinical data at the time of ICU admission and again 3 days later. If patients had capacity at the time of ICU admission, or if a surrogate was readily available, consent was sought prior to initial sample collection; otherwise, a waiver of consent was granted, and deferred consent was sought 3 days later. Quantitative and qualitative data were analyzed. One hundred fifty-seven individuals were approached for consent to participate in the parent study; none objected to the consent process. One hundred thirty-five of 157 (86%) competed the survey, including 94 who consented to the parent study and 41 who declined. Forty-four of 60 individuals (73%) approached for deferred consent responded positively to the question "Did we make the right choice in waiting until now to ask your consent?" three of 60 (5%) responded negatively, and 13 of 60 (22%) made a neutral or unrelated response. The most common reason given for endorsing the deferred consent process was the stress of the early ICU experience 25 of 44 (61%). Most patients and surrogates accept a deferred consent process for minimal risk research in the ICU. For appropriate ICU-based research, investigators and Institutional Review Boards should consider a deferred consent process if the subject lacks capacity and an appropriate surrogate is not readily available.

  16. Single-Parent Family Forms and Children's Educational Performance in a Comparative Perspective: Effects of School's Share of Single-Parent Families

    Science.gov (United States)

    de Lange, Marloes; Dronkers, Jaap; Wolbers, Maarten H. J.

    2014-01-01

    Living in a single-parent family is negatively related with children's educational performance compared to living with 2 biological parents. In this article, we aim to find out to what extent the context of the school's share of single-parent families affects this negative relationship. We use pooled data from the Organisation for Economic…

  17. Single-parent family forms and children's educational performance in a comparative perspective: Effects of school's share of single-parent families

    NARCIS (Netherlands)

    Lange, M. de; Dronkers, J.A.; Wolbers, M.H.J.

    2014-01-01

    Living in a single-parent family is negatively related with children's educational performance compared to living with 2 biological parents. In this article, we aim to find out to what extent the context of the school's share of single-parent families affects this negative relationship. We use

  18. Adolescent-to-Parent Abuse as a Form of "Domestic Violence": A Conceptual Review.

    Science.gov (United States)

    Holt, Amanda

    2016-12-01

    Across the Global North, adolescent-to-parent abuse (APA) is becoming recognized as a significant social problem and is receiving attention from researchers, policymakers, and practitioners who work in the intersecting fields of juvenile justice, child protection, and domestic violence. One of the key questions shaping current debates concerns the extent to which APA maps onto the contours of domestic violence, in terms of research and theory, policy, and practice. In particular, to what extent can our established ways of working with domestic violence be applied when working with APA? This article begins by reviewing definitions and prevalence rates of APA. It then considers how the problem fits into the "family conflicts" and "gender-based violence" paradigms that are most frequently used to conceptualize domestic violence. The article then examines how APA represents a similar but distinct phenomenon to adult-instigated domestic violence and identifies how its departures represent particular challenges in working toward its elimination. The article concludes by reviewing intervention programs that work with APA and exploring some of the ways in which they adopt and reject elements of good practice from the domestic violence practice field. © The Author(s) 2015.

  19. Improving readability of informed consents for research at an academic medical institution.

    Science.gov (United States)

    Hadden, Kristie B; Prince, Latrina Y; Moore, Tina D; James, Laura P; Holland, Jennifer R; Trudeau, Christopher R

    2017-12-01

    The final rule for the protection of human subjects requires that informed consent be "in language understandable to the subject" and mandates that "the informed consent must be organized in such a way that facilitates comprehension." This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention. Readability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year. The mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade. Providing investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.

  20. Informed Consent in Adult Psychiatry

    Directory of Open Access Journals (Sweden)

    Ahmed Bait Amer

    2013-07-01

    Full Text Available This article addresses some of the groundwork of informed consent in people with mental illness whose decision-making capacity has obviously been compromised. This article examines four crucial aspects in particular, namely: i the main elements of informed consent; ii difficulties pertaining to psychiatric illnesses; iii the effect of psychiatric disorders on the patient’s capability; iv how to assess situations in which consents may not be required.

  1. Organ procurement organizations Internet enrollment for organ donation: Abandoning informed consent

    Directory of Open Access Journals (Sweden)

    Verheijde Joseph L

    2006-12-01

    Full Text Available Abstract Background Requirements for organ donation after cardiac or imminent death have been introduced to address the transplantable organs shortage in the United States. Organ procurement organizations (OPOs increasingly use the Internet for organ donation consent. Methods An analysis of OPO Web sites available to the public for enrollment and consent for organ donation. The Web sites and consent forms were examined for the minimal information recommended by the United States Department of Health and Human Services for informed consent. Content scores were calculated as percentages of data elements in four information categories: donor knowledge, donor consent reinforcement, donation promotion, and informed consent. Results There were 60 Web sites for organ donation enrollment serving the 52 states. The median percent (10 percentile-90 percentile content scores of the Web sites for donor knowledge, donor consent reinforcement, and donation promotion were 33% (20–47, 79% (57–86, and 75% (50–100, respectively. The informed consent score was 0% (0–33. The content scores for donor knowledge and informed consent were significantly lower than donor consent reinforcement and donation promotion for all Web sites (P Conclusion The Web sites and consent forms for public enrollment in organ donation do not fulfill the necessary requirements for informed consent. The Web sites predominantly provide positive reinforcement and promotional information rather than the transparent disclosure of organ donation process. Independent regulatory oversight is essential to ensure that Internet enrollment for organ donation complies with legal and ethical standards for informed consent.

  2. Epidural analgesia for labour: maternal knowledge, preferences and informed consent.

    LENUS (Irish Health Repository)

    2012-02-29

    Epidural analgesia has become increasingly popular as a form of labour analgesia in Ireland. However obtaining true inform consent has always been difficult. Our study recruited 100 parturients who had undergone epidural analgesia for labour, aimed to determine the information they received prior to regional analgesia, and to ascertain their preferences regarding informed consent. Only 65 (65%) of patients planned to have an epidural. Knowledge of potential complications was variable and inaccurate, with less than 30 (30%) of women aware of the most common complications. Most women 79 (79%) believed that discomfort during labour affected their ability to provide informed consent, and believe consent should be taken prior to onset of labour (96, 96%). The results of this study helps define the standards of consent Irish patients expect for epidural analgesia during labour.

  3. Influence of Visual Information on Consent for Invasive Procedures ...

    African Journals Online (AJOL)

    2018-05-22

    May 22, 2018 ... decision-making of the physician-patient-relative” as a period of transition. ..... recall of informed consent information by low-income parents: A comparison of ... Media and memory: The efficacy of video and print materials for ...

  4. The Minor's Right to Consent to Medical Treatment: A Corollary of the Constitutional Right of Privacy

    Science.gov (United States)

    Raitt, G. Emmett, Jr.

    1975-01-01

    Argues that the existing rules governing a physician's liability for treating a child without parental consent merit reconsideration because the minor possesses a fundamental constitutional right, stemming from the right of privacy, to consent to medical care. Proposes guidelines for the development of a legislative program implementing these…

  5. Informed consent -- Building consensus

    International Nuclear Information System (INIS)

    Lovenheim, R.

    1990-01-01

    The author shares his observations and offers an approach to 'building consensus' for what he believes is the only environmentally sound option, i.e., safe, permanent disposal of low-level radioactive waste (LLRW). Consensus does not mean unanimity, acceptance, or harmony. The low-level radioactive waste disposal issue is fraught with fear and hysteria. The paper discusses major emotions that fracture public opinion regarding this issue. The author defines consensus as the informed consent of LLRW disposal strategies by a majority of citizens whose cooperation is required to achieve the goals of environmentally sound solution. The political aspects are reviewed. The need for US Department of Energy to fulfill its importance technical assistance role is discussed

  6. Scientists' perspectives on consent in the context of biobanking research.

    Science.gov (United States)

    Master, Zubin; Campo-Engelstein, Lisa; Caulfield, Timothy

    2015-05-01

    Most bioethics studies have focused on capturing the views of patients and the general public on research ethics issues related to informed consent for biobanking and only a handful of studies have examined the perceptions of scientists. Capturing the opinions of scientists is important because they are intimately involved with biobanks as collectors and users of samples and health information. In this study, we performed interviews with scientists followed by qualitative analysis to capture the diversity of perspectives on informed consent. We found that the majority of scientists in our study reported their preference for a general consent approach although they do not believe there to be a consensus on consent type. Despite their overall desire for a general consent model, many reported several concerns including donors needing some form of assurance that nothing unethical will be done with their samples and information. Finally, scientists reported mixed opinions about incorporating exclusion clauses in informed consent as a means of limiting some types of contentious research as a mechanism to assure donors that their samples and information are being handled appropriately. This study is one of the first to capture the views of scientists on informed consent in biobanking. Future studies should attempt to generalize findings on the perspectives of different scientists on informed consent for biobanking.

  7. Nudging, informed consent and bullshit.

    Science.gov (United States)

    Simkulet, William

    2017-11-18

    Some philosophers have argued that during the process of obtaining informed consent, physicians should try to nudge their patients towards consenting to the option the physician believes best, where a nudge is any influence that is expected to predictably alter a person's behaviour without (substantively) restricting her options. Some proponents of nudging even argue that it is a necessary and unavoidable part of securing informed consent. Here I argue that nudging is incompatible with obtaining informed consent. I assume informed consent requires that a physician tells her patient the truth about her options and argue that nudging is incompatible with truth-telling. Instead, nudging satisfies Harry Frankfurt's account of bullshit. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  8. Autonomy, consent and responsibility. Part II. Informed consent in medical care and in the law.

    Science.gov (United States)

    Mellado, J M

    Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

  9. Using a Multimedia Presentation to Enhance Informed Consent in a Pediatric Emergency Department.

    Science.gov (United States)

    Spencer, Sandra P; Stoner, Michael J; Kelleher, Kelly; Cohen, Daniel M

    2015-08-01

    Informed consent is an ethical process for ensuring patient autonomy. Multimedia presentations (MMPs) often aid the informed consent process for research studies. Thus, it follows that MMPs would improve informed consent in clinical settings. The aim of this study was to determine if an MMP for the informed consent process for ketamine sedation improves parental satisfaction and comprehension as compared with standard practice. This 2-phase study compared 2 methods of informed consent for ketamine sedation of pediatric patients. Phase 1 was a randomized, prospective study that compared the standard verbal consent to an MMP. Phase 2 implemented the MMP into daily work flow to validate the previous year's results. Parents completed a survey evaluating their satisfaction of the informed consent process and assessing their knowledge of ketamine sedation. Primary outcome measures were parental overall satisfaction with the informed consent process and knowledge of ketamine sedation. One hundred eighty-four families from a free-standing, urban, tertiary pediatric emergency department with over 85,000 annual visits were enrolled. Different demographics were not associated with a preference for the MMP or improved scores on the content quiz. Intervention families were more likely "to feel involved in the decision to use ketamine" and to understand that "they had the right to refuse the ketamine" as compared with control families. The intervention group scored significantly higher overall on the content section than the control group. Implementation and intervention families responded similarly to all survey sections. Multimedia presentation improves parental understanding of ketamine sedation, whereas parental satisfaction with the informed consent process remains unchanged. Use of MMP in the emergency department for informed consent shows potential for both patients and providers.

  10. The effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol.

    Science.gov (United States)

    Perrenoud, Beatrice; Velonaki, Venetia-Sofia; Bodenmann, Patrick; Ramelet, Anne-Sylvie

    2015-10-01

    on the improvement of the print material, the process (e.g. the communication of the appropriate information) or both. Davis et al. conducted a randomized controlled trial to compare two polio vaccine pamphlets written at a sixth grade level - an international standardized pamphlet and an easy-to-read pamphlet - for the comprehension and preference among parents. Although the parents in the intervention group (N=304) achieved significantly higher comprehension than the control group (N=306) (65% vs 60%, pappeal but not the comprehension to an adequate level without use of instructional graphics. Similarly, Lorenzen et al. found that a reader friendly informed consent document to surgical procedures was more commonly read by the health care users as compared to the original consent document; however, no difference was found in terms of the participants' capacity to describe the procedure in their own words. Kang et al. evaluated recall and comprehension of orthodontic informed consent among pairs of children and their parents (N=90) applying three different informed consent procedures. According to this study, a combination of improving the readability of consent materials and the informed consent process (audio and visual cues) led to better recall for the patients and better recall and comprehension for their parents compared to an improved readability form or the usual informed consent form. Smith et al. used a randomized controlled trial to compare a decision aid (booklet and DVD) specifically designed for adults with low literacy skills (N=357) with a standard information booklet (N=173) on screening for bowel cancer. They found that the proportion of participants making an informed choice was 22% higher in the intervention group than in the control group (34% vs 12%, P<0.001). Matsuyama et al. (ABSTRACT TRUNCATED)

  11. [The origin of informed consent].

    Science.gov (United States)

    Mallardi, V

    2005-10-01

    The principle of informed consent, aimed at the lawfulness of health assistance, tends to reflect the concept of autonomy and of decisional autodetermination of the person requiring and requesting medical and/or surgical interventions. This legal formula, over the last few years, has gained not only considerable space but also importance in the doctrinal elaboration and approaches, as well as juridical interpretations, thereby influencing the everyday activities of the medical profession. Informed consent is still the object of continuous explorations, not only asfar as concerns the already confirmed theoretical profile but, instead, the ambiguous practical and consequential aspect. Analysing how the concept and role of consensus was born and developed with the more adequate and reasonable excursions to make it valid and obtain it, it is impossible not to take into consideration, on the one hand, the very ancient philosophical origins and, on the other, the fact that it was conditioned by religion with the moral aspects and the accelerated deontological evolution with pathways parallel to the needs and the progress offered by new forms of treatment and novel biotechnological applications. The principle of consent is a relatively new condition. In fact, already in the times of not only the Egyptian civilisation, but also the Greek and Roman, documents have been found which show how the doctor's intervention had, in some way, first to be approved by the patient. Plato (law IV) had already foreseen the problems, the procedures and the modes of information which are, in synthesis, at the root of the principles of the present formula of informed consent and correlated the practice of the information and consensus with the quality and social position of the patient. The only guarantee that the patient might have, derived from a fundamental principle of medicine of all times: "in disease, focus on two aims, to improve and not to cause damage". A figure can be recognised

  12. Blockchain protocols in clinical trials: Transparency and traceability of consent

    Science.gov (United States)

    Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

    2018-01-01

    Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be

  13. Blockchain protocols in clinical trials: Transparency and traceability of consent.

    Science.gov (United States)

    Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

    2017-01-01

    Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients' informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient's consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a

  14. Informed Consent and Capacity to Give Consent in Mental Disorders

    OpenAIRE

    Zeynep Mackali

    2014-01-01

    Among four basic principles (respect for autonomy, beneficence, non-malfeasance, and justice) which determine ethical behaviors in healthcare, informed consent is mostly related to and lsquo;respect for autonomy'. Also, it reflects patient/client's right for decision and the value given for the client and his/her autonomy. Informed consent is an information sharing process including both rational decision-making about the most appropriate method among many different options and the interacti...

  15. Emergency Physicians, Beware of the Consent Standard of Care

    OpenAIRE

    Moore, Gregory P.; Matlock, Aaron G.; Kiley, John L.; Percy, Katherine D.

    2018-01-01

    Many emergency physicians view informed consent as a necessary component of treatments or procedures to be performed on their patients. When such procedures are necessary, often there is a discussion of risks, benefits and alternatives with forms signed to validate the discussion. Two Wisconsin emergency department medical-legal cases have expanded liability of the duty of informed consent. These cases have focused on withholding medication and diagnostic tests.

  16. Informed Consent and Capacity to Give Consent in Mental Disorders

    Directory of Open Access Journals (Sweden)

    Zeynep Mackali

    2014-09-01

    Full Text Available Among four basic principles (respect for autonomy, beneficence, non-malfeasance, and justice which determine ethical behaviors in healthcare, informed consent is mostly related to and lsquo;respect for autonomy'. Also, it reflects patient/client's right for decision and the value given for the client and his/her autonomy. Informed consent is an information sharing process including both rational decision-making about the most appropriate method among many different options and the interaction between the clinician and the client. This concept sheds light on criteria regarding the limits of confidentiality, competency, appropriate and sufficient information sharing and voluntariness. In this theoretical review, the definitions and the content of informed consent were shared, and then a section regarding the required content of informed consent for psychotherapy process was provided. Then, the components of informed consent were discussed and the relationship between capacity to consent and mental disorders in terms of aforementioned diagnostic groups was examined. [Psikiyatride Guncel Yaklasimlar - Current Approaches in Psychiatry 2014; 6(3.000: 227-242

  17. Assessing the quality of informed consent in a resource-limited setting: A cross-sectional study

    Directory of Open Access Journals (Sweden)

    Kiguba Ronald

    2012-08-01

    Full Text Available Abstract Background The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Methods Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies had been administered to each study participant. Results Of the 600 participants interviewed, two thirds (64.2%, 385/600 were female. Overall mean age of study participants was 37.6 (SD = 7.7 years. Amongst all participants, less than a tenth (5.9%, 35/598 reported that they were not given enough information before making a decision to participate. A similar proportion (5.7%, 34/597 reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7%, 201/596 of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50% less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95% CI: 0.35-0.78] to perceive that refusal to participate in the parent research project would affect their regular medical care. Conclusions Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care.

  18. Assessing the quality of informed consent in a resource-limited setting: a cross-sectional study.

    Science.gov (United States)

    Kiguba, Ronald; Kutyabami, Paul; Kiwuwa, Stephen; Katabira, Elly; Sewankambo, Nelson K

    2012-08-21

    The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies had been administered to each study participant. Of the 600 participants interviewed, two thirds (64.2%, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9%, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7%, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7%, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50% less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95% CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care. Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care.

  19. Typologies of intimate partner violence-maternal parenting and children's externalizing problems: The moderating effect of the exposure to other forms of family violence.

    Science.gov (United States)

    Lamela, Diogo; Jongenelen, Inês; Pinto, Ricardo; Levendosky, Alytia

    2018-07-01

    Typologies of IPV and parenting practices in mothers who experienced police-reported IPV remain surprisingly unexplored, in addition to how those typologies are linked with children's externalizing problems. Using data from 162 Portuguese mother-child dyads with a police or child protection services referral of IPV, this study aimed to: (a) identify IPV-parenting typologies; (b) test the associations between typologies and children's externalizing problems, and (c) examine the moderating effect of children's exposure to other forms of family violence in those associations. Using a person-centered approach, two IPV-parenting typologies were found: a spillover typology, with high levels of physical, psychological, and sexual violence and high levels of harsh and inconsistent parenting practices; and a compartmentalized typology, with high levels of physical, psychological, and sexual violence and lower ineffective parenting practices. Results also showed that externalizing symptoms (reported by mothers and teachers) were significantly lower in children of mothers in the compartmentalized typology compared to those in the spillover typology. Children's direct exposure to other forms of family violence moderated this association. Findings suggested that children with a high exposure to other forms of family violence showed the highest levels of externalizing problems when their mothers were classified into the spillover typology, and they exhibited the lowest levels of externalizing problems when their mothers were classified in the compartmentalized typology. Copyright © 2018 Elsevier Ltd. All rights reserved.

  20. Informed consent in paediatric critical care research--a South African perspective.

    Science.gov (United States)

    Morrow, Brenda M; Argent, Andrew C; Kling, Sharon

    2015-09-09

    Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources. Ethical oversight is essential for safe, appropriate research conduct. Informed consent by the parent or legal guardian is usually required for child research participation, but obtaining consent may be challenging in paediatric critical care research. Local regulations may also impede important research if overly restrictive. By narratively synthesising and contextualising the results of a comprehensive literature review, this paper describes ethical principles and regulations; potential barriers to obtaining prospective informed consent; and consent options in the context of paediatric critical care research in South Africa. Voluntary prospective informed consent from a parent or legal guardian is a statutory requirement for child research participation in South Africa. However, parents of critically ill or injured children might be incapable of or unwilling to provide the level of consent required to uphold the ethical principle of autonomy. In emergency care research it may not be practical to obtain consent when urgent action is required. Therapeutic misconceptions and sociocultural and language issues are also barriers to obtaining valid consent. Alternative consent options for paediatric critical care research include a waiver or deferred consent for minimal risk and/or emergency research, whilst prospective informed consent is appropriate for randomised trials of novel therapies or devices. We propose that parents or legal guardians of critically ill or injured children should only be approached to consent for their child's participation in clinical research when it is ethically justifiable and in the best interests of both

  1. Hope and persuasion by physicians during informed consent.

    Science.gov (United States)

    Miller, Victoria A; Cousino, Melissa; Leek, Angela C; Kodish, Eric D

    2014-10-10

    To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physician's recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure. Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire. The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physician's strength of recommendation to enroll in the trial lower. Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain. © 2014 by American Society of Clinical Oncology.

  2. Telemedicine Provides Non-Inferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

    Science.gov (United States)

    Bobb, Morgan R.; Van Heukelom, Paul G.; Faine, Brett A.; Ahmed, Azeemuddin; Messerly, Jeffrey T.; Bell, Gregory; Harland, Karisa K.; Simon, Christian; Mohr, Nicholas M.

    2016-01-01

    Objective Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study is to determine whether patient comprehension of telemedicine-enabled research informed consent is non-inferior to standard face-to-face research informed consent. Methods A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic Emergency Department (ED) to test whether telemedicine-enabled research informed consent provided non-inferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of oral chlorhexidine gluconate 0.12% in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard face-to-face consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc., Hackensack, NJ) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified Quality of Informed Consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. Results One-hundred thirty-one patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to face-to-face consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p=0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Conclusion Telemedicine is non-inferior to face

  3. Utilization of a Smartphone Platform for Electronic Informed Consent in Acute Stroke Trials.

    Science.gov (United States)

    Haussen, Diogo C; Doppelheuer, Shannon; Schindler, Kiva; Grossberg, Jonathan A; Bouslama, Mehdi; Schultz, Meagan; Perez, Hilarie; Hall, Alex; Frankel, Michael; Nogueira, Raul G

    2017-11-01

    The informed consent process is a major limitation for enrollment in acute stroke clinical investigations. We aim to describe the novel application of smartphone electronic informed consenting (e-Consent) in trials of cerebral thrombectomy. The e-Consent tool consists of a secure/Health Insurance Portability and Accountability Act compliant smartphone platform based on REDCap (Research Electronic Data Capture; Vanderbilt University, TN) that uses a survey project located on a static webpage. A link to the webpage is sent via text message or email to the legally authorized representative. The e-Consent form is filled and a freehand electronic signature added in the smartphone browser; a record ID and an e-Consent Process Attestation form are automatically generated. The e-Consent application was piloted in a randomized trial comparing endovascular versus medical therapy in late presenting patients (DAWN [Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo]). Trial enrollment began in January 2015; e-Consent was approved by the local institutional review board in December 2016, and the study was stopped in February 2017. During the trial period, Grady Memorial Hospital performed 273 thrombectomies with 47 patients being consented and 38 patients enrolled in the DAWN trial. Of the randomized patients, 29 (76%) were transferred from outside hospitals. A total of 6 surrogates were e-Consented, with 2 patients being screen failures. Enrolled e-Consented patients (n=4) had similar age (73±14 versus 69±12 years; P =0.65) and National Institutes of Health Stroke Scale (16±5 versus 16±5; P =0.88) as compared with conventionally consented (n=25). Time from door-to-randomization was decreased with e-Consenting (28±9 versus 57±24 minutes; P =0.002). e-Consenting streamlined the consenting process in a randomized trial of patients with emergent large vessel occlusion strokes. © 2017 American Heart Association, Inc.

  4. Informed consent in surgical trials.

    Science.gov (United States)

    Etchells, E

    1999-12-01

    All participants must provide a valid consent to surgical clinical trials. A valid consent requires patient capacity, adequate disclosure of information, and voluntariness. Capacity is the ability to understand information relevant to making a decision and to appreciate the reasonably foreseeable consequences of a decision or lack of decision. To protect vulnerable persons, an incapable person should not be enrolled in most clinical trials. The only exception is if the study can only be conducted on incapable persons. If the willing research participant is incapable, consent must be obtained from others through a process called substitute (or proxy) consent. Disclosure refers to the provision of relevant information to the patient and its comprehension by the patient. Most surgical trials carry more than minimal risks, so the requirement for careful disclosure of these risks to potential participants is generally stringent. Voluntariness refers to the freedom of a person to make a treatment decision. In specific circumstances related to emergency research, the requirement for consent may be waived. Waiver can be justified only if the delay required to obtain consent would prevent the research from occurring and only after prior consultation with from the "community" of potential research participants.

  5. The patient's opinion of informed consent

    International Nuclear Information System (INIS)

    Pinto, I.; Paul, L.; Chimeno, P.; Fernandez, J. L.; Vigil, D.

    1999-01-01

    To evaluate the quality of the information provided by informed consent forms for angiography and interventional radiology on the basis of the patients opinion. A descriptive study was performed based on an anonymous survey distributed among patients who were to undergo angiography and interventional radiology, and had previously been informed and provided with the corresponding informed consent form. A descriptive and analytical statistical study was carried out to compare the responses to the questions concerning different factors (Mann-Whitney U test). Of the 182 surveys completed 75.3% corresponded to diagnostic procedures and the remaining 24.7% to therapeutic procedures. When the responses to closed-ended questions were analyzed, 90.1% of respondents considered the amount of information provided by the document to be sufficient 75.3% declared that they found the form easy to comprehend and 34.1% responded that reading it had calmed their nerves. Statistically significant differences were observed, depending on whether the form corresponded to diagnostic or therapeutic procedures, concerning the questions related to comprehension of the document and to the feeling upon reading it, with those used for diagnostic procedures obtaining better scores. There was a statistically significant difference between the responses of the patients to the question concerning their feeling upon reading the document and the responses of family members, with the patients responding more favorably than their relatives. The consent forms prepared for angiography and interventional radiology procedures are acceptable to the patients concerned with respect to both the quantity and the quality of the information. (Author) 22 refs

  6. Frequency and Form of Team Communication from the Perspective of Parents of Preschool Children with Disabilities: Implications for Diverse Families

    Science.gov (United States)

    Sheppard, Mary Erin

    2017-01-01

    Effective communication between parents of children with disabilities and other team members positively impacts family-school collaboration. Parents of children with special needs were asked how and how often they communicated with their children's preschool teams. The frequency of both formal and informal meetings varied tremendously. Parents…

  7. An approach to radiotherapy under informed consent

    International Nuclear Information System (INIS)

    Okazaki, Atsushi; Maehara, Tadayuki; Baba, Sadaaki; Nakamura, Yuji; Kamitani, Hiroshi

    1996-01-01

    Over the past two years, we have attempted to practice radiotherapy in accordance with the principle of informed consent. The procedure used in our radiotherapy, which consists of informing the patient of the seriousness of his or her disease (malignant and benign) and receiving signed consent forms, is a new system in Japan. This is a report of our experience with this system and its advantages and disadvantages. We are satisfied with the clinical results of the attempt. Radiotherapy in accordance with informed consent has now become routine at our hospital. We feel that this practice will produce the mutual enhancement of our responsibility to patients and their trust in us, and improve cure rates. In promoting mutual understanding between our patients and ourselves, we must keep in mind that we, radiation oncologists, are not only radiotherapists but also health-care providers in our capacity as medical and surgical doctors. It is also necessary to achieve the best radiotherapeutic system in Japan. (author)

  8. Consented Autopsy and the Middle-East.

    Science.gov (United States)

    Kharoshah, Magdy A; Hussain, Syed Ather; Madadin, Mohammed; Menezes, Ritesh G

    2017-02-01

    Consented autopsy is almost non-existent in the Middle-East where established social and cultural beliefs regarding the procedure might discourage family members from requesting a consented autopsy. Evidence suggests that new information is obtained from consented autopsies. It would not be in the best interest of medicine if social and cultural misconceptions succeed in erasing the existence of consented autopsies entirely.

  9. Informed consent in Sri Lanka: a survey among ethics committee members.

    Science.gov (United States)

    Sumathipala, Athula; Siribaddana, Sisira; Hewage, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin

    2008-05-20

    Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. Twenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. The number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed

  10. Informed consent in Sri Lanka: A survey among ethics committee members

    Directory of Open Access Journals (Sweden)

    Siriwardhana Chesmal

    2008-05-01

    Full Text Available Abstract Background Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research. However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. Methods We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. Results Twenty-nine members from ethics committees participated. Majority of participants (23, believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%, believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52% believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. Conclusion The number of themes generated for the consent form (N = 18 is as many as for the information leaflet (N = 19 and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and

  11. Validity and reliability of short forms of parental-caregiver perception and family impact scale in a Telugu speaking population of India.

    Science.gov (United States)

    Kumar, Santhosh; Kroon, Jeroen; Lalloo, Ratilal; Johnson, Newell W

    2016-03-01

    Parental-Caregiver Perception Questionnaire (P-CPQ) and Family Impact Scale (FIS) are commonly used measures to evaluate the parent's perception of the impact of children's oral health on quality of life and family respectively. Recently, shorter forms of P-CPQ and FIS have been developed. No study has sought to validate these short forms in other languages and cultures. This study aimed to evaluate the validity and reliability of FIS, 8 and 16-item P-CPQ in a Telugu speaking population of India. For this cross-sectional study, a multi-stage random sampling technique was used to recruit 11-13 year-old schoolchildren of Medak district, Telangana, India and their parents (n = 1342). Parents were approached with questionnaires through their children who underwent clinical examinations for dental caries, fluorosis and malocclusion. The translated versions underwent pilot testing (n = 40), test-retest reliability was also assessed (n = 161). The overall summary scale and subscales of the short forms of P-CPQ and FIS failed to discriminate between the categories of dental caries severity. Also, malocclusion status was not related to the domain or overall scores of both the short forms of P-CPQ. There were significant differences in subscale and overall scores of 16 and 8-item P-CPQ and FIS between the fluorosis categories. Both 16 and 8-item P-CPQ summary scales were significantly related to parent's global rating of oral health (16-item, r = 0.30, p internal consistency and reliability on repeated administrations.

  12. Written versus verbal consent: a qualitative study of stakeholder views of consent procedures used at the time of recruitment into a peripartum trial conducted in an emergency setting.

    Science.gov (United States)

    Lawton, J; Hallowell, N; Snowdon, C; Norman, J E; Carruthers, K; Denison, F C

    2017-05-24

    Obtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention. We explored women's and staff views about the consent procedures used during the internal pilot of a trial (GOT-IT), where the protocol permitted staff to gain verbal consent at recruitment. Interviews with staff (n = 27) and participating women (n = 22). Data were analysed thematically and interviews were cross-compared to identify differences and similarities in participants' views about the consent procedures used. Women and some staff highlighted benefits to obtaining verbal consent at trial enrolment, including expediting recruitment and reducing the burden on those left exhausted by their births. However, most staff with direct responsibility for taking consent expressed extreme reluctance to proceed with enrolment until they had obtained written consent, despite being comfortable using verbal procedures in their clinical practice. To account for this resistance, staff drew a strong distinction between research and clinical care and suggested that a higher level of consent was needed when recruiting into trials. In doing so, staff emphasised the need to engage women in reflexive decision-making and highlighted the role that completing the consent form could play in enabling and evidencing this process. While most staff cited their ethical responsibilities to women, they also voiced concerns that the absence of a signed consent form at recruitment could expose them to greater risk of litigation were an individual to experience a complication during the trial. Inexperience of recruiting into peripartum trials and limited availability of staff trained to take consent also reinforced preferences for

  13. Reliability and validity of the Spanish version of the Child Health and Illness Profile (CHIP Child-Edition, Parent Report Form (CHIP-CE/PRF

    Directory of Open Access Journals (Sweden)

    Tebé Cristian

    2010-08-01

    Full Text Available Abstract Background The objectives of the study were to assess the reliability, and the content, construct, and convergent validity of the Spanish version of the CHIP-CE/PRF, to analyze parent-child agreement, and compare the results with those of the original U.S. version. Methods Parents from a representative sample of children aged 6-12 years were selected from 9 primary schools in Barcelona. Test-retest reliability was assessed in a convenience subsample of parents from 2 schools. Parents completed the Spanish version of the CHIP-CE/PRF. The Achenbach Child Behavioural Checklist (CBCL was administered to a convenience subsample. Results The overall response rate was 67% (n = 871. There was no floor effect. A ceiling effect was found in 4 subdomains. Reliability was acceptable at the domain level (internal consistency = 0.68-0.86; test-retest intraclass correlation coefficients = 0.69-0.85. Younger girls had better scores on Satisfaction and Achievement than older girls. Comfort domain score was lower (worse in children with a probable mental health problem, with high effect size (ES = 1.45. The level of parent-child agreement was low (0.22-0.37. Conclusions The results of this study suggest that the parent version of the Spanish CHIP-CE has acceptable psychometric properties although further research is needed to check reliability at sub-domain level. The CHIP-CE parent report form provides a comprehensive, psychometrically sound measure of health for Spanish children 6 to 12 years old. It can be a complementary perspective to the self-reported measure or an alternative when the child is unable to complete the questionnaire. In general, the results are similar to the original U.S. version.

  14. Changing trends in informed consent

    OpenAIRE

    Victor Lim

    2014-01-01

    Abstract: Consent is defined as the “voluntary agreement to or acquiescence in what another person proposes or desires”. In the context of medical practice it is now universally accepted that every human being of adult years and of sound mind has the right to determine what shall be done with his or her own body. Informed consent is now a central part of medical ethics and medical law. There has been a change in the public’s expectations of their role in medical decisi...

  15. Paper trails, trailing behind: improving informed consent to IVF through multimedia applications

    Science.gov (United States)

    Madeira, Jody Lyneé; Andraka-Christou, Barbara

    2016-01-01

    Though intended to educate patients on the risks, benefits, side effects and alternatives within medical treatment, informed consent documents may have unanticipated consequences for patients. Patients may regard these forms as little more than a ritual to access treatment. Or patients may perceive that these forms exist to protect doctors rather than to contribute to a meaningful, patient-protective educational interaction. To rehabilitate the informed consent project, this essay considers the baggage that informed consent documents have acquired through practical use, explores patients' and providers' lived experience of informed consent, and considers whether a multimedia consent application would be a viable solution to the various difficulties that currently erode perceptions of and confidence in the informed consent process. PMID:27774231

  16. Customising informed consent procedures for people with schizophrenia in India.

    Science.gov (United States)

    Chatterjee, Sudipto; Kieselbach, Berit; Naik, Smita; Kumar, Shuba; John, Sujit; Balaji, Madhumitha; Koschorke, Mirja; Dabholkar, Hamid; Varghese, Mathew; Patel, Vikram; Thornicroft, Graham; Thara, Rangaswamy

    2015-10-01

    There is little information on how the ethical and procedural challenges involved in the informed participation of people with schizophrenia in clinical trials are addressed in low- and middle-income countries (LMICs). The informed consent procedure used in the collaborative community care for people with schizophrenia in India (COPSI) RCT was developed keeping these challenges in mind. We describe the feasibility of conducting the procedure from the trial, researcher and participants perspectives and describe the reasons for people consenting to participate in the trial or refusing to do so. Three sources of information were used to describe the feasibility of the COPSI consent procedure: key process indicators for the trial perspective, data from a specially designed post-interview form for participant's observations and focus group discussion (FGD) with the research interviewers. Categorical data were analysed by calculating frequencies and proportions, while the qualitative data from the FGD, and the reasons for participation or refusal were analysed using a thematic content analysis approach. 434 people with schizophrenia and their primary caregiver(s) were approached for participation in the trial. Consent interviews were conducted with 332, of whom 303 (91%) agreed to participate in the trial. Expectation of improvement was the most common reason for agreeing to participate in the trial, while concerns related to the potential disclosure of the illness, especially for women, were an important reason for refusing consent. The COPSI consent procedure demonstrates preliminary, observational information about the feasibility of customising informed consent procedures for people with schizophrenia LMIC contexts. This and other similar innovations need to be refined and rigorously tested to develop evidence-based guidelines for informed consent procedures in such settings.

  17. 'People form their own support systems - like forming their own families': the role of parents and friends in the first year at dental school.

    Science.gov (United States)

    McMillan, W

    2016-05-01

    Most students experience the transition from school to university as challenging. Students from backgrounds with little or no experience of higher education are most vulnerable in the transition, and most at risk of academic failure or early departure. This study examined the role that parents and friends play in the transition to university and in the first academic year. The study examines the mechanisms of this support so as to understand the ways in which support is provided. It examines whether - and if so, how - support mechanisms differed for first-generation students and those with family familiarity of university. Data were collected through focus group and individual interviews with dentistry students in their first and second academic years at a Faculty of Dentistry in South Africa. Concepts from psychology literature - attachment and friendship quality - provided the analytical framework. Findings from the study suggest that the social relationships which students have access to during the transition and the first academic year have the potential to provide emotional resources which ease transition and practical information about appropriate ways of being and doing at university. First-generation university students are less likely to have access to the latter because their parents have no experience of university. The study concludes with suggestions for ways in which universities and their teachers might provide support for all first-year students. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  18. Key factors in children's competence to consent to clinical research.

    Science.gov (United States)

    Hein, Irma M; Troost, Pieter W; Lindeboom, Robert; Benninga, Marc A; Zwaan, C Michel; van Goudoever, Johannes B; Lindauer, Ramón J L

    2015-10-24

    Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children's consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors including the developmental stage, the influence of parents and peers, and life experience. We examined potential determining factors for children's competence to consent to clinical research and to what extent they explain the variation in competence judgments. From January 1, 2012 through January 1, 2014, pediatric patients aged 6 to 18 years, eligible for clinical research studies were enrolled prospectively at various in- and outpatient pediatric departments. Children's competence to consent was assessed by MacArthur Competence Assessment Tool for Clinical Research. Potential determining child variables included age, gender, intelligence, disease experience, ethnicity and socio-economic status (SES). We used logistic regression analysis and change in explained variance in competence judgments to quantify the contribution of a child variable to the total explained variance. Contextual factors included risk and complexity of the decision to participate, parental competence judgment and the child's or parents decision to participate. Out of 209 eligible patients, 161 were included (mean age, 10.6 years, 47.2 % male). Age, SES, intelligence, ethnicity, complexity, parental competence judgment and trial participation were univariately associated with competence (P competence judgments was 71.5 %. Only age and intelligence significantly and independently explained the variance in competence judgments, explaining 56.6 % and 12.7 % of the total variance respectively. SES, male gender, disease experience and ethnicity each explained less than 1 % of the variance in competence judgments. Contextual factors together explained an extra 2.8 % (P > 0.05). Age is the factor that

  19. The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research.

    Science.gov (United States)

    Megone, Christopher; Wilman, Eleanor; Oliver, Sandy; Duley, Lelia; Gyte, Gill; Wright, Judy

    2016-09-09

    Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet, approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials? In a systematic search, we identified 30 studies. We began our analysis by applying philosophical frameworks, which were then refined as concepts emerged from the analytical studies, to present a coherent picture of a broad literature. Between them, the studies addressed four themes. The first three were the ethical basis for parental informed consent for neonatal and/or perinatal research, the validity of parental consent in this context, and the range of possible options in methods for gaining consent. The last was the issue of risk and the possibility of a double-standard or asymmetry in the current approaches to the requirement for consent for research and consent for clinical treatment. In addressing these issues, the analysed studies showed that, whilst there are a variety of possible defences for seeking parental 'consent' to neonatal and/or perinatal clinical trials, these are all consistent with the strongly and widely held view that it is important that parents do give (or decline) consent for such research. So far as the method of obtaining consent is concerned, none of the existing consent processes reviewed by the research is satisfactory, and there are philosophical reasons for supposing that at least some parents will fail to give valid consent in a neonatal context. Furthermore, in giving parental 'consent' in a perinatal context, parents are authorising infant participation, not giving 'proxy consent'. Finally, there are reasons for giving weight to both parental 'consent' and the infant's best interests in

  20. Organ procurement: let's presume consent

    OpenAIRE

    Moustarah, F

    1998-01-01

    IN WINNING FIRST PRIZE in the Logie Medical Ethics Essay Contest in 1997, Dr. Fady Moustarah made a strong and compelling argument in favour of presumed consent in the procurement of donor organs. He stressed that a major education campaign will be needed when such a policy is adopted lest some people begin to regard physicians as "organ vultures."

  1. 78 FR 77106 - U.S. Air Force Reminder Re: United Launch Alliance (ULA) Consent Order and Recent Change in...

    Science.gov (United States)

    2013-12-20

    ... Consent Order also requires firewalls to prevent information from a space vehicle provider being shared by ULA with its Boeing or LMC parent company. Similarly, Boeing and LMC must have firewalls to ensure...

  2. The Weiss Functional Impairment Rating Scale-Parent Form for assessing ADHD: evaluating diagnostic accuracy and determining optimal thresholds using ROC analysis

    OpenAIRE

    Thompson, Trevor; Lloyd, Andrew; Joseph, Alain; Weiss, Margaret

    2017-01-01

    Purpose The Weiss Functional Impairment Rating Scale-Parent Form (WFIRS-P) is a 50-item scale that assesses functional impairment on six clinically relevant domains typically affected in attention-deficit/hyperactivity disorder (ADHD). As functional impairment is central to ADHD, the WFIRS-P offers potential as a tool for assessing functional impairment in ADHD. These analyses were designed to examine the overall performance of WFIRS-P in differentiating ADHD and non-ADHD cases using receiver...

  3. Increasing Business and Parental Involvement in Grades 4-7 by Forming Partnerships between School and Local Businesses.

    Science.gov (United States)

    Hinson, Kay S.

    This paper describes a practicum designed to increase parent and business involvement in the educational experiences of students in grades 4-7 at a rural school in the southeastern United States. Teacher surveys and other data indicated that the students had very little experience or understanding of the business world in which they eventually…

  4. Orthodontic informed consent considering information load and serial position effect.

    Science.gov (United States)

    Pawlak, Caroline E; Fields, Henry W; Beck, F Michael; Firestone, Allen R

    2015-03-01

    Previous research has demonstrated that current methods of informed consent are relatively ineffective as shown by poor recall and comprehension by adolescent patients and their parents. The purpose of this study was to determine whether adding a short videotape presentation reiterating the issues related to informed consent to a modified informed consent document that emphasizes a limited number of core and patient-specific custom "chunks" at the beginning of an informed consent presentation improved the recall and comprehension of the risks, benefits, and alternatives of orthodontic treatment. A second objective was to evaluate the current related data for recommendable practices. Seventy patient-parent pairs were randomly divided into 2 groups. The intervention group (group A) patients and parents together reviewed a customized slide show and a short videotape presentation describing the key risks of orthodontic treatment. Group B followed the same protocol without viewing the videotape. All patients and parents were interviewed independently by research assistants using an established measurement tool with open-ended questions. Interviews were transcribed and scored for the appropriateness of responses using a previously established codebook. Lastly, the patients and parents were given 2 reading literacy tests, 1 related to health and 1 with general content followed by the self-administered demographic and psychological state questionnaires. There were no significant differences between the groups for sociodemographic variables. There were no significant differences between the groups for overall recall and comprehension; recall and comprehension for the domains of treatment, risk, and responsibility; and recall and comprehension for core, general, and custom items. The positional effects were limited in impact. When compared with previous studies, these data further demonstrate the benefit of improved readability and audiovisual supplementation with the

  5. Getting meaningful informed consent from older adults: a structured literature review of empirical research.

    Science.gov (United States)

    Sugarman, J; McCrory, D C; Hubal, R C

    1998-04-01

    To perform a structured literature review of the published empirical research on informed consent with older adults in order to make recommendations to improve the informed consent process and to highlight areas needing further examination. Relevant literature was identified by searching electronic databases (AGELINE, BIOETHICSLINE, CancerLit, Ethics Index, Health, LegalTrac, MEDLINE, PAIS International, PsycInfo, and Sociofile). Studies were included if they were reports of primary research data about informed consent and, if patients or other subjects were used, older subjects were included in the sample. Data related to the aspect of informed consent under study (recruitment, decision-making capacity, voluntariness, disclosure of information, understanding of information, consent forms, authorization, and policies and procedures) were abstracted and entered into a specially designed database. Characterization of the population, age of subjects, setting, whether informed consent was being studied in the context of research or treatment, study design, the nature of outcome or dependent variables, independent variables (e.g., experimental conditions in a randomized controlled trial or patient/subject characteristics in a nonrandomized comparison), and results according to the aspect of informed consent under study. A total of 99 articles met all the inclusion criteria and posed 289 unique research questions covering a wide range of aspects of informed consent: recruitment (60); decision making capacity (21); voluntariness (6); disclosure (30); understanding (139); consent forms (7); authorization (11); policies (13); and other (2). In the secondary analyses of numerous studies, diminished understanding of informed consent information was associated with older age and fewer years of education. Older age was also sometimes associated with decreased participation in research. Studies of disclosure of informed consent information suggest strategies to improve

  6. Improving consent in patients undergoing surgery for fractured neck of femur.

    Science.gov (United States)

    Thiruchandran, Gajendiran; McKean, Andrew R; Rudran, Branavan; Imam, Mohamed A; Yeong, Keefai; Hassan, Abdel

    2018-05-02

    Background Neck of femur fractures and their subsequent operative fixation are associated with high rates of perioperative morbidity and mortality. Consenting in this setting is suboptimal with the Montgomery court ruling changing the perspective of consent. This quality improvement project assessed the adequacy of consenting against British Orthopaedic Association-endorsed guidance and implemented a series of changes to improve the documentation of risks associated with surgery for fractured neck of femur. Methods Seventy consecutive patients who underwent any operative fixation of a neck of femur fracture were included over a 6-month period at a single centre. Patients unable to consent or without electronic notes were excluded. Consent forms were analysed and the documented potential risks or complications associated with surgery were compared to British Orthopaedic Association-endorsed guidance. A series of changes (using the plan, do study, act (PDSA) approach) was implemented to improve the adequacy of consent. Results Documentation of four out of 12 potential risks or complications was recorded in <50% of cases for patients with intracapsular fractures (n=35), and documentation of seven out of 12 potential risks or complications was recorded in <50% of cases for patients with extracapsular fractures (n=35). Re-audit following raising awareness and attaching consent guidance showed 100% documentation of potential risks or complications in patients with intracapsular and extracapsular fractures (n=70). A neck of femur fracture-specific consent form has been implemented which will hopefully lead to sustained improvement. Conclusions Consenting patients with fractured neck of femur for surgery in the authors' unit was suboptimal when compared to British Orthopaedic Association-endorsed consent guidance. This project has shown that ensuring such guidance is readily available has improved the adequacy of consent. The authors hope that introduction of a neck of

  7. Social Annotation Valence: The Impact on Online Informed Consent Beliefs and Behavior.

    Science.gov (United States)

    Balestra, Martina; Shaer, Orit; Okerlund, Johanna; Westendorf, Lauren; Ball, Madeleine; Nov, Oded

    2016-07-20

    Social media, mobile and wearable technology, and connected devices have significantly expanded the opportunities for conducting biomedical research online. Electronic consent to collecting such data, however, poses new challenges when contrasted to traditional consent processes. It reduces the participant-researcher dialogue but provides an opportunity for the consent deliberation process to move from solitary to social settings. In this research, we propose that social annotations, embedded in the consent form, can help prospective participants deliberate on the research and the organization behind it in ways that traditional consent forms cannot. Furthermore, we examine the role of the comments' valence on prospective participants' beliefs and behavior. This study focuses specifically on the influence of annotations' valence on participants' perceptions and behaviors surrounding online consent for biomedical research. We hope to shed light on how social annotation can be incorporated into digitally mediated consent forms responsibly and effectively. In this controlled between-subjects experiment, participants were presented with an online consent form for a personal genomics study that contained social annotations embedded in its margins. Individuals were randomly assigned to view the consent form with positive-, negative-, or mixed-valence comments beside the text of the consent form. We compared participants' perceptions of being informed and having understood the material, their trust in the organization seeking the consent, and their actual consent across conditions. We find that comment valence has a marginally significant main effect on participants' perception of being informed (F2=2.40, P=.07); specifically, participants in the positive condition (mean 4.17, SD 0.94) felt less informed than those in the mixed condition (mean 4.50, SD 0.69, P=.09). Comment valence also had a marginal main effect on the extent to which participants reported trusting the

  8. Informed Consent in Pediatric Oncology: A Systematic Review of Qualitative Literature.

    Science.gov (United States)

    Alahmad, Ghiath

    2018-01-01

    Obtaining informed consent in pediatric cancer research can be subject to important ethical challenges because of the difficulty in distinguishing between care and research, which are interrelated. Pediatric oncologists also often conduct research, such as clinical trials, on their own patients, which may influence voluntary informed consent. This review aims to determine the ethical issues encountered in obtaining informed consent in pediatric oncology by identifying and summarizing the findings of existing qualitative studies on this topic. A systematic review of qualitative studies was conducted. Medline, Embase, CINAHL, and PubMed were searched using the following terms: (oncolog* or cancer or hematol* or haematol* or leuk* or malign* or neoplasm*) and (child* or adolescent* or minor* or young people or pediatr* or paediatr*) and ethic* or moral*) and (qualitative or interview). Other sources were also mined to identify all relevant studies. The data analysis method used was thematic analysis. At the end of the search process, 2361 studies were identified. Duplicates were removed and irrelevant studies were excluded. After screening the full text of the remaining studies against our inclusion and exclusion criteria, 13 studies were included in the qualitative analysis. All studies were qualitative studies using semistructured and structured interviews, qualitative analysis of open-ended questions, and observation of informed consent conferences. Four themes were identified: parental comprehension of the trial and medical terms, influence of parental distress on decision-making, no offer of an alternative treatment, and influence of the doctor-parent relationship. Many ethical challenges affect the informed consent process. These challenges may include a lack of parental understanding, the potential influence of treating doctors, and vulnerability because of psychological status. All of these result in parents being unable to give well-informed and voluntary

  9. Risk management in clinical practice. Part 2. Getting to 'yes'--the matter of consent.

    Science.gov (United States)

    D'Cruz, L

    2010-07-24

    Consent is an integral part of delivering the care patients want. In order to consent to treatment, patients must have the legal capacity to give valid consent. If this three stage test is satisfied, the patient can elect to have any treatment they wish even if it is not in their best interest. Before a patient is able to consent to treatment they must have adequate knowledge about the risks, benefits and alternatives to the treatment. The amount of information provided to the patient by the dentist is determined to some degree by the legal system prevailing. The patient must voluntarily agree to treatment without being coerced by the dentist or other parties and if things change during treatment the patient needs to be advised. Written consent is very useful in the defence of cases but simply signing the consent form does not mean that the patient knows or understands the treatment to which they have agreed.

  10. 32 CFR 634.8 - Implied consent.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 4 2010-07-01 2010-07-01 true Implied consent. 634.8 Section 634.8 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) LAW ENFORCEMENT AND CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Driving Privileges § 634.8 Implied consent. (a) Implied consent to blood, breath, or urine tests....

  11. Optimization of informed consent for umbilical cord blood banking.

    Science.gov (United States)

    Sugarman, Jeremy; Kurtzberg, Joanne; Box, Tamara L; Horner, Ronnie D

    2002-12-01

    The purpose of this project was to evaluate the informed consent process for donation to a public umbilical cord blood bank. Telephone interviews were conducted with 170 women who had given consent to donate their newborn infants' umbilical cord blood. Of the 170 women who were contacted, 96.8% of the women reported that all their questions had been answered. Nevertheless, approximately one third of the respondents did not consider themselves to be in research, and almost one quarter of the respondents did not know how to contact the umbilical cord blood bank if they or their infant became seriously ill. Further, a substantial proportion of the respondents did not understand the full range of alternatives to donation and incorrectly endorsed potential benefits. Informed consent could be optimized by (1) having those personnel who obtain consent emphasize that banking involves research and to explain the true benefits of donation, (2) ensuring that parents know how and when to contact the umbilical cord blood bank after donation, and (3) using phone surveys to continue assessments and to monitor changes in the process.

  12. Assessment of children's capacity to consent for research: a descriptive qualitative study of researchers' practices.

    Science.gov (United States)

    Gibson, Barbara E; Stasiulis, Elaine; Gutfreund, Shawna; McDonald, Maria; Dade, Lauren

    2011-08-01

    In Canadian jurisdictions without specific legislation pertaining to research consent, the onus is placed on researchers to determine whether a child is capable of independently consenting to participate in a research study. Little, however, is known about how child health researchers are approaching consent and capacity assessment in practice. The aim of this study was to explore and describe researchers' current practices. The study used a qualitative descriptive design consisting of 14 face-to-face interviews with child health researchers and research assistants in Southern Ontario. Transcribed interviews were analysed for common themes. Procedures for assessing capacity varied considerably from the use of age cutoffs to in-depth engagement with each child. Three key issues emerged from the accounts: (1) requirements that consent be provided by a single person thwarted researchers' abilities to support family decision-making; (2) little practical distinction was made between assessing if a child was capable, versus determining if study information had been adequately explained by the researcher; and (3) participants' perceived that review boards' requirements may conflict with what they considered ethical consent practices. The results suggest that researchers' consent and capacity knowledge and skills vary considerably. Perceived discrepancies between ethical practice and ethics boards' requirements suggest the need for dialogue, education and possibly ethics board reforms. Furthermore we propose, where appropriate, a 'family decision-making' model that allows parents and their children to consent together, thereby shifting the focus from separate assent and consent procedures to approaches that appropriately engage the child and family.

  13. 78 FR 27243 - Proposed Collection; 60-Day Comment Request: Interactive Informed Consent for Pediatric Clinical...

    Science.gov (United States)

    2013-05-09

    ... consent or the interactive computer-based program, will be assessed by face-to-face interview. In addition... Comment Request: Interactive Informed Consent for Pediatric Clinical Trials SUMMARY: In compliance with... other technological collection techniques or other forms of information technology. To Submit Comments...

  14. Risk perception and decision processes underlying informed consent to research participation.

    Science.gov (United States)

    Reynolds, William W; Nelson, Robert M

    2007-11-01

    According to the rational choice model, informed consent should consist of a systematic, step-by-step evaluation of all information pertinent to the treatment or research participation decision. Research shows that people frequently deviate from this normative model, however, employing decision-making shortcuts, or heuristics. In this paper we report findings from a qualitative study of 32 adolescents and (their) 31 parents who were recruited from two Northeastern US hospitals and asked to consider the risks of and make hypothetical decisions about research participation. The purpose of this study was to increase our understanding of how diabetic and at-risk adolescents (i.e., those who are obese and/or have a family history of diabetes) and their parents perceive risks and make decisions about research participation. Using data collected from adolescents and parents, we identify heuristic decision processes in which participant perceptions of risk magnitude, which are formed quickly and intuitively and appear to be based on affective responses to information, are far more prominent and central to the participation decision than are perceptions of probability. We discuss participants' use of decision-making heuristics in the context of recent research on affect and decision processes, and we consider the implications of these findings for researchers.

  15. Should we nudge informed consent ?

    OpenAIRE

    Brooks, Thom

    2013-01-01

    Critics argue that nudge theory manipulates rather than respects the informed consent of patients. Cohen (2013) convincingly argues that this criticism falls short of the mark. But we might go one step further: nudges are not only defensible, there are also inescapable. Cohen’s defence should be more robust and recognize the importance of context and unavoidable framing effects. The question is not whether nudges are acceptable, but rather how they might be better employed to improve informed...

  16. Futility, autonomy, and informed consent.

    Science.gov (United States)

    Trau, J M

    1994-03-01

    If clinicians deem a treatment medically futile, is it appropriate to mention such a treatment to patients? Do healthcare professionals violate informed consent if they do not offer patients an opportunity to decline futile treatments? The notion of futility involves an assessment of patient best interest--both short-term and long-term therapeutic benefit for a patient and the community in which he or she intends to survive and flourish. Although survival interests may be construed as long term, a treatment that offers survival without any promise of flourishing is not the goal of medicine and is futile. Flourishing requires some cognitive and affective function. The goal of informed consent practices is to ensure that patients accept the benefits of treatment with cognizance of the burdens and risks. Given the impact of illness on the emotional and psychological states of patients and their families and their resultant vulnerability, the omission of futile options from treatment plans is logical and exemplifies the best of paternalistic behavior. The claim that requests for futile treatment must be honored is based on a perverse understanding of patient autonomy. Rational medicine demands that patients' requests be reasonable from a clinical perspective, as well as from a subjective one. The practice of informed consent can be implemented as a balance between these two interests.

  17. Qualitative evaluation of a deferred consent process in paediatric emergency research: a PREDICT study.

    Science.gov (United States)

    Furyk, Jeremy; McBain-Rigg, Kristin; Watt, Kerrianne; Emeto, Theophilus I; Franklin, Richard C; Franklin, Donna; Schibler, Andreas; Dalziel, Stuart R; Babl, Franz E; Wilson, Catherine; Phillips, Natalie; Ray, Robin

    2017-11-15

    A challenge of conducting research in critically ill children is that the therapeutic window for the intervention may be too short to seek informed consent prior to enrolment. In specific circumstances, most international ethical guidelines allow for children to be enrolled in research with informed consent obtained later, termed deferred consent (DC) or retrospective consent. There is a paucity of data on the attitudes of parents to this method of enrolment in paediatric emergency research. To explore the attitudes of parents to the concept of DC and to expand the knowledge of the limitations to informed consent and DC in these situations. Children presenting with uncomplicated febrile seizures or bronchiolitis were identified from three separate hospital emergency department databases. Parents were invited to participate in a semistructured telephone interview exploring themes of limitations of prospective informed consent, acceptability of the DC process and the most appropriate time to seek DC. Transcripts underwent inductive thematic analysis with intercoder agreement, using Nvivo 11 software. A total of 39 interviews were conducted. Participants comprehended the limitations of informed consent under emergency circumstances and were generally supportive of DC. However, they frequently confused concepts of clinical care and research, and support for participation was commonly linked to their belief of personal benefit. Participants acknowledged the requirement for alternatives to prospective informed consent in emergency research, and were supportive of the concept of DC. Our results suggest that current research practice seems to align with community expectations. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  18. Informed consent in direct-to-consumer personal genome testing: the outline of a model between specific and generic consent.

    Science.gov (United States)

    Bunnik, Eline M; Janssens, A Cecile J W; Schermer, Maartje H N

    2014-09-01

    Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we argue that current practices of information provision are insufficient and that there is a place--and a need--for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. © 2012 John Wiley & Sons Ltd.

  19. Establishing and adhering to sexual consent: the association between reading magazines and college students' sexual consent negotiation.

    Science.gov (United States)

    Hust, Stacey J T; Marett, Emily Garrigues; Ren, Chunbo; Adams, Paula M; Willoughby, Jessica F; Lei, Ming; Ran, Weina; Norman, Cassie

    2014-01-01

    Content analyses have cataloged the sexual scripts present in magazines largely because of their perceived value to readers and their potential role as sex educators. Although it is generally agreed that magazines have the potential to influence sexual attitudes and behavioral intentions, the effects of this medium are not as frequently researched as are other forms of media. The current study tested whether exposure to magazines was associated with intentions related to sexual consent negotiation. A survey of 313 college students indicated that exposure to men's magazines was significantly associated with lower intentions to seek sexual consent and lower intentions to adhere to decisions about sexual consent. In contrast, exposure to women's magazines was significantly associated with greater intentions to refuse unwanted sexual activity. Overall, the findings of this study further reinforce the critical need for responsible and realistic portrayals of sex in entertainment media, specifically magazines.

  20. Autonomy, consent and responsability. Part 1: limitations of the principle of autonomy as a foundation of informed consent.

    Science.gov (United States)

    Mellado, J M

    2016-01-01

    Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

  1. Fiberoptic endoscopic evaluation of swallowing (FEES): proposal for informed consent.

    Science.gov (United States)

    Nacci, A; Ursino, F; La Vela, R; Matteucci, F; Mallardi, V; Fattori, B

    2008-08-01

    Fiberoptic endoscopic evaluation of swallowing (FEES) is now a first choice method for studying swallowing disorders on account of the various advantages it offers: easy to use, very well tolerated, allows bedside examination and is economic. Nevertheless, this diagnostic procedure is not without risks, the most probable consequences of which include discomfort, gagging and/or vomiting, vasovagal syncope, epistaxis, mucosal perforation, adverse reactions to topical anaesthetics and laryngospasm. The risks involved with FEES stress the importance of informing the patient of these; this is an important aspect in medicine that necessarily and immediately implies receiving the patient's so-called "informed consent". Informed consent should be obtained not only by means of specific printed forms but also after the patient has had an interview with the physician who will be performing the procedure and who will offer information according to the personal clinical, psychological, cultural and linguistic situation of the patient and in keeping with the type of procedure proposed. In the case of FEES, as with other invasive or non-invasive diagnostic procedures, therefore, routine written and signed consent, together with a patient/physician interview should fulfil what is known as "complete information". In this report, a specific form for informed consent to FEES procedures, is proposed.

  2. Recruitment of subjects for clinical trials after informed consent: does gender and educational status make a difference?

    Directory of Open Access Journals (Sweden)

    Gitanjali B

    2003-01-01

    Full Text Available CONTEXT: Researchers and investigators have argued that getting fully informed written consent may not be possible in the developing countries where illiteracy is widespread. AIMS: To determine the percentage of patients who agree to participate in a trial after receiving either complete or partial information regarding a trial and to find out whether there were gender or educational status-related differences. To assess reasons for consenting or refusing and their depth of understanding of informed consent. SETTINGS AND DESIGN: A simulated clinical trial in two tertiary health care facilities on in-patients. METHODS AND MATERIAL: An informed consent form for a mock clinical trial of a drug was prepared. The detailed / partial procedure was explained to a purposive sample of selected in-patients and their consent was asked for. Patients were asked to free list the reasons for giving or withholding consent. Their depth of understanding was assessed using a questionnaire. Chi-square test was used for statistical analyses. RESULTS: The percentages of those consenting after full disclosure 29/102 (30% and after partial disclosure 15/50 (30% were the same. There was a significant (p=0.043 gender difference with a lesser percentage of females (30% consenting to participation in a trial. Educational status did not alter this percentage. Most patients withheld consent because they did not want to give blood or take a new drug. Understanding of informed consent was poor in those who consented. CONCLUSIONS: The fact that only one-third of subjects are likely to give consent to participate in a trial needs to be considered while planning clinical trials with a large sample size. Gender but not educational status influences the number of subjects consenting for a study. Poor understanding of the elements of informed consent in patients necessitates evolving better methods of implementing consent procedures in India.

  3. Consent: an event or a memory in lumbar spinal surgery? A multi-centre, multi-specialty prospective study of documentation and patient recall of consent content.

    Science.gov (United States)

    Lo, William B; McAuley, Ciaran P; Gillies, Martin J; Grover, Patrick J; Pereira, Erlick A C

    2017-11-01

    Prospective, multi-centre, multi-specialty medical notes review and patient interview. The consenting process is an important communication tool which also carries medico-legal implications. While written consent is a pre-requisite before spinal surgery in the UK, the standard and effectiveness of the process have not been assessed previously. This study assesses standard of written consent for elective lumbar decompressive surgery for degenerative disc disease across different regions and specialties in the UK; level of patient recall of the consent content; and identifies factors which affect patient recall. Consent forms of 153 in-patients from 4 centres a, b, c, d were reviewed. Written documentation of intended benefits, alternative treatments and operative risks was assessed. Of them, 108 patients were interviewed within 24 h before or after surgeries to assess recall. The written documentation rates of the operative risks showed significant inter-centre variations in haemorrhage and sphincter disturbance (P = 0.000), but not for others. Analysis of pooled data showed variations in written documentation of risks (P recall of these risks, there was no inter-centre variation. Patients' recall of paralysis as a risk was highest (50.9%) and that of recurrence was lowest (6.5%). Patients recalled risks better than those ≥65, significantly so for infection (29.9 vs 9.7%, P = 0.027). Patients consented >14 days compared to recall for paralysis (65.2 vs 43.7%) and recurrence (17.4 vs 2.8%). Patient recall was independent of consenter grade. Overall, the standard of written consent for elective lumbar spinal decompressive surgery was sub-optimal, which was partly reflected in the poor patient recall. While consenter seniority did not affect patient recall, younger age and longer consent-to-surgery time improved it.

  4. But is this really the 'parent' or 'guardian'? Practical strategies for ...

    African Journals Online (AJOL)

    Research ethics committees (RECs) in South Africa may require consent from a parent or legal guardian for child research. In instances where an REC determines that parental or guardianship consent is required, how far should researchers go to establish if the accompanying adult is in fact the parent or guardian? Should ...

  5. Placebo Effects and Informed Consent.

    Science.gov (United States)

    Alfano, Mark

    2015-01-01

    The concepts of placebos and placebo effects refer to extremely diverse phenomena. I recommend dissolving the concepts of placebos and placebo effects into loosely related groups of specific mechanisms, including (potentially among others) expectation-fulfillment, classical conditioning, and attentional-somatic feedback loops. If this approach is on the right track, it has three main implications for the ethics of informed consent. First, because of the expectation-fulfillment mechanism, the process of informing cannot be considered independently from the potential effects of treatment. Obtaining informed consent influences the effects of treatment. This provides support for the authorized concealment and authorized deception paradigms, and perhaps even for outright deceptive placebo use. Second, doctors may easily fail to consider the potential benefits of conditioning, leading them to misjudge the trade-off between beneficence and autonomy. Third, how attentional-somatic feedback loops play out depends not only on the content of the informing process but also on its framing. This suggests a role for libertarian paternalism in clinical practice.

  6. Community perspectives on research consent involving vulnerable children in Western Kenya.

    Science.gov (United States)

    Vreeman, Rachel; Kamaara, Eunice; Kamanda, Allan; Ayuku, David; Nyandiko, Winstone; Atwoli, Lukoye; Ayaya, Samuel; Gisore, Peter; Scanlon, Michael; Braitstein, Paula

    2012-10-01

    Involving vulnerable pediatric populations in international research requires culturally appropriate ethical protections. We sought to use mabaraza, traditional East African community assemblies, to understand how a community in western Kenya viewed participation of children in health research and informed consent and assent processes. Results from 108 participants revealed generally positive attitudes towards involving vulnerable children in research, largely because they assumed children would directly benefit. Consent from parents or guardians was understood as necessary for participation while gaining child assent was not. They felt other caregivers, community leaders, and even community assemblies could participate in the consent process. Community members believed research involving orphans and street children could benefit these vulnerable populations, but would require special processes for consent.

  7. Pediatric data sharing in genomic research: attitudes and preferences of parents.

    Science.gov (United States)

    Burstein, Matthew D; Robinson, Jill Oliver; Hilsenbeck, Susan G; McGuire, Amy L; Lau, Ching C

    2014-04-01

    In the United States, data from federally funded genomics studies are stored in national databases, which may be accessible to anyone online (public release) or only to qualified researchers (restricted release). The availability of such data exposes participants to privacy risk and limits the ability to withdraw from research. This exposure is especially challenging for pediatric participants, who are enrolled in studies with parental permission. The current study examines genomic research participants' attitudes to explore differences in data sharing (DS) preferences between parents of pediatric patients and adult patients. A total of 113 parents of pediatric patients and 196 adult participants from 6 genomics studies were randomly assigned to 3 experimental consent forms. Participants were invited to a follow-up structured interview exploring DS preferences, study understanding, and attitudes. Descriptive analyses and regression models were built on responses. Most parents (73.5%) and adult participants (90.3%) ultimately consented to broad public release. However, parents were significantly more restrictive in their data release decisions, not because of understanding or perceived benefits of participation but rather autonomy and control. Parents want to be more involved in the decision about DS and are significantly more concerned than adult participants about unknown future risks. Parents have the same altruistic motivations and grasp of genomics studies as adult participants. However, they are more concerned about future risks to their child, which probably motivates them to choose more restrictive DS options, but only when such options are made available.

  8. Unanimous Constitutional Consent and the Immigration Problem

    OpenAIRE

    Josten, Stefan D.; Zimmermann, Klaus W.

    2004-01-01

    This paper utilizes the cross-cutting cleavages approach to evaluate the probability of a unanimous constitutional consent and, based on these results, discusses the implications of immigration on an existing constitutional consent. It is shown that previous conclusions of beneficial effects stemming from a multitude of political dimensions for a unanimous constitutional consent crucially depend on the assumption of an extreme mode of intrapersonal compensation of constitutional majority and ...

  9. A Qualitative Study into Dependent Relationships and Voluntary Informed Consent for Research in Pediatric Oncology.

    Science.gov (United States)

    Dekking, Sara A S; van der Graaf, Rieke; Schouten-van Meeteren, Antoinette Y N; Kars, Marijke C; van Delden, Johannes J M

    2016-04-01

    In pediatric oncology, many oncologists invite their own patients to participate in research. Inclusion within a dependent relationship is considered to potentially compromise voluntariness of consent. Currently, it is unknown to what extent those involved in pediatric oncology experience the dependent relationship as a threat to voluntary informed consent, and what they see as safeguards to protect voluntary informed consent within a dependent relationship. We performed a qualitative study among key actors in pediatric oncology to explore their experiences with the dependent relationship and voluntary informed consent. We conducted three focus groups and 25 semi-structured, in-depth interviews with pediatric oncologists, research coordinators, Research Ethics Committee members, parents of children with cancer, and adolescents with cancer. Professionals regarded the dependent relationship both as a potential threat to and as a positive influence on voluntary decision making. Parents and adolescents did not feel as though dependency upon the oncologist influenced their decisions. They valued the involvement of their own physician in the informed consent process. The professionals suggested three strategies to protect voluntariness: emphasizing voluntariness; empowering families; involvement of an independent person. Although the dependent relationship between pediatric oncologists, patients and parents may be problematic for voluntary informed consent, this is not necessarily the case. Moreover, the involvement of treating physicians may even have a positive impact on the informed consent process. Although we studied pediatric oncology, our results may also apply to many other fields of pediatric medicine where research and care are combined, for example, pediatric rheumatology, neurology and nephrology. Clinical trials in these fields are inevitably often designed, initiated and conducted by medical specialists closely involved in patient care.

  10. Obtaining consent to oral and maxillofacial surgery.

    Science.gov (United States)

    Poswillo, D

    1989-09-01

    The question of whether or not a patient has consented to treatment has recently become significant to all who practise oral and maxillofacial surgery. It is often linked to professional negligence when the outcome differs from the patient's perception or expectation of the operation. Consent may be oral or written, applies to referred patients and all those with physical and mental handicap and religious restrictions. Examples of procedure in discussing consent assist the surgeon to inform without creating fear. Knowledge of the benefits of informed consent and current legal opinion assist the oral and maxillofacial surgeon to avoid the pitfalls of failure to inform.

  11. A Longitudinal Study of Families Formed Through Reproductive Donation: Parent-Adolescent Relationships and Adolescent Adjustment at Age 14

    OpenAIRE

    Golombok, Susan; Ilioi, Elena; Blake, Lucy; Roman, Gabriela; Jadva, Vasanti

    2017-01-01

    The aim of the 6th phase of this longitudinal study was to establish whether children born through assisted reproduction involving reproductive donation were at risk for psychological problems following the transition to adolescence at age 14 and, if so, to examine the nature of these problems and the mechanisms involved. Eighty-seven families formed through reproductive donation, including 32 donor insemination families, 27 egg donation families, and 28 surrogacy families, were compared with...

  12. Quality and extent of informed consent for invasive procedures: a pilot study at the institutional level in Turkey.

    Science.gov (United States)

    Dogan, H Hanzade; Işik, Elif; Vural, Ezgi; Vehid, Hayriye; Brezis, Mayer

    2015-02-01

    To assess the quality of informed consent for patients undergoing invasive procedures and to reveal patient preferences for being informed about the potential risks of treatment and alternatives to treatment. This study was planned as a pilot study. Hospitalized patients' perceptions and expectations about the informed-consent process were explored in a general surgery department. The prepared questionnaire was completed by patients via interview. Inpatient services of the general surgery department of a large academic hospital in Istanbul, Turkey. The study population consisted of hospitalized patients in a general surgery department who underwent invasive procedures in March 2013. Recognition of consent forms by the patients, rate of patients' recall of risks, rate of patients who were willing to be involved in decision making, and rate of patients who were satisfied with the whole decision-making process were measured. All patients signed consent forms. Most patients did not properly read the consent form since they trusted their physician. Potential exposure to risk seemed to be important for patient expectations. Paternalism seemed to dominate our clinical setting. The informed-consent process was definitely a separate issue from signing the consent forms. We conclude that the informed-consent process should be modified to be more functional and appropriate to human psychology. We suggest that education is necessary for informed consent to promote better quality and safety in health care. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  13. Arrays in postnatal and prenatal diagnosis: An exploration of the ethics of consent.

    Science.gov (United States)

    Dondorp, Wybo; Sikkema-Raddatz, Birgit; de Die-Smulders, Christine; de Wert, Guido

    2012-06-01

    The introduction of genome-wide arrays in postnatal and prenatal diagnosis raises challenging ethical issues. Here, we explore questions with regard to the ethics of consent. One important issue is whether informed consent for genome-wide array-based testing is in fact feasible, given the wide range of possible outcomes and related options. The proposed alternative of "generic consent" will have to be studied in practice. From an ethical point of view, the question is whether consent would still be sufficiently "informed" in a generic approach. Another issue that has not yet been given much attention is how far parents, or pregnant women and their partners, should be allowed to determine the range of possible outcomes that will or will not be reported back to them. The scope and limits of parents' and prospective parents' right to know or not to know are far from clear. The complex normative issues on the content and weight of these rights can only be answered by taking full account of the rights and interests of all the parties involved: prospective and actual parents, children, and relatives. This paper is the result of a working group meeting preceding the European Society of Human Genetics 2011 Conference, where these issues were addressed. © 2012 Wiley Periodicals, Inc.

  14. What a signature adds to the consent process.

    LENUS (Irish Health Repository)

    Neary, Peter

    2012-02-03

    BACKGROUND: "Consent is a process by which a patient is informed and becomes a participant in decisions regarding their medical management." It is argued, however, that providing a signature to a form adds little to the quality of this process. METHODS: Views regarding the consent ritual of nonselected patients undergoing endoscopy (cystoscopy or sigmoidoscopy) were prospectively studied together with those of the attending staff. Patient volunteers were randomly assigned to one of two groups and given verbal explanation before the procedure, either alone (group A) or with a request to sign a form in addition (group B). A standardized questionnaire regarding preferences then was applied. RESULTS: A total of 37 patients (22 men) were studied along with seven staff members. Most surveyed felt that signing a consent form helped to empower the patient (group A, 84%; group B, 83%; staff, 100%). Although the patients mainly believed that it functioned primarily to protect the hospital and doctor (group A, 89%; group B, 67%), only one patient (3% of total) felt that such a formality undermined the patient-doctor relationship. Most staff members favored signing a form (86%). The majority of patients either favored it (group A, 47%; group B, 78%) or expressed no strong preference (group A, 32%; group B, 11%). Interestingly, more women than men preferred signing (73 vs. 55%; p = 0.25), perhaps because more women believed that it functioned to preserve autonomy (93 vs. 77% of men). Age was no particular determinant of perspective. CONCLUSION: Although it may be viewed as primarily serving to protect the doctor and hospital, the formal process of signing written consent forms appeals to patients and staff.

  15. The limits of informed consent.

    Science.gov (United States)

    1975-09-01

    The patient, a 59-year-old man, was referred to a psychiatric hospital with what appeared initially to be the signs and symptoms of mental disorder. In hospital a lesion of the brain was diagnosed and surgery was proposed to relieve the condition. The patient, however, during this and subsequent admissions to hospital, refused operation. His refusal to consent was regarded as valid as he seemed to have good insight into his condition. Finally, under section 26 of the Mental Health Act, he was treated surgically. Unfortunately the patient died six weeks later of intracranial haemorrhage. Three comments are made on this case - two by psychiatrists, Dr K Davison and Dr Ashley Robin, the other by a professor of Christian ethics, Professor F C Blackie. Both psychiatrists argue that when a patient's mind is affected by mental or organic illness to the degree that 'he cannot bring a rational and conscious mind' to the question of his treatment then the doctor, in consultation with the relatives, making clear to them the likely course of events if an operation is not performed, must take whatever is the proper course of action, in this case surgery. In this view, such an operation performed immediately the diagnosis was confirmed might not have been so complicated. Professor Blackie, commending 'the attempt to regard the patient as a responsible human being' with a 'moral right to be consulted on all aspects of treatment', questions in this patient the limits to which the appeal to reason was carried. He concludes that 'in this situation the advice and consent of the family must weigh more heavily than the statements of the patient'.

  16. What is presumed when we presume consent?

    Directory of Open Access Journals (Sweden)

    Pierscionek Barbara K

    2008-04-01

    Full Text Available Abstract Background The organ donor shortfall in the UK has prompted calls to introduce legislation to allow for presumed consent: if there is no explicit objection to donation of an organ, consent should be presumed. The current debate has not taken in account accepted meanings of presumption in law and science and the consequences for rights of ownership that would arise should presumed consent become law. In addition, arguments revolve around the rights of the competent autonomous adult but do not always consider the more serious implications for children or the disabled. Discussion Any action or decision made on a presumption is accepted in law and science as one based on judgement of a provisional situation. It should therefore allow the possibility of reversing the action or decision. Presumed consent to organ donation will not permit such reversal. Placing prime importance on the functionality of body organs and their capacity to sustain life rather than on explicit consent of the individual will lead to further debate about rights of ownership and potentially to questions about financial incentives and to whom benefits should accrue. Factors that influence donor rates are not fully understood and attitudes of the public to presumed consent require further investigation. Presuming consent will also necessitate considering how such a measure would be applied in situations involving children and mentally incompetent adults. Summary The presumption of consent to organ donation cannot be understood in the same way as is presumption when applied to science or law. Consideration should be given to the consequences of presuming consent and to the questions of ownership and organ monetary value as these questions are likely to arise should presumed consent be permitted. In addition, the implications of presumed consent on children and adults who are unable to object to organ donation, requires serious contemplation if these most vulnerable

  17. Remarks on the Problem of Informed Consent in Japan : The doctor-Patient Relationship and Implicit Personality Theory

    OpenAIRE

    丸山, 久美子

    1998-01-01

    In Japan it is very difficult to investigate the matter of telling the truth to terminally-ill cancer patients or to obtain informed consent from patients. The reason is that there is no consensus about obtaining informed consent from terminally-ill cancer patients or other dying patients. In this study a questionnaire was used regarding cancer notification, informed consent, and the impressions formed of doctors and nurses by various kinds of patients. University students were surveyed regar...

  18. 42 CFR Appendix to Subpart F of... - Required Consent Form

    Science.gov (United States)

    2010-10-01

    ... pregnant, bear children or father children. I was told about those temporary methods of birth control that... can change my mind at any time and that my decision at any time not to be sterilized will not result... control are available which are temporary. I explained that sterilization is different because it is...

  19. Parental overprotection revisited.

    Science.gov (United States)

    Thomasgard, M; Metz, W P

    1993-01-01

    Dimensions of parental overprotection are clarified in a critical review of the research and clinical literature. An indulgent style of parenting is distinguished from an overprotective parent-child relationship. Differential antecedents and outcomes are proposed for each of these forms of parent-child interaction. Measures of protection are reviewed. A new conceptual model of parental overprotection is presented which takes into account child, parent, family, socio-cultural, environmental and resiliency factors. Directions for future research are suggested.

  20. The changing face of informed surgical consent.

    LENUS (Irish Health Repository)

    Oosthuizen, J C

    2012-03-01

    To determine whether procedure-specific brochures improve patients\\' pre-operative knowledge, to determine the amount of information expected by patients during the consenting process, and to determine whether the recently proposed \\'Request for Treatment\\' consenting process is viable on a large scale.

  1. Consenting to Heteronormativity: Assumptions in Biomedical Research

    NARCIS (Netherlands)

    Cottingham, M.D.; Fisher, J.A.

    2015-01-01

    The process of informed consent is fundamental to basic scientific research with human subjects. As one aspect of the scientific enterprise, clinical drug trials rely on informed consent documents to safeguard the ethical treatment of trial participants. This paper explores the role of

  2. HIV testing and informed consent - ethical considerations

    African Journals Online (AJOL)

    donation; and the protection of third parties, including the health care worker. .... closest available relative or, in the case of a minor, the consent of the medical ... case informed consent to the taking of blood is obviously mandatory. . Blood ...

  3. Dynamic axes of informed consent in Japan.

    Science.gov (United States)

    Specker Sullivan, Laura

    2017-02-01

    Scholarship in cross-cultural bioethics routinely frames Japanese informed consent in contrast to informed consent in North America. This contrastive analysis foregrounds cancer diagnosis disclosure and physician paternalism as unique aspects of Japanese informed consent that deviate from American practices. Drawing on in-depth interviews with 15 Japanese medical professionals obtained during fieldwork in Japan from 2013 to 15, this article complicates the informed consent discourse beyond East-West comparisons premised on Anglo-American ethical frameworks. It expands professional perspectives to include nurses, medical social workers, clinical psychologists, and ethicists and it addresses informed consent for a broad range of conditions in addition to cancer. The results suggest that division of affective labor is an under-theorized dimension of informed consent that is perceived as at odds with principled demands for universal informed consent. These practical tensions are conceptualized as cultural differences, with Japan identified in terms of omakase as practical and supportive and the United States identified in terms of jiko kettei as principled and self-determining. These results have implications for the methodology of cross-cultural bioethics as well as for theories and practices of informed consent in both Japan and the United States. I conclude that responsible cross-cultural work in bioethics must begin from the ground up, incorporating all relevant stakeholder perspectives, attitudes, and experiences. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. Lack of consent for mediation between companies and its reasons

    OpenAIRE

    Karpińska-Królikowska, Iwona

    2011-01-01

    This article discusses commercial mediation, presenting its principles and procedure. It shows the reason why I became interested in the topic of companies’ lack of willingness to solve problems through mediation. It presents empirical statistics from mediation in commercial cases, including those on lack of consents or settlements. The figures are shown against the background of court statistics. On the basis of research conducted in the form of case studies, it presents...

  5. Ethical considerations in investigating youth alcohol norms and behaviours: a case for mature minor consent.

    Science.gov (United States)

    Hildebrand, J; Maycock, B; Comfort, J; Burns, S; Adams, E; Howat, P

    2015-12-01

    Mature minor consent only became available in Australia in 2007. There is neither an explicitly defined protocol, nor a clear definition evident in the literature relating to use of the mature minor concept in health research. Due to difficulties in defining fixed age ranges to varying levels of maturity and vulnerability, there is a lack of clarity surrounding when it might be reasonable and ethical to apply for or grant a waiver for parental consent. This paper describes the challenges faced and solutions created when gaining approval for use of mature minor consent in a respondent-driven sampling (RDS) study to explore the social norms and alcohol consumption among 14-17-year-old adolescents (n = 1012) in the community. The University's Human Research Ethics Committee granted mature minor consent for this study, and the techniques applied enabled recruitment of adolescents from community-based settings through use of RDS to achieve the required sample. This paper has relevance for research that requires a waiver for parental consent; it presents a case study for assessing mature minors and makes recommendations on how ethical guidelines can be improved to assist human research ethics application processes.

  6. Young people's views about consenting to data linkage: findings from the PEARL qualitative study.

    Science.gov (United States)

    Audrey, Suzanne; Brown, Lindsey; Campbell, Rona; Boyd, Andy; Macleod, John

    2016-03-21

    Electronic administrative data exist in several domains which, if linked, are potentially useful for research. However, benefits from data linkage should be considered alongside risks such as the threat to privacy. Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study. The Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. Qualitative research was incorporated in the PEARL study to examine participants' views about data linkage and inform approaches to information sharing. This paper focusses on issues of consent. Digitally recorded interviews were conducted with 55 participants aged 17-19 years. Terms and processes relating to consent, anonymization and data linkage were explained to interviewees. Scenarios were used to prompt consideration of linking different sources of data, and whether consent should be requested. Interview recordings were fully transcribed. Thematic analysis was undertaken using the Framework approach. Participant views on data linkage appeared to be most influenced by: considerations around the social sensitivity of the research question, and; the possibility of tangible health benefits in the public interest. Some participants appeared unsure about the effectiveness of anonymization, or did not always view effective anonymization as making consent unnecessary. This was related to notions of ownership of personal information and etiquette around asking permission for secondary use. Despite different consent procedures being explained, participants tended to equate consent with 'opt-in' consent through which participants are 'asked' if their data can be used for a specific study. Participants raising similar concerns came to differing conclusions about whether consent was needed. Views changed when presented with different scenarios, and were sometimes inconsistent. Findings

  7. Exploring informed consent in HIV clinical trials: A case study in Uganda

    Directory of Open Access Journals (Sweden)

    Agnes Ssali

    2016-11-01

    Conclusion: This study’s findings indicated that obtaining a volunteer’s signature or thumbprint on a consent form did not necessarily mean that the participant was fully-informed about the information relevant to their taking part nor that they understood all the information shared with them. Informed consent requires sufficient time in the research process to have staff trained well enough before research begins. Ensuring and gaining informed consent should be understood and treated as a relation-centred, dynamic supportive process throughout the duration of a research study.

  8. Competence for Contract and Competence to Consent to Treatment

    OpenAIRE

    前田, 泰

    2008-01-01

    This paper analyzes assessing competence to consent to treatment. It focuses on problems of competence for contract and competence to consent to treatment. Finally, it discusses the degree of assessing competence to consent to treatment.

  9. [Informed consent consultation as a part of patient safety in pediatric traumatology].

    Science.gov (United States)

    Kraus, R; Heberer, J

    2013-10-01

    In pediatric traumatology as in any other surgical specialty, every treatment measure has to be protected by an adequate clarification. A legally effective clarification has to cover various aspects, such as diagnosis, treatment, risk and safety clarification and leads to an informed consent consultation. The contents of this informed consent discussion must be documented. The nature and extent of clarification, among other things depend on the urgency of the procedure and in an emergency it can be dispensed with in pediatric traumatology. In the case of minors the conversation must be conducted basically in the presence of both parents as they alone are legally entitled to give approval. General treatment proxies are not allowed. If it is not possible to talk to both parents the physician is allowed to trust that the parent present represents the will of the absent parent. Intervention cannot be carried out against the will of adolescents capable of self-determination even with the consent of the parents. The application of these rules is illustrated by means of practical examples.

  10. Improving the Proficiency of Research Consent Administrators

    Science.gov (United States)

    Larson, Elaine L.; Lally, Rachel; Foe, Gabriella; Joaquin, Gabriela; Meyer, Dodi D.; Cohn, Elizabeth G.

    2015-01-01

    Abstract Objective: To describe the development and testing of a module to improve consent administrators’ skills when obtaining research consent from culturally and linguistically diverse and low literacy populations. Design: Development and psychometric testing of video module including community vignettes. Methods: Following initial content, face, and construct validity testing by experts, a field trial was conducted with pre‐ and postknowledge tests and satisfaction surveys completed by 112 consent administrators. Results: Mean score out of a possible 10 on pretest was 8.6 (±standard deviation [SD], 1.55) and on posttest was 9.1 (±SD, 1.2; paired t‐test 95% confidence interval of difference: –0.18 to –0.88; two‐tailed p = 0.003). The average years of experience with obtaining consent was 6.42 years (range: 0–35), but years of experience was not significantly associated with either pre‐ or posttest scores (p = 0.82 and 0.44, respectively). Most user evaluations were positive, although suggestions for improvements were made. Conclusion: Although pretest scores were relatively high, training needs of research consent administrators for consenting diverse and low literacy populations may be unmet. We urge that institutional review boards, researchers, policymakers, educators, and bioethicists address the training needs of research consent administrators and we offer this training module as one potential resource and adjunct to such training. PMID:25676061

  11. Informed consent for radiotherapy: Our responsibility

    International Nuclear Information System (INIS)

    Colyer, Hazel

    2007-01-01

    This article describes and contextualises the findings from an email survey of cancer centres in the United Kingdom (UK) conducted early in 2005. It sought to discover how widely the model consent policy and process, published in 2001 [Department of Health. Good practice in consent. Achieving the NHS Plan commitment to patient-centred consent practice. HSC 2001/023. NHS Executive; November 2001], had been implemented and, more controversially, which professional groups gained the consent of patients to radiotherapy. The survey was sent on the author's behalf by the Society and College of Radiographers (SCoR) to all cancer centres in the UK, including five private sector facilities (n = 63). Forty-eight responses were received (76%). A majority of cancer centres have implemented the new procedures and these are undertaken most commonly by consultant oncologists and trained specialist registrars. In 10 centres, therapeutic radiographers (radiographers) are among the team gaining consent to radiotherapy and other centres have radiographers in training. There is widespread adherence to government guidance for obtaining consent and a growing number of centres are implementing radiographer-led consent. However, this is controversial from both medical and radiographic professional perspectives despite guidance indicating that the person who is actually treating the patients should seek their consent [Department of Health. 12 Key points on consent: the law in England. March 2001]. In the context of creating person-centred services, the significance for the development of the profession of therapeutic radiography is evaluated. In particular, the implications of radiographers both capitalising on and failing to assume this professional responsibility were explored

  12. [QOL questionnaire for pediatric patients with bronchial asthma and their parents or caregivers. Preparation and evaluation of the short form version 2008 (Gifu)].

    Science.gov (United States)

    Kondo, Naomi; Hirayama, Koichiro; Matsui, Eiko; Teramoto, Takahide; Kaneko, Hideo; Fukao, Toshiyuki; Orii, Kenji; Kawamoto, Minako; Funato, Michinori; Ohnishi, Hidenori; Kawamoto, Norio; Morita, Hideyuki; Kimura, Takeshi; Nada, Masatoshi; Tokumi, Tetsuji; Hori, Tomohiro; Watanabe, Rinko

    2008-08-01

    The QOL questionnaire version 2001 for pediatric patients with bronchial asthma and their parents or caregivers includes 15 questions for patients under the age of 4 years and 20 questions for patients over the age of 4 years. We have already reported that the QOL questionnaire version 2001 reflects reliability (including reproducibility), factorial validity, and changes in paroxysmal attacks of asthma. In this study, we revised the questionnaire for use in routine medical practice. In this study, based on the data of a previous report, the number of questions was reduced further and it was revised to the questionnaire the short form by integrated data. The revised version 2008 (Gifu) consisted of emotional burden, asthma attack, instability of symptoms and proper acceptance of asthma as a common factor, moreover 4 or more years old added load of exercise factor which consisted of two questions in each factor. This QOL short form questionnaire version 2008 (Gifu) is a disease specific questionnaire in comparison with health control, bronchial asthma and non-asthmatic patients, such as atopic dermatitis and allergic rhinitis. Although Cronbach's alpha fell with reduction of the number of questions, we conclude that it was acceptable in the clinical practice.

  13. Organ donation in Switzerland--an analysis of factors associated with consent rate.

    Directory of Open Access Journals (Sweden)

    Julius Weiss

    Full Text Available BACKGROUND AND AIM: Switzerland has a low post mortem organ donation rate. Here we examine variables that are associated with the consent of the deceased's next of kin (NOK for organ donation, which is a prerequisite for donation in Switzerland. METHODS AND ANALYSIS: During one year, we registered information from NOK of all deceased patients in Swiss intensive care units, who were approached for consent to organ donation. We collected data on patient demographics, characteristics of NOK, factors related to the request process and to the clinical setting. We analyzed the association of collected predictors with consent rate using univariable logistic regression models; predictors with p-values <0.2 were selected for a multivariable logistic regression. RESULTS: Of 266 NOK approached for consent, consent was given in 137 (51.5% cases. In multivariable analysis, we found associations of consent rates with Swiss nationality (OR 3.09, 95% CI: 1.46-6.54 and German language area (OR 0.31, 95% CI: 0.14-0.73. Consent rates tended to be higher if a parent was present during the request (OR 1.76, 95% CI: 0.93-3.33 and if the request was done before brain death was formally declared (OR 1.87, 95% CI: 0.90-3.87. CONCLUSION: Establishing an atmosphere of trust between the medical staff putting forward a request and the NOK, allowing sufficient time for the NOK to consider donation, and respecting personal values and cultural differences, could be of importance for increasing donation rates. Additional measures are needed to address the pronounced differences in consent rates between language regions.

  14. Informed consent in Sri Lanka: A survey among ethics committee members

    OpenAIRE

    Sumathipala, Athula; Siribaddana, Sisira; Hewage, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin

    2008-01-01

    Abstract Background Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research. However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. Methods We obtained ethical ap...

  15. Informed consent: information or knowledge?

    Science.gov (United States)

    Berger, Ken

    2003-01-01

    A fiduciary relationship should be nurtured between patient and physician. This requires effective communication throughout all aspects of care - especially pertaining to treatment decisions. In the context of illness as experienced by the patient a unique set of circumstances is presented. However, communication in an illness context is fraught with problems. The patient is vulnerable and the situation may be overwhelming. Voluminous amounts of information are available to patients from a host of health care providers, family members, support groups, advocacy centers, books, journals, and the internet. Often conflicting and confusion, frequently complex, this information may be of greater burden than benefit. Some information is of high validity and reliability while other information is of dubious reliability. The emotional freight of bad news may further inhibit understanding. An overload of information may pose an obstacle in decision-making. To facilitate the transformation of information into knowledge, the health care provider must act on some occasions as a filter, on other occasions as a conduit, and on still other occasions simply as a reservoir. The evolution of patient rights to receive or refuse treatment, the right to know or not to know calls for a change in processing of overwhelming information in our modem era. In this paper we will discuss the difference between information and knowledge. How can health care providers ensure they have given their patients all necessary and sufficient information to make an autonomous decision? How can they facilitate the transformation of information into knowledge? The effect of knowledge to consent allows a more focused, relevant and modern approach to choice in health care.

  16. [Readability of surgical informed consent in Spain].

    Science.gov (United States)

    San Norberto, Enrique María; Gómez-Alonso, Daniel; Trigueros, José M; Quiroga, Jorge; Gualis, Javier; Vaquero, Carlos

    2014-03-01

    To assess the readability of informed consent documents (IC) of the different national surgical societies. During January 2012 we collected 504 IC protocols of different specialties. To calculate readability parameters the following criteria were assessed: number of words, syllables and phrases, syllables/word and word/phrase averages, Word correlation index, Flesch-Szigriszt index, Huerta Fernández index, Inflesz scale degree and the Gunning-Fog index. The mean Flesch-Szigriszt index was 50.65 ± 6,72, so readability is considered normal. There are significant differences between specialties such as Urology (43.00 ± 4.17) and Angiology and Vascular Surgery (63.00 ± 3.26, P<.001). No IC would be appropriate for adult readability according to the Fernández-Huerta index (total mean 55.77 ± 6.57); the IC of Angiology and Vascular Surgery were the closest ones (67.85 ± 3.20). Considering the Inflesz scale degree (total mean of 2.84 ± 3,23), IC can be described as «somewhat difficult». There are significant differences between the IC of Angiology and Vascular Surgery (3.23 ± 0.47) that could be qualified as normal, or Cardiovascular Surgery (2.79 ± 0.43) as «nearly normal readability»; and others such as Urology (1, 70 ± 0.46, P<.001) and Thoracic Surgery (1.90 ± 0.30, P<.001), with a readability between «very» and «somewhat» difficult. The Gunning-Fog indexes are far from the readability for a general audience (total mean of 26.29 ± 10,89). IC developed by scientific societies of different surgical specialties do not have an adequate readability for patients. We recommend the use of readability indexes during the writing of these consent forms. Copyright © 2012 AEC. Published by Elsevier Espana. All rights reserved.

  17. Informed consent in colonoscopy: A comparative analysis of 2 methods.

    Science.gov (United States)

    Sanguinetti, J M; Lotero Polesel, J C; Iriarte, S M; Ledesma, C; Canseco Fuentes, S E; Caro, L E

    2015-01-01

    The manner in which informed consent is obtained varies. The aim of this study is to evaluate the level of knowledge about colonoscopy and comparing 2 methods of obtaining informed consent. A comparative, cross-sectional, observational study was conducted on patients that underwent colonoscopy in a public hospital (Group A) and in a private hospital (Group B). Group A received information verbally from a physician, as well as in the form of printed material, and Group B only received printed material. A telephone survey was carried out one or 2 weeks later. The study included a total of 176 subjects (group A [n=55] and group B [n=121]). As regards education level, 69.88% (n=123) of the patients had completed university education, 23.29% (n= 41) secondary level, 5.68% (n=10) primary level, and the remaining subjects (n=2) had not completed any level of education. All (100%) of the subjects knew the characteristics of the procedure, and 99.43% were aware of its benefits. A total of 97.7% received information about complications, 93.7% named some of them, and 25% (n=44) remembered major complications. All the subjects received, read, and signed the informed consent statement before the study. There were no differences between the groups with respect to knowledge of the characteristics and benefits of the procedure, or the receipt and reading of the consent form. Group B responded better in relation to complications (P=.0027) and group A had a better recollection of the major complications (P<.0001). Group A had a higher number of affirmative answers (P<.0001). The combination of verbal and written information provides the patient with a more comprehensive level of knowledge about the procedure. Copyright © 2014 Asociación Mexicana de Gastroenterología. Published by Masson Doyma México S.A. All rights reserved.

  18. Conditions for Australian consent to reprocessing

    International Nuclear Information System (INIS)

    Anon.

    1980-01-01

    This article contains the text of the statement by the Australian Minister for Foreign Affairs to the House of Representatives, Noember 1980, on conditions for Australian consent to the reprocessing of nuclear material of Australian origin

  19. Sole risk and non-consent

    International Nuclear Information System (INIS)

    Winsor, Tom

    1994-01-01

    This article discusses the subjects of sole risk and non-consent in joint operation agreements as used by oil and gas joint ventures in the United Kingdom. The difference between these two concepts is examined in detail. (UK)

  20. [Dentistry and healthcare legislation 3: informed consent].

    Science.gov (United States)

    Brands, W G; van der Ven, J M; Eijkman, M A J

    2013-06-01

    The relationship between a dentist and his patient is based on trust. The principle of informed consent contributes to the quality of that relationship of trust. According to the professional standards for such a relationship, it is up to the dentist to make sure that the patient is well informed. Reliable information is necessary if the patient is to be in a position to give his or her consent for treatment. The Dutch Law of Agreement to Medical Treatment (WGBO) provides aframework for informed consent. Disciplinary judges establish the scope and if necessary the limits. It is clear that, among other things, not defining the risks beforehand can be the basis for a (disciplinary) complaint. Determining the requirements of informed consent calls for familiarity with the law and communication skills. Programmes in dental education ought to devote more attention to this issue.

  1. Testing Consent Order for Sodium Cyanide

    Science.gov (United States)

    This document announces that EPA has signed an enforceable testing Consent Order with E.I. du Pont de Nemours and Company (DuPont), FMC Corporation (FMC), Degussa Corporation (Degussa), ICI Americas Incorporated (ICI), and Cyanco Company (Cyanco).

  2. Consent Codes: Upholding Standard Data Use Conditions.

    Directory of Open Access Journals (Sweden)

    Stephanie O M Dyke

    2016-01-01

    Full Text Available A systematic way of recording data use conditions that are based on consent permissions as found in the datasets of the main public genome archives (NCBI dbGaP and EMBL-EBI/CRG EGA.

  3. Testing Consent Order on Refractory Ceramic Fibers

    Science.gov (United States)

    This notice announces that EPA has signed signed an enforceable testing consent order under the Toxic Substances Control Act (TSCA), 15 U.S.C. section 2601 at seq., with three of the primary producers of refractory ceramic fibers (RCF).

  4. Young people’s views about consenting to data linkage: findings from the PEARL qualitative study

    Directory of Open Access Journals (Sweden)

    Suzanne Audrey

    2016-03-01

    Full Text Available Abstract Background Electronic administrative data exist in several domains which, if linked, are potentially useful for research. However, benefits from data linkage should be considered alongside risks such as the threat to privacy. Avon Longitudinal Study of Parents and Children (ALSPAC is a birth cohort study. The Project to Enhance ALSPAC through Record Linkage (PEARL was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. Qualitative research was incorporated in the PEARL study to examine participants’ views about data linkage and inform approaches to information sharing. This paper focusses on issues of consent. Methods Digitally recorded interviews were conducted with 55 participants aged 17–19 years. Terms and processes relating to consent, anonymization and data linkage were explained to interviewees. Scenarios were used to prompt consideration of linking different sources of data, and whether consent should be requested. Interview recordings were fully transcribed. Thematic analysis was undertaken using the Framework approach. Results Participant views on data linkage appeared to be most influenced by: considerations around the social sensitivity of the research question, and; the possibility of tangible health benefits in the public interest. Some participants appeared unsure about the effectiveness of anonymization, or did not always view effective anonymization as making consent unnecessary. This was related to notions of ownership of personal information and etiquette around asking permission for secondary use. Despite different consent procedures being explained, participants tended to equate consent with ‘opt-in’ consent through which participants are ‘asked’ if their data can be used for a specific study. Participants raising similar concerns came to differing conclusions about whether consent was needed. Views changed when presented

  5. Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review.

    Science.gov (United States)

    Armstrong, Stephanie; Langlois, Adele; Laparidou, Despina; Dixon, Mark; Appleton, Jason P; Bath, Philip M; Snooks, Helen; Siriwardena, A Niroshan

    2017-09-16

    We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on ethical considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent. Consent was the main ethical consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent). Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.

  6. Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review

    Directory of Open Access Journals (Sweden)

    Stephanie Armstrong

    2017-09-01

    Full Text Available Abstract Background We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. Methods A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on ethical considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. Results In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent. Conclusions Consent was the main ethical consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent. Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.

  7. Semantic Representation of Mutual-Consent Divorce

    Directory of Open Access Journals (Sweden)

    مهری سادات موسوی

    2016-09-01

    Full Text Available This article discussed mutual-consent divorce in the context of thoughts and attitude of female applicants of this type of divorce with an inductive qualitative and ethnographic method. Based on the qualitative purposive sampling, 30 women of those who had referred for divorce to family court of Karaj, were selected and deeply interviewed. The results obtained in six major categories as follows: Rethinking the role of men as families’ breadwinners, inappropriate sexual relationships, emotional conflicts, cultural- social dissensions, normative pressures of family and relatives, and personality and behavioral disorders. The core-oriented category of this study is "Women's attitude towards mutual-consent divorce" that includes other major categories and can semantically alter and redirect women’s opinion about mutual-consent divorce. According to the results, the term of mutual-consent is thought-provoking in this type of divorce; because considering the situations which were leaded to mutual-consent divorce and quantifying them revealed that nearly 32% of mutual-consent divorces were not mutual in fact; since, these women accepted divorce with desperation, coercion and threat.

  8. Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research.

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    Hein, Irma M; De Vries, Martine C; Troost, Pieter W; Meynen, Gerben; Van Goudoever, Johannes B; Lindauer, Ramón J L

    2015-11-09

    For many decades, the debate on children's competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children's competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children of 11.2 years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children's competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives. Although assessment of children's competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad. Previous research outcomes showed that children's medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents

  9. Parental decision making around perinatal autopsy: a qualitative investigation.

    Science.gov (United States)

    Meaney, Sarah; Gallagher, Stephen; Lutomski, Jennifer E; O'Donoghue, Keelin

    2015-12-01

    Decades of decline in uptake rates of perinatal autopsies has limited investigation into the causes and risk factors for stillbirth. This study aimed to qualitatively explore perinatal autopsy decision-making processes in parents who experienced antepartum and intrapartum stillbirths. A qualitative semi-structured interview format was utilized. The line of questioning centred on how parents came to decide on consenting or declining to have a perinatal autopsy undertaken. Interpretative phenomenological analysis was employed as the analytic strategy. Purposive sampling was used to recruit 10 parents who either consented or declined autopsy from a large tertiary maternity hospital in Cork Ireland, where there were 30 stillbirths in 2011. Findings revealed four superordinate themes influencing parents' decision-making which varied with type of stillbirth experienced. Those parents who experienced antepartum stillbirths were more likely to consent; thus, knowing that the child was stillborn prior to delivery rather than on the day of delivery was associated with consent. In fact, these parents had more time for meaning-making; those consenting wanted to rule out self-blame and were fearful about future pregnancies. Parents who declined autopsy wanted to protect their infant from further harm. Interestingly, parents' knowledge and understanding of the autopsy itself were acquired primarily from public discourse. Parents' decision-making regarding autopsy is profoundly affected by their emotional response to stillbirth; clinicians and other health professionals may play a key role, especially if they can address parental concerns regarding the invasiveness of the autopsy procedure. © 2014 John Wiley & Sons Ltd.

  10. Involving Medical Students in Informed Consent: A Pilot Study.

    Science.gov (United States)

    Chiapponi, Costanza; Meyer, Frank; Jannasch, Olof; Arndt, Stephan; Stübs, Patrick; Bruns, Christiane J

    2015-09-01

    Studies have reported that patients often sign consent documents without understanding the content. Written paperwork, audio-visual materials, and decision aids have shown to consistently improve patients' knowledge. How informed consent should be taken is not properly taught at most universities in Germany. In this cross-sectional study, we investigated how much information about their procedure our patients retain. In particular, it should be elucidated whether an additional conversation between patients and properly prepared medical students shortly before surgery as an adjunct to informed consent can be introduced as a new teaching unit aimed to increase the understanding of surgery by patients and students. Informed consent of all patients had been previously obtained by three surgical residents 1-3 days in advance. All patients had received a copy of their consent form. The same residents developed assessment forms for thyroidectomy, laparoscopic cholecystectomy, umbilical hernia repair, and Lichtenstein procedure for inguinal hernia, respectively, containing 3-4 major common complications (e.g., bile duct injury, hepatic artery injury, stone spillage, and retained stones for laparoscopic cholecystectomy) and briefed the medical students before seeing the patients. Structured one-to-one interviews between students (n = 9) and patients (n = 55) based on four different assessment forms were performed and recorded by students. Both patients and students were asked to assess the new teaching unit using a short structured questionnaire. Although 100% of patients said at the beginning of their interview to have understood and memorized the risks of their imminent procedure, 5.8% (3/55) were not even able to indicate the correct part of the body where the incision would take place. Only 18.2% (10/55) of the patients were able to mention 2 or more complications, and 45.3% (25/55) could not even recall a single one. 96.4% (53/55) of the patients and 100% (9/9) of the

  11. Securing recruitment and obtaining informed consent in minority ethnic groups in the UK

    Directory of Open Access Journals (Sweden)

    Roy Tapash

    2008-03-01

    Full Text Available Abstract Background Previous health research has often explicitly excluded individuals from minority ethnic backgrounds due to perceived cultural and communication difficulties, including studies where there might be language/literacy problems in obtaining informed consent. This study addressed these difficulties by developing audio-recorded methods of obtaining informed consent and recording data. This report outlines 1 our experiences with securing recruitment to a qualitative study investigating alternative methods of data collection, and 2 the development of a standardised process for obtaining informed consent from individuals from minority ethnic backgrounds whose main language does not have an agreed written form. Methods Two researchers from South Asian backgrounds recruited adults with Type 2 diabetes whose main language was spoken and not written, to attend a series of focus groups. A screening tool was used at recruitment in order to assess literacy skills in potential participants. Informed consent was obtained using audio-recordings of the patient information and recording patients' verbal consent. Participants' perceptions of this method of obtaining consent were recorded. Results Recruitment rates were improved by using telephone compared to face-to-face methods. The screening tool was found to be acceptable by all potential participants. Audio-recorded methods of obtaining informed consent were easy to implement and accepted by all participants. Attrition rates differed according to ethnic group. Snowballing techniques only partly improved participation rates. Conclusion Audio-recorded methods of obtaining informed consent are an acceptable alternative to written consent in study populations where literacy skills are variable. Further exploration of issues relating to attrition is required, and a range of methods may be necessary in order to maximise response and participation rates.

  12. 77 FR 12594 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2012-03-01

    ... Script. Refusal Questions Form.. 62 1 2/60 Individual Consent Form. 250 1 3/60 Contact Information Form... Screening 92 1 5/60 Survey. Informed Consent........ 50 1 1/60 Interview Questionnaire. 50 1 1 Network Size...-12-12BL] Agency Forms Undergoing Paperwork Reduction Act Review The Agency for Toxic Substances and...

  13. Factor structure of the Child Health Questionnaire Parent Form-50 and predictors of health-related quality of life in children with epilepsy.

    Science.gov (United States)

    Ferro, Mark A; Landgraf, Jeanne M; Speechley, Kathy N

    2013-10-01

    The present study investigated the higher-order summary factor structure of the Child Health Questionnaire Parent Form-50 (CHQ) in a sample of children with new-onset epilepsy. The secondary aim was to identify risk factors predicting health-related quality of life (HRQL) 24 months post-diagnosis. Data came from the Health-related Quality of Life in Children with Epilepsy Study (HERQULES, N = 374), a multi-site study documenting HRQL among children with epilepsy from diagnosis through 24 months. Confirmatory factor analysis was used to determine goodness of fit between the original structure of the CHQ and HERQULES data. Multiple regression was used to identify risk factors at diagnosis for HRQL at 24 months. The models demonstrated good fit: baseline: CFI = 0.945; TLI = 0.941; WRMR = 1.461; RMSEA = 0.058; 24 months: CFI = 0.957; TLI = 0.954; WRMR = 1.393; RMSEA = 0.055. Factor loadings were high and no cross-loadings observed (first order: λ = 0.27-0.99, 0.24-0.98; second order: λ = 0.69-0.86, 0.54-0.92; p children with new-onset epilepsy, and child and family risk factors at diagnosis were found to predict HRQL 24 months post-diagnosis. These findings suggest it is possible to identify at-risk children early in the illness process and provide impetus for adopting family-centered care practices.

  14. Under-age girls and contraception: the parent's right to be informed.

    Science.gov (United States)

    Brahams, Diana

    1983-08-06

    A British barrister considers the issue of whether the giving of advice or the prescribing of contraceptives to girls younger than 16 without parental consent constitutes criminal conduct by the physician. Brahams examines relevant criminal and family law, common law, recent court decisions, and Department of Health and Human Services policy concerning the minor's right to consent, parental interests, and physician responsibilities.

  15. Standard Versus Simplified Consent Materials for Biobank Participation: Differences in Patient Knowledge and Trial Accrual.

    Science.gov (United States)

    Garrett, Sarah B; Murphy, Marie; Wiley, James; Dohan, Daniel

    2017-12-01

    Replacing standard consent materials with simplified materials is a promising intervention to improve patient comprehension, but there is little evidence on its real-world implementation. We employed a sequential two-arm design to compare the effect of standard versus simplified consent materials on potential donors' understanding of biobank processes and their accrual to an active biobanking program. Participants were female patients of a California breast health clinic. Subjects from the simplified arm answered more items correctly ( p = .064), reported "don't know" for fewer items ( p = .077), and consented to donate to the biobank at higher rates ( p = .025) than those from the standard arm. Replacing an extant consent form with a simplified version is feasible and may benefit patient comprehension and study accrual.

  16. Universal donor education and consent: what we know and where we should go.

    Science.gov (United States)

    Wehrli, Gay; Sazama, Kathleen

    2010-11-01

    Each day thousands of blood donors across the country are given educational materials and sign a consent form, thus fulfilling two blood collection accreditation requirements. Very few donors will experience a documented adverse event, although a disproportionate number of these events occur in the youngest donor cohort. The literature reflects this disproportion and suggests mitigation strategies. Studies describe subjective, undocumented donor reactions and decreased donor return rates after a documented or subjective reaction. Additionally, studies have shown donor consent form variability among blood collection facilities and that donor comprehension of the educational materials and consent is limited. There are few standardized donor education materials or consent documents. Current accreditation standards for educational materials are limited to aspects of transfusion-transmitted diseases and for donor consent process and documentation are vague and nonspecific. Recent experiences with young donors and current research compel our community to engage in creating standardized, expanded donor educational materials and standardized donor consent processes and documents. © 2010 American Association of Blood Banks.

  17. Facilitating enrollment in a Cancer Registry through modified consent procedures: a pilot study.

    Science.gov (United States)

    Mazanec, Susan; Daly, Barbara; Meropol, Neal J; Step, Mary

    2012-12-01

    Research registries are increasingly important in medical research and are essential to the mission of cancer centers. However, designing enrollment and data collection procedures that are consistent with ethical norms and regulatory requirements yet are efficient and cost effective is a major challenge. Current standard consent forms can be a barrier to enrollment because of their length, multiple components, and technical language. We pilot tested an IRB-approved registry booklet and simplified one-page, tiered consent form, allowing for choice of extent of participation. The booklet was mailed to patients with breast cancer as part of their routine information packet prior to the first clinic appointment. A research nurse met with 27 patients at initial treatment to review the booklet, answer questions, obtain informed consent, and collect quality of life data. The consent rate was 78% with 21 patients enrolling in the study. Twelve of the 21 patients (57%) did not read the booklet prior to the visit. The 9 patients (43%) who had read the booklet prior to arrival found it easy to understand. The multi-stage, simplified consent process and data collection were acceptable to these patients and readily integrated into clinical operations. An easy-to-read registry booklet may be an effective guide for discussion, but in-person consent procedures and further testing of the approach are required.

  18. Consenting options for posthumous organ donation: presumed consent and incentives are not favored

    Directory of Open Access Journals (Sweden)

    Hammami Muhammad M

    2012-11-01

    Full Text Available Abstract Background Posthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries. Methods We surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed consent by donor-only, informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive. Results Mean(SD age was 32(9 year, 27% were males, 50% were patients’ companions, 60% had ≥ college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p vs. 11[6,11], respectively, p = 0.002. Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p vs. 8[4,9], p vs. 5[2,7], p  Conclusions We conclude that: 1 most respondents were in favor of posthumous organ donation, 2 mandated choice system was the most preferred and presumed consent system was the least preferred, 3 there was no difference between preference and perception of norm in consenting systems ranking, and 4 financial (especially in females and medical (especially in males incentives reduced preference.

  19. A cognitive approach for design of a multimedia informed consent video and website in pediatric research.

    Science.gov (United States)

    Antal, Holly; Bunnell, H Timothy; McCahan, Suzanne M; Pennington, Chris; Wysocki, Tim; Blake, Kathryn V

    2017-02-01

    Poor participant comprehension of research procedures following the conventional face-to-face consent process for biomedical research is common. We describe the development of a multimedia informed consent video and website that incorporates cognitive strategies to enhance comprehension of study related material directed to parents and adolescents. A multidisciplinary team was assembled for development of the video and website that included human subjects professionals; psychologist researchers; institutional video and web developers; bioinformaticians and programmers; and parent and adolescent stakeholders. Five learning strategies that included Sensory-Modality view, Coherence, Signaling, Redundancy, and Personalization were integrated into a 15-min video and website material that describes a clinical research trial. A diverse team collaborated extensively over 15months to design and build a multimedia platform for obtaining parental permission and adolescent assent for participant in as asthma clinical trial. Examples of the learning principles included, having a narrator describe what was being viewed on the video (sensory-modality); eliminating unnecessary text and graphics (coherence); having the initial portion of the video explain the sections of the video to be viewed (signaling); avoiding simultaneous presentation of text and graphics (redundancy); and having a consistent narrator throughout the video (personalization). Existing conventional and multimedia processes for obtaining research informed consent have not actively incorporated basic principles of human cognition and learning in the design and implementation of these processes. The present paper illustrates how this can be achieved, setting the stage for rigorous evaluation of potential benefits such as improved comprehension, satisfaction with the consent process, and completion of research objectives. New consent strategies that have an integrated cognitive approach need to be developed and

  20. iConsent an Electronic Consent Platform with the MS Register

    Directory of Open Access Journals (Sweden)

    Rod Middleton

    2017-04-01

    Patients who have been e-consented have expressed satisfaction in the ease of use and security of the software. Patients being unable to rest their hands on the screen is being examined. Newer tablets can ignore inputs other than the stylus. The MS Register intends to use the software in additional centres to capture patient consent.

  1. Autonomy and informed consent: a mistaken association?

    Science.gov (United States)

    Kristinsson, Sigurdur

    2007-09-01

    For decades, the greater part of efforts to improve regulatory frameworks for research ethics has focused on informed consent procedures; their design, codification and regulation. Why is informed consent thought to be so important? Since the publication of the Belmont Report in 1979, the standard response has been that obtaining informed consent is a way of treating individuals as autonomous agents. Despite its political success, the philosophical validity of this Belmont view cannot be taken for granted. If the Belmont view is to be based on a conception of autonomy that generates moral justification, it will either have to be reinterpreted along Kantian lines or coupled with a something like Mill's conception of individuality. The Kantian interpretation would be a radical reinterpretation of the Belmont view, while the Millian justification is incompatible with the liberal requirement that justification for public policy should be neutral between controversial conceptions of the good. This consequence might be avoided by replacing Mill's conception of individuality with a procedural conception of autonomy, but I argue that the resulting view would in fact fail to support a non-Kantian, autonomy-based justification of informed consent. These difficulties suggest that insofar as informed consent is justified by respect for persons and considerations of autonomy, as the Belmont report maintained, the justification should be along the lines of Kantian autonomy and not individual autonomy.

  2. Quality of life in pediatric cancer survivors: contributions of parental distress and psychosocial family risk.

    Science.gov (United States)

    Racine, N M; Khu, M; Reynolds, K; Guilcher, G M T; Schulte, F S M

    2018-02-01

    Pediatric survivors of childhood cancer are at increased risk of poor quality of life and social-emotional outcomes following treatment. The relationship between parent psychological distress and child adjustment in pediatric cancer survivors has been well established. However, limited research has examined the factors that may buffer this association. The current study examined the associations between psychosocial family risk factors, parental psychological distress, and health-related quality of life (hrql) in pediatric cancer survivors. Fifty-two pediatric cancer survivors (34 males, 18 females, mean age = 11.92) and their parents were recruited from a long-term cancer survivor clinic. Children and their parents who consented to participate completed the Pediatric Quality of Life Inventory 4.0. Parents completed a demographic information form, the Psychosocial Assessment Tool (pat 2.0) and the Brief Symptom Inventory (bsi). The Intensity of Treatment Rating (itr-3) was evaluated by the research team. Multiple regression analyses revealed that parental psychological distress negatively predicted parent-reported hrql, while treatment intensity, gender, and psychosocial risk negatively predicted parent and child-reported hrql. Psychosocial risk moderated the association between parent psychological distress and parent-reported child hrql ( p = 0.03), whereby parents with high psychological distress but low levels of psychosocial risk reported their children to have higher hrql. Low levels of family psychosocial risk buffer the impact of parent psychological distress on child hrql in pediatric cancer survivors. The findings highlight the importance of identifying parents and families with at-risk psychological distress and psychosocial risk in order to provide targeted support interventions to mitigate the impact on hrql.

  3. The Weiss Functional Impairment Rating Scale-Parent Form for assessing ADHD: evaluating diagnostic accuracy and determining optimal thresholds using ROC analysis.

    Science.gov (United States)

    Thompson, Trevor; Lloyd, Andrew; Joseph, Alain; Weiss, Margaret

    2017-07-01

    The Weiss Functional Impairment Rating Scale-Parent Form (WFIRS-P) is a 50-item scale that assesses functional impairment on six clinically relevant domains typically affected in attention-deficit/hyperactivity disorder (ADHD). As functional impairment is central to ADHD, the WFIRS-P offers potential as a tool for assessing functional impairment in ADHD. These analyses were designed to examine the overall performance of WFIRS-P in differentiating ADHD and non-ADHD cases using receiver operating characteristics (ROC) analysis. This is the first attempt to empirically determine the level of functional impairment that differentiates ADHD children from normal controls. This observational study comprised 5-19-year-olds with physician-diagnosed ADHD (n = 476) and non-ADHD controls (n = 202). ROC analysis evaluated the ability of WFIRS-P to discriminate between ADHD and non-ADHD, and identified a WFIRS-P cut-off score that optimises correct classification. Data were analysed for the complete sample, for males versus females and for participants in two age groups (5-12 versus 13-19 years). Area under the curve (AUC) was 0.91 (95% confidence interval 0.88-0.93) for the overall WFIRS-P score, suggesting highly accurate classification of ADHD distinct from non-ADHD. Sensitivity (0.83) and specificity (0.85) were maximal for a mean overall WFIRS-P score of 0.65, suggesting that this is an appropriate threshold for differentiation. DeLong's test found no significant differences in AUCs for males versus females or 5-12 versus 13-19 years, suggesting that WFIRS-P is an accurate classifier of ADHD across gender and age. When assessing function, WFIRS-P appears to provide a simple and effective basis for differentiating between individuals with/without ADHD in terms of functional impairment. Disease-specific applications of QOL research.

  4. Psychometric validation of the Weiss Functional Impairment Rating Scale-Parent Report Form in children and adolescents with attention-deficit/hyperactivity disorder.

    Science.gov (United States)

    Gajria, Kavita; Kosinski, Mark; Sikirica, Vanja; Huss, Michael; Livote, Elayne; Reilly, Kathleen; Dittmann, Ralf W; Erder, M Haim

    2015-11-17

    Measurement properties of the Weiss Functional Impairment Rating Scale-Parent Report Form (WFIRS-P), which assesses attention-deficit/hyperactivity disorder (ADHD)-related functional impairment in children/adolescents (6-17 years), were examined. Data from seven randomized, controlled trials were pooled. Analyses were conducted in two random half-samples. WFIRS-P conceptual framework was evaluated using confirmatory factor analyses (CFA). Reliability was estimated using internal consistency (Cronbach's alpha) and test-retest reliability methods. Convergent validity was assessed using correlations between WFIRS-P domain scores and the ADHD-RS-IV and Clinical Global Impression-Severity (CGI-S) scales. Responsiveness was tested by comparing mean changes in WFIRS-P domain scores between responders and non-responders based on clinical criteria. CFA adequately confirmed the item-to-scale relationships defined in the WFIRS-P conceptual framework. Cronbach's alpha coefficient exceeded 0.7 for all domains and test-retest reliability exceeded 0.7 for all but Risky Activities. With few exceptions, WFIRS-P domains correlated significantly (p ADHD-RS-IV Total, Inattention and Hyperactivity-Impulsivity scores and CGI-S at baseline and follow-up in both random half-samples. Mean changes in WFIRS-P domain scores differed significantly between responder and non-responder groups in the expected direction (p < 0.001). Study results support the reliability, validity and responsiveness of the WFIRS-P. Findings were replicated between two random samples, further demonstrating the robustness of results.

  5. Parenting, relational aggression, and borderline personality features: associations over time in a Russian longitudinal sample.

    Science.gov (United States)

    Nelson, David A; Coyne, Sarah M; Swanson, Savannah M; Hart, Craig H; Olsen, Joseph A

    2014-08-01

    Crick, Murray-Close, and Woods (2005) encouraged the study of relational aggression as a developmental precursor to borderline personality features in children and adolescents. A longitudinal study is needed to more fully explore this association, to contrast potential associations with physical aggression, and to assess generalizability across various cultural contexts. In addition, parenting is of particular interest in the prediction of aggression or borderline personality disorder. Early aggression and parenting experiences may differ in their long-term prediction of aggression or borderline features, which may have important implications for early intervention. The currrent study incorporated a longitudinal sample of preschool children (84 boys, 84 girls) living in intact, two-parent biological households in Voronezh, Russia. Teachers provided ratings of children's relational and physical aggression in preschool. Mothers and fathers also self-reported their engagement in authoritative, authoritarian, permissive, and psychological controlling forms of parenting with their preschooler. A decade later, 70.8% of the original child participants consented to a follow-up study in which they completed self-reports of relational and physical aggression and borderline personality features. The multivariate results of this study showed that preschool relational aggression in girls predicted adolescent relational aggression. Preschool aversive parenting (i.e., authoritarian, permissive, and psychologically controlling forms) significantly predicted aggression and borderline features in adolescent females. For adolescent males, preschool authoritative parenting served as a protective factor against aggression and borderline features, whereas authoritarian parenting was a risk factor for later aggression.

  6. Knowledge, mistakes, communication with patients and informed consent

    Directory of Open Access Journals (Sweden)

    Alessandra De Palma

    2013-04-01

    Full Text Available BACKGROUND Communication is very important in medical activity, particularly to maintain or re-establish trust-based relationships between patients, doctors, nurses and all the people who work in Hospital or for the Italian National Health Service. Health services include the relationship between doctors and patients: the partnership is important as much as the technical ability in Medicine. But it is difficult to learn empathy: doctors are not taught about that at University, nor afterwards, at least not sufficiently. CONCLUSIONS The informed consent form, even if it is very detailed, is not the real answer to that problem.

  7. The unbearable lightness of user consent

    Directory of Open Access Journals (Sweden)

    Rikke Frank Joergensen

    2014-10-01

    Full Text Available The article discusses challenges to privacy protection in social media platforms, focusing in particular on the principle of user consent. Based on a Danish study, the article argues that in relation to Facebook, user consent de facto served as the price for participating and for gaining access to a social infrastructure. The article opens with a brief introduction to privacy as a human right, followed by a discussion of some of the critique that has been raised towards social media platforms vis-à-vis the right to privacy. Second, it presents the findings from a study conducted amongst 68 Danish high school students in October 2013 concerning their privacy perceptions and practices when using social media platforms. Thirdly, it discusses the implications of these findings in relation to the principle of user consent as a means of providing individuals with control over their personal information in the context of social media platforms.

  8. Informed consent: not just for procedures anymore.

    Science.gov (United States)

    Feld, Andrew D

    2004-06-01

    The ethical and legal requirement to obtain informed consent prior to performing a procedure or administering a treatment derives from the concept of personal (patient) autonomy. The competent patient, after receiving appropriate disclosure of the material risks of the procedure or treatment, understanding those risks, the benefits, and the alternative approaches, makes a voluntary and uncoerced informed decision to proceed. This article will present a general overview of the modern concept of informed consent as a process (mutual communication) rather than an event (document signing). The historical evolution of this concept and the legal rulings that have shaped the requirements of informed consent will be cited. The benefits of informed decision making as a communication and risk management tool are presented. This review is intended as general information, and not as legal advice, which should be sought from a health-care attorney.

  9. Non-completion and informed consent.

    Science.gov (United States)

    Wertheimer, Alan

    2014-02-01

    There is a good deal of biomedical research that does not produce scientifically useful data because it fails to recruit a sufficient number of subjects. This fact is typically not disclosed to prospective subjects. In general, the guidance about consent concerns the information required to make intelligent self-interested decisions and ignores some of the information required for intelligent altruistic decisions. Bioethics has worried about the 'therapeutic misconception', but has ignored the 'completion misconception'. This article argues that, other things being equal, prospective subjects should be informed about the possibility of non-completion as part of the standard consent process if (1) it is or should be anticipatable that there is a non-trivial possibility of non-completion and (2) that information is likely to be relevant to a prospective subject's decision to consent. The article then considers several objections to the argument, including the objection that disclosing non-completion information would make recruitment even more difficult.

  10. Parent education: an evaluation of STEP on abusive parents' perceptions and abuse potential.

    Science.gov (United States)

    Fennell, D C; Fishel, A H

    1998-01-01

    To examine the effects of a structured, time-limited parent training group on abusive or potentially abusive parents. A pretest-posttest control group design was used with consenting parents (N = 18) to examine the effects of Systematic Training for Effective Parenting (STEP) on abusive parents' perceptions of their children's behaviors and on the parents' potential to physically abuse. The Adlerian Parental Assessment of Child Behavior Scale and the Child Abuse Potential Inventory were used to measure treatment effects. After participating in STEP, abusive parents had significantly more positive perceptions of their children and were significantly less potentially abusive. Using volunteers, the project cost an average of $100 for each parent. The research lends empirical support to individual psychology and family systems theory. Future research is indicated using larger samples to examine lay vs. professional leadership of the groups, as well as comparisons of different parenting programs with abusive parents.

  11. Autism beyond pediatrics: why bioethicists ought to rethink consent in light of chronicity and genetic identity.

    Science.gov (United States)

    Perry, Alexandra

    2012-06-01

    Autism is a chronic neurodevelopmental disorder that presents unique challenges to bioethicists. In particular, bioethicists ought to reconsider pediatric consent in light of disparity between beliefs that are held about the disorder by parents and adults with autism. The neurodiverse community ought to be given some consideration in this debate, and, as such, there may be a role for autistic narratives in clarifying this problem. © 2011 Blackwell Publishing Ltd.

  12. The consent and counselling of patients for cataract surgery: a prospective audit.

    Science.gov (United States)

    Cheung, D; Sandramouli, S

    2005-09-01

    The aims of ideal preoperative informed consent include educating the patient adequately to enable an autonomous decision to be made without causing undue anxiety. We study how the paternalistic and nonpaternalistic approaches meet this ideal. The influence of the new patient consent forms is also assessed. Two cycles of a prospective clinical audit are presented. An assessment of relevant patient knowledge was performed by patient interview. Visual analogue scales were used to quantify patient anxiety. The first cycle, examining a paternalistic approach, demonstrated: 37% of patients understood what a cataract was and 48% understood what surgery involved. 48% misunderstood that cataract surgery was completely risk free. In total, 80% of patients undergoing second eye surgery believed that it was completely risk-free. Average anxiety visual analogue scores (VAS) for cataract surgery were low (2.89). The second cycle, examining the nonpaternalistic approach combined with the implementation of new consent forms showed that, despite more explicit repeated preoperative consent: 39% of patients understood correctly what a cataract was, 28% understood what surgery involved and 43% misunderstood that surgery was completely risk-free. All patients undergoing second eye surgery thought that it was risk-free. The average anxiety VAS for cataract surgery were moderate (5.00). Both paternalistic and non-paternalistic approaches to informed consent are inadequate in meeting the demands of the ideal informed consent. The new patient consent forms appear to have little effect in influencing patient knowledge about their surgery. Patients undergoing second eye surgery often have an overoptimistic view of cataract surgery.

  13. Consent for third molar tooth extractions in Australia and New Zealand: a review of current practice.

    Science.gov (United States)

    Badenoch-Jones, E K; Lynham, A J; Loessner, D

    2016-06-01

    Informed consent is the legal requirement to educate a patient about a proposed medical treatment or procedure so that he or she can make informed decisions. The purpose of the study was to examine the current practice for obtaining informed consent for third molar tooth extractions (wisdom teeth) by oral and maxillofacial surgeons in Australia and New Zealand. An online survey was sent to 180 consultant oral and maxillofacial surgeons in Australia and New Zealand. Surgeons were asked to answer (yes/no) whether they routinely warned of a specific risk of third molar tooth extraction in their written consent. Seventy-one replies were received (39%). The only risks that surgeons agreed should be routinely included in written consent were a general warning of infection (not alveolar osteitis), inferior alveolar nerve damage (temporary and permanent) and lingual nerve damage (temporary and permanent). There is significant variability among Australian and New Zealand oral and maxillofacial surgeons regarding risk disclosure for third molar tooth extractions. We aim to improve consistency in consent for third molar extractions by developing an evidence-based consent form. © 2016 Australian Dental Association.

  14. Current approaches for informed consent in pediatrics

    Directory of Open Access Journals (Sweden)

    Hatice Betül Gemici

    2014-09-01

    Full Text Available Today in medical practis; codes of ethic are becoming important. New aprroaches has emerged that about to participate with patient’s consent and child absent understand the own situation should be taken for treatment or process on child. Means of child informing is to given simple information about understandable language. Physicians should support to be shared with the patient’s medical decision according to the child’s age and understanding capacity. Informed consent in pediatric patients makes contribution to develepmont of future individuals; therefore that is an important ethic assignment for doctors. J Clin Exp Invest 2014; 5 (3: 496-503

  15. Children's competency to consent: an ethical dilemma.

    Science.gov (United States)

    Spencer, G E

    2000-01-01

    The application of the best interests principle in current legislation creates an ethical dilemma in relation to children's consent to treatment. The guiding principle of the UN Convention on the Rights of the Child (1989) symbolises a formal expression of children's participation rights. Children's rights to consent to treatment are granted on socially determined ideals of competency. Children's participation in health care is increasingly advocated in legislation but many barriers remain. Nurses can facilitate children's participation through communicating information and creating partnerships with children.

  16. Can children withhold consent to treatment?

    OpenAIRE

    Devereux, J A; Jones, D P; Dickenson, D L

    1993-01-01

    A dilemma exists when a doctor is faced with a child or young person who refuses medically indicated treatment. The Gillick case has been interpreted by many to mean that a child of sufficient age and intelligence could validly consent or refuse consent to treatment. Recent decisions of the Court of Appeal on a child's refusal of medical treatment have clouded the issue and undermined the spirit of the Gillick decision and the Children Act 1989. It is now the case that a child patient whose c...

  17. Parenting style, parenting stress, and children's health-related behaviors.

    Science.gov (United States)

    Park, Hyunjeong; Walton-Moss, Benita

    2012-07-01

    Parental guidance is critical to the development of children's health-related behaviors. The purpose of this study was to look at the relationship between parenting factors, including parenting style and parenting stress, and children's health-related behaviors. In this descriptive, correlational study, 284 parents of preschool children were interviewed using the Child Rearing Questionnaire and the Korean Parenting Stress Index-Short Form. Parent distress, authoritative and permissive parenting styles, family income, and mother's education were significantly associated with children's health-related behaviors. These findings suggest that higher levels of warmth, characteristics of both parenting styles, may be a critical factor in the development of health-related behaviors.

  18. Informed consent for the administration of an intravenous contrast agent: importance and determinants of patient refusal

    International Nuclear Information System (INIS)

    Martel, J.; Garcia-Diaz, J. D.

    1999-01-01

    We proposed to determine the proportion of patients who refuse to undergo intravenous contrast administration and the factors that influence their refusal. Our series consisted of 442 patients who were supposed to undergo imaging studies involving the intravenous injection of an iodine contrast. In a personal interview, the patients were issued a questionnaire specifically designed for this study. The following parameters were recorded: sex, age, inpatient or outpatient status, medical history available, person who informed them about the procedure, person signing the informed consent (patient or other) , highest academic degree, attitude toward receiving the information and degree of concern after reading and signing the consent form. In our series 8.6% of the patients (95% confidence interval: 6-11.2) refused to sign the informed consent form. In addition, there were a number of patients who delayed the procedure or hindered the daily work schedule by some other means. When the relationship between each of the variables studied and refusal to sign the consent form was assessed, significant associations were observed between the latter and the academic level of the patient, his or her degree of concern and having received the information from a trained person. There was also a nearly significant trend toward the association between refusal and the patient's background. Relatively few patients refuse to sign the informed consent to receive intravenous contrast administration but this negative decision interferes with the health care practice. It is possible to identify certain correctable factors that influence the patient in this respect. (Author) 13 refs

  19. Intervention Research with Youths at Elevated Risk for Suicide: Meeting the Ethical and Regulatory Challenges of Informed Consent and Assent

    Science.gov (United States)

    King, Cheryl A.; Kramer, Anne C.

    2008-01-01

    Intervention research with youths at elevated risk for suicidal behavior and suicide--a vulnerable and high risk population--presents investigators with numerous ethical challenges. This report specifically addresses those challenges involving the informed consent and assent process with parents/guardians and youths. The challenges are delineated…

  20. FOSTER FAMILY AS A FORM OF UNITS FOR ORPHANS AND CHILDREN WITHOUT PARENTAL CARE (CASE STUDY OF SARATOV AND BELGOROD REGIONS

    Directory of Open Access Journals (Sweden)

    Oksana Vladimirovna Besschetnova

    2013-09-01

    Full Text Available This paper discusses the development and functioning of foster families, one of the priority interventions for children without parental care in Russia and abroad. The paper analyzes the current official statistics on the problem of child abandonment in Russia as a whole and in the Saratov and Belgorod regions of Russia in particular. The mechanism of social adaptation of children in foster care is based on the qualitative and quantitative methods (surveys and interviews of foster parents and foster children. The author identifies obstacles to the development of social institutions in the regions and the necessity of its active implementation in domestic social practices. The study found that foster care has been successful in areas where accepted legal basis allowed the recruiting, selecting candidates for adoptive parents, and foster care maintenance are carried out by social services. In addition, in order to reduce risk factors such as the secondary abandonment of foster children it is necessarily to increase assistance from the social guardianship bodies and professionals as well as building trusting parent-child relationships that use the democratic parenting style by foster parents.DOI: http://dx.doi.org/10.12731/2218-7405-2013-8-8

  1. Rapid Ethical Assessment on Informed Consent Content and Procedure in Hintalo-Wajirat, Northern Ethiopia: A Qualitative Study.

    Directory of Open Access Journals (Sweden)

    Serebe Abay

    Full Text Available Informed consent is a key component of bio-medical research involving human participants. However, obtaining informed consent is challenging in low literacy and resource limited settings. Rapid Ethical Assessment (REA can be used to contextualize and simplify consent information within a given study community. The current study aimed to explore the effects of social, cultural, and religious factors during informed consent process on a proposed HPV-serotype prevalence study.A qualitative community-based REA was conducted in Adigudom and Mynebri Kebeles, Northern Ethiopia, from July to August 2013. Data were collected by a multi-disciplinary team using open ended questions concerning informed consent components in relation to the parent study. The team conducted one-to-one In-Depth Interviews (IDI and Focus Group Discussions (FGDs with key informants and community members to collect data based on the themes of the study. Tape recorded data were transcribed in Tigrigna and then translated into English. Data were categorized and thematically analyzed using open coding and content analysis based on pre-defined themes.The REA study revealed a number of socio-cultural issues relevant to the proposed study. Low community awareness about health research, participant rights and cervical cancer were documented. Giving a vaginal sample for testing was considered to be highly embarrassing, whereas giving a blood sample made participants worry that they might be given a result without the possibility of treatment. Verbal consent was preferred to written consent for the proposed study.This rapid ethical assessment disclosed important socio-cultural issues which might act as barriers to informed decision making. The findings were important for contextual modification of the Information Sheet, and to guide the best consent process for the proposed study. Both are likely to have enabled participants to understand the informed consent better and consequently to

  2. Clinicians' views and experiences of offering two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study.

    Science.gov (United States)

    Chhoa, Celine Y; Sawyer, Alexandra; Ayers, Susan; Pushpa-Rajah, Angela; Duley, Lelia

    2017-04-26

    The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. Preterm birth can be rapid and unexpected, allowing little time for the usual consent process. Therefore, in addition to the usual procedure for written consent, a two-stage pathway for consent for use when birth was imminent was developed. The aims of this study were to explore clinicians' views and experiences of offering two consent pathways for recruitment to a randomised trial of timing of cord clamping at very preterm birth. This was a qualitative study using semi-structured interviews. Clinicians from eight hospitals in the UK who had been involved in offering consent to the Cord Pilot Trial were invited to take part in an interview. Clinicians were interviewed in person or by telephone. Interviews were analysed using inductive systematic thematic analysis. Seventeen clinicians who had either offered usual written consent only (n = 6) or both the two-stage pathway (with oral assent before the birth and written consent after the birth) and usual written consent (n = 11) were interviewed. Six themes were identified: (1) team approach to offering participation; (2) consent form as a record; (3) consent and participation as a continual process; (4) different consent pathways for different trials; (5) balance between time, information, and understanding; and (6) validity of consent. Overall, clinicians were supportive of the two-stage consent pathway. Some clinicians felt that in time-critical situations oral assent presented an advantage over the usual written consent as they provided information on a "need to know" basis. However, there was some concern about how much information should be given for oral assent, and how this is understood by women when birth is imminent. The two-stage pathway for consent developed for use in the Cord Pilot Trial when birth was imminent was acceptable to clinicians for comparable low-risk studies

  3. How accurate are parental responses concerning their fourth-grade children's school-meal participation, and what is the relationship between children's body mass index and school-meal participation based on parental responses?

    Directory of Open Access Journals (Sweden)

    Paxton-Aiken Amy E

    2012-03-01

    Full Text Available Abstract Background This article investigated (1 parental response accuracy of fourth-grade children's school-meal participation and whether accuracy differed by children's body mass index (BMI, sex, and race, and (2 the relationship between BMI and school-meal participation (based on parental responses. Methods Data were from four cross-sectional studies conducted from fall 1999 to spring 2003 with fourth-grade children from 13 schools total. Consent forms asked parents to report children's usual school-meal participation. As two studies' consent forms did not ask about lunch participation, complete data were available for breakfast on 1,496 children (51% Black; 49% boys and for lunch on 785 children (46% Black; 48% boys. Researchers compiled nametag records (during meal observations of meal participation on randomly selected days during children's fourth-grade school year for breakfast (average nametag days across studies: 7-35 and for lunch (average nametag days across studies: 4-10 and categorized participation as "usually" (≥ 50% of days or "not usually" ( Results Concerning breakfast participation and lunch participation, 74% and 92% of parents provided accurate responses, respectively. Parental response accuracy was better for older children for breakfast and lunch participation, and for Black than White children for lunch participation. Usual school-meal participation was significantly related to children's BMI but in opposite directions -- positively for breakfast and inversely for lunch. Conclusions Parental response accuracy of children's school-meal participation was moderately high; however, disparate effects for children's age and race warrant caution when relying on parental responses. The BMI results, which showed a relationship between school-meal participation (based on parental responses and childhood obesity, conflict with results from a recent article that used data from the same four studies and found no significant

  4. 10 CFR 850.36 - Medical consent.

    Science.gov (United States)

    2010-01-01

    ... consent. (a) The responsible employer must provide each beryllium-associated worker with a summary of the... will be protected. (b) Responsible employers must also provide each beryllium-associated worker with... answered. (c) The responsible employer must have the SOMD obtain a beryllium-associated worker's signature...

  5. Learning Ethics through Everyday Problems: Informed Consent

    Science.gov (United States)

    Verdu, Fernando; Frances, Francesc; Castello, Ana

    2012-01-01

    The teaching of bioethics and its importance in clinical relationships is to a certain extent complicated when we address students of medicine, young people who are more used to dealing with and solving strictly clinical problems. Informed Consent is one of the aspects of professional practice that is generally and widely accepted in Western…

  6. Consent in dentistry: ethical and deontological issues.

    Science.gov (United States)

    Conti, Adelaide; Delbon, Paola; Laffranchi, Laura; Paganelli, Corrado

    2013-01-01

    In Italy, consent for health treatment, aside from being an ethical and deontological obligation, constitutes an essential requirement for any medical treatment according to articles 13 and 32 of the National Constitution and also in accordance with the Council of Europe's 'Convention on Human Rights and Biomedicine'. An essential requirement for the validity of consent is that clear, exhaustive and adequate information be provided to the patient himself: the practice of informed consent is a communicative relationship in which the patient can express doubts, perplexities and clarification requests to the dentist. Furthermore, dental treatment has specific peculiarities: the relationship between dentistry and aesthetics, the concomitant presence of pathologies requiring different treatments, the elongated care process and the establishment of a trustworthy relationship and familiarity with the patient represent important aspects in the configuration of the dentist-patient relationship and in the process of acquiring informed consent. The dentist must offer correct information on diagnosis, prognosis, the therapeutic perspective and the likely consequences of therapy, alternative therapy and refusal of therapy, as well as eventual commitments for the period after treatment. Particular consideration must be given to minors and patients of unsound mind: the dentist's approach to these patients needs to be clear and appropriate to the person's age and understanding ability, even if the decisional power for sanitary treatment may be in the hands of a third person.

  7. Informed consent in Malaysia: an overview.

    Science.gov (United States)

    Che Ngah, Anisah

    2005-01-01

    The right of a person to control his body is a concept that has long been recognized in Malaysia under the law of torts. The purpose of requiring informed consent is to preserve that right in medical decision-making. Informed Consent is a relatively new concept in medical litigation cases. However in the late 1990's, it has become one of the important claims under negligence made against the doctor for failure to disclose relevant information to patients in respect of the treatment proposed. Whether Malaysia has begun to recognize patient's right to decision-making is yet to be seen. Furthermore the social-cultural relationship between doctors and patients had to be considered. In this respect, the researcher had conducted interviews with doctors and patients to gauge their reaction towards a shared process of decision-making, which is the central issue in the doctrine of informed consent. Findings suggest that in society where primary health care is the main thrust to achieve health for all, the possibility of recognition of the rights of patients to receive information before making decisions about treatment appears remote. The findings also underscore the importance of incorporating aspects of informed consent as part of providing quality service to patients.

  8. 47 CFR 76.64 - Retransmission consent.

    Science.gov (United States)

    2010-10-01

    ...) The retransmission consent requirements of this section are not applicable to broadcast signals... systems. Such elections shall take effect 90 days after they are made. (g) If one or more franchise areas served by a cable system overlaps with one or more franchise areas served by another cable system...

  9. Students' Consent to a Teacher's Pedagogical Authority

    Science.gov (United States)

    Harjunen, Elina

    2011-01-01

    In this paper student comments are examined to identify a typology of demands for granting their consent to a teacher's pedagogical authority. The data for this study (136 written responses and 66 interviews) have been collected from students in a Finnish comprehensive school and examined by means of a theory-bounded content analysis. The results…

  10. Language, cultural brokerage and informed consent - will ...

    African Journals Online (AJOL)

    Language, cultural brokerage and informed consent - will technological terms impede telemedicine use? C Jack, Y Hlombe, M Mars. Abstract. Background. Telemedicine provides a solution to treatment of economically and geographically compromised patients and enhances the level of care. However, a problem has ...

  11. 12 CFR 347.119 - Specific consent.

    Science.gov (United States)

    2010-01-01

    ... processing procedure. (d) Specific consent. Direct or indirect investments in or activities of foreign... control such organization as a result of a foreign investment; or (ii) A bank would be establishing a... foreign country. (1) Applicable law or practice in the foreign country where the foreign organization or...

  12. Tandheelkunde en gezondheidsrecht 3: informed consent

    NARCIS (Netherlands)

    Brands, W.G.; van der Ven, J.M.; Eijkman, M.A.J.

    2013-01-01

    De relatie tussen een tandarts en zijn patiënt is gebaseerd op vertrouwen. Het principe van informed consent draagt bij aan de kwaliteit van die vertrouwensrelatie. De relationele professionele standaard brengt met zich mee dat het op de weg van de tandarts ligt patiënten goed te informeren. Goede

  13. Recommendations for communication to enhance informed consent ...

    African Journals Online (AJOL)

    Recommendations for communication to enhance informed consent and enrolment at multilingual research sites. Claire Penn, Melanie Evans. Abstract. Language issues can affect HIV and AIDS research trial enrolment, but little is understood about variables in this process. Some evidence indicates barriers exist even ...

  14. Research Participation Decision-Making Among Youth and Parents of Youth With Chronic Health Conditions.

    Science.gov (United States)

    Pagano-Therrien, Jesica; Sullivan-Bolyai, Susan

    The aims of this qualitative descriptive study were to describe how past experiences with research (including communication, information, values, and support) may contribute to research fatigue among youth and parents of youth with HIV, cystic fibrosis, and Type 1 diabetes. Eighteen parents and youth were purposively recruited from outpatient subspecialty clinics at a major academic medical center. They took part in qualitative interviews and completed a demographics form and the Decisional Conflict Scale. Youth participants also completed the Erikson Psychosocial Stage Inventory. Two major themes emerged: Blurred Lines and Hope for the Future. Research fatigue was not found in this sample. Results point to challenges with informed consent in settings where research and clinical care are integrated and suggest that protective factors allow for continued participation without excess burden on youth and parents. Strategies to minimize research fatigue and support engagement in research are offered. Copyright © 2016 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

  15. GENERAL AND SPECIFIC COMBINING ABILITY OF INITIAL PARENTAL FORMS IN TOMATO FOR COMPLEX OF ECONOMICALLY VALUABLE TRAITS TO DEVELOP HYBRIDS F1 OF CHERRY AND COCKTAIL TYPES

    Directory of Open Access Journals (Sweden)

    R. K. Rechets

    2017-01-01

    Full Text Available Results of estimation of general and specific combining ability of male and female parental tomato forms were given for complex of traits. The estimation was carried out according to incomplete diallel crosses 15x15. Such varities   as   ‘Trapeza’,  Rosovaya  kapelka’,  ‘Seniorita’, ‘Ocharovanie’,  ‘Tigris’   ‘Vishnya  Zheltaya’  (Gavrish, ‘Denezhnoye Derevo’ (national breeding, and  lines: ‘46/06’,  ‘49/09’,  ‘295/09’,  ‘336/11’,  ‘354/11’,  ‘357/11’, ‘388/09’ (nor, ‘498’ (selection of TARI were used as intial breeding accessions, differing in bush type (determinate and indeterminate, duration of vegetative phase (ultraearly,  early, medium early, middle-ripening, fruit  shape (rounded, oval, fruit color (red, pink, black, orange, tiger and with the gene nor, fruit weight (10 g. and more, brush structure (dense, friable. As a results, ‘Trapeza’, ‘Vishnya Zheltaya’, ‘Ocharovaniye’, ‘Seniorita’, and lines: ‘295/10’, ‘49/09’,  ‘498’,  ‘357/11’,  ‘354/11’,  ‘388/09’  (nor were selected and recommended to be used in breeding program for development of heterotic hybrids with high fruit setting and generative bush type. The promising hybrids F1 with high constants of specific combining ability for a complex of economically valuable traits have been observed. Because of different lines and accessions were used in crossings, these hybrids varied in internode length of cluster type, classical or shorten; rounded or oval fruit shape; fruit  color, red (F1   combinations ‘354/11’ х ‘Seniorita’, ‘Trapeza’ х  ‘L.49/09’,  L.  ‘49/09’  х  L.354/11, pink (F1 combination ‘Rosovaya Kapelka’ х ‘L.354/11’, yellow (F1 combination ‘Ocharovaniye’ х  ‘Vishiya Zheltaya’, deep brown (F1 combination  ‘L.357/11’ х ‘L.354/11’.

  16. 1,1,2-Trichloroethane (TCE); Final Enforceable Consent Agreement and Testing Consent Order

    Science.gov (United States)

    EPA has issued an enforceable consent agreement (ECA) with The Dow Chemical Company; Vulcan Materials Company; Occidental Chemical Corp; Oxy Vinyls, LP; Georgia Gulf Corp; Westlake Chemical Corp; PPG, Borden Chemicals & Plastics, and Formosa Plastics.

  17. 1,2-Ethylene Dichloride; Final Enforceable Consent Agreement and Testing Consent Order

    Science.gov (United States)

    This document announces that EPA has signed an enforceable testing Consent Order with the Dow Chemical Co, Vulcan Materials Co, Occidental Chemical Corp, Oxy Vinyls, LP, Georgia Gulf Corp, Westlake Chemical Corp, PPG Industries, Inc., and Formosa Plastics.

  18. Consenting options for posthumous organ donation: presumed consent and incentives are not favored

    Science.gov (United States)

    2012-01-01

    Background Posthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries. Methods We surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable) the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed consent by donor-only, informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive. Results Mean(SD) age was 32(9) year, 27% were males, 50% were patients’ companions, 60% had ≥ college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p < 0.001), donor-only informed consent (5[3,7], p < 0.001), and presumed consent (7[3,10], p < 0.001). The addition of a financial or medical incentive, respectively, reduced ranking of mandated choice to 7[4,9], p < 0.001, and 5[3,8], p < 0.001; for donor-or-surrogate informed consent to 7[5,9], p < 0.001, and 5[3,7], p = 0.004; and for donor-only informed consent to 8[6,10], p < 0.001, and 5[3,7], p = 0.56. Distribution of ranking score of perception of norm and preference were similar except for no-organ donation (11[7,11] vs. 11[6,11], respectively, p = 0.002). Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p < 0.001), more preferred mandated choice with financial incentive option (6[3,8] vs. 8[4,9], p < 0.001), and

  19. Informed Consent: An Ethical Obligation or Legal Compulsion?

    OpenAIRE

    Satyanarayana Rao, K H

    2008-01-01

    Informed consent is a vital document while performing all surgical and aesthetic procedures, particularly in the current day practice. Proper documentation and counseling of patients is important in any informed consent.

  20. Is The Consent Process Appropriate - The Interns’ Perspective?

    LENUS (Irish Health Repository)

    Rohan, P

    2018-04-01

    Consent is an integral component to any medical procedure involving a competent patient, a communicating doctor, and transfer of information about the procedure. The aim of this study was to assess interns’ experience of the consent process.

  1. Who's doing the talking? Teacher and parent experiences of parent ...

    African Journals Online (AJOL)

    The most common form of direct communication between parents and teachers in schools worldwide is the parent-teacher conference. Purposeful parent-teacher conferences afford the teacher and the parent the opportunity to address a particular topic related to the child, such as academic progress and behaviour.

  2. Longitudinal validity and responsiveness of the Food Allergy Quality of Life Questionnaire - Parent Form in children 0-12 years following positive and negative food challenges

    NARCIS (Netherlands)

    DunnGalvin, A.; Cullinane, C.; Daly, D. A.; Flokstra-de Blok, B. M. J.; Dubois, A. E. J.; Hourihane, J. O'B.

    P>Background There are no published studies of longitudinal health-related quality of life (HRQL) assessments of food-allergic children using a disease-specific measure. Objective This study assessed the longitudinal measurement properties of the Food Allergy Quality of Life Questionnaire - Parent

  3. Characteristics and attitudes of parents of children born with the use of assisted reproductive technology.

    Science.gov (United States)

    Braverman, A M; Boxer, A S; Corson, S L; Coutifaris, C; Hendrix, A

    1998-11-01

    To explore the medical issues, attitudes, concerns, and choices that parents have about their children born with the use of assisted reproductive technology (ART). Retrospective and prospective survey. An academic medical center and a private practice. Participants who conceived and were delivered of infants in two ART programs. A total of 373 patients were mailed an anonymous survey, a consent form, and the Parent Child Relationship Inventory. The rate of response was approximately 49% for clinic A and 33% for clinic B. Pregnancy outcomes and attitudes about parenting. Respondents' major concerns during pregnancy revolved around miscarriage and the infant's health; complications occurred in 38.9% of first pregnancies. Parents believed that their children were more appreciated, that their children were not emotionally different, that ART did not create ongoing medical or emotional problems, and they were not overprotective as parents. Gender differences were statistically significant on attitudinal variables. Parents had concerns about pregnancy. Overall, men and women felt positive about ART and their parenting. The ART experience is associated with complex choices, attitudes, and emotions.

  4. Versión española del perfil de salud infantil, cuestionario para padres y madres: Child Health and Illness Profile-Child Edition Parent Report Form (CHIP-CE/PRF Spanish version of the Child Health and Illness Profile-Child Edition Parent Report Form [CHIP-CE/PRF

    Directory of Open Access Journals (Sweden)

    Luis Rajmil

    2004-08-01

    Full Text Available Objetivos: Analizar la fiabilidad y validez de las dimensiones del Child Health and Illness Profile-Child Edition Parent Report Form (CHIP-CE/PRF incluidas en la Encuesta de Salud de Barcelona 2000 (ESB-2000 y obtener sus valores de referencia poblacional. Métodos: Los datos del estudio provienen de las entrevistas a los informadores indirectos de los menores de 5-14 años de edad (n = 836 participantes en la ESB-2000. Se analizaron 4 subdimensiones de la versión para padres del cuestionario CHIP-PRF: «satisfacción con la salud», y bienestar físico, bienestar emocional y limitación de actividad, que constituyen la dimensión de «bienestar». Se analizó la consistencia interna a partir del coeficiente α de Cronbach. Se realizσ un anαlisis factorial exploratorio y se compararon las puntuaciones medias mediante análisis de la covarianza para evaluar la validez de constructo de las subdimensiones. Resultados: El coeficiente alfa fue mayor de 0,70 en todas las subdimensiones analizadas (rango, 0,76-0,98. En el análisis factorial, casi todos los ítems (31/35 presentaron la carga más elevada en su subdimensión correspondiente. Se comprobó la mayoría de las diferencias estadísticas esperadas en las puntuaciones medias entre grupos. Las niñas de 10-14 años de edad presentaron las puntuaciones más bajas tanto en «satisfacción con la salud» (48,93; intervalo de confianza del 95% [IC del 95%], 47,40-50,47 como en «bienestar» (48,87; IC del 95%, 47,51-50,22. No se encontraron diferencias según la clase social de la persona cabeza de familia. Conclusiones: El estudio permite disponer de una medida de salud percibida útil en las encuestas de salud infantil.Objectives: To analyze the reliability and validity of the domains of the Child Health and Illness Profile-Child Edition Parent Report Form (CHIP-CE/PRF included in the Barcelona Health Survey conducted in 2000 and to obtain population-based reference values. Methods: Data were

  5. 26 CFR 301.7216-3 - Disclosure or use permitted only with the taxpayer's consent.

    Science.gov (United States)

    2010-04-01

    ... tax return preparation services for employees of Company C. An employee of Company C, Employee E... return in the Form 1040 series may be in any format, including an engagement letter to a client, as long..., Taxpayer C, an engagement letter. Part of the engagement letter requests the consent of Taxpayer C for the...

  6. REALIZATION OF INFORMED CONSENT AS ONE OF PATIENT'S RIGHTS: CURRENT SITUATION IN AZERBAIJAN.

    Science.gov (United States)

    Rustamova, F A; Mammadov, V G; Munir, K M

    Azerbaijan is a country in which the law is based on democratic principles. The mentioned principles underlie the national health care law. Democratic values, such as respect for human rights and freedoms, human dignity, as well as universal bioethical principles that are widely implemented in the national law, create conditions for the implementation of the patient's rights. The basic law governing the doctor-patient relationship, Law on Protection of Health of Population in Azerbaijan, reflects the basic patients' rights and obligations of doctors and medical institutions. Informed consent, which is a key component of patient rights, is also reflected, however, to date, a significant drawback of the Azerbaijan medical legislation is described in the article in this field. For example, at the moment there is no single standardized informed consent form in the country's different medical institutions. Due to the absence of any legally approved standards for informed consent forms, public and private health care institutions individually develop such forms, which sometimes can differ significantly. At the moment, one of the important directions in the field of healthcare is its improvement in accordance with international standards. The research made it possible to make conclusions about the necessary measures to improve and unify the informed consent form. The authors also analyzed the main provisions of the medical law of Azerbaijan and identified the main trends of its further development.

  7. [Ethical dilemma in research: informed consent in clinical studies on persons with dementia].

    Science.gov (United States)

    Sinoff, Gary

    2012-09-01

    With the world's population aging, there is an increase in the number of demented elderly. It is vital to study this phenomenon in epidemiological and clinical studies, particularly the effects on the increasing numbers of demented elderly. Researchers need to understand the factors predicting the general decline in the demented elderly. However, before any research is undertaken, it is necessary to obtain approval from the Local Internal Review Board. This committee is responsible to maintain accepted national and international ethical standards. The basis for recruitment to a study is the signature on the informed consent form, where the patient is required to understand the study, internalize the study's aim, to consider all options and finally, to express an opinion. Potential elderly participants need to have their judgment evaluated before signing the form. In cases where the subject is incapable, some countries, including Israel, require that there be a legal guardianship. This is a long and complicated process that causes researchers not to recruit demented patients into a study which may actually be beneficial to all. Some countries allow a proxy to sign informed consent forms to permit the demented subject to participate in the study. Often the threshold may depend on the invasiveness of the intervention. The problem of proxies to sign informed consent form troubles researchers worldwide. This article addresses the history and development of ethics in research, and raises the issue to promote an official policy for proxy consent signing.

  8. 75 FR 37806 - Twitter, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

    Science.gov (United States)

    2010-06-30

    ... FEDERAL TRADE COMMISSION [File No. 092 3093] Twitter, Inc.; Analysis of Proposed Consent Order to... in paper form. Comments should refer to``Twitter, Inc., File No. 092 3093'' to facilitate the... weblink: ( http://public.commentworks.com/ftc/twitter ) and following the instructions on the web-based...

  9. 16 CFR 2.31 - Opportunity to submit a proposed consent order.

    Science.gov (United States)

    2010-01-01

    ... order. 2.31 Section 2.31 Commercial Practices FEDERAL TRADE COMMISSION ORGANIZATION, PROCEDURES AND... through the operating Bureau or Regional Office having responsibility in the matter a proposal for disposition of the matter in the form of a consent order agreement executed by the party being investigated...

  10. Recruiting women smokers: the engineering of consent.

    Science.gov (United States)

    Brandt, A M

    1996-01-01

    A range of social forces contributed to the effective recruitment of women to cigarette smoking in the crucial period between 1900 and 1940. Cigarette advertisers and public relations experts recognized the significance of women's changing roles and the rising culture of consumption, and worked to create specific meanings for the cigarette to make it appeal to women. The cigarette was a flexible symbol, with a remarkably elastic set of meanings; for women, it represented rebellious independence, glamour, seduction, and sexual allure, and served as a symbol for both feminists and flappers. The industry, with the help of advertisers and public relations experts, effectively engineered consent for women as smokers. The "engineering of consent" has a role to play in smoking cessation, since negative meanings for the cigarette can be engineered as well.

  11. Informed consent needed for sterilization or research.

    Science.gov (United States)

    Barnett, B

    1998-01-01

    Informed choice involves enabling family planning clients to base their decisions about contraceptive use upon adequate information. It is a process in which clients give their permission to undergo a procedure, take a medication, or participate in a study after being fully informed. Informed consent protects an individual's freedom of choice, respects his or her autonomy, is important in both family planning programs and reproductive health research, and should always be available to clients seeking health services. Although written informed consent is not needed for most reproductive health services, it should be obtained from men and women who undergo sterilization, since that involves surgery and is considered permanent. In addition, people who volunteer to participate in contraceptive studies need to be fully informed of the risks and benefits of any new drugs or devices they receive. Volunteers should understand the potential effects of methods upon their physical health and other aspects of their lives. Ethical reviews need to be conducted before research begins.

  12. Consenting process for radiation facilities. V. 4

    International Nuclear Information System (INIS)

    2011-03-01

    Safety codes and standards are formulated on the basis of nationally and internationally accepted safety criteria for design, construction and operation of specific equipment, systems, structures and components of nuclear and radiation facilities. Safety, codes establish the objectives and set requirements that shall be fulfilled to provide adequate assurance for safety. Safety codes establish the objectives and set requirements that shall be fulfilled to provide adequate assurance for safety. Safety guides elaborate various requirements and furnish approaches for their implementation. Safety manuals deal with specific topics and contain detailed scientific and technical information on the subject. These documents are prepared by experts in the relevant fields and are extensively reviewed by advisory committees of the Atomic Energy Regulatory Board (AERB) before they are published. The documents are revised when necessary, in the light of experience and feedback from users as well as new developments in the field. AERB issued a safety code on Regulation of Nuclear and Radiation Facilities (AERB/SC/G) to spell out the requirements/obligations to be met by a nuclear or radiation facility for the issue of regulatory consent at every stage. This safety guide apprises the details of the regulatory requirements for setting up the radiation facility such as consenting process, the stages requiring consent, wherever applicable documents to be submitted and the nature and extent of review. The guide also gives information on methods of review and assessment adopted by AERB

  13. Consenting process for radiation facilities. V. 3

    International Nuclear Information System (INIS)

    2011-03-01

    Safety codes and standards are formulated on the basis of nationally and internationally accepted safety criteria for design, construction and operation of specific equipment, systems, structures and components of nuclear and radiation facilities. Safety, codes establish the objectives and set requirements that shall be fulfilled to provide adequate assurance for safety. Safety codes establish the objectives and set requirements that shall be fulfilled to provide adequate assurance for safety. Safety guides elaborate various requirements and furnish approaches for their implementation. Safety manuals deal with specific topics and contain detailed scientific and technical information on the subject. These documents are prepared by experts in the relevant fields and are extensively reviewed by advisory committees of the Atomic Energy Regulatory Board (AERB) before they are published. The documents are revised when necessary, in the light of experience and feedback from users as well as new developments in the field. AERB issued a safety code on Regulation of Nuclear and Radiation Facilities (AERB/SC/G) to spell out the requirements/obligations to be met by a nuclear or radiation facility for the issue of regulatory consent at every stage. This safety guide apprises the details of the regulatory requirements for setting up the radiation facility such as consenting process, the stages requiring consent, wherever applicable documents to be submitted and the nature and extent of review. The guide also gives information on methods of review and assessment adopted by AERB

  14. Consenting process for radiation facilities. V. 1

    International Nuclear Information System (INIS)

    2011-03-01

    Safety codes and standards are formulated on the basis of nationally and internationally accepted safety criteria for design, construction and operation of specific equipment, systems, structures and components of nuclear and radiation facilities. Safety, codes establish the objectives and set requirements that shall be fulfilled to provide adequate assurance for safety. Safety codes establish the objectives and set requirements that shall be fulfilled to provide adequate assurance for safety. Safety guides elaborate various requirements and furnish approaches for their implementation. Safety manuals deal with specific topics and contain detailed scientific and technical information on the subject. These documents are prepared by experts in the relevant fields and are extensively reviewed by advisory committees of the Atomic Energy Regulatory Board (AERB) before they are published. The documents are revised when necessary, in the light of experience and feedback from users as well as new developments in the field. AERB issued a safety code on Regulation of Nuclear and Radiation Facilities (AERB/SC/G) to spell out the requirements/obligations to be met by a nuclear or radiation facility for the issue of regulatory consent at every stage. This safety guide apprises the details of the regulatory requirements for setting up the radiation facility such as consenting process, the stages requiring consent, wherever applicable documents to be submitted and the nature and extent of review. The guide also gives information on methods of review and assessment adopted by AERB

  15. Informed consent: Do not be afraid

    Directory of Open Access Journals (Sweden)

    Dominique Sprumont

    2017-04-01

    Full Text Available Informed consent is the cornerstone of the doctor–patient relationship. At least this is how it is presented in theory. In practice, doctors struggle with their obligation to inform their patient before obtaining their approval prior to a medical intervention. In Taiwan, the culture is often mentioned to justify the doctor's reluctance to speak openly with their patient. Invoking the importance of the family in the society, doctors tend to rely less on their patients and more on their relatives to make important decisions. Yet, the cultural argument for not seeking the patients' informed consent sounds more like a mere excuse than the real cause of the difficulties doctors face today in obtaining their patients' consent. This paper argues that today the doctors in Taiwan are mostly governed by the same fear that was the rule in the USA and Europe until the 1980s. It may be time for changing the paradigm, admitting that patients are able to handle even the most dramatic diagnosis. It seems also important to get away from the sterile opposition of doctor's paternalism versus patient's autonomy and to introduce a true partnership between doctors and patients.

  16. Informed consent: is it a myth?

    Science.gov (United States)

    Herz, D A; Looman, J E; Lewis, S K

    1992-03-01

    The issue of informed consent at it relates to neurosurgical professional malpractice liability and litigation has been of concern for 20 years or more. The problem persists, and the subject has been addressed by providing patient education with full disclosure regarding neurosurgical procedures. In the process of imparting informed consent, the authors studied the effectiveness of specific neurosurgical health care teaching. One hundred six persons undergoing anterior cervical fusion or lumbar laminectomy were instructed by a neurosurgeon and clinical nurse specialist with a master's degree in neurosurgery. Written testing was performed in each case immediately after a formal teaching session before surgery. Questions were simple and covered only four general topics: 1) diagnosis and surgical techniques; 2) operative risks; 3) postoperative care; and 4) goals and benefits relating to surgery. The mean score on testing immediate retention of information revealed a 43.5% overall performance rate. When patients were tested approximately 6 weeks later, the score dropped to 38.4%. This was statistically significant (chi 2, P less than 0.05). The authors encourage the concept of patient education. The data in the current study, however, suggest that the reasonable and prudent neurosurgeon making a concerted effort at patient education, with the assistance of a professional educator, cannot necessarily expect accurate patient or family recall or comprehension. Fulfillment of the doctrine of informed consent by neurosurgeons may very well be mythical.

  17. Can children withhold consent to treatment?

    Science.gov (United States)

    Devereux, J A; Jones, D P; Dickenson, D L

    1993-05-29

    A dilemma exists when a doctor is faced with a child or young person who refuses medically indicated treatment. The Gillick case has been interpreted by many to mean that a child of sufficient age and intelligence could validly consent or refuse consent to treatment. Recent decisions of the Court of Appeal on a child's refusal of medical treatment have clouded the issue and undermined the spirit of the Gillick decision and the Children Act 1989. It is now the case that a child patient whose competence is in doubt will be found rational if he or she accepts the proposal to treat but may be found incompetent if he or she disagrees. Practitioners are alerted to the anomalies now exhibited by the law on the issue of children's consent and refusal. The impact of the decisions from the perspectives of medicine, ethics, and the law are examined. Practitioners should review each case of child care carefully and in cases of doubt seek legal advice.

  18. Minors' rights to consent to treatment: navigating the complexity of State laws.

    Science.gov (United States)

    Vukadinovich, David M

    2004-01-01

    State laws recognize that a competent adult patient has the right to consent to or refuse medical treatment. While the law is clear with regard to the right of competent adults, state statutes are more complicated when the patient is a minor. While the law should, and does, attempt to balance the rights and obligations of parents and guardians against the access and privacy rights of minors, complicated state statutory schemes often fail to simultaneously address those contrasting goals in a consistent and uniform manner. The result is a confusing set of seemingly arbitrary and sometimes conflicting provisions that require the detailed attention of healthcare providers to ensure legal compliance. With the aim of helping healthcare practitioners meet their legal obligations, this Article examines state laws governing minor's consent rights byfocusing on the instances in which a minor's parent, guardian, or other authorized adult is permitted to consent to treatment on behalf of a minor and the instances in which a minor is authorized to act independent of adult intervention.

  19. Cross-cultural perspectives on research participation and informed consent.

    Science.gov (United States)

    Barata, Paula C; Gucciardi, Enza; Ahmad, Farah; Stewart, Donna E

    2006-01-01

    This study examined Portuguese Canadian and Caribbean Canadian immigrants' perceptions of health research and informed consent procedures. Six focus groups (three in each cultural group) involving 42 participants and two individual interviews were conducted. The focus groups began with a general question about health research. This was followed by three short role-plays between the moderator and the assistant. The role-plays involved a fictional health research study in which a patient is approached for recruitment, is read a consent form, and is asked to sign. The role-plays stopped at key moments at which time focus group participants were asked questions about their understanding and their perceptions. Focus group transcripts were coded in QSR NUDIST software using open coding and then compared across cultural groups. Six overriding themes emerged: two were common in both the Portuguese and Caribbean transcripts, one emphasized the importance of trust and mistrust, and the other highlighted the need and desire for more information about health research. However, these themes were expressed somewhat differently in the two groups. In addition, there were four overriding themes that were specific to only one cultural group. In the Portuguese groups, there was an overwhelming positive regard for the research process and an emphasis on verbal as opposed to written information. The Caribbean participants qualified their participation in research studies and repeatedly raised images of invasive research.

  20. Health literacy, self-efficacy, and patients' assessment of medical disclosure and consent documentation.

    Science.gov (United States)

    Donovan-Kicken, Erin; Mackert, Michael; Guinn, Trey D; Tollison, Andrew C; Breckinridge, Barbara; Pont, Stephen J

    2012-01-01

    Informed consent documents are designed to convey the risks of medical procedures to patients, yet they are often difficult to understand; this is especially true for individuals with limited health literacy. An important opportunity for advancing knowledge about health literacy and informed consent involves examining the theoretical pathways that help to explain how health literacy relates to information processing when patients read consent forms. In this study, we proposed and tested a model that positioned self-efficacy as a mediator of the association between health literacy and patients' comprehension and assessment of informed consent documentation. Findings from structured interviews with patients (n = 254) indicated that lower health literacy predicted lower self-efficacy, which predicted feeling less well informed and less prepared, being more confused about the procedure and its hazards, and wanting more information about risks. Incorporating awareness of self-efficacy into disclosure documents and consent conversations may be a useful means of prompting patients to ask questions that can help them make informed decisions about care.

  1. Modified informed consent in a viral seroprevalence study in the Caribbean.

    Science.gov (United States)

    Cox, Cheryl; Macpherson, CNL

    1996-07-01

    An unlinked seroprevalence study of HIV and other viruses was conducted on pregnant women on the Caribbean island of Grenada in 1994. Investigators were from both the developed world and the Grenadian Ministry of Health (MOH). There was then no board on Grenada to protect research subjects or review ethical aspects of studies. Nurses from the MOH were asked to verbally inform their patients about the study, and request that patients become subjects of the study and give blood for screening. If consent was given nurses took blood and administered a survey about each subjects' knowledge of HIV transmission routes. Nurses shared a spoken dialect and cultural heritage with prospective subjects and were probably more effective than foreign researchers at informing subjects. Informed consent was obtained with a simplified consent form supplemented with conversation with each prospective research subject. Facilitating discussion between people with common cultural backgrounds helps apply the Western approach to informed consent to communites in the developing world. Researchers must disclose all information to nurses or other mediators, and ensure that nurses disclose as much information as possible to prospective subjects. So modified, informed consent maintains respect for persons and becomes applicable and relevant to various cultures.

  2. Childhood immunization: when physicians and parents disagree.

    Science.gov (United States)

    Gilmour, Joan; Harrison, Christine; Asadi, Leyla; Cohen, Michael H; Vohra, Sunita

    2011-11-01

    Persistent fears about the safety and efficacy of vaccines, and whether immunization programs are still needed, have led a significant minority of parents to refuse vaccination. Are parents within their rights when refusing to consent to vaccination? How ought physicians respond? Focusing on routine childhood immunization, we consider the ethical, legal, and clinical issues raised by 3 aspects of parental vaccine refusal: (1) physician counseling; (2) parental decision-making; and (3) continuing the physician-patient relationship despite disagreement. We also suggest initiatives that could increase confidence in immunization programs.

  3. Role of informed consent for intravascular contrast media

    International Nuclear Information System (INIS)

    Hopper, K.D.; Tyler, H.N. Jr.

    1988-01-01

    To evaluate the usefulness of different degrees of informed consent for intravascular contrast media, the authors divided 100 patients into four groups: (1) informed consent with no information on intravascular contrast media, (2) simple written informed consent that detailed common risks, (3) detailed written informed consent that detailed all known risks, and (4) MD informed consent, during which a radiologist discussed all known risks of intravascular contrast media. Physician counseling time for group 4 averaged 11.4 minutes. On a postprocedure test about the common complications and risk factors of intravascular contrast media, the average scores were: group 1, 38.4%; group 2, 68.2%; group 3, 63.2%; and group 4, 69.8%. There was no statistical difference between groups 2-4 on the postprocedure test. If informed consent is to be used prior to intravascular contrast media administration, a simple written consent detailing the common risks and risk factors appears to be the best method

  4. Informed Consent in Clinical Trials Using Stem Cells: Suggestions and Points of Attention from Informed Consent Training Workshops in Japan

    Directory of Open Access Journals (Sweden)

    M Kusunose

    2015-09-01

    Full Text Available Informed consent (IC is an essential requirement of ethical research involving human participants, and usually is achieved by providing prospective research participants (PRPs with a document that explains the study and its procedures. However, results of a series of IC workshops held in Tokyo during 2014 indicate that consent forms alone are not enough to achieve full IC in regenerative medicine research due to the necessity of long-term patient-safety observations to meet the ethical challenges of such research. Adequate training of the people who are responsible for obtaining IC (elucidators is also necessary to ensure full IC. Elucidators must be able to provide PRPs with sufficient information to assure adequate comprehension of the study and its potential aftereffects; judge PRPs’ voluntariness and eligibility; and establish/maintain partnerships with PRPs. The workshops used role-playing simulations to demonstrate how to effectively obtain fuller IC to members of several Japanese research groups preparing for clinical stem cell trials. Workshop results were correlated with the results of a 2013 workshop on what information is patients want when considering participation in iPSC research. The correlated results showed the need for continuous training and education of elucidators in order to have them acquire and maintain IC competency. 

  5. The influence of process and patient factors on the recall of consent information in mentally competent patients undergoing surgery for neck of femur fractures.

    Science.gov (United States)

    Khan, S K; Karuppaiah, K; Bajwa, A S

    2012-07-01

    Informed consent is an ethical and legal prerequisite for major surgical procedures. Recent literature has identified 'poor consent' as a major cause of litigation in trauma cases. We aimed to investigate the patient and process factors that influence consent information recall in mentally competent patients (abbreviated mental test score [AMTS] ≥6) presenting with neck of femur (NOF) fractures. A prospective study was conducted at a tertiary unit. Fifty NOF patients (cases) and fifty total hip replacement (THR) patients (controls) were assessed for process factors (adequacy and validity of consent) as well as patient factors (comprehension and retention) using consent forms and structured interview proformas. The two groups were matched for ASA (American Society of Anesthesiologists) grade and AMTS. The consent forms were adequate in both groups but scored poorly for validity in the NOF group. Only 26% of NOF patients remembered correctly what surgery they had while only 48% recalled the risks and benefits of the procedure. These results were significantly poorer than in THR patients (p = 0.0001). This study confirms that NOF patients are poor at remembering the information conveyed to them at the time of consent when compared with THR patients despite being intellectually and physiologically matched. We suggest using preprinted consent forms (process factors), information sheets and visual aids (patient factors) to improve retention and recall.

  6. An Observational Study of Children's Involvement in Informed Consent for Exome Sequencing Research.

    Science.gov (United States)

    Miller, Victoria A; Werner-Lin, Allison; Walser, Sarah A; Biswas, Sawona; Bernhardt, Barbara A

    2017-02-01

    The goal of this study was to examine children's involvement in consent sessions for exome sequencing research and associations of involvement with provider and parent communication. Participants included 44 children (8-17 years) from five cohorts who were offered participation in an exome sequencing study. The consent sessions were audiotaped, transcribed, and coded. Providers attempted to facilitate the child's involvement in the majority (73%) of sessions, and most (75%) children also verbally participated. Provider facilitation was strongly associated with likelihood of child participation. These findings underscore that strategies such as asking for children's opinions and soliciting their questions show respect for children and may increase the likelihood that they are engaged and involved in decisions about research participation.

  7. Ophthalmologists' awareness of informed consent and their compliance to its requirements.

    Science.gov (United States)

    Ehteshami, Asghar; Isfahani, Sakineh Saghaeiannejad; Saeedbakhsh, Saeed; Isfahani, Mahtab Kasaei

    2013-01-01

    Healthcare providers' awareness of laws governing medical documents and patients' health-related information is essential in securing the patients' rights. Given the existing legal problems in documentation of medical record of Consent and Acquittal, we decided to perform an investigation examining the levels of ophthalmologists' awareness of legal requirements for medical record of consent and acquittal and how they complied with such requirements at Feiz Teaching Hospital, Isfahan in the year 2011. This research is an applied, descriptive-analytic one. The research population for awareness measurement includes attending ophthalmologists at Feiz Hospital. Filled-in consent record forms recorded in medical document were used to examine the levels of compliance with legal requirements governing medical record of consent and acquittal. Sampling among the attending ophthalmologists was performed using consensus which included 14 ophthalmologists. The files were samples using the statistical formula, resulting in a sample of 303 files. Data collection tools included a questionnaire and a check list. The questionnaire's reliability was estimated through Cronbach's alpha calculation (0.8); and the check list was completed through a survey among professors of Health Information Technology Management department. In a first step, investigators handed a questionnaire containing 12 items to the ophthalmologists in order to assess their levels of awareness from legal Aspects of medical Informed consent and acquittal, and received the completed questionnaire after answering their possible queries on the issue. In the next step the researchers went to the hospital and evaluated the levels of compliance with legal aspects of medical informed consent and acquittal within the files using a check list and by direct observation. Analytic statistics and SPSS software were used to analyze the data; and Pearson test was applied to evaluate the assumed relationship. The findings were

  8. Level of knowledge and understanding of informed consent amongst the training grade group orthodontists in England, Wales and Northern Ireland.

    Science.gov (United States)

    Sharma, Pratik K; Chate, Robert A

    2011-06-01

    To assess the level of knowledge and understanding of informed consent in UK orthodontic trainees. A cross-sectional, written questionnaire-based study. Hospital orthodontic departments in England, Wales and Northern Ireland. A one page questionnaire which covered a range of legal issues pertinent to informed consent was circulated to 207 members of the Training Grades Group (TGG) of the British Orthodontic Society (BOS). The questionnaire consisted of four open questions with 11 responses, which the investigators considered to be ideal, seven closed questions requiring yes/no responses and one question requiring a yes/no response followed by two open responses. Following the initial circulation, a second posting to non-responders was conducted. The response rate was 61% (N=126). The mean number of complete answers to the 21 questions was 13 (62%; median 13; mode 14). There were a low number of complete responses to specific questions in the following areas - explanations patients need from clinicians prior to obtaining consent; how to fully judge if a patient is capable of consenting; how to manage a patient incapable of giving consent; the legal status of fathers consenting on behalf of their children; whether consent forms have to be re-signed if the start of treatment is delayed by six months or more and responsibility for obtaining consent for dental treatment under general anaesthesia. There was a disappointingly high proportion of incomplete answers to questions testing the knowledge and understanding of the law as it pertains to informed consent exists amongst members of the TGG of BOS.

  9. [Informed consent and experimental treatments: the case of mesotherapy].

    Science.gov (United States)

    Mammucari, Massimo; Gatti, Antonio; Maggiori, Enrica; Vergari, Benedetto; Gafforio, Paolo; Tufaro, Giuseppe; Maggiori, Sergio

    2013-05-01

    Mesotherapy is a minimally invasive technique based on the introduction of pharmacologically active compounds in the surface layer of the skin. The intradermal route has been known for many years and it has the aim of reducing the dose and slowing the diffusion into the underlying tissues. Mesotherapy requires a clinical diagnosis and informed consent. Patient should be well informed about potential benefits, limitations, and risks (even mild). The process of doctor-patient interaction in mesotherapy is an example of compliance with the basic concept: "first do no harm" and, at the same time, the advantage for the patient to conclude a "therapeutic alliance". We propose a draft form to facilitate the decision-making process.

  10. Informed consent: Enforcing pharmaceutical companies' obligations abroad.

    Science.gov (United States)

    Lee, Stacey B

    2010-06-15

    The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, multinational pharmaceutical companies, the United States government and courts, and the media, have played a significant role in defining these obligations. This article examines how such obligations have developed through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust obligations appear, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement by an international tribunal or through one universally adopted code of ethics. This article argues that, rather than continuing to pursue an untenable international approach, the Alien Torts Statute (ATS) offers a viable enforcement mechanism, at least for US-based pharmaceutical companies. Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victims redress and enforcing accountability of sponsors (usually pharmaceutical companies and research and academic institutions) for informed consent misconduct. Substantive human rights protections are vital in order to ensure that every person can realize the "right to health." This article concludes that by building on the federal appellate court's ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in US courts, a mechanism can be created for enforcing not only substantive informed consent, but also human rights protections.

  11. Readability and Understanding of Informed Consent Among Participants With Low Incomes: A Preliminary Report.

    Science.gov (United States)

    Ittenbach, Richard F; Senft, Elizabeth C; Huang, Guixia; Corsmo, Jeremy J; Sieber, Joan E

    2015-12-01

    With passage and implementation of the Affordable Health Care Act, more vulnerable segments of the U.S. population will now have access to regular health care and increased opportunities to participate in biomedical research. Yet, access to new groups brings with it new responsibilities for investigators, most importantly, reducing burdens for participants. Data collected through this small pilot study suggest several preliminary but potentially important findings when working with adults from low-income populations: First, while all participants read some parts of the consent forms (55%), only a minority reported reading the entire form (45%); second, 73% of participants reported understanding the study very well whereas only 27% reported understanding the study "a little"; third, there was a slight reported advantage of the simplified form over the regular form; however, this difference varied by section. Relatedly, other research has shown a high incidence of persons reading none of the consent form, but signing a statement that they have read and understood the study. Why does this occur? What are we teaching people when we request that they sign a consent form they have chosen not to read? What are the ethical and regulatory implications? Embedded ethics studies such as this one, although pilot and preliminary in nature, offer a number of advantages, such as stimulating additional scientific inquiry as well as challenging established institutional practices. © The Author(s) 2015.

  12. Parent and medical professional willingness to enroll children in a hypothetical pediatric optic neuritis treatment trial

    Directory of Open Access Journals (Sweden)

    Amy eWaldman

    2011-11-01

    Full Text Available The Optic Neuritis Treatment Trial and subsequent studies have had a tremendous impact on the treatment and prognosis of optic neuritis and multiple sclerosis in adults. The results of these studies have been extrapolated to children; however, pediatric data are sparse. Using the method of prospective preference assessment, the willingness of parents and medical professionals to enroll children in a hypothetical Pediatric Optic Neuritis Treatment Trial was assessed using a mock consent form and questionnaire. A 3-arm trial was proposed: 1 intravenous corticosteroids, 2 high-dose oral corticosteroids, and 3 an oral placebo. The forms were completed by 198 parents and 49 physicians. After reviewing the hypothetical scenario, trial design, risks and benefits, and alternatives to the study, 21% of parents would enroll their children in the trial whereas 98% of medical professionals would enroll their patients. With medical professional recommendation, 43% of parents would enroll their children. The manner in which this hypothetical trial was presented to parents, specifically with respect to the recommendation of their child’s health care team, influenced a parent’s willingness to participate.

  13. Informed consent for exome sequencing research in families with genetic disease: the emerging issue of incidental findings.

    Science.gov (United States)

    Bergner, Amanda L; Bollinger, Juli; Raraigh, Karen S; Tichnell, Crystal; Murray, Brittney; Blout, Carrie Lynn; Telegrafi, Aida Bytyci; James, Cynthia A

    2014-11-01

    Genomic sequencing technology is increasingly used in genetic research. Studies of informed consent for exome and genome sequencing (ES/GS) research have largely involved hypothetical scenarios or healthy individuals enrolling in population-based studies. Studies have yet to explore the consent experiences of adults with inherited disease. We conducted a qualitative interview study of 15 adults recently enrolled in a large-scale ES/GS study (11 affected adults, four parents of affected children). Our study had two goals: (1) to explore three theoretical barriers to consent for ES/GS research (interpretive/technical complexity, possibility of incidental findings, and risks of loss of privacy); and (2) to explore how interviewees experienced the consent process. Interviewees could articulate study goals and processes, describe incidental findings, discuss risks of privacy loss, and reflect on their consent experience. Few expected the study would identify the genetic cause of their condition. All elected to receive incidental findings. Interviewees acknowledged paying little attention to potential implications of incidental findings in light of more pressing goals of supporting research regarding their own medical conditions. Interviewees suggested that experience living with a genetic condition prepared them to adjust to incidental findings. Interviewees also expressed little concern about loss of confidentiality of study data. Some experienced the consent process as very long. None desired reconsent prior to return of study results. Families with inherited disease likely would benefit from a consent process in which study risks and benefits were discussed in the context of prior experiences with genetic research and genetic disease. © 2014 Wiley Periodicals, Inc.

  14. The quality of informed consent in Croatia-a cross-sectional study and instrument development.

    Science.gov (United States)

    Vučemilo, Luka; Milošević, Milan; Dodig, Doris; Grabušić, Bruno; Đapić, Biljana; Borovečki, Ana

    2016-03-01

    To examine the informed consent process implementation and quality in Croatia using a specially developed instrument. A cross-sectional questionnaire study was conducted in 300 patients (response rate 73%) from six hospitals in Croatia, along with psychometric evaluation of the questionnaire. Signing the informed consent form was a formality for 64% of patients, 54% of patients did not give their written consent, and in 39% of cases physicians made treatment decisions by themselves. The overall informed consent process score was 4.06±0.60 (of 5.00). Physician-patient relationship score was 4.61±0.57, Verbal information 3.99±0.98, Decision making 3.94±0.75, and Written information 3.60±1.42. The overall Cronbach's alpha coefficient was 0.890. Significant correlations were found in relation to Physician-patient relationship and education levels (OR=0.43, 95% CI=0.18-0.99, p=0.048), and Verbal information and duration of health problems (OR=1.83, 95% CI=1.02-3.25, p=0.041). The developed questionnaire is reliable and valid. The informed consent process quality in Croatia was reasonably high, although insufficient and inadequate written materials represent a weak spot that require enhancement. The study contributes to the development of suitable measuring instrument for assessment of the informed consent process quality in clinical practice. The questionnaire could be of use in the hospital accreditation process. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  15. "Consent Is Good, Joyous, Sexy": A Banner Campaign to Market Consent to College Students

    Science.gov (United States)

    Thomas, Kristie A.; Sorenson, Susan B.; Joshi, Manisha

    2016-01-01

    Objective: This study assessed the recall of, reaction to, and understanding of a brief campus banner campaign promoting consent in sexual relationships, and determined whether campaign exposure was associated with subsequent engagement in activities related to sexual assault education, awareness, and prevention. Participants: A stratified random…

  16. Schizophrenia research participants' responses to protocol safeguards: recruitment, consent, and debriefing.

    Science.gov (United States)

    Roberts, Laura Weiss; Warner, Teddy D; Anderson, Charles T; Smithpeter, Megan V; Rogers, Melinda K

    2004-04-01

    To examine the perspectives and preferences regarding ethically important aspects of recruitment, consent, and debriefing of people with schizophrenia who volunteered for research protocols. A structured interview to assess research-related views of people with schizophrenia was developed and piloted. Data collection occurred at three sites. For this analysis, we examined the subset of responses from schizophrenia patients currently enrolled in a protocol. Data from 28 schizophrenia research volunteers were analyzed. Of these, 22 were men and 11 were voluntary inpatients. Most (n=23) recalled speaking with someone before enrolling in the protocol, and most (n=26) reported trusting the person who told them about it. Participants reported a moderate understanding of their protocols. All but one person (n=27) remembered signing a consent form. Twenty-one volunteers indicated that consent forms are meant to help both the patient and the researcher. Most (n=23) reported making the enrollment decision alone, with 22 making this decision prior to reviewing the consent form. The decision was described as relatively easy. Respondents felt some pressure to enroll, with women experiencing more pressure. Debriefing practices were strongly endorsed by participants. All 28 of the volunteers wished to be informed if a health problem (i.e., "something wrong") was discovered during the protocol. The persons living with schizophrenia who were interviewed for this project expressed interesting perspectives and preferences regarding ethically important aspects of recruitment, consent, and debriefing in clinical research that may help guide efforts to make research processes more attuned to participants and merit further inquiry.

  17. Informed consent: a socio-legal study.

    Science.gov (United States)

    Rathor, M Y; Rani, Mohammad Fauzi Abdul; Shah, Azarisman Mohammad; Akter, Sheikh Fariuddin

    2011-12-01

    Informed consent [IC] is a recognized socio-legal obligation for the medical profession. The doctrine of IC involves the law, which aims to ensure the lawfulness of health assistance and tends to reflect the concept of autonomy of the person requiring and requesting medical and/or surgical treatment. Recent changes in the health care delivery system and the complex sociological settings, in which it is practiced, have resulted in an increase in judicial activity and medical negligence lawsuits for physicians. While IC is a well-established practice, it often fails to meet its stated purpose. In the common law, the standard of medical care to disclose risks has been laid down by the Bolam test- a familiar concept to most physicians, but it has been challenged recently in many jurisdictions. This paper aims to discuss some important judgments in cases of alleged medical negligence so as to familiarize doctors regarding their socio-legal obligations. We also propose to discuss some factors that influence the quality of IC in clinical practice. Literature review. The law of medical consent has been undergoing changes in recent years. Case law appears to be evolving towards a more patient centered standard of disclosure. Patient's expectations are higher and they are aware of the power of exercising their rights. Failure to obtain IC is one of the common allegations in medical malpractice suits. The medical professionals need to change their mindset and avoid claims of negligence by providing information that is "reasonable" in the eyes of the court.

  18. 78 FR 36642 - Proposed Information Collection (Statement of Dependency of Parent(s)) Activity: Comment Request

    Science.gov (United States)

    2013-06-18

    ...-0089'' in any correspondence. During the comment period, comments may be viewed online through the FDMS... use of other forms of information technology. Title: Statement of Dependency of Parent(s), VA Form 21... injuries and depends on his or her parent(s) for support complete VA Form 21-509 to report income and...

  19. 75 FR 61251 - Proposed Information Collection (Statement of Dependency of Parent(s)) Activity: Comment Request

    Science.gov (United States)

    2010-10-04

    ... No. 2900-0089'' in any correspondence. During the comment period, comments may be viewed online... use of other forms of information technology. Title: Statement of Dependency of Parent(s), VA Form 21... injuries and depends on his or her parent(s) for support complete VA Form 21-509 to report income and...

  20. 12 CFR 980.6 - Finance Board consent.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Finance Board consent. 980.6 Section 980.6 Banks and Banking FEDERAL HOUSING FINANCE BOARD NEW FEDERAL HOME LOAN BANK ACTIVITIES NEW BUSINESS ACTIVITIES § 980.6 Finance Board consent. The Finance Board may at any time provide consent for a Bank to undertake a particular new business activity and...

  1. Teaching Form as Form

    DEFF Research Database (Denmark)

    Keiding, Tina Bering

    2012-01-01

    understanding of form per se, or, to use an expression from this text, of form as form. This challenge can be reduced to one question: how can design teaching support students in achieving not only the ability to recognize and describe different form-related concepts in existing design (i.e. analytical...

  2. Parenting Perfectionism and Parental Adjustment

    OpenAIRE

    Lee, Meghan A.; Schoppe-Sullivan, Sarah J.; Kamp Dush, Claire M.

    2012-01-01

    The parental role is expected to be one of the most gratifying and rewarding roles in life. As expectations of parenting become ever higher, the implications of parenting perfectionism for parental adjustment warrant investigation. Using longitudinal data from 182 couples, this study examined the associations between societal- and self-oriented parenting perfectionism and new mothers’ and fathers’ parenting self-efficacy, stress, and satisfaction. For mothers, societal-oriented parenting perf...

  3. Dignity and informed consent in the treatment of mature minors.

    Science.gov (United States)

    Bello, Bidemi Ademola

    2010-12-01

    In today's world, as evinced in various human rights provisions, emphasis is placed on the assertion and protection of the entrenched rights of every human and particularly the dignity of humans and respect of human autonomy. Medical/health workers are concerned about protecting every patient's right to the dignity of his or her person. This led to the formulation of the concept of self determination and informed consent in medical diagnosis and treatments. However, serious concern is placed on these principles especially as it affects mature minors, a group of individuals who by conduct demand a level of respect but may at the same time be viewed as not capable of making the "best" informed decisions, especially about health. The following issues may arise as a result of the aforementioned concerns: --are mature young ones entitled to right of self determination and informed consent despite the alleged fear that they may lack capacity to make informed decisions? --if no, who should decide on their behalf--their parents, their medical/health provider or the society/government (especially since the 3 (three) interested groups may have different and conflicting stands on what is best for the child); --if the answer to the initial question is yes, to what extent should mature minors be informed of their medical choices and be allowed to exercise their right of self determination? --should they be guided? --and who should so guide them? In resolving the above issue, due consideration has been given not only to legal and bio-ethical provisions of some countries but also to international conventions which several countries are party to. Thereafter, it became clear that most authorities are of the view that mature minors should be fully informed and be allowed to have a say in health decisions, coaching them with few exceptions. Ultimately, because of the importance of respect for human dignity, autonomy and self determination along with medical disclosure in today

  4. 78 FR 63566 - Proposed Collection; Comment Request for Form 8838

    Science.gov (United States)

    2013-10-24

    ... concerning Form 8838, Consent To Extend the Time To Assess Tax Under Section 367-Gain Recognition Agreement.... ADDRESSES: Direct all written comments to Yvette Lawrence, Internal Revenue Service, Room 6129, 1111... . SUPPLEMENTARY INFORMATION: Title: Consent To Extend the Time To Assess Tax Under Section 367- Gain Recognition...

  5. REXIC project: retrospective cross-sectional study of documentation of informed consent for research biobanking in a public research and teaching hospital

    Directory of Open Access Journals (Sweden)

    Marta Nobile

    2013-07-01

    Full Text Available Background. The Center for Transfusion Medicine, Cell Therapy and Cryobiology, Milan, Northern Italy, is the headquarter of the POLI-MI biobank. It co-ordinates the biobank activities of the Fondazione Ca’ Granda Ospedale Maggiore Policlinico of Milan. Such activities require specific safeguarding of donors’ rights and protection of sensitive and genetic data. The Fondazione Ca’ Granda Ospedale Maggiore Policlinico has set up a project on informed consent with the aim of developing awareness and understanding of this issue. Within this project, it has been decided to evaluate how consent for biobanking material is expressed. Design and methods. The aim of the study was to evaluate the quality and completeness of consent to biobanking in the POLI-MI biobank. This was a retrospective study carried out in 2012 on samples of consent declarations collected by biobank units in 2011. Some units used a single, standard consent model available from a previous POLI-MI biobank workgroup. Other units used models which had been previouly formulated. Evaluation was made using a form that indicated the essential elements of consent. Results. A total of 48 consent declarations were collected using the single, standard model and 84 were collected using other models. The consent declarations that used the single, standard model were found to be the most complete and were filled in better than other models. Conclusions. Progressive adoption of a simple, standard consent model is expected to improve the quality of consent acquisition. Regular audit of the compliance of consent practices with ethical and legal requirements is mandatory to improve the quality of research biobanking.

  6. A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group.

    Science.gov (United States)

    Bleiberg, H; Decoster, G; de Gramont, A; Rougier, P; Sobrero, A; Benson, A; Chibaudel, B; Douillard, J Y; Eng, C; Fuchs, C; Fujii, M; Labianca, R; Larsen, A K; Mitchell, E; Schmoll, H J; Sprumont, D; Zalcberg, J

    2017-05-01

    In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. A simplified form of informed consent with the leading part of 1200-1800 words containing all of the key information necessary to meet ethical and regulatory requirements and 'relevant supportive information appendix' of 2000-3000 words is provided. This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

  7. Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study

    Science.gov (United States)

    de Laat, Sonya; Schwartz, Lisa

    2016-01-01

    Introduction Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known about substitute decision-maker (SDM) experiences. A paediatric resuscitation trial (SQUEEZE) (NCT01973907) using an exception to consent process began enrolling at McMaster Children's Hospital in January 2014. This qualitative research study aims to generate new knowledge on SDM experiences with the exception to consent process as implemented in a randomised controlled trial. Methods and analysis The SDMs of children enrolled into the SQUEEZE pilot trial will be the sampling frame from which ethics study participants will be derived. Design: Qualitative research study involving individual interviews and grounded theory methodology. Participants: SDMs for children enrolled into the SQUEEZE pilot trial. Sample size: Up to 25 SDMs. Qualitative methodology: SDMs will be invited to participate in the qualitative ethics study. Interviews with consenting SDMs will be conducted in person or by telephone, taped and professionally transcribed. Participants will be encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. Analysis: Data gathering and analysis will be undertaken simultaneously. The investigators will collaborate in developing the coding scheme, and data will be coded using NVivo. Emerging themes will be identified. Ethics and dissemination This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent

  8. Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study.

    Science.gov (United States)

    Parker, Melissa J; de Laat, Sonya; Schwartz, Lisa

    2016-09-13

    Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known about substitute decision-maker (SDM) experiences. A paediatric resuscitation trial (SQUEEZE) (NCT01973907) using an exception to consent process began enrolling at McMaster Children's Hospital in January 2014. This qualitative research study aims to generate new knowledge on SDM experiences with the exception to consent process as implemented in a randomised controlled trial. The SDMs of children enrolled into the SQUEEZE pilot trial will be the sampling frame from which ethics study participants will be derived. Qualitative research study involving individual interviews and grounded theory methodology. SDMs for children enrolled into the SQUEEZE pilot trial. Up to 25 SDMs. Qualitative methodology: SDMs will be invited to participate in the qualitative ethics study. Interviews with consenting SDMs will be conducted in person or by telephone, taped and professionally transcribed. Participants will be encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. Data gathering and analysis will be undertaken simultaneously. The investigators will collaborate in developing the coding scheme, and data will be coded using NVivo. Emerging themes will be identified. This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent. Findings will inform implementation of the exception to consent process in the planned definitive SQUEEZE

  9. Kidney Stones (For Parents)

    Science.gov (United States)

    ... Staying Safe Videos for Educators Search English Español Kidney Stones KidsHealth / For Parents / Kidney Stones What's in ... other treatments to help remove the stones. How Kidney Stones Form It's the kidneys' job to remove ...

  10. Email-Based Informed Consent: Innovative Method for Reaching Large Numbers of Subjects for Data Mining Research

    Science.gov (United States)

    Lee, Lesley R.; Mason, Sara S.; Babiak-Vazquez, Adriana; Ray, Stacie L.; Van Baalen, Mary

    2015-01-01

    Since the 2010 NASA authorization to make the Life Sciences Data Archive (LSDA) and Lifetime Surveillance of Astronaut Health (LSAH) data archives more accessible by the research and operational communities, demand for data has greatly increased. Correspondingly, both the number and scope of requests have increased, from 142 requests fulfilled in 2011 to 224 in 2014, and with some datasets comprising up to 1 million data points. To meet the demand, the LSAH and LSDA Repositories project was launched, which allows active and retired astronauts to authorize full, partial, or no access to their data for research without individual, study-specific informed consent. A one-on-one personal informed consent briefing is required to fully communicate the implications of the several tiers of consent. Due to the need for personal contact to conduct Repositories consent meetings, the rate of consenting has not kept up with demand for individualized, possibly attributable data. As a result, other methods had to be implemented to allow the release of large datasets, such as release of only de-identified data. However the compilation of large, de-identified data sets places a significant resource burden on LSAH and LSDA and may result in diminished scientific usefulness of the dataset. As a result, LSAH and LSDA worked with the JSC Institutional Review Board Chair, Astronaut Office physicians, and NASA Office of General Counsel personnel to develop a "Remote Consenting" process for retrospective data mining studies. This is particularly useful since the majority of the astronaut cohort is retired from the agency and living outside the Houston area. Originally planned as a method to send informed consent briefing slides and consent forms only by mail, Remote Consenting has evolved into a means to accept crewmember decisions on individual studies via their method of choice: email or paper copy by mail. To date, 100 emails have been sent to request participation in eight HRP

  11. US public cord blood banking practices: recruitment, donation, and the timing of consent.

    Science.gov (United States)

    Broder, Sherri M; Ponsaran, Roselle S; Goldenberg, Aaron J

    2013-03-01

    Cord blood has moved rapidly from an experimental stem cell source to an accepted and important source of hematopoietic stem cells. There has been no comprehensive assessment of US public cord blood banking practices since the Institute of Medicine study in 2005. Of 34 US public cord blood banks identified, 16 participated in our qualitative survey of public cord blood banking practices. Participants took part in in-depth telephone interviews in which they were asked structured and open-ended questions regarding recruitment, donation, and the informed consent process at these banks. Thirteen of 16 participants reported a variably high percentage of women who consented to public cord blood donation. Fifteen banks offered donor registration at the time of hospital admission for labor and delivery. Seven obtained full informed consent and medical history during early labor and eight conducted some form of phased consent and/or phased medical screening and history. Nine participants identified initial selection of the collection site location as the chief mode by which they recruited minority donors. Since 2005, more public banks offer cord blood donor registration at the time of admission for labor and delivery. That and the targeted location of cord blood collection sites are the main methods used to increase access to donation and HLA diversity of banked units. Currently, the ability to collect and process donations, rather than donor willingness, is the major barrier to public cord blood banking. © 2012 American Association of Blood Banks.

  12. [The meaning of autonomy in Chinese culture: obtaining informed consent for operation].

    Science.gov (United States)

    Lin, Mei-Ling; Wu, Jo Yung-Wei; Huang, Mei-Chih

    2008-10-01

    The purpose of gaining the patient's informed consent is ethical, lying in respect for his or her autonomy, and such consent forms the foundation for the performance of clinical medical treatment. In order to respect the patient's autonomy, for example, during decisions about operations, doctors have the obligation to clearly explain that patient's medical condition to him/her. A thorough briefing should be given prior to the obtaining of the patients' consent. In fulfillment of their duties as medical professionals, both doctors and nurses should be involved in clinically informing patients as well as in obtaining their signature for operation and anesthesia. Although informing patients about their physical state is not the responsibility of nurses, it remains absolutely necessary for nurses to understand how people in Asian cultures understand autonomy. This paper begins with a discussion of autonomy in ethics, and then outlines the differences between the Eastern and Western concepts of autonomy, before discussing the obtaining of the signature of consent, a process performed by the nursing staff during clinical treatment, and resulting in the provision of such signatures by patients with the legal capacity to provide them.

  13. US Public Cord Blood Banking Practices: Recruitment, Donation, and the Timing of Consent

    Science.gov (United States)

    Broder, Sherri; Ponsaran, Roselle; Goldenberg, Aaron

    2012-01-01

    BACKGROUND Cord blood has moved rapidly from an experimental stem cell source to an accepted and important source of hematopoietic stem cells. There has been no comprehensive assessment of US public cord blood banking practices since the Institute of Medicine study in 2005. STUDY DESIGN AND METHODS Of 34 US public cord blood banks identified, 16 participated in our qualitative survey of public cord blood banking practices. Participants took part in in-depth telephone interviews in which they were asked structured and open-ended questions regarding recruitment, donation, and the informed consent process at these banks. RESULTS 13 of 16 participants reported a variably high percentage of women who consented to public cord blood donation. 15 banks offered donor registration at the time of hospital admission for labor and delivery. 7 obtained full informed consent and medical history during early labor and 8 conducted some form of phased consent and/or phased medical screening and history. 9 participants identified initial selection of the collection site location as the chief mode by which they recruited minority donors. CONCLUSION Since 2005, more public banks offer cord blood donor registration at the time of admission for labor and delivery. That, and the targeted location of cord blood collection sites, are the main methods used to increase access to donation and HLA diversity of banked units. Currently, the ability to collect and process donations, rather than donor willingness, is the major barrier to public cord blood banking. PMID:22803637

  14. Assessing children’s competence to consent in research by a standardized tool: a validity study

    Science.gov (United States)

    2012-01-01

    Background Currently over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. One key reason why children have been excluded from clinical trials is that they are not considered able to exercise meaningful autonomy over the decision to participate. Dutch law states that competence to consent can be presumed present at the age of 12 and above; however, in pediatric practice children’s competence is not that clearly presented and the transition from assent to active consent is gradual. A gold standard for competence assessment in children does not exist. In this article we describe a study protocol on the development of a standardized tool for assessing competence to consent in research in children and adolescents. Methods/design In this study we modified the MacCAT-CR, the best evaluated competence assessment tool for adults, for use in children and adolescents. We will administer the tool prospectively to a cohort of pediatric patients from 6 to18 years during the selection stages of ongoing clinical trials. The outcomes of the MacCAT-CR interviews will be compared to a reference standard, established by the judgments of clinical investigators, and an expert panel consisting of child psychiatrists, child psychologists and medical ethicists. The reliability, criterion-related validity and reproducibility of the tool will be determined. As MacCAT-CR is a multi-item scale consisting of 13 items, power was justified at 130–190 subjects, providing a minimum of 10–15 observations per item. MacCAT-CR outcomes will be correlated with age, life experience, IQ, ethnicity, socio-economic status and competence judgment of the parent(s). It is anticipated that 160 participants will be recruited over 2 years to complete enrollment. Discussion A validity study on an assessment tool of competence to consent is strongly needed in research practice, particularly in the child and adolescent population. In this study we will establish

  15. Assessing children’s competence to consent in research by a standardized tool: a validity study

    Directory of Open Access Journals (Sweden)

    Hein Irma M

    2012-09-01

    Full Text Available Abstract Background Currently over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. One key reason why children have been excluded from clinical trials is that they are not considered able to exercise meaningful autonomy over the decision to participate. Dutch law states that competence to consent can be presumed present at the age of 12 and above; however, in pediatric practice children’s competence is not that clearly presented and the transition from assent to active consent is gradual. A gold standard for competence assessment in children does not exist. In this article we describe a study protocol on the development of a standardized tool for assessing competence to consent in research in children and adolescents. Methods/design In this study we modified the MacCAT-CR, the best evaluated competence assessment tool for adults, for use in children and adolescents. We will administer the tool prospectively to a cohort of pediatric patients from 6 to18 years during the selection stages of ongoing clinical trials. The outcomes of the MacCAT-CR interviews will be compared to a reference standard, established by the judgments of clinical investigators, and an expert panel consisting of child psychiatrists, child psychologists and medical ethicists. The reliability, criterion-related validity and reproducibility of the tool will be determined. As MacCAT-CR is a multi-item scale consisting of 13 items, power was justified at 130–190 subjects, providing a minimum of 10–15 observations per item. MacCAT-CR outcomes will be correlated with age, life experience, IQ, ethnicity, socio-economic status and competence judgment of the parent(s. It is anticipated that 160 participants will be recruited over 2 years to complete enrollment. Discussion A validity study on an assessment tool of competence to consent is strongly needed in research practice, particularly in the child and adolescent population. In

  16. Requesting a unique personal identifier or providing a souvenir incentive did not affect overall consent to health record linkage: evidence from an RCT nested within a cohort.

    Science.gov (United States)

    Ni, Michael Y; Li, Tom K; Hui, Rex W H; McDowell, Ian; Leung, Gabriel M

    2017-04-01

    It is unclear if unique personal identifiers should be requested from participants for health record linkage: this permits high-quality data linkage but at the potential cost of lower consent rates due to privacy concerns. Drawing from a sampling frame based on the FAMILY Cohort, using a 2 × 2 factorial design, we randomly assigned 1,200 participants to (1) request for Hong Kong Identity Card number (HKID) or no request and (2) receiving a souvenir incentive (valued at USD4) or no incentive. The primary outcome was consent to health record linkage. We also investigated associations between demographics, health status, and postal reminders with consent. Overall, we received signed consent forms from 33.3% (95% confidence interval [CI] 30.6-36.0%) of respondents. We did not find an overall effect of requesting HKID (-4.3%, 95% CI -9.8% to 1.2%) or offering souvenir incentives (2.4%, 95% CI -3.1% to 7.9%) on consent to linkage. In subgroup analyses, requesting HKID significantly reduced consent among adults aged 18-44 years (odds ratio [OR] 0.53, 95% CI 0.30-0.94, compared to no request). Souvenir incentives increased consent among women (OR 1.55, 95% CI 1.13-2.11, compared to no souvenirs). Requesting a unique personal identifier or providing a souvenir incentive did not affect overall consent to health record linkage. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. "Consent is Good, Joyous, Sexy": A banner campaign to market consent to college students.

    Science.gov (United States)

    Thomas, Kristie A; Sorenson, Susan B; Joshi, Manisha

    2016-01-01

    This study assessed the recall of, reaction to, and understanding of a brief campus banner campaign promoting consent in sexual relationships, and determined whether campaign exposure was associated with subsequent engagement in activities related to sexual assault education, awareness, and prevention. A stratified random sample of 1,200 undergraduates was recruited during fall of 2010; 628 (52.3%) participated. To account for history and maturation, an experimental research design was employed with an online survey. Direct and indirect campaign exposure was associated with increased action. Students expressed primarily positive reactions to and appeared to understand the consent message. The campaign appealed to and was associated with increased activity among a wide range of students with one exception: a negative effect was observed for business students. Colorful banners with pithy, upbeat messages hold promise for engaging undergraduates in conversations and proactive activities related to sexual assault prevention.

  18. Associations between general parenting styles and specific food-related parenting practices and children's food consumption.

    Science.gov (United States)

    Vereecken, Carine; Legiest, Erwin; De Bourdeaudhuij, Ilse; Maes, Lea

    2009-01-01

    Explore the impact of general parenting style and specific food-related parenting practices on children's dietary habits. Cross-sectional study of sixth graders and their parents. Data were gathered (in 2003) in 69 of 100 randomly selected elementary schools in Belgium. All sixth graders (N = 1957) were invited to participate; 82.4% of their parents gave consent and completed questionnaires, resulting in 1614 parent-child pairs. Children's consumption of breakfast, fruit, vegetables, soft drinks, and sweets was assessed by self-administered food frequency questionnaires. Parents completed questionnaires on sociodemographic characteristics, general parenting styles (authoritarian, authoritative, indulgent, or neglecting) and specific food-related parenting practices (pressure, reward, encouragement through negotiation, catering on children's demands, permissiveness, avoiding negative modeling, and praise). Logistic regression analyses were performed, with general parenting style and specific food-related parenting practices as predictors and dietary habits as dependent variables, controlling for sociodemographic characteristics and children's weight status. General parenting style did not show any significant impact on dietary habits. In contrast, the food-related parenting practice "encouragement through negotiation" showed a significant positive impact, whereas "pressure," "catering on demand," and "permissiveness" were practices with an unhealthy impact. Nutrition education programs that guide parents in firm but not coercive food parenting skills are likely to have a positive impact upon children's dietary habits.

  19. Medical research using governments' health claims databases: with or without patients' consent?

    Science.gov (United States)

    Tsai, Feng-Jen; Junod, Valérie

    2018-03-01

    Taking advantage of its single-payer, universal insurance system, Taiwan has leveraged its exhaustive database of health claims data for research purposes. Researchers can apply to receive access to pseudonymized (coded) medical data about insured patients, notably their diagnoses, health status and treatments. In view of the strict safeguards implemented, the Taiwanese government considers that this research use does not require patients' consent (either in the form of an opt-in or in the form of an opt-out). A group of non-governmental organizations has challenged this view in the Taiwanese Courts, but to no avail. The present article reviews the arguments both against and in favor of patients' consent for re-use of their data in research. It concludes that offering patients an opt-out would be appropriate as it would best balance the important interests at issue.

  20. 29 CFR 1921.8 - Consent findings and order.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 7 2010-07-01 2010-07-01 false Consent findings and order. 1921.8 Section 1921.8 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... WORKERS' COMPENSATION ACT Prehearing Procedures § 1921.8 Consent findings and order. (a) General. At any...

  1. Sexual Consent as a Scientific Subject: A Literature Review

    Science.gov (United States)

    Fenner, Lydia

    2017-01-01

    Despite the presumed centrality of sexual consent to definitions of sexual violence, it remains an ambiguous and often unexamined concept both in lay and professional/scientific discourses. The following literature review of peer-reviewed research studying sexual consent as a scientific object will thematically present major findings from said…

  2. Readability of Informed Consent Documents at University Counseling Centers

    Science.gov (United States)

    Lustgarten, Samuel D.; Elchert, Daniel M.; Cederberg, Charles; Garrison, Yunkyoung L.; Ho, Y. C. S.

    2017-01-01

    The extent to which clients understand the nature and anticipated course of therapy is referred to as informed consent. Counseling psychologists often provide informed consent documents to enhance the education of services and for liability purposes. Professionals in numerous health care settings have evaluated the readability of their informed…

  3. 21 CFR 50.25 - Elements of informed consent.

    Science.gov (United States)

    2010-04-01

    ... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic... pertinent questions about the research and research subjects' rights, and whom to contact in the event of a...

  4. 75 FR 68620 - Notice of Lodging Proposed Consent Decree

    Science.gov (United States)

    2010-11-08

    ... Florida on November 1, 2010. The proposed Consent Decree concerns a First Amended Complaint filed by the...; Century Partners Group, Ltd.; Century Homebuilders of South Florida, LLC; and Cesar E. Llano to obtain...). The proposed Consent Decree resolves these allegations by requiring the defendants to enhance wetlands...

  5. 17 CFR 230.263 - Consent to Service of Process.

    Science.gov (United States)

    2010-04-01

    ... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Consent to Service of Process... Consent to Service of Process. (a) If the issuer is not organized under the laws of any of the states of... [§ 239.42 of this chapter]. (b) Any change to the name or address of the agent for service of the issuer...

  6. Informed consent for medical photography in Nigerian surgical ...

    African Journals Online (AJOL)

    Background: The aim of this study is to assess the current practice of informed consent for medical photography in the Nigerian surgical practice and how it compares to international best practices. Methods: Self-administered questionnaires were distributed to consenting surgeons attending two major surgical conferences.

  7. 29 CFR 70.42 - Consent to Pay Fees.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true Consent to Pay Fees. 70.42 Section 70.42 Labor Office of the....42 Consent to Pay Fees. (a) The filing of a request under this subpart will be deemed to constitute an agreement by the requester to pay all applicable fees charged under this part up to and including...

  8. Alcohol and Sexual Consent Scale: Development and Validation

    Science.gov (United States)

    Ward, Rose Marie; Matthews, Molly R.; Weiner, Judith; Hogan, Kathryn M.; Popson, Halle C.

    2012-01-01

    Objective: To establish a short measure of attitudes toward sexual consent in the context of alcohol consumption. Methods: Using a multistage and systematic measurement development process, the investigators developed the Alcohol and Sexual Consent Scale using a sample of college students. Results: The resulting 12-item scale, the Alcohol and…

  9. Informed Consent in Research on Second Language Acquisition

    Science.gov (United States)

    Thomas, Margaret; Pettitt, Nicole

    2017-01-01

    The practice of securing informed consent from research participants has a relatively low profile in second language (L2) acquisition research, despite its prominence in the biomedical and social sciences. This review article analyses the role that informed consent now typically plays in L2 research; discusses an example of an L2 study where…

  10. Key factors in children's competence to consent to clinical research

    NARCIS (Netherlands)

    Hein, Irma M.; Troost, Pieter W.; Lindeboom, Robert; Benninga, Marc A.; Zwaan, C. Michel; van Goudoever, Johannes B.; Lindauer, Ramón J. L.

    2015-01-01

    Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children's consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors

  11. 42 CFR 35.15 - Consent to operative procedures.

    Science.gov (United States)

    2010-10-01

    ... emergencies when the patient is physically or mentally incapable of consenting and the delay required to... operative procedure shall be undertaken unless the patient or, in the case of a minor or incompetent, his... or refusal of consent shall be made a part of the clinical record. ...

  12. Informed consent for telemedicine in South Africa: A survey of ...

    African Journals Online (AJOL)

    Informed consent for telemedicine in South Africa: A survey of consent practices among healthcare professionals in Durban, KwaZulu-Natal. C Jack, M Mars. Abstract. Background. The Health Professions Council of South Africa is drafting guidelines to regulate the practice of telemedicine. These emphasise the need for ...

  13. Language, cultural brokerage and informed consent – will ...

    African Journals Online (AJOL)

    2014-05-14

    May 14, 2014 ... focus of recent debate around ethical issues relating to the standard of care and ... Forty-one key words relevant to computer terminology and concepts required to gain informed consent for a .... patients did not understand the meaning of the word 'consent' and .... [24] Lindegger and Richter[25] looked at.

  14. Informed consent and collaborative research: perspectives from the developing world.

    Science.gov (United States)

    Hyder, Adnan A; Wali, Salman A

    2006-03-01

    Informed consent has been recognized as an important component of research protocols and procedures of disclosure and consent in collaborative research have been criticized, as they may not be in keeping with cultural norms of developing countries. This study, which is part of a larger project funded by the United States National Bioethics Advisory Commission, explores the opinions of developing country researchers regarding informed consent in collaborative research. A survey of developing country researchers, involved in human subject research, was conducted by distributing a questionnaire with 169 questions, which included questions relating to informed consent. In addition, six focus group discussions, eight in-depth interviews and 78 responses to open-ended questions in the questionnaire provided qualitative data. 203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers in their most recent studies. A large proportion of respondents recommended that human subject regulations should allow more flexibility in ways of documenting informed consent. 84% of researchers agreed that a mechanism to measure understanding should be incorporated in research studies as part of the process of informed consent. This paper is an empirical step in highlighting the ethical issues concerning disclosure. Health researchers in developing countries are well aware of the importance of consent in health research, and equally value the significance of educating human subjects regarding study protocols and associated risks and benefits. However, respondents emphasize the need for modifying ethical regulations in collaborative research.

  15. Consent to tissue banking for research: qualitative study and recommendations.

    Science.gov (United States)

    Soto, Carmen; Tarrant, Carolyn; Pritchard-Jones, Kathy; Dixon-Woods, Mary

    2012-07-01

    To explore how families of children with cancer experience giving consent for tissue banking and to produce recommendations on good practice. 79 participants from 42 families (41 mothers, 18 fathers, 20 children and young people with cancer) took part in semistructured interviews to explore their experiences of being approached for consent to tissue banking. Tertiary care facilities for childhood cancer. Families are generally supportive of tissue banking, although they report that it may be difficult for them to consider all the implications when asked for consent. They typically do not want detailed information when consent is sought close to diagnosis, preferring to see tissue banking as part of routine practice. Families often recognise that their consent may not be fully informed, but are content to give consent based on their understanding at the time. Some may want a chance to go over the information and revisit their decision when things have settled. Families' views can inform practical recommendations for optimising the experience of consent for tissue banking. Current guidelines for obtaining consent should be revisited to take account of families' preferences.

  16. Consent and assessment of capacity to decide or refuse treatment.

    Science.gov (United States)

    Simpson, Owena

    Consent protects the right of patients to decide what happens to them. Before any medical intervention, adults must give valid consent, which must be voluntary, informed and given free of undue influence. When consent is being obtained, patients must be informed about the intervention, why it is being done and its risks; information they are given must be recorded. Every effort should be made to explain the issues in terms that the patient can understand and by providing support and aids to communicate. Consent can be expressed, where patients say they consent or put it in writing, or implied, where a healthcare professional infers from their behaviour that they consent. While different types of consent are valid, some are evidence of stronger proof in court that valid consent has been given. Competent adults have the right to refuse treatment, regardless of the reasons they give for refusal and even if the refusal will result in death; clinicians must respect their decision. In some circumstances-such as when an unconscious person is admitted as an emergency-healthcare professionals can make decisions on behalf of patients, and must do so in patients' best interests.

  17. Informed Consent for Inclusion into Clinical Trials: A Serious Subject ...

    African Journals Online (AJOL)

    Informed Consent for Inclusion into Clinical Trials: A Serious Subject to Note in the Developing World Morteza. ... Review: The process of taking informed consent is wellunderstood in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of ...

  18. 40 CFR 26.1117 - Documentation of informed consent.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF... Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1117 Documentation of informed consent. (a...

  19. Informed consent for caesarean section at a Nigerian university ...

    African Journals Online (AJOL)

    Results: The mean age of the respondents was 32±1.8 yearswith 118(79%) of the surgeries being emergency Cesarean sections. The consent for CS were mostly given by the patients (96, 64.0%) and husbands (43, 28.6%). Majority of the respondents 123(81.5%) had the consent obtained in the labour ward with profuse ...

  20. Black Boxing Restraints: The Need for Full Disclosure and Consent

    Science.gov (United States)

    Mohr, Wanda K.; Nunno, Michael A.

    2011-01-01

    In this article we discuss the necessity of fully informing patients and their families of what constitutes physical interventions and their attendant risks under the established principles and obligations of informed consent. After a brief review of the elements of informed consent and the nature of the duty to advise patients and their families…

  1. Ethical Issues Regarding Informed Consent for Minors for Space Tourism

    Science.gov (United States)

    Marsh, Melvin S.

    2010-01-01

    This paper describes the difficulty with informed consent and debates whether or not whether adults should be able to ethically, morally, and legally consent for their children during the high-risk activity of space tourism. The experimental nature of space vehicles combined with the high likelihood of medical complications and the destination places space tourism legally in the category of "adventure activities," which include adventure travel to exotic locations as well as adventure sports, such as mountain climbing, rafting, etc. which carry a high risk of danger (http://rescommunis.wordpress.com/2008/02/14/interview-tracey-l-knutson-adventure-sports-defense-attorney-on-space-tourism-risk-and-informed-consente/). However, unlike other adventure sports, adults currently cannot consent for their minor children. Other topics also receive attention, such as a "mature minors" clause, radiation exposure of potential future children, and other difficulties preventing adults from legally consenting to space travel.

  2. Manufacturing Consent revisité Manufacturing Consent revisited Una nueva aproximación a Manufacturing Consent

    Directory of Open Access Journals (Sweden)

    Michael Burawoy

    2012-12-01

    Full Text Available Cet article présente rapidement Manufacturing Consent publié en 1979 dans lequel la direction d’Allis Chalmer organisait la discipline du travail ouvrier par la coercition et par le consentement, en particulier à travers l’établissement des quotas de production qui fondait une sorte de jeu social entre ouvriers (the game of making out. L’auteur revient sur la méthode ethnographique utilisée alors pour la critiquer et il propose de la remplacer par « l’étude de cas élargie » (the extented case method qui prend en compte le contexte du travail dont les trajectoires des acteurs, les transformations des marchés et du rôle de l’État, sans négliger les éléments spatio-temporels facteurs de changement. C’est l’occasion pour l’auteur de passer en revue les publications récentes qui ont élargi les objets de recherches à la question du genre, au travail domestique, aux travailleurs migrants, aux services, au syndicalisme, etc. L’article suggère que l’enjeu des luttes passerait de l’exploitation à la marchandisation (commodification avec les luttes consuméristes qui l’accompagneraient ; lesquelles inaugureraient une nouvelle ère de mobilisations transnationales étendues à l’Europe de l’Est et à l’Asie. Ce qui conduit l’auteur à reprendre les thèses de Polanyi sur La Grande Transformation en les actualisant avec l’avènement présent d’une troisième vague ultra-libérale qui étend la marchandisation à la nature (terre, eau et air et aux connaissances : les mouvements « d’occupation » (“occupy” movements en seraient les premières ripostes.The article briefly presents Manufacturing Consent, a 1979 publication directed by Allis Chalmer that deals with the way in which work discipline for manual labourers is organised through coercion and consent, based in particular on the establishment of production quota creating a kind of "game of making out" between works. The author reviews

  3. Manufacturing Consent revisited Manufacturing Consent revisité Una nueva aproximación a Manufacturing Consent

    Directory of Open Access Journals (Sweden)

    Michael Burawoy

    2012-12-01

    Full Text Available Cet article présente rapidement Manufacturing Consent publié en 1979 dans lequel la direction d’Allis Chalmer organisait la discipline du travail ouvrier par la coercition et par le consentement, en particulier à travers l’établissement des quotas de production qui fondait une sorte de jeu social entre ouvriers (the game of making out. L’auteur revient sur la méthode ethnographique utilisée alors pour la critiquer et il propose de la remplacer par « l’étude de cas élargie » (the extented case method qui prend en compte le contexte du travail dont les trajectoires des acteurs, les transformations des marchés et du rôle de l’État, sans négliger les éléments spatio-temporels facteurs de changement. C’est l’occasion pour l’auteur de passer en revue les publications récentes qui ont élargi les objets de recherches à la question du genre, au travail domestique, aux travailleurs migrants, aux services, au syndicalisme, etc. L’article suggère que l’enjeu des luttes passerait de l’exploitation à la marchandisation (commodification avec les luttes consuméristes qui l’accompagneraient ; lesquelles inaugureraient une nouvelle ère de mobilisations transnationales étendues à l’Europe de l’Est et à l’Asie. Ce qui conduit l’auteur à reprendre les thèses de Polanyi sur La Grande Transformation en les actualisant avec l’avènement présent d’une troisième vague ultra-libérale qui étend la marchandisation à la nature (terre, eau et air et aux connaissances : les mouvements « d’occupation » (“occupy” movements en seraient les premières ripostes.The article briefly presents Manufacturing Consent, a 1979 publication directed by Allis Chalmer that deals with the way in which work discipline for manual labourers is organised through coercion and consent, based in particular on the establishment of production quota creating a kind of "game of making out" between works. The author reviews

  4. Two dechlorinated chlordecone derivatives formed by in situ chemical reduction are devoid of genotoxicity and mutagenicity and have lower proangiogenic properties compared to the parent compound.

    Science.gov (United States)

    Legeay, Samuel; Billat, Pierre-André; Clere, Nicolas; Nesslany, Fabrice; Bristeau, Sébastien; Faure, Sébastien; Mouvet, Christophe

    2018-05-01

    Chlordecone (CLD) is a chlorinated hydrocarbon insecticide, now classified as a persistent organic pollutant. Several studies have previously reported that chronic exposure to CLD leads to hepatotoxicity, neurotoxicity, raises early child development and pregnancy complications, and increases the risk of liver and prostate cancer. In situ chemical reduction (ISCR) has been identified as a possible way for the remediation of soils contaminated by CLD. In the present study, the objectives were (i) to evaluate the genotoxicity and the mutagenicity of two CLD metabolites formed by ISCR, CLD-5a-hydro, or CLD-5-hydro (5a- or 5- according to CAS nomenclature; CLD-1Cl) and tri-hydroCLD (CLD-3Cl), and (ii) to explore the angiogenic properties of these molecules. Mutagenicity and genotoxicity were investigated using the Ames's technique on Salmonella typhimurium and the in vitro micronucleus micromethod with TK6 human lymphoblastoid cells. The proangiogenic properties were evaluated on the in vitro capillary network formation of human primary endothelial cells. Like CLD, the dechlorinated derivatives of CLD studied were devoid of genotoxic and mutagenic activity. In the assay targeting angiogenic properties, significantly lower microvessel lengths formed by endothelial cells were observed for the CLD-3Cl-treated cells compared to the CLD-treated cells for two of the three tested concentrations. These results suggest that dechlorinated CLD derivatives are devoid of mutagenicity and genotoxicity and have lower proangiogenic properties than CLD.

  5. Ethical Considerations for the Participation of Children of Minor Parents in Clinical Trials.

    Science.gov (United States)

    Ott, Mary A; Crawley, Francis P; Sáez-Llorens, Xavier; Owusu-Agyei, Seth; Neubauer, David; Dubin, Gary; Poplazarova, Tatjana; Begg, Norman; Rosenthal, Susan L

    2018-06-01

    Children of minor parents are under-represented in clinical trials. This is largely because of the ethical, legal, and regulatory complexities in the enrolment, consent, and appropriate access of children of minor parents to clinical research. Using a case-based approach, we examine appropriate access of children of minor parents in an international vaccine trial. We first consider the scientific justification for inclusion of children of minor parents in a vaccine trial. Laws and regulations governing consent generally do not address the issue of minor parents. In their absence, local community and cultural contexts may influence consent processes. Rights of the minor parent include dignity in their role as a parent and respect for their decision-making capacity in that role. Rights of the child include the right to have decisions made in their best interest and the right to the highest attainable standard of health. Children of minor parents may have vulnerabilities related to the age of their parent, such as increased rates of poverty, that have implications for consent. Neuroscience research suggests that, by age 12-14 years, minors have adult-level capacity to make research decisions in situations with low emotion and low distraction. We conclude with a set of recommendations based on these findings to facilitate appropriate access and equity related to the participation of children of minor parents in clinical research.

  6. Influence of parental alcohol-related attitudes, behavior and parenting styles on alcohol use in late and very late adolescence.

    Science.gov (United States)

    Stafström, Martin

    2014-01-01

    Parents influence adolescent drinking behavior, but to what extent does this association diminish with age, however? The cross-sectional data was drawn from the Scania drug use survey 2007, consisting of 4,828 secondary education students in the 9th and 11th grade. The age- and gender-adjusted findings indicate that having parents who are consenting to alcohol use (OR 1.4), having been provided with alcohol by one's parents (OR 1.8), having parents with an authoritarian (OR 1.5) or neglectful (OR 2.1) parenting style, and having parents who both have a university degree (OR 1.3) were factors significantly associated with monthly heavy episodic drinking. These findings lead to the conclusion that parenting styles as well as parental attitudes and behaviors are important throughout the high school years. Thus, prevention targeting parents should emphasize both these domains. © 2014 S. Karger AG, Basel.

  7. Specimen collection for induced pluripotent stem cell research: harmonizing the approach to informed consent.

    Science.gov (United States)

    Lowenthal, Justin; Lipnick, Scott; Rao, Mahendra; Hull, Sara Chandros

    2012-05-01

    Induced pluripotent stem cells (iPSCs) have elicited excitement in both the scientific and ethics communities for their potential to advance basic and translational research. They have been hailed as an alternative to derivation from embryos that provides a virtually unlimited source of pluripotent stem cells for research and therapeutic applications. However, research with iPSCs is ethically complex, uniquely encompassing the concerns associated with genomics, immortalized cell lines, transplantation, human reproduction, and biobanking. Prospective donation of tissue specimens for iPSC research thus requires an approach to informed consent that is constructed for this context. Even in the nascent stages of this field, approaches to informed consent have been variable in ways that threaten the simultaneous goals of protecting donors and safeguarding future research and translation, and investigators are seeking guidance. We address this need by providing concrete recommendations for informed consent that balance the perspectives of a variety of stakeholders. Our work combines analysis of consent form language collected from investigators worldwide with a conceptual balancing of normative ethical concerns, policy precedents, and scientific realities. Our framework asks people to consent prospectively to a broad umbrella of foreseeable research, including future therapeutic applications, with recontact possible in limited circumstances. We argue that the long-term goals of regenerative medicine, interest in sharing iPSC lines, and uncertain landscape of future research all would be served by a framework of ongoing communication with donors. Our approach balances the goals of iPSC and regenerative medicine researchers with the interests of individual research participants.

  8. Intimacy and Family Consent: A Confucian Ideal.

    Science.gov (United States)

    Lee, Shui Chuen

    2015-08-01

    In the West, mainstream bioethicists tend to appreciate intimate relationships as a hindrance to individual autonomy. Scholars have even argued against approaching a mother to donate a kidney to save the life of her child; the request, they claim, is too manipulative and, thereby, violates her autonomy. For Chinese bioethicists, such a moral analysis is absurd. The intimate relationship between mother and child establishes strong mutual obligations. It creates mutual moral responsibilities that often require sacrifices for each other. This paper argues that while aiding others is a moral duty, helping one's family is a much stronger duty and poses no threat to one's autonomy. For Confucianism, empathetic intimate feelings, the heart and mind of ren, rest at the root of morality. It requires that we, as moral beings, assume duties to relieve the suffering of others. The more intimate the relationship the stronger the obligation to assist. The family is a closely knitted moral community. Family members often share living resources, mutual experiences, and a sense of identity. Family members act as a social unit, and, ordinarily, mutual obligations among members have priority over duties to those outside of the family. For Confucian bioethics, family-based consent to medical treatment is regarded as natural and reasonable. Family-based decision making is a taken-for-granted norm of social life. While close family members have priority, Confucianism extends such obligations outward toward members of the extended family and the society at large. There is a general principle of gradation of love, which reflects different degrees of personal intimacy and, therefore, of moral obligation. In this fashion, Confucianism seeks to treat the whole of society as one extended family. Hence, in bioethics, mutual responsibility and family-based consent are regarded as basic principles. Through a series of case discussions, this paper illustrates that atomistic individual

  9. Blockchain protocols in clinical trials: Transparency and traceability of consent [version 5; referees: 1 approved, 2 approved with reservations, 2 not approved

    Directory of Open Access Journals (Sweden)

    Mehdi Benchoufi

    2018-02-01

    Full Text Available Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security

  10. Blockchain protocols in clinical trials: Transparency and traceability of consent [version 4; referees: 1 approved, 2 approved with reservations, 2 not approved

    Directory of Open Access Journals (Sweden)

    Mehdi Benchoufi

    2017-12-01

    Full Text Available Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security

  11. Blockchain protocols in clinical trials: Transparency and traceability of consent [version 3; referees: 1 approved, 2 approved with reservations, 1 not approved

    Directory of Open Access Journals (Sweden)

    Mehdi Benchoufi

    2017-07-01

    Full Text Available Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing the collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we will built a consent workflow using a rising technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain; thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each revision of the protocol, consent was sought again. We obtained a single document, in a standard open format, that accounted for the whole consent collection process: timestamped consent status with regards to each version of the protocol. This document cannot be corrupted, and can be checked on any dedicated public website. It should be considered as a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened in order to remove the need for third parties, here the trial stakeholders, and give participative control to the peer-to-peer users. In the future, we think that the complex data flow of a clinical trial can be tracked using Blockchain, that a blockchain core functionality, named Smart Contract, could help prevent clinical trial events not to happen in the right chronological order: for example including patients before they consented or analysing case report forms data before freezing the database

  12. Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study.

    Science.gov (United States)

    Williams, Barbara F; French, John K; White, Harvey D

    2003-03-15

    Anxiety, fear, pain, and treatment with morphine might compromise the ability of patients to comprehend information about, and give informed consent for, participation in clinical trials. We aimed to assess whether patients with acute myocardial infarction could understand written and verbal information and whether they were competent to give autonomous informed consent to participate in a clinical trial. We prospectively studied 399 patients with acute myocardial infarction in 16 hospitals in New Zealand and Australia who were eligible for participation in the Hirulog and Early Reperfusion or Occlusion (HERO)-2 trial. We assessed readability of patient information sheets, patients' educational status, their views of the consent process, comprehension of verbal and written information, and competence to give consent. The patient information sheet needed a year 13 (age 18) educational level for comprehension, although only 75 of 345 patients (22%) had been educated beyond secondary school. Only 63 of 346 (18%) read the patient information sheet before giving or refusing consent to participate. Patients who gave consent were more likely to report good or partial comprehension of the information provided than were those who refused consent (272 [89%] vs 14 [70%], respectively; p=0.009). In an assessment of competence to make an autonomous decision, 75 of 145 (52%) were ranked at the lowest grade and 26 (18%) were not competent to consent. Although the consent process for HERO-2 met regulatory requirements for clinical trials, it was inappropriate for the needs of most patients. The patients' comprehension of the information provided and their competence to autonomously give consent was less than optimum.

  13. Anesthesiological ethics: can informed consent be implied?

    Science.gov (United States)

    Spike, Jeffrey R

    2012-01-01

    Surgical ethics is a well-recognized field in clinical ethics, distinct from medical ethics. It includes at least a dozen important issues common to surgery that do not exist in internal medicine simply because of the differences in their practices. But until now there has been a tendency to include ethical issues of anesthesiology as a part of surgical ethics. This may mask the importance of ethical issues in anesthesiology, and even help perpetuate an unfortunate view that surgeons are "captain of the ship" in the operating theater (leaving anesthesiologists in a subservient role). We will have a better ethical understanding if we see surgery and anesthesia as two equal partners, ethically as well as in terms of patient care. Informed consent is one such issue, but it is not limited to that. Even on the topic of what type of anesthesia to use, anesthesiologists have often felt subsumed to the surgeon's preferences. This commentary takes the case study and uses it as a exemplar for this very claim: it is time to give due recognition for a new field in clinical ethics, ethics in anesthesia.

  14. USign--a security enhanced electronic consent model.

    Science.gov (United States)

    Li, Yanyan; Xie, Mengjun; Bian, Jiang

    2014-01-01

    Electronic consent becomes increasingly popular in the healthcare sector given the many benefits it provides. However, security concerns, e.g., how to verify the identity of a person who is remotely accessing the electronic consent system in a secure and user-friendly manner, also arise along with the popularity of electronic consent. Unfortunately, existing electronic consent systems do not pay sufficient attention to those issues. They mainly rely on conventional password based authentication to verify the identity of an electronic consent user, which is far from being sufficient given that identity theft threat is real and significant in reality. In this paper, we present a security enhanced electronic consent model called USign. USign enhances the identity protection and authentication for electronic consent systems by leveraging handwritten signatures everyone is familiar with and mobile computing technologies that are becoming ubiquitous. We developed a prototype of USign and conducted preliminary evaluation on accuracy and usability of signature verification. Our experimental results show the feasibility of the proposed model.

  15. Preoperative parental information and parents' presence at induction of anaesthesia.

    Science.gov (United States)

    Astuto, M; Rosano, G; Rizzo, G; Disma, N; Raciti, L; Sciuto, O

    2006-06-01

    Preoperative preparation of paediatric patients and their environment in order to prevent anxiety is an important issue in paediatric anaesthesia. Anxiety in paediatric patients may lead to immediate negative postoperative responses. When a child undergoes surgery, information about the child's anaesthesia must be provided to parents who are responsible for making informed choices about healthcare on their child's behalf. A combination of written, pictorial, and verbal information would improve the process of informed consent. The issue of parental presence during induction of anaesthesia has been a controversial topic for many years. Potential benefits from parental presence at induction include reducing or avoiding the fear and anxiety that might occur in both the child and its parents, reducing the need for preoperative sedatives, and improving the child's compliance even if other studies showed no effects on the anxiety and satisfaction level. The presence of other figures such as clowns in the operating room, together with one of the child's parents, is an effective intervention for managing child and parent anxiety during the preoperative period.

  16. Evaluating nurse understanding and participation in the informed consent process.

    Science.gov (United States)

    Axson, Sydney A; Giordano, Nicholas A; Hermann, Robin M; Ulrich, Connie M

    2017-01-01

    Informed consent is fundamental to the autonomous decision-making of patients, yet much is still unknown about the process in the clinical setting. In an evolving healthcare landscape, nurses must be prepared to address patient understanding and participate in the informed consent process to better fulfill their well-established role as patient advocates. This study examines hospital-based nurses' experiences and understandings of the informed consent process. This qualitative descriptive study utilized a semi-structured interview approach identifying thematic concerns, experiences, and knowledge of informed consent across a selected population of clinically practicing nurses. Participants and research context: In all, 20 baccalaureate prepared registered nurses practicing in various clinical settings (i.e. critical care, oncology, medical/surgical) at a large northeastern academic medical center in the United States completed semi-structured interviews and a demographic survey. The mean age of participants was 36.6 years old, with a mean of 12.2 years of clinical experience. Ethical considerations: Participation in this study involved minimal risk and no invasive measures. This study received Institutional Review Board approval from the University of Pennsylvania. All participants voluntarily consented. The majority of participants (N = 19) believe patient safety is directly linked to patient comprehension of the informed consent process. However, when asked if nurses have a defined role in the informed consent process, nearly half did not agree (N = 9). Through this qualitative approach, three major nursing roles emerged: the nurse as a communicator, the nurse as an advocate, and the clerical role of the nurse. This investigation contributes to the foundation of ethical research that will better prepare nurses for patient engagement, advance current understanding of informed consent, and allow for future development of solutions. Nurses are at the forefront of

  17. Interactive multimedia consent for biobanking: a randomized trial.

    Science.gov (United States)

    Simon, Christian M; Klein, David W; Schartz, Helen A

    2016-01-01

    The potential of interactive multimedia to improve biobank informed consent has yet to be investigated. The aim of this study was to test the separate effectiveness of interactivity and multimedia at improving participant understanding and confidence in understanding of informed consent compared with a standard, face-to-face (F2F) biobank consent process. A 2 (face-to-face versus multimedia) × 2 (standard versus enhanced interactivity) experimental design was used with 200 patients randomly assigned to receive informed consent. All patients received the same information provided in the biobank's nine-page consent document. Interactivity (F(1,196) = 7.56, P = 0.007, partial η(2) = 0.037) and media (F(1,196) = 4.27, P = 0.04, partial η(2) = 0.021) independently improved participants' understanding of the biobank consent. Interactivity (F(1,196) = 6.793, P = 0.01, partial η(2) = 0.033), but not media (F(1,196) = 0.455, not significant), resulted in increased participant confidence in their understanding of the biobank's consent materials. Patients took more time to complete the multimedia condition (mean = 18.2 min) than the face-to-face condition (mean = 12.6 min). This study demonstrated that interactivity and multimedia each can be effective at promoting an individual's understanding and confidence in their understanding of a biobank consent, albeit with additional time investment. Researchers should not assume that multimedia is inherently interactive, but rather should separate the two constructs when studying electronic consent.

  18. Misclassification of fourth-grade children's participation in school-provided meals based on parental responses relative to administrative daily records.

    Science.gov (United States)

    Baxter, Suzanne Domel; Paxton-Aiken, Amy E; Royer, Julie A; Hitchcock, David B; Guinn, Caroline H; Finney, Christopher J

    2014-09-01

    Although many studies have relied on parental responses concerning children's school-meal participation, few studies have evaluated parental response accuracy. We investigated misclassification of fourth-grade children's participation in school-meal programs based on parental responses relative to administrative daily records using cross-sectional study data collected for 3 school years (2004-05, 2005-06, and 2006-07) for 1,100 fourth-grade children (87% black; 52% girls) from 18 schools total in one district. Parents reported children's usual school-meal participation on paper consent forms. The district provided administrative daily records of individual children's school-meal participation. Researchers measured children's weight and height. "Usual participation" in breakfast/lunch was defined as ≥50% of days. Parental responses misclassified 16.3%, 12.8%, 19.8%, and 4.7% of children for participation in breakfast, classroom breakfast, cafeteria breakfast, and lunch, respectively. Parental responses misclassified more children for participation in cafeteria than classroom breakfast (P=0.0008); usual-participant misclassification probabilities were less than nonusual-participant misclassification probabilities for classroom breakfast, cafeteria breakfast, and lunch (Pschool year, breakfast location, and school). Relying on parental responses concerning children's school-meal participation may hamper researchers' abilities to detect relationships that have policy implications for the child nutrition community. The use of administrative daily records of children's school-meal participation is recommended. Copyright © 2014 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  19. Can a subject consent to a 'Ulysses contract'?

    Science.gov (United States)

    1982-08-01

    A case study is presented in which a schizophrenic consents to experimental drug treatment while competent and then refuses the treatment when in a psychotic state. Three commentaries consider the ethical and legal issues involved in permitting informed consent by the mentally ill by means of a "Ulysses contract," i.e., by agreeing at the time of consent that later refusal of treatment is to be ignored if the patient is no longer competent. The commentators see value in such agreements, provided that safeguards are included to ensure that the patient's legitimate wishes and interests are not ignored.

  20. The Consent Solution to Punishment and the Explicit Denial Objection

    Directory of Open Access Journals (Sweden)

    Miroslav Imbrisevic

    2010-06-01

    Full Text Available Recently, David Boonin has put forward several objections to Carlos S. Nino's 'Consensual Theory of Punishment'. In this paper I will defend Nino against the 'explicit denial objection'. I will discuss whether Boonin's interpretation of Nino as a tacit consent theorist is right. I will argue that the offender's consent is neither tacit nor express, but a special category of implicit consent. Further, for Nino the legal-normative consequences of an act (of crime are 'irrevocable', i.e. one cannot (expressly and successfully deny liability to them. I will suggest an explanation for Nino's irrevocability claim.

  1. Parenting Stress in Parents of Infants With Congenital Heart Disease and Parents of Healthy Infants: The First Year of Life.

    Science.gov (United States)

    Golfenshtein, Nadya; Hanlon, Alexandra L; Deatrick, Janet A; Medoff-Cooper, Barbara

    2017-12-01

    While we know that the parents of infants with congenital heart disease (CHD), the most prevalent group of congenital anomalies, experience increased parenting stress, the stress levels throughout infancy have yet to be studied. Stress experienced by parents beyond the normative stress of parenting can interfere with parenting processes, and bear adverse family outcomes. This prospective cohort study was conducted to describe and compare parenting stress levels during infancy between parents of infants with complex CHD and parents of healthy infants. The Parenting Stress Index-Long Form was distributed to parents of infants with complex CHD and parents of healthy infants (N = 129). T-tests were used to compare stress between groups at 3, 6, 9, and 12 months of age. Parents of infants with complex CHD had higher parenting stress than parents of healthy infants on multiple subscales on the Child and Parent Domains, at 3 months of age. The stress remained higher on the demandingness subscale throughout infancy. Parents of CHD infants also demonstrated significantly higher stress scores on the life stress subscale at 12 months of age. Findings highlight stressful periods related to parenting infants with CHD, which may increase existing psycho-social risk for parents of infants with CHD. Early family intervention may promote parental adaptation to the illness, and help establishing healthy parenting practices.

  2. Oncologists’ view of informed consent and shared decision making in paediatric radiation oncology

    International Nuclear Information System (INIS)

    Olson, Robert A.; Bobinski, Mary Ann; Ho, Anita; Goddard, Karen J.

    2012-01-01

    Background and purpose: Cure rates of paediatric malignancies have dramatically improved with therapy intensification, at the cost of late treatment side effects. A survey was developed, centred around medulloblastoma scenarios, in order to explore paediatric oncology physicians’ views on discussing late effects and involving parents in treatment decisions. Materials and methods: Participants were 59 paediatric radiation and medical oncologists or fellows from USA (22), Canada (18), Europe (16), Australia (2), and Asia (1). Results: Ninety-five percent of respondents indicated late effects discussion prior to multimodality treatment was important. Of those who supported it, 100%, 83%, 64%, and 48% thought discussing cognitive impairment, infertility, stroke, and seizures as potential late effects was important, respectively. Only 71% of respondents believed parents should be involved in treatment decisions, which did not significantly vary by respondent age, country, specialty, gender, or years in practice. Conclusions: The majority of oncologists who treat children believe discussing late effects with parents is important. However, there is mixed opinion on which late effects should be discussed and whether parents should be involved in deciding which treatments should be pursued. Research into perceived barriers to shared decision making and effective methods of improving the informed consent process in paediatric malignancies is needed.

  3. Reasons for non-vaccination: Parental vaccine hesitancy and the childhood influenza vaccination school pilot programme in England.

    Science.gov (United States)

    Paterson, Pauline; Chantler, Tracey; Larson, Heidi J

    2017-08-14

    In 2013, the annual influenza immunisation programme in England was extended to children to reduce the burden of influenza, but uptake was sub-optimal at 53.2%. To explore the reasons some parents decided not to vaccinate their child against influenza as part of the pilot programme offered in schools. Cross-sectional qualitative study conducted between February and July 2015. 913 parents whose children were not vaccinated against influenza in the school pilots in West Yorkshire and Greater Manchester, England, were asked to comment on their reasons for non-vaccination and invited to take part in a semi-structured interview. 138 parents returned response forms, of which 38 were eligible and interested in participating and 25 were interviewed. Interview transcripts were coded by theme in NVivo. A third of parents who returned response forms had either vaccinated their child elsewhere, intended to have them vaccinated, or had not vaccinated them due to medical reasons (valid or perceived). Most interviewees were not convinced of the need to vaccinate their child against influenza. Parents expressed concerns about influenza vaccine effectiveness and vaccine side effects. Several parents interviewed declined the vaccine for faith reasons due to the presence of porcine gelatine in the vaccine. To significantly decrease the burden of influenza in England, influenza vaccination coverage in children needs to be >60%. Hence, it is important to understand the reasons why parents are not vaccinating their children, and to tailor the communication and immunisation programme accordingly. Our finding that a third of parents, who did not consent to their child being vaccinated as part of the school programme, had actually vaccinated their child elsewhere, intended to have their child vaccinated, or had not vaccinated them due to medical reasons, illustrates the importance of including additional questions or data sources when investigating under-vaccination. Copyright © 2017 The

  4. Adolescents' aggression to parents: longitudinal links with parents' physical aggression.

    Science.gov (United States)

    Margolin, Gayla; Baucom, Brian R

    2014-11-01

    To investigate whether parents' previous physical aggression (PPA) exhibited during early adolescence is associated with adolescents' subsequent parent-directed aggression even beyond parents' concurrent physical aggression (CPA) and to investigate whether adolescents' emotion dysregulation and attitudes condoning child-to-parent aggression moderate associations. Adolescents (N = 93) and their parents participated in a prospective longitudinal study. Adolescents and parents reported at waves 1-3 on four types of parents' PPA (mother to adolescent, father to adolescent, mother to father, and father to mother). Wave 3 assessments also included adolescents' emotion dysregulation, attitudes condoning aggression, and externalizing behaviors. At waves 4 and 5, adolescents and parents reported on adolescents' parent-directed physical aggression, property damage, and verbal aggression and on parents' CPA. Parents' PPA emerged as a significant indicator of adolescents' parent-directed physical aggression (odds ratio [OR]: 1.25, 95% confidence interval [CI]: 1.0-1.55; p = .047), property damage (OR: 1.29, 95% CI: 1.1-1.5, p = .002), and verbal aggression (OR: 1.35, 95% CI: 1.15-1.6, p controlling for adolescents' sex, externalizing behaviors, and family income. When controlling for parents' CPA, previous mother-to-adolescent aggression still predicted adolescents' parent-directed physical aggression (OR: 5.56, 95% CI: 1.82-17.0, p = .003), and father-to-mother aggression predicted adolescents' parent-directed verbal aggression (OR: 1.86, 95% CI: 1.0-3.3, p = .036). Emotion dysregulation and attitudes condoning aggression did not produce direct or moderated the effects. Adolescents' parent-directed aggression deserves greater attention in discourse about lasting, adverse effects of even minor forms of parents' physical aggression. Future research should investigate parent-directed aggression as an early signal of aggression into adulthood. Copyright © 2014 Society for

  5. Public consent for mining: An industry viewpoint

    International Nuclear Information System (INIS)

    Zelms, J.L.

    1990-01-01

    The predominance of the mining industry was never intentionally destructive to the environment. Even when laws and regulations were far more relaxed than they are today, our operations were conducted professionally, But when change came, mining companies took a noncooperative attitude. We knew that we were the mining experts and that regulators or lawmakers were not. And it became accepted in our industry to stonewall change -- not to work with regulators and lawmakers but to resist change. This same attitude spilled over into attitudes with the media. Reporters were percieved as the enemy and many felt the press misrepresented their views. So we didn't work with the media unless we absolutely had to. In the process, industry did not participate in establishing guidelines and criteria for environmental regulation. Business ceded the environmental agenda to others and we have ended up with laws that forced billions of dollars of expenditures without ensuring that those expenditures had maximum impact on environmental problems. New rules are written by people less knowledgeable about the industry, consequently they cost more than they should and may not even have the desired result. Companies end up spending more than if they had addressed the problem themselves originally. It is no longer enough merely to be mining professionals. Today, it's only a threshold requirement for enduring success. We will best earn public consent to operate by anticipating what society will expect of us and by working to meet those expectations. We must set our own public policy before they become law or regulation and before we are branded as nonresponsive and noncaring

  6. Radiological informed consent in cardiovascular imaging: towards the medico-legal perfect storm?

    Directory of Open Access Journals (Sweden)

    Loré Cosimo

    2007-10-01

    Full Text Available Abstract Use of radiation for medical examinations and tests is the largest manmade source of radiation exposure. No one can doubt the immense clinical and scientific benefits of imaging to the modern practice of medicine. Every radiological and nuclear medicine examination confers a definite (albeit low long-term risk of cancer, but patients undergoing such examinations often receive no or inaccurate information about radiological dose exposure and corresponding risk directly related to the radiological dose received. Too detailed information on radiological dose and risk may result in undue anxiety, but information "economical with the truth" may violate basic patients' rights well embedded in ethics (Oviedo convention 1997 and law (97/43 Euratom Directive 1997. Informed consent is a procedure needed to establish a respectful and ethical relation between doctors and patients. Nevertheless, in an "ideal" consent process, the principle of patient autonomy in current radiological practice might be reinforced by making it mandatory to obtain explicit and transparent informed consent form for radiological examination with high exposure (≥ 500 chest x-rays. The form may spell-out the type of examination, the exposure in effective dose (mSv, derived from reference values in guidelines or – better – from actual values from their department. The dose equivalent might be also expressed in number of chest radiographs and the risk of cancer as number of extra cases in the exposed population, derived from most recent and authorative guidelines (e.g., BEIR VII Committee, release 2006. Common sense, deontological code, patients'rights, medical imaging guidelines, Euratom law, all coherently and concordantly encourage and recommend a justified, optimized, responsible and informed use of testing with ionizing radiation. Although the idea of informed consent for radiation dose does not seem to be on the immediate radar screen at least in the US, the

  7. Cross-sectional Analysis of the Standards of Consent Applied to Anaesthesia in Ireland: Are Anaesthetists Aware of their Legal and Ethical Obligations?

    LENUS (Irish Health Repository)

    2018-01-01

    Consent to a medical intervention has legally and ethically evolved to a process prioritising autonomy and patient-led decision-making. This cross-sectional analysis investigated Irish anaesthetists’ practices of taking consent. Following ethical approval, trainees and fellows of the College of Anaesthetists of Ireland were invited to participate in a 33 question online survey. One hundred and sixty responses (11.8%) were received, an equal number coming from consultants and trainees. The majority (93.7%) worked in a teaching hospital. Fifteen percent said their department had guidelines on obtaining consent for anaesthesia, but only 4.5% said their department used a separate consent form. Most (63.8%) do not usually document consent. A significant number rarely (21.8%) or never (27.8%) explained risks to patients. Lack of time was identified as the most frequent barrier (77.6%), with just under half first meeting the patient in the theatre holding-bay or the anaesthetic room. Forty-one percent felt the ultimate decision regarding which anaesthetic technique is employed should usually lie with the anaesthetist alone. These results suggest a wide variation in the practice of obtaining consent for anaesthesia. Less than half deemed their practice to be adequate in this regard, while 50% were concerned about litigation stemming from inadequate consent.

  8. Informed consent for anaesthesiological and intensive care unit ...

    African Journals Online (AJOL)

    2013-03-04

    Mar 4, 2013 ... care unit research: a South African perspective. De Roubaix JAM, MBChB, .... (g) the development of new applications of health technology. The last two items .... Consent in emergency and ICU care: SA regulatory guidelines.

  9. Informed consent and the law--an English legal perspective.

    Science.gov (United States)

    Hassan, Majid

    2008-01-01

    'Informed consent' is a widely used term, but its application in a legal perspective can be varied. American and Commonwealth jurisdictions have developed a 'patient-based' true informed consent approach, whereas in the English legal system a 'doctor-based' approach has traditionally been applied in relation to disclosure of risk. This article will seek to compare these approaches and give a brief overview of some of the key legal rulings which have shaped the requirement of consent. The decision in the English case of Chester vs. Afshar is considered as showing the significance the court attached to the principle of autonomy and using ethical and policy considerations to depart from established principles of English law relating to consent to treatment and disclosure of risk. This review is intended as general information and not as legal advice which should be sought from defence organisation and specialist health care lawyers. Copyright 2008 S. Karger AG, Basel.

  10. Socio-Cultural Factors Influencing Consent For Research In Nigeria ...

    African Journals Online (AJOL)

    Socio-Cultural Factors Influencing Consent For Research In Nigeria: Lessons ... for Health Research Ethics in enforcing researchers' compliance with ethical standards in ... Genuine respect for human dignity requires deeper understanding of ...

  11. Consent to research by mentally ill children and adolescents: The ...

    African Journals Online (AJOL)

    , the Act's statutory requirements relating to the informed consent to participation in clinical research by mentally ill children and adolescents in South Africa are examined. The necessity of doing clinical research in mentally ill children and ...

  12. Informed consent: attitudes, knowledge and information concerning prenatal examination

    DEFF Research Database (Denmark)

    Dahl, Katja; Kesmodel, Ulrik; hvidman, lone

    2006-01-01

    Background: Providing women with information enabling an informed consent to prenatal examinations has been widely recommended. Objective: The primary purpose of this review is to summarise current knowledge of the pregnant woman's expectations and attitudes concerning prenatal examinations, as w...

  13. Boni mores and consent for child research in South Africa

    African Journals Online (AJOL)

    2015-05-22

    May 22, 2015 ... 2 HIV/AIDS Vaccines Ethics Group, School of Applied Human Sciences, University of ... procedural requirements for approving research – for example, if a study does not obtain ethical approval for consent to participation –.

  14. Access to special care dentistry, part 3. Consent and capacity.

    Science.gov (United States)

    Dougall, A; Fiske, J

    2008-07-26

    This article considers what is meant by informed consent and the implications of the Mental Capacity Act in obtaining consent from vulnerable adults. It explores a number of conditions which impact on this task, namely dyslexia, literacy problems and learning disability. The focus on encouraging and facilitating autonomy and the use of the appropriate level of language in the consent giving process ensures that consent is valid. The use of appropriate methods to facilitate communication with individuals in order to be able to assess capacity and ensure that any treatment options that are chosen on their behalf are in their best interests are outlined. The use of physical intervention in special care dentistry in order to provide dental care safely for both the patient and the dental team is also considered.

  15. Should informed consent be based on rational beliefs?

    OpenAIRE

    Savulescu, J; Momeyer, R W

    1997-01-01

    Our aim is to expand the regulative ideal governing consent. We argue that consent should not only be informed but also based on rational beliefs. We argue that holding true beliefs promotes autonomy. Information is important insofar as it helps a person to hold the relevant true beliefs. But in order to hold the relevant true beliefs, competent people must also think rationally. Insofar as information is important, rational deliberation is important. Just as physicians should aim to provide ...

  16. [Informed consent and neuromodulation techniques for psychiatric purposes: an introduction].

    Science.gov (United States)

    Mandarelli, Gabriele; Moscati, Filippo Maria; Venturini, Paola; Ferracuti, Stefano

    2013-01-01

    The aim of this review was to investigate informed consent-related issues concerning vagus nerve stimulation and deep brain stimulation in the treatment of psychiatric disorders. We searched the principal medical databases for studies concerning informed consent, as well as ethical and deontological issues in psychosurgery. Data were critically analysed. We also provided guidelines for the evaluation of accuracy of the informed consent in such treatments. Despite major deontological and ethical implications, there is substantial lack of information pertaining informed consent decision-making in psychiatric patients with an indication for psychosurgery. In clinical research studies, deep brain stimulation and vagus nerve stimulation have been mainly used in drug-resistant major depressive disorder, Tourette syndrome and obsessive-compulsive disorder. Existing data on efficacy and tolerability, as well as those studies indicating the risk for incapacity in drug-resistant severe mental disorders, suggest the need to achieve a better understanding of the capacity to consent to psychosurgery in patients affected by mental disorders. Informed consent decision-making in clinical trials of deep brain stimulation and vagus nerve stimulation in psychiatric patients is largely unknown and deserves further investigation.

  17. Informed consent in neurosurgery--translating ethical theory into action.

    Science.gov (United States)

    Schmitz, Dagmar; Reinacher, Peter C

    2006-09-01

    Although a main principle of medical ethics and law since the 1970s, standards of informed consent are regarded with great scepticism by many clinicans. By reviewing the reactions to and adoption of this principle of medical ethics in neurosurgery, the characteristic conflicts that emerge between theory and everyday clinical experience are emphasised and a modified conception of informed consent is proposed. The adoption and debate of informed consent in neurosurgery took place in two steps. Firstly, respect for patient autonomy was included into the ethical codes of the professional organisations. Secondly, the legal demands of the principle were questioned by clinicians. Informed consent is mainly interpreted in terms of freedom from interference and absolute autonomy. It lacks a constructive notion of physician-patient interaction in its effort to promote the best interest of the patient, which, however, potentially emerges from a reconsideration of the principle of beneficence. To avoid insufficient legal interpretations, informed consent should be understood in terms of autonomy and beneficence. A continuous interaction between the patient and the given physician is considered as an essential prerequisite for the realisation of the standards of informed consent.

  18. Capacity to consent to research among patients with bipolar disorder.

    Science.gov (United States)

    Misra, Sahana; Ganzini, Linda

    2004-06-01

    Experts have debated the influence of mental illness on decision-making capacity. This paper reviews concepts of decision-making capacity and existing research on the influence of mental illness on capacity to consent to research. We propose how bipolar disorder, especially mania, may have an effect on consent capacity. The current conceptualization of capacity utilizes legal standards of 'choice', 'understanding', 'appreciation' and 'rational reasoning', as well as voluntarism, or the assurance that the patient is free to agree or to decline to participate in research. Studies of patients with schizophrenia suggest impaired cognition influences 'understanding' and is more important than severity of psychosis in affecting decision-making abilities. There are no studies of sources and extent of impairment to consent to research among manic patients. Mania may influence a patient's understanding of the research protocol, but also alter the patient's views, values and level of insight, thus impairing decision-making abilities at the 'appreciation' standard even when the patient understands the relevant information. Mania may impact freedom to decide, yet paradoxically, manic patients may be less influenced by others and less vulnerable to coercion, undue influence and undue incentives compared to patients without mental illness. We suggest that in patients with mood disorders, the legal standard of appreciation be thoroughly probed during the consent procedure. Studies of the effect of mania and depression on consent capacity and voluntarism are needed in order to develop processes that increase safeguards in the informed consent process.

  19. Informed consent in neurosurgery—translating ethical theory into action

    Science.gov (United States)

    Schmitz, Dagmar; Reinacher, Peter C

    2006-01-01

    Objective Although a main principle of medical ethics and law since the 1970s, standards of informed consent are regarded with great scepticism by many clinicans. Methods By reviewing the reactions to and adoption of this principle of medical ethics in neurosurgery, the characteristic conflicts that emerge between theory and everyday clinical experience are emphasised and a modified conception of informed consent is proposed. Results The adoption and debate of informed consent in neurosurgery took place in two steps. Firstly, respect for patient autonomy was included into the ethical codes of the professional organisations. Secondly, the legal demands of the principle were questioned by clinicians. Informed consent is mainly interpreted in terms of freedom from interference and absolute autonomy. It lacks a constructive notion of physician–patient interaction in its effort to promote the best interest of the patient, which, however, potentially emerges from a reconsideration of the principle of beneficence. Conclusion To avoid insufficient legal interpretations, informed consent should be understood in terms of autonomy and beneficence. A continuous interaction between the patient and the given physician is considered as an essential prerequisite for the realisation of the standards of informed consent. PMID:16943326

  20. 75 FR 47818 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2010-08-09

    .... Qualitative data will be collected through student focus groups and teacher interviews. Students will complete.... Informed written consent from parents for each student's participation and informed written assent from... interviews. Students and teachers will be asked about their experiences with the Safe Dates program and ideas...

  1. Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board-approved informed permission and assent forms for 3 multicenter pediatric clinical trials.

    Science.gov (United States)

    Kimberly, Michael B; Hoehn, K Sarah; Feudtner, Chris; Nelson, Robert M; Schreiner, Mark

    2006-05-01

    To systematically compare standards for compensation and child participant assent in informed permission, assent, and consent forms (IP-A-CFs) approved by 55 local institutional review boards (IRBs) reviewing 3 standardized multicenter research protocols. Sixty-nine principal investigators participating in any of 3 national, multicenter clinical trials submitted standardized research protocols for their trials to their local IRBs for approval. Copies of the subsequently IRB-approved IP-A-CFs were then forwarded to an academic clinical research organization. This collection of IRB-approved forms allowed for a quasiexperimental retrospective evaluation of the variation in informed permission, assent, and consent standards operationalized by the local IRBs. Standards for compensation and child participant assent varied substantially across 69 IRB-approved IP-A-CFs. Among the 48 IP-A-CFs offering compensation, monetary compensation was offered by 33 as reimbursement for travel, parking, or food expenses, whereas monetary or material compensation was offered by 22 for subject inconvenience and by 13 for subject time. Compensation ranged widely within and across studies (study 1, $180-1425; study 2, $0-500; and study 3, $0-100). Regarding child participant assent, among the 57 IP-A-CFs that included a form of assent documentation, 33 included a line for assent on the informed permission or consent form, whereas 35 included a separate form written in simplified language. Of the IP-A-CFs that stipulated the documentation of assent, 31 specified > or =1 age ranges for obtaining assent. Informed permission or consent forms were addressed either to parents or child participants. In response to identical clinical trial protocols, local IRBs generate IP-A-CFs that vary considerably regarding compensation and child participant assent.

  2. The Challenges of Research Informed Consent in Socio-Economically Vulnerable Populations: A Viewpoint From the Democratic Republic of Congo.

    Science.gov (United States)

    Kalabuanga, Marion; Ravinetto, Raffaella; Maketa, Vivi; Muhindo Mavoko, Hypolite; Fungula, Blaise; Inocêncio da Luz, Raquel; Van Geertruyden, Jean-Pierre; Lutumba, Pascal

    2016-08-01

    In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio-cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of socio-economic vulnerability. To ensure children's protection, consent is required by the parents or, in their absence, by a legally mandated representative. In our setting, children's responsibility is often entrusted permanently or temporarily to relatives or friends without a tribunal mandate. Hence, a notion of 'culturally acceptable representative' under supervision of the local Ethics Committee may be more suitable. To ensure protection of illiterate subjects, an independent witness is required to confirm that the consent was freely given. However, in low-literacy contexts, potential witnesses often don't have any previous relationship with patient and there may be power-unbalance in their relationship, rather than genuine dialogue. In poor communities, trial participation may be seen as an opportunity to secure access to healthcare. Poverty may also lead to 'competition' to access the research-related benefits, with a risk of disturbance at societal or household level. Adjusting consent procedures to sociocultural and socioeconomic realities is essential for fulfilling the underlying ethical principles. This requires a collaborative dialogue between researchers, regulators and ethics committees. © 2015 John Wiley & Sons Ltd.

  3. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials.

    Science.gov (United States)

    Nishimura, Adam; Carey, Jantey; Erwin, Patricia J; Tilburt, Jon C; Murad, M Hassan; McCormick, Jennifer B

    2013-07-23

    Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods. The search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique. Meta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation

  4. 32 CFR Appendix F to Part 57 - Parent and Student Rights

    Science.gov (United States)

    2010-07-01

    ... child 3 through 21 years, inclusive, refuses consent to initial evaluation, reevaluation, or initial... child, age 3 through 21 years, inclusive. (2) The right to confidentiality of personally identifiable... the native language of the parent or other mode of communication used by the parent, unless it is...

  5. Effective Group Work for Elementary School-Age Children Whose Parents Are Divorcing.

    Science.gov (United States)

    DeLucia-Waack, Janice; Gerrity, Deborah

    2001-01-01

    Parental divorce is the issue of most concern for elementary school children. This article describes interventions for children-of-divorce groups for elementary school children. Suggests guidelines related to goal setting; securing agency and parental consent; leadership planning; recruitment, screening, and selection of members; group member…

  6. Issues of informed consent for intrapartum trials: a suggested consent pathway from the experience of the Release trial [ISRCTN13204258

    Directory of Open Access Journals (Sweden)

    Weeks Andrew

    2006-05-01

    Full Text Available Abstract Service users within the NHS are increasingly being asked to participate in clinical research. In Liverpool Women's NHS Foundation Trust, approximately 35% of women take part in research during their pregnancy. For many studies the consent process is simple; information is provided and signed consent is given. There is a difficulty, however, with obtaining informed consent from women in pregnancy who become eligible only when they develop unforeseen complications, especially when they occur acutely. The problem is compounded with women in labour who may be frightened, vulnerable, in pain, under the effect of opiate analgesia, or all of the above. If research to improve the care of these women is to continue, then special consent procedures are needed. These procedures must ensure that the woman's autonomy is protected whilst recognising that women under these circumstances vary enormously, both in their desire for information and their ability to comprehend it. This paper will discuss the obtaining of consent in this situation, and describe an information and consent pathway for intrapartum research which has been developed in collaboration with consumer groups as a way in which these issues can be tackled.

  7. Consent for routine neonatal procedures: A study of practices in Irish neonatal units. How do we compare with the gold standard BAPM guidelines?

    Science.gov (United States)

    Ryan, M A; Ryan, C A; Dempsey, E; O'Connell, R

    2017-06-09

    The Irish National Consent Policy (NCP) proposes that the legal requirement for consent extends to all forms of interventions, investigations and treatment, carried out on or behalf of the Health Service Executive (HSE). This study employs a quantitative descriptive approach to investigate the practices for obtaining consent for an identified group of routine neonatal procedures in neonatal facilities throughout Ireland. The BAPM (British Association of Perinatal Medicine) guidelines were identified as 'gold standard' for the purposes of this study. The results indicated a lack of consistency between participating units pertaining to the modes of consent utilised and notable variances from 'gold standard' guidelines. Unanimity was evident for 3 procedures only (administering BCG, 6-in-1, and donor breast milk to infant). Significant findings related to EEG with video recordings, MRI/CT and gastro intestinal imaging, screening of an infant with suspected substance abuse or retinopathy of prematurity screening (ROP), administration of Vitamin K, and the carrying out of a lumbar puncture.

  8. The social dynamics of consent and refusal in HIV surveillance in rural South Africa.

    Science.gov (United States)

    Reynolds, Lindsey; Cousins, Thomas; Newell, Marie-Louise; Imrie, John

    2013-01-01

    In the context of low rates of participation in a prospective, population-based HIV surveillance programme, researchers at a surveillance site in rural KwaZulu-Natal, South Africa, conducted an operational study from January 2009 to February 2010, with the aim of improving participation rates, particularly in the provision of dried blood spots for the surveillance. Findings suggest, firstly, that consent to participation in the HIV surveillance is informed by the dynamics of relationality in the HIV surveillance "consent encounter." Secondly, it emerged that both fieldworkers and participants found it difficult to differentiate between HIV surveillance and HIV testing in the surveillance procedure, and tended to understand and explain giving blood under the aegis of the surveillance as an HIV test. The conflation of surveillance and testing, we argue, is not merely a semantic confusion, but reveals an important tension inherent to global health research between individual risks and benefits and collective good, or between private morality and public good. Because of these structural tensions, we suggest, the HIV surveillance consent encounter activates multiple gift economies in the collection of blood samples. Thinking beyond the complex ethical dimensions provoked by new forms of long-term surveillance and health research, we therefore suggest that deepening relations between scientists, fieldworkers, and study participants in locality deserve more careful methodological consideration and descriptive attention. Copyright © 2012 Elsevier Ltd. All rights reserved.

  9. Lessons learned obtaining informed consent in research with vulnerable populations in community health center settings

    Directory of Open Access Journals (Sweden)

    Riden Heather E

    2012-11-01

    Full Text Available Abstract Background To improve equity in access to medical research, successful strategies are needed to recruit diverse populations. Here, we examine experiences of community health center (CHC staff who guided an informed consent process to overcome recruitment barriers in a medical record review study. Methods We conducted ten semi-structured interviews with CHC staff members. Interviews were audiotaped, transcribed, and structurally and thematically coded. We used NVivo, an ethnographic data management software program, to analyze themes related to recruitment challenges. Results CHC interviewees reported that a key challenge to recruitment included the difficult balance between institutional review board (IRB requirements for informed consent, and conveying an appropriate level of risk to patients. CHC staff perceived that the requirements of IRB certification itself posed a barrier to allowing diverse staff to participate in recruitment efforts. A key barrier to recruitment also included the lack of updated contact information on CHC patients. CHC interviewees reported that the successes they experienced reflected an alignment between study aims and CHC goals, and trusted relationships between CHCs and staff and the patients they recruited. Conclusions Making IRB training more accessible to CHC-based staff, improving consent form clarity for participants, and developing processes for routinely updating patient information would greatly lower recruitment barriers for diverse populations in health services research.

  10. "Informed" Consent: An Audit of Informed Consent of Cesarean Section Evaluating Patient Education and Awareness.

    Science.gov (United States)

    Kirane, Akhilesh G; Gaikwad, Nandkishor B; Bhingare, Prashant E; Mule, Vidya D

    2015-12-01

    Better diagnosis and early referral due to increased health care coverage have increased the cesarean deliveries at tertiary-care hospitals of India. Improvements in the health care system raise many concerns and need of cross-checking system in place to counter the problems pertaining to patient education and participation of patient. While most of the cesarean sections are done in good faith for the patient, it does not escape the purview of consumer awareness and protection. This cross-sectional study was undertaken at a tertiary level government institution to understand the level of awareness of 220 patients regarding the various aspects of cesarean delivery which are essential for women to know before giving an informed consent. 71 % of the women had knowledge about the indication and need to do cesarean delivery. Of these, only one-third (25 % of total women) were properly explained about procedure and complications. Other demographic and social characteristics were also evaluated. While the health care schemes have had their improved results, the onus lies upon the caregivers to improve and maintain the quality of health care in these tertiary-care government hospitals in proportion to the increase in patient load. The results of this study highlight the need for proper counseling of patients regarding complications of cesarean section. The fact that only 25 % of total cases were explained proper procedure and complication as opposed to 71 % of patients having proper knowledge about the indication of cesarean section points out the lack of information in seemingly "informed" consent. To bring about awareness about the risks and complications of cesarean section, there is a need that patients be counseled during the antenatal visits, specifically when patients visit near term for antenatal check up.

  11. Parents as passengers during pediatric transport.

    Science.gov (United States)

    Lewis, M M; Holditch-Davis, D; Brunssen, S

    1997-01-01

    The transport environment presents a unique setting in which the feasibility, advantages, and disadvantages of passengers accompanying a patient must be assessed carefully. The purpose of this study was to describe the current practice of including parents as passengers during pediatric interfacility transport. One-hundred-eighty-eight critical care transport programs in the United States responded to a voluntary mail survey, providing information about current policies, practices, and crew perceptions of the advantages and disadvantages of carrying parents as passengers. Extra seating for passengers was available in 96% of ambulances, 86% of fixed-wing aircraft, and 54% of helicopters used for pediatric transport. Parents traveled as passengers in all types of vehicles; most frequently in ambulances and fixed-wing aircraft. Twenty percent of helicopter programs allowed parent passengers on more than half of their pediatric transports in this vehicle. Advantages of parent passengers included emotional benefit for the parent and child, availability of parents for history and consent, good public relations, and having the parent present if the child dies. Disadvantages included potential parent anxiety, crew distraction, and space limitations. This study reflects the widely diverse policies, practices, and opinions relevant to this topic and confirms a need for further study.

  12. Glassfrog embryos hatch early after parental desertion

    OpenAIRE

    Delia, Jesse R. J.; Ramírez-Bautista, Aurelio; Summers, Kyle

    2014-01-01

    Both parental care and hatching plasticity can improve embryo survival. Research has found that parents can alter hatching time owing to a direct effect of care on embryogenesis or via forms of care that cue the hatching process. Because parental care alters conditions critical for offspring development, hatching plasticity could allow embryos to exploit variation in parental behaviour. However, this interaction of parental care and hatching plasticity remains largely unexplored. We tested th...

  13. Parenting Seminars for Divorcing Parents.

    Science.gov (United States)

    Frieman, Barry B.

    1995-01-01

    Profiles the parenting seminars and counseling services for divorcing parents offered by the Children of Separation and Divorce Center, a community service agency in Maryland. The seminars are designed to help parents adjust to divorce and understand the needs of their children during and after the divorce process. (MDM)

  14. Communicating with parents of premature infants: who is the informant?

    Science.gov (United States)

    Kowalski, W J; Leef, K H; Mackley, A; Spear, M L; Paul, D A

    2006-01-01

    To determine what sources of information are most helpful for neonatal intensive care unit (NICU) parents, who provides NICU parents with the information, and also what expectations parents have regarding obtaining information. A 19-item questionnaire was given to the parents of infants 32 weeks or younger prior to discharge from the NICU. Out of the 101 parents who consented, almost all of the parents (96%) felt that 'the medical team gave them the information they needed about their baby' and that the 'neonatologist did a good job of communicating' with them (91%). However, the nurse was chosen as 'the person who spent the most time explaining the baby's condition, 'the best source of information,' and the person who told them 'about important changes in their baby's condition' (Pparent education is satisfactory, the parents identified the nurses as the primary source of information.

  15. [Issues related to consent to healthcare decisions in children and adolescents].

    Science.gov (United States)

    Bailly, D

    2010-02-01

    The process of consent to healthcare decisions in children and adolescents often set physicians difficult problems. From what age is a child able to understand the information given to him or her about illness and treatment? Is an ill child indeed in the capacity to give his or her voluntary consent to treatment? How to define and to assess the capacity of an ill child to take part in treatment decisions? More than the age of the child, it is his or her level of cognitive, emotional and social development and its interactions with illness that will determine his or her degree of involvement in the decision-making process. There is a moral and ethical need to respect the rights and autonomy of every individual, regardless of age. This does not mean viewing children and adolescents as rational and autonomous decision-makers. This implies that we must promote their developmentally appropriate participation in shared decision-making with parents and physicians. Therefore, instead of asking, "should children and adolescents be granted absolute autonomy in decision making?" we ought to ask, "should we treat children and adolescents like people?" Copyright (c) 2010 Elsevier Masson SAS. All rights reserved.

  16. Children's views on research without prior consent in emergency situations: a UK qualitative study.

    Science.gov (United States)

    Roper, Louise; Sherratt, Frances C; Young, Bridget; McNamara, Paul; Dawson, Angus; Appleton, Richard; Crawley, Esther; Frith, Lucy; Gamble, Carrol; Woolfall, Kerry

    2018-06-09

    We explored children's views on research without prior consent (RWPC) and sought to identify ways of involving children in research discussions. Qualitative interview study. Participants were recruited through a UK children's hospital and online advertising. 16 children aged 7-15 years with a diagnosis of asthma (n=14) or anaphylaxis (n=2) with recent (<12 months) experience of emergency care. Children were keen to be included in medical research and viewed RWPC as acceptable in emergency situations if trial interventions were judged safe. Children trusted that doctors would know about their trial participation and act in their best interests. All felt that children should be informed about the research following their recovery and involved in discussions with a clinician or their parent(s) about the use of data already collected as well as continued participation in the trial (if applicable). Participants suggested methods to inform children about their trial participation including an animation. Children supported, and were keen to be involved in, clinical trials in emergency situations. We present guidance and an animation that practitioners and parents might use to involve children in trial discussions following their recovery. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  17. IMPLEMENTASI PERSETUJUAN TINDAKAN KEDOKTERAN (INFORMED CONSENT DALAM PERJANJIAN TERAPEUTIK OLEH TENAGA KESEHATAN TERHADAP PASIEN RUMAH SAKIT DI PROVINSI BALI

    Directory of Open Access Journals (Sweden)

    Ida Ayu Sri Kusuma Wardhani

    2014-03-01

    Full Text Available Health is the most important part of human life that can affect productivity and optimal human activity. When a person's health is compromised, then that person will seek treatment in health care facilities in the hospital one of them in order to get action. Measures of medicine containing the high risk should get written consent from patient/family called Informed Consent. The legal relationship between health professionals with patients occurs because of the agreement that causes the therapeutic relationship inspaningverbintenis law (treaty effort. Similarly in the Bali Provincial Hospital in any medical act especially those containing a high risk, which is done by some health professionals are also using the Informed Consent. But if there is negligence actions that cause harm, who will be responsible for the risks in the suffering patient / family? and how the efforts of patient / family to resolve medical disputes against the risk of Informed Consent? The method used in this research is an empirical law derived from primary data and secondary data. The nature of the study is descriptive, with qualitative data analysis. Overall the results of these analyzes are presented in the description which describes the complete problem under study, along with a critical discussion. Based on the Theory of Legal System of L. M. Friedman, legal systems theory described by Soerjono Soekanto be legal efficacy theory, the theory of Hans Kelsen responsibility, and legislation as well as the results of research in the field, it is known that the liability of health professionals based on Informed Consent Agreement Therapeutic Hospital in Bali province is on the doctor who signed the operator of the informed consent form. However, if the patient / family prosecute acts of negligence committed by health professionals, the hospital will be responsible jointly and severally against such negligence. From the result of  research in the hospital in the province of

  18. Lowering the Age of Consent: Pushing Back against the Anti-Vaccine Movement.

    Science.gov (United States)

    Whelan, Allison M

    2016-09-01

    This article examines the rise of the anti-vaccination movement, the proliferation of laws allowing parental exemptions to mandatory school vaccines, and the impact of the movement on immunization rates for all vaccines. It uses the ongoing debate about the Human Papillomavirus (HPV) vaccine as an example to highlight the ripple effect and consequences of the anti-vaccine movement despite robust evidence of the vaccine's safety and efficacy. The article scrutinizes how state legislatures ironically promote vaccination while simultaneously deferring to the opposition by promulgating broad opt-outs from mandatory vaccine laws. This article concludes by offering an alternative legislative approach to specifically combat the anti-vaccine movement's impact on HPV vaccination rates. Lowering the age of consent has not been widely attempted or proposed and provides an alternative statutory mechanism to push back against vaccine resistance. © 2016 American Society of Law, Medicine & Ethics.

  19. No Understanding, No Consent: The Case Against Alternative Medicine.

    Science.gov (United States)

    Shahvisi, Arianne

    2016-02-01

    The demand for informed consent in clinical medicine is usually justified on the basis that it promotes patient autonomy. In this article I argue that the most effective way to promote autonomy is to improve patient understanding in order to reduce the epistemic disparity between patient and medical professional. Informed consent therefore derives its moral value from its capacity to reduce inequalities of power as they derive from epistemic inequalities. So in order for a patient to have given informed consent, she must understand the treatment. I take this to mean that she has sufficient knowledge of its causal mechanisms and has accepted the explanations in which the treatment is implicated. If this interpretation of informed consent is correct, it is unethical for medical professionals to offer or endorse 'alternative medicine' treatments, for which there is no known causal mechanism, for if they do, they may end up widening the epistemic disparity. In this way, informed consent may be understood as an effective way of ruling out particular treatments in order to improve patient autonomy and maintain trust in the medical profession. © 2016 John Wiley & Sons Ltd.

  20. Informed consent for and regulation of critical care research.

    Science.gov (United States)

    Lemaire, François

    2008-12-01

    Critical care is a special area in which research needs to take place, because of the severity of the diseases which are treated there, but it is also a place where research faces a lot of hurdles and difficulties. The main cause of difficulties is the consent issue, as most patients cannot consent for themselves. Recently, all national legislations in the countries of the European Union have been modified to include the provisions of directive 2001/20. This review article provides a summary of the recent literature concerning the issue of consent for clinical care research such as how the surrogate consent reflects the view of the patient and how time consuming and inaccurate can be the consultation of a community before the start of a trial with a waiver of consent. Another hurdle to research is the rigidity of our legislations concerning clinical research, especially the absence of a simplified way for low or no-risk research. This article shows how this situation is potentially deleterious and how it could ultimately forbid low-risk research. Critical research remains a domain in which research on patients is difficult and controversial. Regulation can be difficult to implement, largely inadequate or uselessly complicated. Intensive care physicians need to keep pressure on politicians and lawmakers to constantly explain the necessity and specificities of critical care research.

  1. Reliability and validity of the Chinese version of Weiss Functional Impairment Scale-Parent form for school age children%Weiss功能缺陷量表父母版的信效度

    Institute of Scientific and Technical Information of China (English)

    钱英; 杜巧新; 曲姗; 王玉凤

    2011-01-01

    Objective: To test the reliability and validity of Chinese version of the Weiss Functional Impairment Scale-Parent form (WFIRS-P) in China. Methods: Totally 123 outpatients who met the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for attention deficit hyperactivity disorder (ADHD) and 240 normal children were recruited in this study. The parents of the subjects completed the WFIRS-P. At the same time, the parents of 39 outpatients comleted the ADHD Rating Scale-IV (ADHD RS-IV) and Behavior Rating Inventory of Executive Function (BRIEF) and doctors who made diagnosis for these 39 outpatients filled in the Global Assessment Function (GAF) to test the criteria validity. One or two weeks later, the parents of 29 outpatients were required to complete the WFIRS-P again to test the test-retest reliability. Results: The test-retest reliability were 0. 61 - 0. 87 and the Cronbach a coefficients were 0. 70 - 0. 92. Subscale scores of WFIRS-P were significantly correlated with scores of ADHD RS-IV (r = 0. 32 - 0. 50, P < 0. 05), BRIEF (r = 0. 23 -0. 71, P < 0. 05) and GAF (r = - 0. 29 - - 0. 59, P < 0. 05). Lisrel Confirmatory factor analysis showed the 5 -subscale model of BRIEF was reasonable (CFI = 0. 97 for control group, 0. 89 for ADHD group, RMSEA < 0. 08). Compared with control group, the ADHD group got significant higher scores in all subscales of WFIRS-P respectively (Ps < 0. 01) . Conclusion: The Chinese version of the Weiss Functional Impairment Scale-Parent form WFIRS-P have adequate reliability and validity.%目的:评价Weiss功能缺陷量表父母版(WFIRS-P)中文版的信效度.方法:选取符合美国精神障碍诊断与统计手册第四版(DSM-Ⅳ)注意缺陷多动障碍(ADHD)诊断标准的门诊患者123名及正常儿童240名,同时请病例组中39名儿童父母填写执行功能行为评定量表父母版(BRIEF)和ADHD评定量表-Ⅳ(ADHD RS-Ⅳ),并请进行诊断的医师对这39名患

  2. From genetic privacy to open consent.

    NARCIS (Netherlands)

    Lunshof, J.; Chadwick, R.; Vorhaus, D.B.; Church, G.M.

    2008-01-01

    Recent advances in high-throughput genomic technologies are showing concrete results in the form of an increasing number of genome-wide association studies and in the publication of comprehensive individual genome-phenome data sets. As a consequence of this flood of information the established

  3. Engaging Urban Parents of Early Adolescents in Parenting Interventions: Home Visits vs. Group Sessions.

    Science.gov (United States)

    Finigan-Carr, Nadine M; Copeland-Linder, Nikeea; Haynie, Denise L; Cheng, Tina L

    2014-01-01

    Interventions targeting parents of young children have shown effectiveness, but research is lacking about best practices for engaging parents of early adolescents. Low levels of enrollment and attendance in parenting interventions present major problems for researchers and clinicians. Effective and efficient ways to engage and collaborate with parents to strengthen parenting practices and to promote healthy development of early adolescents are needed. This exploratory mixed methods study examined the feasibility of three methods of engaging parents in positive parenting activities. Participants were parents of youth ages 11-13 enrolled in three urban, public middle schools in neighborhoods characterized by high rates of community violence. Families ( N = 144) were randomized into one of three interventions: six home sessions, two home sessions followed by four group sessions, or six group sessions. The majority of parents were single, non-Hispanic, African American mothers. Urban parents of middle school students were more likely to participate in home visits than in group sessions; offering a combination did not increase participation in the group sessions. As only 34% of those who consented participated in the intervention, qualitative data were examined to explain the reasons for non-participation.

  4. Consent, competence, and confidentiality related to psychiatric conditions in adolescent medicine practice.

    Science.gov (United States)

    Campbell, Amy T

    2006-02-01

    Health care for adolescents with psychiatric conditions plays out on a complex stage with considerable state variation, based on a mix of statutory and case law. Added to this are less defined factors such as level of trust in community providers, level of cooperation between generalists and specialists, and local regulatory stances toward adolescent health care and mental health care. And, of course, there is the great diversity in diagnosis and maturity level, as well as family cohesion, from patient to patient (and even within a given patient across time). Finally, this situation resides within a larger environment of stigma vis-a-vis mental health care, most notably evident in the United States in disparate insurance coverage of mental versus physical health treatment. With so complex and varied a picture, clinicians should consult with legal counsel to understand applicable state law and local regulatory guidance (if any)and should also seek out ethical consultation when law does not apply or is not decisive, leaving ongoing concerns. And, as with clinical decision-making, in law and ethics "facts matter" [4]. A growing body of law carves out exceptions to general requirements for parental consent, including in mental health care. Ethically informed discussion around capacity determinations, the consent process, and confidentiality can help engage adolescents as "emerging adults"while remaining mindful of risky behavior and "immediate future" orientation that can be hallmarks of adolescence [30]. Respect for the adolescent, parental responsibility toward their child's best interests, and the family unit generally are paramount. Respect--coupled with caution, greater disclosure and cultural sensitivity, and a participatory approach to decision-making that seeks out the least restrictive and coercive options-can help avoid potential legal traps. How best to proceed? It truly depends-with law and ethics the start (not end) of the discussion and analysis.

  5. Parental supervision and discomfort with children walking to school in low-income communities in Cape Town, South Africa.

    Science.gov (United States)

    Simons, Abigail; Koekemoer, Karin; Niekerk, Ashley van; Govender, Rajen

    2018-05-19

    The risk of pedestrian injury is compounded for children living in low-income communities due to factors such as poor road and pedestrian infrastructure, reliance on walking as a means of transport, and compromised supervision. Parents play an important role in child pedestrian safety. The primary objective of this study was to examine the effects of child pedestrian variables on parental discomfort with regard to letting their child walk to and from school and on the frequency of adult supervision. A cross-sectional study was conducted using a convenience sample from 3 schools participating in a pedestrian safety school initiative. The schools are situated in low-income, high-risk communities in the City of Cape Town. A parent survey form was translated into isiXhosa and sent home with learners to those parents who had consented to participate. The response rate was 70.4%, and only parents of children who walk to and from school were included in the final sample (n = 359). Child pedestrian variables include the time taken to walk to school, parental rating of the child's ability to safely cross the road, and the frequency of adult supervision. More than half of parents reported that their child walked to and from school without adult supervision. About 56% of children took less than 20 min to walk to school. Most parents (61%) were uncomfortable with their child walking to school, although the majority of parents (55.7%) rated their child's ability to cross the road safely as better or significantly better than average (compared to peers). The parents did not perceive any differences in pedestrian risk factors between boys and girls or between younger (6-9 years) and older (10-15 years) children. The time spent by a child walking to school and parents' perceptions of their child's road-crossing ability were found to be significant predictors of parental discomfort (in letting their child walk). Younger children and children who spent less time walking were more

  6. [Parenting styles].

    Science.gov (United States)

    Torío López, Susana; Peña Calvo, José Vicente; Inda Caro, Mercedes

    2008-02-01

    Parental educational styles constitute one of the key elements of family socialization. The aim of the present essay is to present the results of a research project carried out in the Principality of Asturias (Spain) among 2,965 families with children of infant and primary-school age (5-8 years old). This research attempts to analyse, among other aspects, parental behaviour tendencies in child upbringing. The analysis of the results obtained allows us to: 1) identify the most common attitudinal and behavioural tendencies of parents in the upbringing of their children; 2) determine how many people have a well defined parental style, and delimit their socio-educational characteristics. Lastly, we consider the need to change some parental behaviour patterns and stress the importance of family education programmes, with the aim of promoting appropriate parenting models and modifying or improving current practices.

  7. Adoptive parenting.

    Science.gov (United States)

    Grotevant, Harold D; Lo, Albert Yh

    2017-06-01

    Challenges in adoptive parenting continue to emerge as adoption policies and practices evolve. We review three areas of research in adoptive parenting that reflect contemporary shifts in adoption. First, we highlight recent findings concerning openness in adoption contact arrangements, or contact between a child's families of birth and rearing. Second, we examine research regarding racial and cultural socialization in transracial and international adoptions. Finally, we review investigations of parenting experiences of lesbian and gay adoptive parents. Overall, parenting processes (e.g., supportive vs. problematic family interaction) are better predictors of child adjustment than are group differences (e.g., open vs. closed adoptions; adoption by heterosexual vs. same-sex parents). The distinctive needs of adopted children call for preparation of adoption-competent mental health, casework, education, and health care professionals. Copyright © 2017 Elsevier Ltd. All rights reserved.

  8. Use of altered informed consent in pragmatic clinical research.

    Science.gov (United States)

    McKinney, Ross E; Beskow, Laura M; Ford, Daniel E; Lantos, John D; McCall, Jonathan; Patrick-Lake, Bray; Pletcher, Mark J; Rath, Brian; Schmidt, Hollie; Weinfurt, Kevin

    2015-10-01

    There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to institutional review boards as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients' rights and interests. © The Author(s) 2015.

  9. Body integrity identity disorder beyond amputation: consent and liberty.

    Science.gov (United States)

    White, Amy

    2014-09-01

    In this article, I argue that persons suffering from Body Integrity Identity Disorder (BIID) can give informed consent to surgical measures designed to treat this disorder. This is true even if the surgery seems radical or irrational to most people. The decision to have surgery made by a BIID patient is not necessarily coerced, incompetent or uninformed. If surgery for BIID is offered, there should certainly be a screening process in place to insure informed consent. It is beyond the scope of this work, however, to define all the conditions that should be placed on the availability of surgery. However, I argue, given the similarities between BIID and gender dysphoria and the success of such gatekeeping measures for the surgical treatment of gender dysphoria, it is reasonable that similar conditions be in place for BIID. Once other treatment options are tried and gatekeeping measures satisfied, A BIID patient can give informed consent to radical surgery.

  10. Negligence in securing informed consent and medical malpractice.

    Science.gov (United States)

    Perry, C

    1988-01-01

    The doctrine of informed consent requires that the patient must act voluntarily and in the light of adequate information in order to give legally valid consent to medical care. Different models have been developed by various courts to determine whether the informational requirement, what the physician must disclose to the patient about the potential risks of the proposed treatment, has been met under the tort theory of negligence. To prevail, the patient plaintiff must show that a particular jurisdiction's disclosure standard has been breached, that harm has resulted, and that the defendant physician's negligent failure to discuss certain risks was causally responsible for the patient's failure to withhold consent. Perry discusses possible problems of redundancy or inconsistency concerning the relationship between different models for disclosure and causality, and notes that these problems may have serious implications for patient autonomy.

  11. Disclosure of information and informed consent: ethical and practical considerations.

    Science.gov (United States)

    Steinberg, Avraham

    2009-12-01

    Disclosure of information and informed consent are relatively new concepts in the patient-physician relationship. They are based primarily on the principle of autonomy and they have many favorable practical advantages. However, the practical implementation of these requirements is fraught with difficulties, some of which can cause harm to the patient or be obstacles in fulfilling the moral obligation of beneficence. This is particularly true when disclosure of information and informed consent are done by physicians in a defensive way for fear of malpractice suits. The most ethically defensible approach is to tailor and navigate the information according to the needs and desires of each individual patient in a sensitive and empathic manner. The informed consent should be a process of mutually shared responsibility by the patient and the physician, ensuring adequate and relevant information that is well comprehended by the individual patient, and is used correctly for his or her decision making.

  12. Patient and public attitudes towards informed consent models and levels of awareness of Electronic Health Records in the UK

    Science.gov (United States)

    Riordan, Fiona; Papoutsi, Chrysanthi; Reed, Julie E.; Marston, Cicely; Bell, Derek; Majeed, Azeem

    2015-01-01

    Background The development of Electronic Health Records (EHRs) forms an integral part of the information strategy for the National Health Service (NHS) in the UK, with the aim of facilitating health information exchange for patient care and secondary use, including research and healthcare planning. Implementing EHR systems requires an understanding of patient expectations for consent mechanisms and consideration of public awareness towards information sharing as might be made possible through integrated EHRs across primary and secondary health providers. Objectives To explore levels of public awareness about EHRs and to examine attitudes towards different consent models with respect to sharing identifiable and de-identified records for healthcare provision, research and planning. Methods A cross-sectional questionnaire survey was administered to adult patients and members of the public in primary and secondary care clinics in West London, UK in 2011. In total, 5331 individuals participated in the survey, and 3157 were included in the final analysis. Results The majority (91%) of respondents expected to be explicitly asked for consent for their identifiable records to be accessed for health provision, research or planning. Half the respondents (49%) did not expect to be asked for consent before their de-identified records were accessed. Compared with White British respondents, those from all other ethnic groups were more likely to anticipate their permission would be obtained before their de-identified records were used. Of the study population, 59% reported already being aware of EHRs before the survey. Older respondents and individuals with complex patterns of interaction with healthcare services were more likely to report prior awareness of EHRs. Individuals self-identifying as belonging to ethnic groups other than White British, and those with lower educational qualifications were less likely to report being aware of EHRs than White British respondents and

  13. Relational autonomy in informed consent (RAIC) as an ethics of care approach to the concept of informed consent.

    Science.gov (United States)

    Osuji, Peter I

    2018-03-01

    The perspectives of the dominant Western ethical theories, have dominated the concepts of autonomy and informed consent for many years. Recently this dominant understanding has been challenged by ethics of care which, although, also emanates from the West presents a more nuanced concept: relational autonomy, which is more faithful to our human experience. By paying particular attention to relational autonomy, particularity and Process approach to ethical deliberations in ethics of care, this paper seeks to construct a concept of informed consent from the perspective of ethics of care which is here called relational autonomy-in-informed consent (RAIC). Thus, providing a broader theoretical basis for informed consent beyond the usual theoretical perspectives that are particularly Western. Care ethics provides such a broader basis because it appeals to a global perspective that encompasses lessons from other cultures, and this will help to enrich the current ideas of bioethics principles of autonomy and informed consent. This objective will be achieved by exploring the ethics of care emphasis on relationships based on a universal experience of caring; and by contrasting its concept of autonomy as relational with the understanding of autonomy in the approaches of the dominant moral theories that reflect rational, individualistic, and rights-oriented autonomy of the American liberalism.

  14. Parental Bonding

    Directory of Open Access Journals (Sweden)

    T. Paul de Cock

    2014-08-01

    Full Text Available Estimating the early parent–child bonding relationship can be valuable in research and practice. Retrospective dimensional measures of parental bonding provide a means for assessing the experience of the early parent–child relationship. However, combinations of dimensional scores may provide information that is not readily captured with a dimensional approach. This study was designed to assess the presence of homogeneous groups in the population with similar profiles on parental bonding dimensions. Using a short version of the Parental Bonding Instrument (PBI, three parental bonding dimensions (care, authoritarianism, and overprotection were used to assess the presence of unobserved groups in the population using latent profile analysis. The class solutions were regressed on 23 covariates (demographics, parental psychopathology, loss events, and childhood contextual factors to assess the validity of the class solution. The results indicated four distinct profiles of parental bonding for fathers as well as mothers. Parental bonding profiles were significantly associated with a broad range of covariates. This person-centered approach to parental bonding has broad utility in future research which takes into account the effect of parent–child bonding, especially with regard to “affectionless control” style parenting.

  15. Time to Improve Informed Consent for Dialysis: An International Perspective.

    Science.gov (United States)

    Brennan, Frank; Stewart, Cameron; Burgess, Hannah; Davison, Sara N; Moss, Alvin H; Murtagh, Fliss E M; Germain, Michael; Tranter, Shelley; Brown, Mark

    2017-06-07

    The literature reveals that current nephrology practice in obtaining informed consent for dialysis falls short of ethical and legal requirements. Meeting these requirements represents a significant challenge, especially because the benefits and risks of dialysis have shifted significantly with the growing number of older, comorbid patients. The importance of informed consent for dialysis is heightened by several concerns, including: ( 1 ) the proportion of predialysis patients and patients on dialysis who lack capacity in decision making and ( 2 ) whether older, comorbid, and frail patients understand their poor prognosis and the full implications to their independence and functional status of being on dialysis. This article outlines the ethical and legal requirements for a valid informed consent to dialysis: ( 1 ) the patient was competent, ( 2 ) the consent was made voluntarily, and ( 3 ) the patient was given sufficient information in an understandable manner to make the decision. It then considers the application of these requirements to practice across different countries. In the process of informed consent, the law requires a discussion by the physician of the material risks associated with dialysis and alternative options. We argue that, legally and ethically, this discussion should include both the anticipated trajectory of the illness and the effect on the life of the patient with particular regard to the outcomes most important to the individual. In addition, a discussion should occur about the option of a conservative, nondialysis pathway. These requirements ensure that the ethical principle of respect for patient autonomy is honored in the context of dialysis. Nephrologists need to be open to, comfortable with, and skillful in communicating this information. From these clear, open, ethically, and legally valid consent discussions, a significant dividend will hopefully flow for patients, families, and nephrologists alike. Copyright © 2017 by the

  16. Improving participant comprehension in the informed consent process.

    Science.gov (United States)

    Cohn, Elizabeth; Larson, Elaine

    2007-01-01

    To critically analyze studies published within the past decade about participants' comprehension of informed consent in clinical research and to identify promising intervention strategies. Integrative review of literature. The Cumulative Index of Nursing and Allied Health Literature (CINAHL), PubMed, and the Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials were searched. Inclusion criteria included studies (a) published between January 1, 1996 and January 1, 2007, (b) designed as descriptive or interventional studies of comprehension of informed consent for clinical research, (c) conducted in nonpsychiatric adult populations who were either patients or volunteer participants, (d) written in English, and (e) published in peer-reviewed journals. Of the 980 studies identified, 319 abstracts were screened, 154 studies were reviewed, and 23 met the inclusion criteria. Thirteen studies (57%) were descriptive, and 10 (43%) were interventional. Interventions tested included simplified written consent documents, multimedia approaches, and the use of a trained professional (consent educator) to assist in the consent process. Collectively, no single intervention strategy was consistently associated with improved comprehension. Studies also varied in regard to the definition of comprehension and the tools used to measure it. Despite increasing regulatory scrutiny, deficiencies still exist in participant comprehension of the research in which they participate, as well as differences in how comprehension is measured and assessed. No single intervention was identified as consistently successful for improving participant comprehension, and results indicated that any successful consent process should at a minimum include various communication modes and is likely to require one-to-one interaction with someone knowledgeable about the study.

  17. Do parents of adolescents request the same universal parental support as parents of younger children? A random sample of Swedish parents.

    Science.gov (United States)

    Thorslund, Karin; Johansson Hanse, Jan; Axberg, Ulf

    2017-07-01

    Universal parental support intended to enhance parents' capacity for parenting is an important aspect of public health strategies. However, support has mostly been aimed at parents, especially mothers, of younger children. There is a gap in the research concerning parents of adolescents and fathers' interest in parenting support. To investigate and compare the interest in parenting support of parents of adolescents and younger children, potential differences between mothers and fathers, and their knowledge of what is being offered to them already, and to explore their requirements for future universal parental support. Telephone interviews were conducted with a random sample of 1336 parents. Quantitative methods were used to analyze differences between groups and qualitative methods were used to analyze open-ended questions in regard to parents' requirements for future universal parental support. About 82% of the parents of adolescents interviewed think that offering universal parental support is most important during child's adolescence. There is a substantial interest, particularly among mothers, in most forms of support. Despite their interest, parents have limited awareness of the support available. Only 7% knew about the local municipality website, although 70% reported a possible interest in such a website. Similarly, 3% knew that a parent phone line was available to them, while 59% reported a possible interest. It poses a challenge but is nevertheless important for municipalities to develop support targeted at parents of adolescents which is tailored to their needs, and to reach out with information.

  18. Sources of patient uncertainty when reviewing medical disclosure and consent documentation.

    Science.gov (United States)

    Donovan-Kicken, Erin; Mackert, Michael; Guinn, Trey D; Tollison, Andrew C; Breckinridge, Barbara

    2013-02-01

    Despite evidence that medical disclosure and consent forms are ineffective at communicating the risks and hazards of treatment and diagnostic procedures, little is known about exactly why they are difficult for patients to understand. The objective of this research was to examine what features of the forms increase people's uncertainty. Interviews were conducted with 254 individuals. After reading a sample consent form, participants described what they found confusing in the document. With uncertainty management as a theoretical framework, interview responses were analyzed for prominent themes. Four distinct sources of uncertainty emerged from participants' responses: (a) language, (b) risks and hazards, (c) the nature of the procedure, and (d) document composition and format. Findings indicate the value of simplifying medico-legal jargon, signposting definitions of terms, removing language that addresses multiple readers simultaneously, reorganizing bulleted lists of risks, and adding section breaks or negative space. These findings offer suggestions for providing more straightforward details about risks and hazards to patients, not necessarily through greater amounts of information but rather through more clear and sufficient material and better formatting. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  19. 75 FR 6671 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2010-02-10

    ... programs implemented a new consent form. This form asked participants for permission for CDC to contact...] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention... prevention behaviors, CDC will conduct telephone interviews of 425 Matter of Balance program participants six...

  20. PARENTING AND ITS INFLUENCE ON CHILD BEHAVIOUR

    Directory of Open Access Journals (Sweden)

    Jiji Mary Antony

    2017-12-01

    Full Text Available BACKGROUND Parenting is the process of giving care to the young and preparing them to face the challenges of life. Diana Baumrind introduced the models of parenting, authoritative, authoritarian and permissive depending on the level of demandingness and responsiveness. Defective parenting is associated with problem behaviours in children. This study was undertaken to find out which parenting style is least associated with behavioural problems and what are the problems associated with the different parenting style. MATERIALS AND METHODS 46 children who were admitted with minor illness at the institute of Child Health, Kottayam from January 2017 to Oct 2017 were enrolled after getting informed consent and IRB clearance. Purposive sampling method were used for the study. Demographic data was entered into a proforma. The PSDQ and CBCL 1½ -5 questionnaire was given to mothers to assess the parenting style and behavioural problems in their children. Data was analysed with statistical tests. The t test, one way ANOVA, Pearson correlation coefficient and regression analyses were used for the analyses. RESULTS The parenting styles of the mothers and the behavioural problems seen in their children were studied in this research. There was no significant difference in behavioural problems between the different age group studied and there was no difference in problem behaviours between male children and female children. Authoritative parenting style was least associated with problem behaviour. Authoritarian parenting style is associated with internalizing problems and permissive parenting is associated with externalizing problems. CONCLUSION Since the behaviour problems tends to linger through adolescence and adulthood, parental education regarding the positive parenting style and interventions can be given from early childhood during routine child care and structured programs.