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Sample records for spousal consent form

  1. 5 CFR 831.618 - Waiver of spousal consent requirement.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Waiver of spousal consent requirement. 831.618 Section 831.618 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL... locate the spouse; and (ii) Documentary corroboration such as tax returns filed separately or newspaper...

  2. 5 CFR 842.607 - Waiver of spousal consent requirement.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Waiver of spousal consent requirement. 842.607 Section 842.607 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL... locate the spouse; and (ii) Documentary corroboration such as tax returns filed separately or newspaper...

  3. 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.

  4. 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.

  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. 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.

  7. 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...

  8. 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.

  9. 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...

  10. 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.

  11. 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

  12. 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...

  13. 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.

  14. 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.

  15. 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.

  16. 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

  17. 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

  18. 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.

  19. 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%.

  20. 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.

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. [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.

  8. 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

  9. 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.

  10. 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

  11. 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

  12. 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.

  13. 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...

  14. 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...

  15. 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

  16. 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.

  17. 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.

  18. Sex differences in depressive effects of experiencing spousal bereavement.

    Science.gov (United States)

    Lee, Hyo Jung; Lee, Sang Gyu; Chun, Sung-Youn; Park, Eun-Cheol

    2017-02-01

    Spousal death is a significant event that becomes a turning point in an individual's life. Widowed persons experience new circumstances, which might induce depression. However, the effects of spousal death on depression can differ by sex and culture. Thus, the present study examined the association between depressive levels and experience of spousal death in Korean adults aged older than 45 years. The data were from the Korean Longitudinal Study of Aging from 2010 to 2012. The analysis used frequency analysis to compare the distribution of demographic variables between men and women, and anova to compare 10-item short-form Center for Epidemiological Studies Depression Scale scores as the dependent variable among comparison groups. We also carried out linear mixed model analysis on the association between the 10-item short-form Center for Epidemiological Studies Depression Scale and experience of spousal death. Among 5481 respondents, 2735 were men and 2741 were women. The number of men and women who experienced spousal death were 43 (1.6%) and 181 (6.6%), respectively. Men had lower depressive levels than women when they had been married (men 2.99, women 3.64). Both men and women experiencing spousal death had significantly higher 10-item short-form Center for Epidemiological Studies Depression Scale scores than married men and women (men β = 0.911, P = 0.003; women β = 0.512, P = 0.001; ref: no experience of spousal death). There was a significant association between experience of spousal death and depressive level for both men and women. We suggest that policy practitioners promote community programs that provide bereaved adults with easy access to meaningful social participation and support the minimum cost of living of the widowed. Geriatr Gerontol Int 2017; 17: 322-329. © 2016 Japan Geriatrics Society.

  19. 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.

  20. 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.

  1. [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.

  2. 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...

  3. 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

  4. Marriage Matters: Spousal Similarity in Life Satisfaction

    OpenAIRE

    Ulrich Schimmack; Richard Lucas

    2006-01-01

    Examined the concurrent and cross-lagged spousal similarity in life satisfaction over a 21-year period. Analyses were based on married couples (N = 847) in the German Socio-Economic Panel (SOEP). Concurrent spousal similarity was considerably higher than one-year retest similarity, revealing spousal similarity in the variable component of life satisfac-tion. Spousal similarity systematically decreased with length of retest interval, revealing simi-larity in the changing component of life sati...

  5. 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...

  6. 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…

  7. 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.

  8. 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.

  9. 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

  10. 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.

  11. 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...

  12. 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.

  13. Spousal violence and pregnancy termination among married ...

    African Journals Online (AJOL)

    2013-08-25

    spousal sexual violence, and 19% had experienced spou- sal emotional violence7. ... ment of women's fundamental human rights and sexual ..... Gender Issues and National Response to HIV/AIDS in Nigeria. ... tation.pdf , August 25, 2013. 16.

  14. Spousal rape: A challenge for pastoral counsellors

    OpenAIRE

    James A. Glanville; Yolanda Dreyer

    2013-01-01

    This article reflects on the criticism regarding the pastoral counsellor’s dealings with spousal rape victims. It argues that counsellors should be sensitive not to be biased, either personally or theologically, and should have an understanding of the biopsychosocial (biological, psychological and social) impact of spousal rape, such as rape-related post-traumatic stress and other related illnesses such as depression, victimisation and stigmatisation. The pastoral counsellors should be awar...

  15. 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.

  16. Spousal communication about HIV prevention in Kenya.

    Science.gov (United States)

    Chiao, Chi; Mishra, Vinod; Ksobiech, Kate

    2011-11-01

    High HIV rates among cohabiting couples in many African countries have led to greater programmatic emphasis on spousal communication in HIV prevention. This study examines how demographic and socioeconomic characteristics of cohabiting adults influence their dyadic communication about HIV. A central focus of this research is on how the position of women relative to their male partners influences spousal communication about HIV prevention. The authors analyze gaps in spousal age and education and females' participation in household decision making as key factors influencing spousal communication about HIV, while controlling for sexual behaviors of both partners as well as other individual and contextual factors. Data were obtained from the 2003 Kenya Demographic and Health Survey for 1,388 cohabiting couples. Information regarding spousal communication was self-reported, assessing whether both, either, or neither partner ever discussed HIV prevention with the other. Analyses showed higher levels of education for the female partner and participation in household decision making are positively associated with spousal communication about HIV prevention. With females' education and other factors controlled, couples with more educated male partners were more likely to have discussed HIV prevention than couples in which both partners have the same level of education. Spousal communication was also positively associated with household wealth status and exposure to the mass media, but couples in which male partners reported having nonspousal sex in the past year were less likely to have discussed HIV prevention with their spouses. Findings suggest HIV prevention programs should promote female empowerment and encourage male participation in sexual health discussion.

  17. Spousal Religiosity, Religious Bonding, and Pornography Consumption.

    Science.gov (United States)

    Perry, Samuel L

    2017-02-01

    Religiosity and pornography use are often closely connected. Relatively few studies, however, have examined how this religion-pornography connection plays out within the context of committed romantic relationships. Moreover, virtually all studies of religion and pornography use conceptualize religiosity as a quality intrinsic to the person that typically reduces pornography viewing. Focusing on married Americans, this study shifted the focus to consider whether the religiosity of one's spouse relates to one's own pornography viewing and under what circumstances. Analyses of the nationally representative Portraits of American Life Study (N = 1026) revealed that spousal religiosity was strongly and negatively related to participants viewing pornography, controlling for participants' own religious or sociodemographic characteristics or sexual satisfaction. This relationship held whether spousal religiosity was measured with participants' evaluations of their spouses' religiosity or spouses' self-reported religiosity. The association between spousal religiosity and pornography use was also moderated by participants' religious service attendance, gender, and age. Considering mechanisms, the association between spousal religiosity and pornography use was mediated by frequent participation in religious bonding activities as a couple, suggesting that spousal religiosity may decrease pornography viewing among married Americans by promoting greater religious intimacy and unity between the couple, consequently decreasing one's interest or opportunities to view pornography.

  18. Partner dependency and intimate partner abuse: A sociocultural grounding of spousal abuse in Ghana

    DEFF Research Database (Denmark)

    Adjei, Stephen Baffour

    2015-01-01

    While sociocultural scholarship has attempted an ecological explanation of intimate partner violence, it has largely been criticized for ignoring dispositional factors of both perpetrators and victims. Dependent personality and attachment-related emotional problems have been implicated in the ext......While sociocultural scholarship has attempted an ecological explanation of intimate partner violence, it has largely been criticized for ignoring dispositional factors of both perpetrators and victims. Dependent personality and attachment-related emotional problems have been implicated...... of dependency and attachment-related spousal violence as a form of a psychopathology. This article discusses partner dependency and jealousy-motivated spousal violence as socioculturally situated, dependent on contextual and relational conditions of meaning embedded in the communal society of Ghana....... It highlights Ghanaian communal personality, gendered socialization and meaning systems of marriage as salient sociocultural features for conceptualizing partner dependency and emotional-related spousal violence....

  19. [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.

  20. A study of spousal domestic violence in an urban slum of Mumbai

    Directory of Open Access Journals (Sweden)

    Prateek S Shrivastava

    2013-01-01

    Results: The proportion of domestic violence was 36.9%. The most common form of violence was verbal in 87 (86.1% followed by physical in 64 (63.4%. Conclusion: A significant association was found between domestic violence and age, education, spousal alcoholism, and duration of marriage.

  1. Influence of alcohol on condom use pattern during non-spousal sexual encounter in male migrant workers in north India.

    Science.gov (United States)

    Rizwan, S A; Kant, S; Goswami, K; Rai, S K; Misra, P

    2014-01-01

    Migrant workers constitute an important risk group for Human Immunodeficiency Virus/Acquired Immuno-Deficiency Syndrome transmission in India. Alcohol consumption before sexual intercourse has been postulated to influence condom use practices. This study aimed to assess this association with regard to non-spousal sexual encounters among male migrant workers in northern India. A cross-sectional facility-based survey was conducted in 2011. Male migrant workers aged ≥18 years, who were born outside Haryana, who had moved to the current location after 15 years of age,had worked in the current factory for at least 1 year, who were willing to participate and were able to give written, informed consent were included in the study. A consecutive sampling was performed. Descriptive, bivariate and multiple logistic regression analyses were carried out. A total of 162 participants reported having experienced non-spousal sexual encounters in the last 1 year. The proportion of men who reported not having used a condom at their last non-spousal sexual encounter was 59.3%, and 78.4% of the men reported having consumed alcohol in the last 1 year. About 48.1% of men reported having consumed alcohol before their last non-spousal sexual encounter. Men who consumed alcohol were three times more likely to not use a condom at their last non-spousal sexual encounter (OR = 3.1, 95% CI: 1.5-6.4). This association persisted even after adjusting for relevant confounders. Alcohol consumption had a negative influence on condom use during non-spousal sexual encounter among male migrant workers. An integrated approach to promote condom use and reduce alcohol consumption among migrant men needs to be undertaken through targeted intervention strategies.

  2. Spousal rape: A challenge for pastoral counsellors

    Directory of Open Access Journals (Sweden)

    James A. Glanville

    2013-06-01

    Full Text Available This article reflects on the criticism regarding the pastoral counsellor’s dealings with spousal rape victims. It argues that counsellors should be sensitive not to be biased, either personally or theologically, and should have an understanding of the biopsychosocial (biological, psychological and social impact of spousal rape, such as rape-related post-traumatic stress and other related illnesses such as depression, victimisation and stigmatisation. The pastoral counsellors should be aware of the legal and medical ramifications of spousal rape and have knowledge of the correct referral resources and procedures (trusted professionals, shelters and support structures. They should be self-aware and understand the effect that gender or previous traumatic personal experiences may have on their reactions. The article consists of the following sections: the phenomenon ‘rape’; acquaintance rape; spousal rape; post-traumatic stress; post-traumatic stress disorder; rape trauma syndrome; cognitive behavioural therapy; spirituality; doctrinal matters; social system of patriarchy; a pastoral counselling model; self-care.

  3. Men's Knowledge and Spousal Communication about Modern ...

    African Journals Online (AJOL)

    Erah

    Men's Knowledge, Spousal Communication about Family Planning ... 1Department of Health Education and Promotion, Public Health Faculty, Jimma ... male involvement in reproductive health services 1. The ... are likely to be more effective for women when men are ..... more equitable gender roles; discussion between.

  4. Spousal rape: A challenge for pastoral counsellors

    Directory of Open Access Journals (Sweden)

    James A. Glanville

    2013-01-01

    Full Text Available This article reflects on the criticism regarding the pastoral counsellor’s dealings with spousal rape victims. It argues that counsellors should be sensitive not to be biased, either personally or theologically, and should have an understanding of the biopsychosocial (biological, psychological and social impact of spousal rape, such as rape-related post-traumatic stress and other related illnesses such as depression, victimisation and stigmatisation. The pastoral counsellors should be aware of the legal and medical ramifications of spousal rape and have knowledge of the correct referral resources and procedures (trusted professionals, shelters and support structures. They should be self-aware and understand the effect that gender or previous traumatic personal experiences may have on their reactions. The article consists of the following sections: the phenomenon ‘rape’; acquaintance rape; spousal rape; post-traumatic stress; post-traumatic stress disorder; rape trauma syndrome; cognitive behavioural therapy; spirituality; doctrinal matters; social system of patriarchy; a pastoral counselling model; self-care.

  5. Child marriage and its associations with controlling behaviors and spousal violence against adolescent and young women in Pakistan.

    Science.gov (United States)

    Nasrullah, Muazzam; Zakar, Rubeena; Zakar, Muhammad Zakria

    2014-12-01

    Child marriage (before 18 years) is widely prevalent in Pakistan, and disproportionately affects young girls in rural, low-income, and poorly educated households. Our study aims to determine the associations between child marriage and controlling behaviors (CB) and spousal violence by husbands against adolescent and young women in Pakistan beyond those attributed to social vulnerabilities. We analyzed data from the Pakistan Demographic and Health Survey, 2012-2013, of currently married women aged 15-24 years who had participated in the domestic violence module (n = 589, 22.5% [589/2,615] of the subsample aged 15-24 years) to identify differences in CB and spousal violence experiences between early (marriage. Associations between child marriage and CB and spousal violence by husband were assessed by calculating adjusted odds ratios (AOR) using logistic regression models after controlling for demographics, social equity indicators (education, wealth index, and rural residence), spousal age gap, and husband's education. Overall, 47.8% of currently married women aged 15-24 years in Pakistan were married before the age of 18 years. About one third of women aged 15-24 years in Pakistan reported experiencing CB (31.8%) and spousal violence (31.1%) by their husbands. Compared with adult marriage, child marriage was significantly associated with CB (AOR = 1.50; 95% confidence interval [CI], 1.042-2.157), any form of spousal violence (physical or emotional) (AOR = 2.03; 95% CI, 1.392-2.969), emotional violence (AOR = 1.86; 95% CI, 1.254-2.767), and physical violence (AOR = 2.44; 95% CI, 1.582-3.760), including severe physical violence (AOR = 2.57; 95% CI, 1.122-5.872). Effective interventions are needed to prevent child marriages and raise awareness about their negative consequences, with special reference to spousal violence. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  6. Predictors of Spousal Support for the Work Commitments of Husbands.

    Science.gov (United States)

    Pittman, Joe F.; Orthner, Dennis K.

    1988-01-01

    Examined antecedents of spousal support of husbands' work commitment from perspective of wives. Found spousal support influenced directly only by satisfaction with quality of life made possible by local work organization and length of involvement with organization. Marital and social adjustment, and perceptions of husband's work environment…

  7. Spousal Capital as a Resource for Couples Starting a Business

    Science.gov (United States)

    Matzek, Amanda E.; Gudmunson, Clinton G.; Danes, Sharon M.

    2010-01-01

    This longitudinal study finds that spousal capital is an important resource for entrepreneurs starting a business because it has implications for business sustainability and couple relationship quality. Structural equation modeling supported a process whereby gender had an impact on spousal involvement in the business, which was positively…

  8. 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

  9. 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

  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.

    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.

  11. Quality of Spousal Relationship on Procurement of Abortion in Peri ...

    African Journals Online (AJOL)

    AJRH Managing Editor

    Couples'-Communication and Abortion in Nigeria ... The quality of spousal relationship may influence the acceptance of the status of pregnancies and the decision to .... partner, parity, age-difference among couples, ..... Public health, 2009.

  12. Quality of Spousal Relationship on Procurement of Abortion in Peri ...

    African Journals Online (AJOL)

    Quality of Spousal Relationship on Procurement of Abortion in Peri-Urban Nigeria. ... Communication was the only dimension of relationship quality that showed significant association with history of induced ... AJOL African Journals Online.

  13. Barriers to spousal contribution to childbirth pain relief in Nigeria.

    Science.gov (United States)

    Emelonye, A U; Pitkäaho, T; Aregbesola, A; Vehviläinen-Julkunen, K

    2017-12-01

    The aim of this study was to investigate the barriers inhibiting the use of spousal presence for childbirth pain relief in health facilities and recommendations from three perspectives: the midwife, the woman, and the spouse. Spousal presence is a non-invasive, participatory and inexpensive technique used in pain management during childbirth. Although it contributes to a large extent in relieving childbirth pain, it is underutilized in Nigerian hospitals. Overcoming the challenges impeding spousal presence and participation during childbirth will improve maternal outcome, satisfaction and midwifery care practices. A cross-sectional survey conducted in four hospitals in Nigeria involving midwives (n = 100), women (n = 142) and their spouses (n = 142) from June to December 2014 using pretested questionnaires. Five themes were identified: poor infrastructural facility, lack of adequate pain management policy, lack of midwife pain management practices, midwives' attitudes towards spousal presence during childbirth and feelings about spousal presence during childbirth pain relief. Infrastructural defects in the health facilities resulting in the lack of privacy in maternity units for both spouses and partners negatively influence the presence of a spouse during childbirth and pain relief. Adopting effective strategies such as good infrastructural facilities, staff training and spouse-friendly hospital policies will encourage spouses to fully participate in and contribute to childbirth pain relief. This study identified poor staff attitudes towards pain relief and spousal presence during childbirth as barriers. Providing adequate policies on pain management, continuous staff education and orientation on spousal relationship will improve active spousal participation and maternal satisfaction during childbirth. © 2016 International Council of Nurses.

  14. 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.

  15. [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.

  16. Gender Differences in Dementia Spousal Caregiving

    Directory of Open Access Journals (Sweden)

    Minna Maria Pöysti

    2012-01-01

    Full Text Available The proportion of male caregivers is rapidly increasing. However, there are few large scale studies exploring gender differences in the burden or coping with caregiving. We investigated this among caregivers of patients with dementia. The study cohort consisted of 335 dyads of wife-husband couples from two studies including dementia patients and their spousal caregivers. Baseline mini-mental state examination (MMSE, clinical dementia rating scale (CDR, neuropsychiatric inventory (NPI, cornell depression scale and charlson comorbidity index (CCI were used to describe patients with dementia, Zarit burden scale and geriatric depression scale were used to measure experienced burden and depression of caregivers. Mean age of caregivers was 78 years. There were no differences in depression, satisfaction with life, or loneliness according to caregivers' gender. Male caregivers had more comorbidities than females (CCI 1.9 versus 1.1, P<0.001, and the wives of male caregivers had a more severe stage of dementia than husbands of female caregivers (CDR, P=0.048; MMSE14.0 versus 17.7, P<0.001. However, the mean Zarit burden scale was significantly lower among male than female caregivers (31.5 versus 37.5; P<0.001. Lower education of male caregivers tended to be associated with less experienced burden. In conclusion, male caregivers of dementia experienced lower burden than female caregivers despite care recipients' more severe disease.

  17. 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.

  18. 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...

  19. 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.

  20. Does spousal participation in Gamblers Anonymous benefit compulsive gamblers?

    Science.gov (United States)

    Johnson, E E; Nora, R M

    1992-12-01

    Extent of gambling-free periods was compared for 90 compulsive gamblers, 44 with spouses who participated in Gamblers Anonymous and 46 with spouses who did not. Although the results were in the direction of a beneficial effect of spousal participation, the relationship was statistically nonsignificant.

  1. Influence of Spousal Communication on Marital Stability: Implication ...

    African Journals Online (AJOL)

    It is often said that the home is the basic unit of the larger society. Thus when the home is settled, the society is at peace. The main focus of this study was to find out the influence of spousal communication on marital stability: Implications for Conducive Home Environment. A researcher-designed questionnaire titled ...

  2. Work and Family: Satisfaction, Stress, and Spousal Support.

    Science.gov (United States)

    Phillips-Miller, Dianne L.; Campbell, N. Jo; Morrison, Charles R.

    2000-01-01

    Married veterinarians were surveyed about work satisfaction, work-related stress, marital-family stress, and spousal support for their career. Female veterinarians reported greater effect of martial/family stress on career and less perceived support than did their male counterparts. Areas of greatest work dissatisfaction for both genders were…

  3. Spousal Recollections of Early Signs of Primary Progressive Aphasia

    Science.gov (United States)

    Pozzebon, Margaret; Douglas, Jacinta; Ames, David

    2018-01-01

    Background: Although primary progressive aphasia (PPA) is characterized by progressive loss of language and communication skills, knowledge about the earliest emerging signs announcing the onset of this condition is limited. Aims: To explore spousal recollections regarding the earliest signs of PPA and to compare the nature of the earliest…

  4. Effect of male partner's support on spousal modern contraception in ...

    African Journals Online (AJOL)

    Conclusion: Male partner hindrances and costs of contraceptive or transportation to clinic are important in noncompliance. Male partner education, subsidized/free contraceptives and mobile/community services will improve compliance. Keywords: Female contraception; Male partner support; Spousal contraception ...

  5. 107 SPOUSAL RAPE IN A GLOBALIZED WORLD Abstract Sexual

    African Journals Online (AJOL)

    Fr. Ikenga

    5 Some have wondered why a married woman will cry foul and ... for the retention of spousal rape exemption among others is the fact that establishing rape within marriage is usually an uphill task, it is believed that such allegations can .... between unmarried persons is unlawful; it is noted that this act do not carry with it any ...

  6. 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.

  7. 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…

  8. 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...

  9. 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,

  10. 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,

  11. 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,

  12. 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

  13. Living with loss: middle-aged men face spousal bereavement.

    Science.gov (United States)

    Daggett, Luann M

    2002-05-01

    Spousal bereavement is one of the most profoundly disturbing events encountered in the human life span. Research has shown that conjugal bereavement has significant physical and psychological consequences for the surviving spouse. In American culture, men and women experience bereavement in different ways. The author used in-depth interviews in the tradition of phenomenology to collect data from 8 men aged 41 to 54 years who had experienced the death of their spouse within the previous 8 months to 6 years. The research revealed the lived experience of spousal bereavement to be a journey from the realization of irreconcilable loss through themes of responding to the loss and living through the loss toward reclamation and reconstruction of a life.

  14. Effect of Marriage and Spousal Criminality on Recidivism

    DEFF Research Database (Denmark)

    Andersen, Signe Hald; Andersen, Lars Højsgaard; Skov, Peer Ebbesen

    2015-01-01

    The authors analyzed whether the effect of marriage on recidivism varied by spousal criminality. For this purpose, they used propensity score matching and full population data from Statistics Denmark on all unmarried and previously convicted men from birth cohorts 1965–1985 (N = 102,839). The res......The authors analyzed whether the effect of marriage on recidivism varied by spousal criminality. For this purpose, they used propensity score matching and full population data from Statistics Denmark on all unmarried and previously convicted men from birth cohorts 1965–1985 (N = 102......,839). The results showed that marriage reduced recidivism compared to nonmarriage only when the spouse had no criminal record. Similarly, marriage to a nonconvicted spouse reduced recidivism significantly more than marriage to a convicted spouse. These findings not only underline how important marriage...... is for social integration but also stress the heterogeneous nature of the protective effects of marriage....

  15. 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.

  16. Relationships between soldiers' PTSD symptoms and spousal communication during deployment.

    Science.gov (United States)

    Carter, Sarah; Loew, Benjamin; Allen, Elizabeth; Stanley, Scott; Rhoades, Galena; Markman, Howard

    2011-06-01

    Social support, including support from spouses, may buffer against posttraumatic stress disorder (PTSD) symptoms. The current study assessed whether the frequency of spousal communication during a recent deployment, a potentially important source of support for soldiers, was related to postdeployment PTSD symptoms. Data came from 193 married male Army soldiers who returned from military deployment within the past year. For communication modalities conceptualized as delayed (i.e., letters, care packages, and e-mails), greater spousal communication frequency during deployment was associated with lower postdeployment PTSD symptom scores, but only at higher levels of marital satisfaction (p = .009). At lower marital satisfaction, more delayed spousal communication during deployment was associated with more PTSD symptoms (p = .042). For communication modalities conceptualized as interactive (i.e., phone calls, instant messaging, instant messaging with video), the same general direction of effects was seen, but the interaction between communication frequency and marital satisfaction predicting PTSD symptoms did not reach significance. Copyright © 2011 International Society for Traumatic Stress Studies.

  17. Effect of Male Partner's Support on Spousal Modern Contraception in a Low Resource Setting.

    Science.gov (United States)

    Balogun, Olayinka; Adeniran, Abiodun; Fawole, Adegboyega; Adesina, Kikelomo; Aboyeji, Abiodun; Adeniran, Peace

    2016-09-01

    As efforts continue to increase contraceptive uptake, male partner support remains important in spousal modern contraceptive use. A prospective cross-sectional survey involving women on modern contraception was conducted at the family planning clinic of the University of Ilorin Teaching Hospital, Nigeria, between December 2013 and April 2014. All consenting participants completed a self-administered questionnaire designed for the study, and statistical analysis was done with SPSS version 20.0 using with chi square test and logistic regression; p value contraceptives used were IUD and injectables while male partner was responsible for discontinuation in 30(23.3%) of previous users. Covert contraceptive use was 22(7.2%), male partner support was 209(68.5%) as payment for the contraceptives (203; 66.6%) or transportation to the clinic (198; 64.9%). Also, 55(18.0%) women failed to comply with contraception recently due to male partner hindrance (25; 45.5%) or inability to pay for contraceptive (11; 20%) or transportation to the clinic (8; 14.5%). Male partners hindered contraception by reporting the woman to relatives/friends (8; 32%) or denying her money for feeding allowance (6; 24%); 277(90.8%) women want contraception to be couple decision while 261(85.6%) want contraception administered only if both partners consented. The significant predictors of male partner support were awareness about the contraceptive use (pMale partner hindrances and costs of contraceptive or transportation to clinic are important in noncompliance. Male partner education, subsidized/free contraceptives and mobile/community services will improve compliance.

  18. Prevalence and predictors of help-seeking for women exposed to spousal violence in India - a cross-sectional study.

    Science.gov (United States)

    Leonardsson, Malin; San Sebastian, Miguel

    2017-11-03

    Spousal violence against women is prevalent in India (29%). Studies from various countries have shown that few women exposed to intimate partner violence or spousal violence seek help, especially in low-income countries. The objective of this study was to estimate the prevalence and predictors of help-seeking among women in India who have experienced various types of spousal violence. Cross-sectional data on 19,125 married, separated, divorced or widowed women in India who had experienced physical or sexual violence at the hands of their husbands were obtained from the India National Family Health Survey III 2005-2006. Bivariate and multivariate logistic regression analyses were carried out. Less than one fourth (23.7%) of married, separated, divorced or widowed women in India who had experienced some form of physical or sexual spousal violence had sought help, but only 1% had sought help from formal institutions. Help-seeking was most prevalent in women who had been exposed to a combination of physical, sexual and emotional abuse (48.8%) and the least prevalent in women who had experienced sexual violence only (1.5%). Experience of severe violence and violence resulting in injury were the strongest predictors of help-seeking. Having education, being Christian or an acknowledged adherent of another minority religion - mainly Buddhism and Sikhism (Islam not included), getting married after the age of 21 and living in the South region were also associated with seeking help. Women in the North and Northeast regions were less likely to seek help, as were women with children and women who thought that a husband could be justified in hitting his wife. Very few Indian women who experience spousal violence seek help. The characteristics of the violence are the strongest predictors of help-seeking, but sociodemographic factors are also influential. We recommend efforts to ensure educational attainment for girls, prevention of child marriages, and that police officers and

  19. Emotional Expression and Spousal Support as Predictors of Marital Satisfaction: The Case of Turkey

    Science.gov (United States)

    Yedirir, Sabiha; Hamarta, Erdal

    2015-01-01

    This study examines the relationship between spousal support and the ability to express feelings of marital satisfaction, and the extent to which spousal support and the ability to express feelings can predict marital satisfaction. Research was conducted in accordance with general survey models. The study group comprised 195 married couples (N =…

  20. Spousal violence in sub-Saharan Africa: does household poverty-wealth matter?

    Science.gov (United States)

    Bamiwuye, Samson Olusina; Odimegwu, Clifford

    2014-06-17

    Despite the threat of violence to the health and rights of women yet, for many years, there has been a dearth of nationally comparable data on domestic violence in sub-Saharan Africa. This paper examines whether women from poor households are more likely to experience violence from husband/partner than other women who are from middle or rich households. Data for the study are derived from most recent DHS surveys of ever-married women age 15-49 in Cameroun(3,691), Kenya(4,336), Mozambique(5610), Nigeria (16,763), Zambia(3,010) and Zimbabwe(5,016) who participated in the questions on Domestic Violence Module. Bivariate analysis and Binary Logistic Regression Analysis are used to explore the linkage between household poverty-wealth and spousal violence while simultaneously controlling for confounding variables. The overall prevalence of any form of violence (physical, sexual or emotional) ranges from 30.5% in Nigeria to 43.4% in Zimbabwe; 45.3% in Kenya; 45.5% in Mozambique; 53.9% in Zambia and 57.6% in Cameroun. Both bivariate and multivariate analyses show that in two of the six countries -Zambia and Mozambique, experience of violence is significantly higher among women from non-poor (rich) households than those from other households (poor and middle). For Zimbabwe and Kenya, women from poor households are more likely to have ever experienced spousal violence than those from non-poor households. In the remaining two countries- Nigeria and Cameroun, women from the middle class are more likely to have ever suffered abuse from husband/partner than those from the poor and rich households. Our results thus show that similar measurements of household poverty-wealth have produced varying relationships with respect to experience of spousal violence in six sub-Saharan African countries. In other words, experience of violence cuts across all household poverty-wealth statuses and therefore may not provide enough explanations on whether household-poverty necessarily serves to

  1. Work-family conflict, job satisfaction and spousal support: an exploratory study of nurses' experience.

    Science.gov (United States)

    Patel, C J; Beekhan, A; Paruk, Z; Ramgoon, S

    2008-03-01

    In recognising the highly stressful nature of the nursing profession, the added burden of hospital staff shortages, and patient overload, the present study explored the impact of work on family functioning, its relationship to job satisfaction and the role of spousal support in a group of 80 female nurses working in a government hospital. Using a descriptive, correlational design, the relationships among job satisfaction, work-family conflict (WFC) and spousal/partner support were explored. The hypotheses that job satisfaction and WFC would be negatively correlated, that job satisfaction and spousal support would be positively correlated, and that WFC and spousal support would be negatively correlated, were tested using correlation techniques. All hypotheses were confirmed. The role of spousal support in the relationship between job satisfaction and work -family conflict was highlighted.

  2. Prevalence and risk factors for spousal violence among women attending health care centres in Alexandria, Egypt.

    Science.gov (United States)

    Mamdouh, H M; Ismail, H M; Kharboush, I F; Tawfik, M M; El Sharkawy, O G; Abdel-Baky, M; Sallam, H N

    2012-11-01

    We conducted a cross-sectional survey to determine the prevalence of, and factors affecting, spousal violence among 3271 ever-married women attending 12 randomly selected family health centres in Alexandria Governorate. More than three-quarters of the participants (77%) reported experiencing spousal violence during their marital life. Emotional violence was the most common type reported (71.0%), followed by physical (50.3%), economic (40.8%) and sexual (37.1%) violence. The study confirms the high prevalence of spousal violence across all socioeconomic strata. Logistic regression analysis indicated large family size, divorce or separation, low educational attainment of husband, smoking habit and drug use in husband, husband's psychological status and history of exposure to physical violence during adolescence were associated with spousal violence. This high rate of spousal violence highlights the urgent need for government and civil society to address the issue, which hinders progress toward Egypt's development goals.

  3. Work-family conflict, job satisfaction and spousal support: An exploratory study of nurses’ experience

    Directory of Open Access Journals (Sweden)

    CJ Patel

    2008-09-01

    Full Text Available In recognising the highly stressful nature of the nursing profession, the added burden of hospital staff shortages, and patient overload, the present study explored the impact of work on family functioning, its relationship to job satisfaction and the role of spousal support in a group of 80 female nurses working in a government hospital. Using a descriptive, correlational design, the relationships among job satisfaction, work-family conflict (WFC and spousal/partner support were explored. The hypotheses that job satisfaction and WFC would be negatively correlated, that job satisfaction and spousal support would be positively correlated, and that WFC and spousal support would be negatively correlated, were tested using correlation techniques. All hypotheses were confirmed. The role of spousal support in the relationship between job satisfaction and work -family conflict was highlighted.

  4. Characteristics of spousal homicide perpetrators: a study of all cases of spousal homicide in Sweden 1990-1999.

    Science.gov (United States)

    Belfrage, Henrik; Rying, Mikael

    2004-01-01

    In Sweden 20 000 cases of assault against women are reported to the police every year. All data on the perpetrators of spousal homicide in Sweden between 1990 and 1999 were investigated (n = 164). A control group of all other perpetrators of homicide in Sweden during the same period, i.e. cases of homicide not committed in the context of spouse violence (n = 690) was used. All verdicts, as well as all material in the police investigations, including interviews with all of the police investigators, were analysed. Copies of police examinations of the suspects, and forensic reports from the autopsies, were also examined. Data on all registered criminality were collected from the National Police Register, and in cases where the perpetrators had been subject to forensic psychiatric examinations, those reports were obtained from the Swedish National Board of Forensic Medicine. In addition, the Psychopathy Checklist: Screening Version scores were rated from the forensic psychiatric examinations. There was a four times higher suicide rate among the spousal homicide perpetrators (24%, n = 40) compared with the perpetrators in the control-group (6%, n = 39, chi-squared = 55,42 df = 1, p suicidal ideation must be considered as an important risk factor for spousal homicide. In 79% of the cases the spousal homicide perpetrators were subject to forensic psychiatric examinations. All except 5% were diagnosed with at least one psychiatric diagnosis, and 34% were sentenced to forensic psychiatric treatment. If it is assumed that the psychiatric morbidity was high in the 24% of the perpetrators who committed suicide, then 80% of all perpetrators of spouse homicide during the study period can be characterized as mentally disordered. 'Psychopathic' perpetrators, who generally are over-represented in most violent criminality, were comparatively uncommon. Only seven (4%) in the study group met the diagnostic criteria for psychopathy as measured with the PCL:SV. The group of spouse

  5. Neuropsychological correlates of complicated grief in older spousally bereaved adults.

    Science.gov (United States)

    O'Connor, Mary-Frances; Arizmendi, Brian J

    2014-01-01

    Across many research domains, evidence for complicated grief as a distinct psychopathology continues to grow. Previous research from neuropsychology has shown an increased attentional bias to emotionally relevant stimuli in those suffering from complicated grief. This study furthers our understanding of the characteristics that distinguish complicated grief. We expand on previous research by (a) testing older adults, (b) excluding those with comorbid major depressive disorder, (c) using participant-chosen grief-related stimuli, and (d) using a married, nonbereaved control group. We recruited 76 older adults in 3 groups: spousally bereaved with complicated grief, spousally bereaved with noncomplicated grief, and nonbereaved controls. Performance on the Wisconsin Card Sorting Task, Digit Span Backwards, and the emotional counting Stroop was examined. Results indicate longer reaction time across 3 blocks of grief-related words in the complicated grief group but no difference across 3 blocks of the neutral words. The 3 groups performed comparably on the other neurocognitive tasks, indicating no cognitive differences in working memory or set shifting between groups. Furthermore, these effects of complicated grief generalize to older adults and appear independent of major depression. Complicated grief has cognitive interference as a neuropsychological component highlighting it as distinct from noncomplicated grief.

  6. 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

  7. 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

  8. [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.

  9. 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.

  10. 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.

  11. 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 ...

  12. Association Between Spousal Suicide and Mental, Physical, and Social Health Outcomes

    DEFF Research Database (Denmark)

    Erlangsen, Annette; Runeson, Bo; Bolton, James M.

    2017-01-01

    Importance: Bereavement after spousal suicide has been linked to mental disorders; however, a comprehensive assessment of the effect of spousal suicide is needed. Objective: To determine whether bereavement after spousal suicide was linked to an excessive risk of mental, physical, and social health......-years and compared people bereaved by spousal suicide with the general population and people bereaved by other manners of death. Incidence rate ratios were calculated using Poisson regressions while adjusting for sociodemographic characteristics and the presence of mental and physical disorders. Main Outcomes...... and Measures: Mental disorders (any disorder, mood, posttraumatic stress disorder, anxiety, alcohol use disorders, drug use disorders, and self-harm); physical disorders (cancers, diabetes, sleep disorder, cardiovascular diseases, chronic lower respiratory tract diseases, liver cirrhosis, and spinal disc...

  13. Entrapment of victims of spousal abuse in Ghana

    DEFF Research Database (Denmark)

    Adjei, Stephen Baffour

    2017-01-01

    Drawing on discursive psychology and positioning theory, this study explores the influence of cultural and familial value orientations on battered women’s identity, agency and decision to leave or stay in abusive conjugal relationship in Ghana. Two semi-structured focus group discussions and four...... in-depth personal interviews were conducted with 16 victims of husband-to-wife abuse from rural and urban Ghana. The findings indicate that entrapment of victims of spousal abuse in Ghana reflects their social embeddedness and that battered women’s identities and agency are expressed in the context...... of familial and cultural value orientations. The primacy of family identity and victims’ apparent implicit moral obligation to preserve the social image of their extended family influence their entrapment. Participants’ discursive accounts further suggest that stay/leave decisions of battered women in Ghana...

  14. 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.

  15. Smoking within the Household: Spousal Peer Effects and Children's Health Implications

    OpenAIRE

    Canta, Chiara; Dubois, Pierre

    2011-01-01

    This paper studies spousal peer effects on the smoking behaviour and their implication for the health of children through passive smoking. Smoking decisions are modeled as equilibrium strategies of an incomplete information game within the couple. Using data from the French Health Survey 2002-2003, we identify two distinct effects linked to spousal behaviour: a smoking enhancing effect of smoking partners and a smoking deterring effect of non smoking partners. On the one hand, ...

  16. 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.

  17. [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.

  18. 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.

  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. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Spousal Coping Strategies in the Shadow of Terrorism.

    Science.gov (United States)

    Shechory-Bitton, Mally; Cohen-Louck, Keren

    2017-11-01

    The present study focuses on spousal differences in reaction to ongoing exposure to terror and security threats. Sixty-eight married couples with children living in a region exposed to ongoing security threats were evaluated. All participants completed questionnaires on objective exposure (number of incidents) and subjective exposure (sense of fear) to terrorism and security threats, posttraumatic stress disorder (PTSD) symptoms, and their coping strategies with this ongoing exposure. Mothers reported higher levels of fear and PTSD symptoms, although their objective levels of exposure did not differ from those of their husbands. Similarities were found in coping strategies adopted by mothers and fathers to cope with life in the shadow of terrorism. Both mothers and fathers integrated emotion- and problem-focused coping strategies, with greater use of the latter. These similarities partially contradict research findings suggesting gender differences in coping with exposure to security threats. The results support the need for further research into investigating the role of dyadic coping in the context of prolonged exposure to security threats.

  6. Spousal Involvement and CPAP Adherence: A Dyadic Perspective

    Science.gov (United States)

    Ye, Lichuan; Malhotra, Atul; Kayser, Karen; Willis, Danny G.; Horowitz, June; Aloia, Mark; Weaver, Terri E.

    2014-01-01

    Summary Poor adherence to continuous positive airway pressure (CPAP) treatment is associated with substantial health care costs, morbidity and mortality, and has been a leading obstacle in the effective management of obstructive sleep apnea (OSA). Successful interventions to improve CPAP adherence may ultimately include a variety of components. For patients living with spouses (refers to all domestic partners), the spouse will likely be an integral component to any successful intervention. Developing understanding of the role of spouses in adherence to CPAP has been identified to be a critical research need. This review expands the investigation of CPAP adherence to a broader context, from an exclusive focus on individual patients to a dyadic perspective encompassing both patients and their spouses. A conceptual framework based on social support and social control theories is proposed to understand spousal involvement in CPAP adherence. Methodologies for future investigations are discussed, along with implications for developing interventions that engage both patients and their spouses to improve CPAP use. PMID:24906222

  7. 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.

  8. 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.

  9. The Relationship between Spousal Age Difference and Violence against Wife in Nigeria: A Generalized Linear Modelling Approach

    Directory of Open Access Journals (Sweden)

    Anthony C. Akpanta

    2017-11-01

    Full Text Available The act of violence against wife is condemnable and attracts various legal penalties, globally. This article attempts to find a link between spousal age difference and violence (Emotional, Physical and Sexual against wives in Nigeria. The result show that wives who are older than their partners are more likely to experience sexual and emotional violence; also, wives who are same age as their husbands are more likely to experience sexual violence; whereas wives who are 1-4 years younger than their husbands are more likely to experience physical violence; while wives 5 years or more younger than their husbands are generally less likely to experience any form of violence.

  10. Spousal support and changes in distress over time in couples coping with cancer : the role of personal control

    NARCIS (Netherlands)

    Dagan, Meirav; Sanderman, Robbert; Schokker, Marike C; Wiggers, Theo; Baas, Peter C; van Haastert, Michiel; Hagedoorn, Mariët

    This longitudinal study has examined the associations between perceived supportive and unsupportive spousal behavior and changes in distress in couples coping with cancer. We tested whether people relatively low in their sense of personal control were more responsive to spousal supportive and

  11. 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.

  12. 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.

  13. Comparison of long-term outcomes between spousal transplants and other living unrelated donor transplants: single-center experience.

    Science.gov (United States)

    Yoon, Hye Eun; Song, Joon Chang; Hyoung, Bok Jin; Hwang, Hyeon Seok; Lee, So Young; Jeon, Youn Joo; Park, Sun Cheol; Choi, Bum Soon; Kim, Yong Soo; Moon, In Sung; Yang, Chul Woo

    2009-01-01

    The greater use of living unrelated donors (LUDs) as kidney donors is a worldwide trend in the current era of organ shortage, and spouses are an important source of LUDs. This study was to compare the long-term outcomes of spousal donor grafts with other LUD grafts. Among 445 LUD grafts, 77 were spouses and 368 were other LUDs. The clinical characteristics and long-term survival rates for spousal transplants were compared with those for other LUD transplants, and risk factors affecting graft survival were assessed. Spousal donors had a significantly higher average number of human leukocyte antigen (HLA) mismatches (4.2 vs. 3.4, p HLA mismatching, the spousal donor type or donor age did not affect the graft survival. Renal transplants from spousal donors show similar long-term outcomes to those from better HLA-matched and younger LUDs. (c) 2009 S. Karger AG, Basel.

  14. Spousal communication and contraceptive use in rural Nepal: an event history analysis.

    Science.gov (United States)

    Link, Cynthia F

    2011-06-01

    This study analyzes longitudinal data from couples in rural Nepal to investigate the influence of spousal communication about family planning on their subsequent contraceptive use. The study expands current understanding of the communication-contraception link by (a) exploiting monthly panel data to conduct an event history analysis, (b) incorporating both wives' and husbands' perceptions of communication, and (c) distinguishing effects of spousal communication on the use of four contraceptive methods. The findings provide new evidence of a strong positive impact of spousal communication on contraceptive use, even when controlling for confounding variables. Wives' reports of communication are substantial explanatory factors in couples' initiation of all contraceptive methods examined. Husbands' reports of communication predict couples'subsequent use of male-controlled methods. This analysis advances our understanding of how marital dynamics--as well as husbands' perceptions of these dynamics--influence fertility behavior, and should encourage policies to promote greater integration of men into family planning programs.

  15. The impact of spousal violence on the children: A pastoral care approach

    Directory of Open Access Journals (Sweden)

    Luvuyo G. Sifo

    2014-07-01

    Full Text Available This article investigates the impact of spousal violence on children. Spousal violence in the home affects children negatively and its impact goes beyond their childhood years into adulthood. Some children become dysfunctional in life as a result of their exposure to violence between their parents. These children may exhibit symptoms associated with post-traumatic stress disorder (PTSD later on in life. A case study of a family exposed to violence was undertaken. Findings from this case scenario were measured against existing literature. A pastoral care method of responding to the victims is proposed in order for them to be healed.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. Influence of community social norms on spousal violence: a population-based multilevel study of Nigerian women.

    Science.gov (United States)

    Linos, Natalia; Slopen, Natalie; Subramanian, S V; Berkman, Lisa; Kawachi, Ichiro

    2013-01-01

    We examined whether social norms toward spousal violence in Nigeria, at the state level, are associated with a woman's exposure to physical and sexual violence perpetrated by her husband. Using data from the 2008 Demographic and Health Survey, we fit four 3-level random intercepts models to examine contextual factors associated with spousal violence while accounting for individual-level predictors. Of the 18,798 ever-married Nigerian women in our sample, 18.7% reported exposure to spousal sexual or physical violence. The prevalence was geographically patterned by state and ranged from 3% to 50%. Permissive state-level social norms toward spousal violence were positively associated with a woman's report of physical and sexual violence perpetrated by her husband (odds ratio [OR] = 1.80; 95% confidence interval [CI] = 1.17, 2.77), after adjusting for individual-level characteristics. A number of individual-level variables were significantly associated with victimization, including a woman's accepting beliefs toward spousal violence (OR = 1.11; 95% CI = 1.09, 1.14). Women living in states with Sharia law were less likely to report spousal violence (OR = 0.58; 95% CI = 0.35, 0.95). Efforts to end violence against women, particularly spousal violence, should consider broader social and contextual determinants of violence including social norms.

  1. 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

  2. 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.

  3. Spousal Perceptions of Marital Stress and Support among Grandparent Caregivers: Variations by Life Stage

    Science.gov (United States)

    Matzek, Amanda E.; Cooney, Teresa M.

    2009-01-01

    Few studies have examined how raising grandchildren influences the marital relationship of grandparent caregivers although half of such caregivers are married. This study used national survey data from Midlife Development in the United States (MIDUS) to contrast perceptions of spousal support and strain for grandparents who had recently provided…

  4. "Correcting an Erring Wife Is Normal": Moral Discourses of Spousal Violence in Ghana.

    Science.gov (United States)

    Adjei, Stephen Baffour

    2018-06-01

    This study draws insights from discursive psychology to explore moral discourses of spousal violence in Ghana. In particular, it investigates how sociocultural norms and practices are invoked in talk of perpetrators and victims as moral warrants for husband-to-wife abuse in Ghana. Semi-structured focus group and personal interviews were conducted with a total of 40 participants: 16 victims, 16 perpetrators, and eight key informants from rural and urban Ghana. Participants' discursive accounts suggest that husbands have implicit moral right and obligation to punish their wives for disobedience and other infractions against male authority in marriage. Both perpetrators and victims build their talk around familiar normative discourses and practices that provide tacit support for spousal violence in Ghana. While perpetrators mobilize culturally resonant and normative repertoires to justify abuse, blame their victims, and manage their moral accountability; victims position husband-to-wife abuse as normal, legitimate, disciplinary, and corrective. These moral discourses of spousal violence apparently serve to relieve perpetrators of moral agency; prime battered women to accept abuse; and devastate their agency to leave abusive marital relationships. The findings contribute to our understanding of how cultural and social norms of spousal violence are morally constituted, reproduced, and sustained in talk of perpetrators, victims, and other key members of society.

  5. Individual and spousal unemployment as predictors of smoking and drinking behavior.

    Science.gov (United States)

    Arcaya, Mariana; Glymour, M Maria; Christakis, Nicholas A; Kawachi, Ichiro; Subramanian, S V

    2014-06-01

    The effects of unemployment on health behaviors, and substance use in particular, is still unclear despite substantial existing research. This study aimed to assess the effects of individual and spousal unemployment on smoking and alcohol consumption. The study was based on eight waves of geocoded Framingham Heart Study Offspring Cohort data (US) from 1971 to 2008 that contained social network information. We fit three series of models to assess whether lagged 1) unemployment, and 2) spousal unemployment predicted odds of being a current smoker or drinks consumed per week, adjusting for a range of socioeconomic and demographic covariates. Compared with employment, unemployment was associated with nearly twice the subsequent odds of smoking, and with increased cigarette consumption among male, but not female, smokers. In contrast, unemployment predicted a one drink reduction in weekly alcohol consumption, though effects varied according to intensity of consumption, and appeared stronger among women. While spousal unemployment had no effect on substance use behaviors among men, wives responded to husbands' unemployment by reducing their alcohol consumption. We conclude that individual, and among women, spousal unemployment predicted changes in substance use behaviors, and that the direction of the change was substance-dependent. Complex interactions among employment status, sex, and intensity and type of consumption appear to be at play and should be investigated further. Copyright © 2014 Elsevier Ltd. All rights reserved.

  6. Japanese spousal smoking study revisited: how a tobacco industry funded paper reached erroneous conclusions

    OpenAIRE

    Yano, E

    2005-01-01

    Objectives: To provide a participant's account of the development of a paper commissioned by the tobacco industry examining the reliability of self reported smoking status; to redress the distorted report of this Japanese spousal smoking study which evaluated the reliability and validity of self reported smoking status, and estimated confounding by diet and lifestyle factors.

  7. Effects of own and spousal disability on loneliness among older adults

    NARCIS (Netherlands)

    Korporaal, M.; Broese Van Groenou, M.I.; van Tilburg, T.G.

    2008-01-01

    Objectives: This study examines the effects of own and spousal disability on social and emotional loneliness among married adults aged 65 and older. Method: Data from 710 men and 379 women of a Dutch community sample were analyzed with linear regression analyses. Results: For men, only their wives'

  8. “Correcting an Erring Wife Is Normal”: Moral Discourses of Spousal Violence in Ghana

    DEFF Research Database (Denmark)

    Adjei, Stephen Baffour

    2015-01-01

    , blame their victims, and manage their moral accountability; victims position husband-to-wife abuse as normal, legitimate, disciplinary, and corrective. These moral discourses of spousal violence apparently serve to relieve perpetrators of moral agency; prime battered women to accept abuse; and devastate...

  9. Relationships and cardiovascular risk: perceived spousal ambivalence in specific relationship contexts and its links to inflammation

    NARCIS (Netherlands)

    Uchino, B.N.; Bosch, J.A.; Smith, T.W.; Carlisle, M.; Birmingham, W.; Bowen, K.S.; Light, K.C.; O'Hartaigh, B.

    2013-01-01

    Objectives: Although perceiving one’s social ties as sources of ambivalence has been linked to negative health outcomes, the more specific contexts by which such relationships influence health remain less studied. We thus examined if perceived spousal relationship quality in three theoretically

  10. Spousal Support and Work--Family Balance in Launching a Family Business

    Science.gov (United States)

    Gudmunson, Clinton G.; Danes, Sharon M.; Werbel, James D.; Loy, Johnben Teik-Cheok

    2009-01-01

    This study examines whether emotional spousal support contributes to business owners' perceived work-family balance while launching a family business. Hobfoll's Conservation of Resources theory of stress is applied to 109 family business owners and their spouses. Results from structural equation models support several hypotheses. First, reports of…

  11. Putting context into a cultural perspective: examining Arab and Jewish adolescents' judgments and reasoning about spousal retribution.

    Science.gov (United States)

    Pitner, Ronald O; Astor, Ron Avi; Benbenishty, Rami; Haj-Yahia, Muhammad M; Zeira, Anat

    2011-05-01

    In this study, we examined what contextual factors influence adolescents' judgments and reasoning about spousal retribution. Adolescents were drawn from Central and Northern Israel and consisted of 2,324 Arab and Jewish students (Grades 7-11). The study was set up in a 2 (Arab/Jewish respondent) × 2 (spousal retribution scenarios) factorial design. Our findings suggest that societal and cultural norms may be more powerful contextual variables than group stereotypes in influencing Arab and Jewish adolescents' evaluations of spousal retribution. Theoretical and practical implications are discussed.

  12. 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.

  13. Spousal violence and receipt of skilled maternity care during and after pregnancy in Nepal.

    Science.gov (United States)

    Furuta, Marie; Bick, Debra; Matsufuji, Hiromi; Coxon, Kirstie

    2016-12-01

    a substantial number of Nepali women experience spousal violence, which affects their health in many ways, including during and after pregnancy. This study aimed to examine associations between women's experiences of spousal violence and their receipt of skilled maternity care, using two indicators: (1) receiving skilled maternity care across a continuum from pregnancy to the early postnatal period and (2) receiving any skilled maternity care in pregnancy, childbirth, or postpartum. data were analysed for married women aged 15-49 from the 2011 Nepal Demographic and Health Survey. Data were included on women who completed an interview on spousal violence as part of the survey and had given birth within the five years preceding the survey (weighted n=1375). Logistic regression models were developed for analyses. the proportion of women who received skilled maternity care across the pregnancy continuum and those who received any skilled maternity care was 24.1% and 53.7%, respectively. Logistic regression analyses showed that spousal violence was statistically significantly associated with receiving low levels of skilled maternity care, after adjusting for accessibility of health care. However, after controlling for women's sociodemographic backgrounds (age, number of children born, educational level, husband's education level, husband's occupation, region of residence, urban/rural residence, wealth index), these significant associations disappeared. Better-educated women, women whose husbands were professionals or skilled workers and women from well-off households were more likely to receive skilled maternity care either across the pregnancy continuum or at recommended points during or after pregnancy. spousal violence and low uptake of skilled maternity care are deeply embedded in a society in which gender inequality prevails. Factors affecting the receipt of skilled maternity care are multidimensional; simply expanding geographical access to maternity services may

  14. Shadow of domestic violence and extramarital sex cohesive with spousal communication among males in Nepal

    Science.gov (United States)

    2014-01-01

    Background Public health and human right issues are challenging in low and middle income countries. The main objectives of this paper were to determine the prevalence and factors associated with domestic violence, extramarital sex, and spousal communication among male. Methods A cross-sectional study among 2466 married males in Kathmandu, Nepal was conducted using random sampling method. Adjusted odds ratios (AORs) and 95% confidence intervals (CI) of associated factors were estimated by stepwise backward likelihood ratio method. Results Prevalence of domestic violence was 63.14% (95% CI 61.20-65.05), extramarital sex was 32.12% (95% CI 30.27-34.00), and spousal communication was 48.87% (95% CI 46.85-50.90). Nearly one in five male (18.20%) had not used condom during extramarital sex. Interestingly, male who had more than three or equal children were less likely to have perpetrated domestic violence compared with those who had less children. Older male aged 25 and above were more likely (AORs = 1.55, 95% CI 1.19-2.03) to have extramarital sex compared with male aged 24 or below. Those male who had studied secondary or higher level of education were less likely to have extramarital sex compared to those who had primary level or no education. Male who had higher income were more likely to have spousal communication compared to those who had less income. Surprisingly, those male who had extramarital sex were less likely to have spousal communication compared with those was not involved in extramarital sex. Conclusion Practice of domestic violence and extramarital sex is quite common among married male in Nepal, where spousal communication is sparse. These findings can be used to advocate for immediate attention and activities needs to be endorsed by policymakers and programmers. PMID:24924872

  15. 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.

  16. 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

  17. [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

  18. 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

  19. 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

  20. 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

  1. 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...

  2. 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.

  3. 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

  4. Association Between Spousal Suicide and Mental, Physical, and Social Health Outcomes

    Science.gov (United States)

    Runeson, Bo; Bolton, James M.; Wilcox, Holly C.; Forman, Julie L; Krogh, Jesper; Shear, M. Katherine; Nordentoft, Merete; Conwell, Yeates

    2017-01-01

    Importance Bereavement after spousal suicide has been linked to mental disorders; however, a comprehensive assessment of the effect of spousal suicide is needed. Objective To determine whether bereavement after spousal suicide was linked to an excessive risk of mental, physical, and social health outcomes when compared with the general population and spouses bereaved by other manners. Design, Setting, and Participants This nationwide, register-based cohort study conducted in Denmark of 6.7 million individuals aged 18 years and older from 1980 to 2014 covered more than 136 million person-years and compared people bereaved by spousal suicide with the general population and people bereaved by other manners of death. Incidence rate ratios were calculated using Poisson regressions while adjusting for sociodemographic characteristics and the presence of mental and physical disorders. Main Outcomes and Measures Mental disorders (any disorder, mood, posttraumatic stress disorder, anxiety, alcohol use disorders, drug use disorders, and self-harm); physical disorders (cancers, diabetes, sleep disorder, cardiovascular diseases, chronic lower respiratory tract diseases, liver cirrhosis, and spinal disc herniation); causes of mortality (all-cause, natural, unintentional, suicide, and homicide); social health outcomes; and health care use. Results The total study population included 3 491 939 men, 4814 of whom were bereaved by spousal suicide, and 3 514 959 women, 10 793 of whom were bereaved by spousal suicide. Spouses bereaved by a partner’s suicide had higher risks of developing mental disorders within 5 years of the loss (men: incidence rate ratio, 1.8; 95% CI, 1.6-2.0; women: incidence rate ratio, 1.7; 95% CI, 1.6-1.8) than the general population. Elevated risks for developing physical disorders, such as cirrhosis and sleep disorders, were also noted as well as the use of more municipal support, sick leave benefits, and disability pension funds than the general

  5. Spousal Violence in 5 Transitional Countries: A Population-Based Multilevel Analysis of Individual and Contextual Factors.

    Science.gov (United States)

    Ismayilova, Leyla

    2015-11-01

    I examined the individual- and community-level factors associated with spousal violence in post-Soviet countries. I used population-based data from the Demographic and Health Survey conducted between 2005 and 2012. My sample included currently married women of reproductive age (n = 3932 in Azerbaijan, n = 4053 in Moldova, n = 1932 in Ukraine, n = 4361 in Kyrgyzstan, and n = 4093 in Tajikistan). I selected respondents using stratified multistage cluster sampling. Because of the nested structure of the data, multilevel logistic regressions for survey data were fitted to examine factors associated with spousal violence in the last 12 months. Partner's problem drinking was the strongest risk factor associated with spousal violence in all 5 countries. In Moldova, Ukraine, and Kyrgyzstan, women with greater financial power than their spouses were more likely to experience violence. Effects of community economic deprivation and of empowerment status of women in the community on spousal violence differed across countries. Women living in communities with a high tolerance of violence faced a higher risk of spousal violence in Moldova and Ukraine. In more traditional countries (Azerbaijan, Kyrgyzstan, and Tajikistan), spousal violence was lower in conservative communities with patriarchal gender beliefs or higher financial dependency on husbands. My findings underscore the importance of examining individual risk factors in the context of community-level factors and developing individual- and community-level interventions.

  6. 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.

  7. 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.

  8. 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

  9. The influence of marital status and spousal employment on retirement behavior in Germany and Spain.

    Science.gov (United States)

    Radl, Jonas; Himmelreicher, Ralf K

    2015-05-01

    This article analyzes the impact of marital status and spousal employment on the timing of retirement in Germany and Spain. Retirement behavior is examined by means of event-history models, with a competing risks framework being used to distinguish between voluntary and involuntary work-exit transitions. To take account of the role of social policies, we adopt a comparative approach. Data are drawn from a 2006 special retirement module implemented analogously in national labor force surveys. The results show that spousal labor market participation plays a large role in work-exit transitions, even when retirement is involuntary. This finding questions the widespread belief that coretirement is exclusively due to preference for joint retirement shared among spouses. Moreover, widows and widowers tend to retire prematurely in Germany, whereas no such effect could be found in Spain. This finding is explained by reference to specific economic incentives arising from national pension legislation. © The Author(s) 2014.

  10. Do personality traits moderate the effect of late-life spousal loss on psychological distress?

    Science.gov (United States)

    Pai, Manacy; Carr, Deborah

    2010-06-01

    We use data from the Changing Lives of Older Couples (CLOC) study to investigate the extent to which: (1) five personality traits (agreeableness, conscientiousness, emotional stability/neuroticism, extraversion, and openness) moderate the effect of late-life spousal loss on depressive symptoms; (2) these patterns vary based on the expectedness of the death; and (3) the patterns documented in (1) and (2) are explained by secondary stressors and social support. Widowed persons report significantly more depressive symptoms than married persons, yet the deleterious effects of loss are significantly smaller for highly extraverted and conscientious individuals. The protective effects of personality traits, however, vary based on the expectedness of the death. Extraversion is protective against depression only for persons who had forewarning of the death. Extraverts may be particularly good at marshalling social support during prolonged periods of spousal illness. We discuss the ways that extraversion and conscientiousness may buffer against bereavement-related stressors.

  11. The Effects of Military Change-of-Station Moves on Spousal Earnings

    Science.gov (United States)

    2016-12-02

    Career Advancement Accounts program, available to assist some Figure 1. Impact of PCS Moves on Military Spousal Earnings NOTES: The “working spouses...Spouses’ career earnings may be especially affected by permanent change-of-station (PCS) moves. Job-specific skills and knowledge gained while one is...Finally, the inherently disruptive nature of moving could have negative effects on productivity , thereby lowering wages. To date, our understanding of

  12. [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.

  13. 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)

  14. 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.

  15. Post-migration employment changes and health: A dyadic spousal analysis.

    Science.gov (United States)

    Ro, Annie; Goldberg, Rachel E

    2017-10-01

    Prospective studies have found unemployment and job loss to be associated with negative psychological and physical health outcomes. For immigrants, the health implications of employment change cannot be considered apart from pre-migration experiences. While immigrants demonstrate relative success in securing employment in the United States, their work is often not commensurate with their education or expertise. Previous research has linked downward employment with adverse health outcomes among immigrants, but with gender differences. We extended this literature by considering a wider range of employment states and accounting for the interdependence of husbands' and wives' employment trajectories. We examined the relationships between personal and spousal post-migration employment changes and self-rated health and depressive symptoms using dyadic data from the 2003 New Immigrant Survey (NIS) (n = 5682 individuals/2841 spousal pairs). We used the Actor Partner Interdependence Model (APIM) to model cross-partner effects and account for spousal interdependence. In general, men's downward employment trajectories were associated with poorer health for themselves. Women's employment trajectories had fewer statistically significant associations with their own or their husbands' health, underscoring the generally more peripheral nature of women's work in the household. However, women's current unemployment in particular was associated with poorer health outcomes for themselves and their husbands, suggesting that unmet need for women's work can produce health risks within immigrant households. Our findings suggest that employment change should be considered a household event that can impact the wellbeing of linked individuals within. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. Spousal recovery support, recovery experiences, and life satisfaction crossover among dual-earner couples.

    Science.gov (United States)

    Park, YoungAh; Fritz, Charlotte

    2015-03-01

    Research has indicated the importance of recovery from work stress for employee well-being and work engagement. However, very little is known about the specific factors that may support or hinder recovery in the context of dual-earner couples. This study proposes spousal recovery support as a potential resource that dual-earner couples can draw on to enhance their recovery experiences and well-being. It was hypothesized that spousal recovery support would be related to the recipient spouse's life satisfaction via his or her own recovery experiences (i.e., psychological detachment, relaxation, and mastery experiences). The study further investigated the crossover of life satisfaction between working spouses as a potential outcome of recovery processes. Data from 318 full-time employed married couples in South Korea were analyzed using structural equation modeling. Results showed that spousal recovery support was positively related to all 3 recovery experiences of the recipient spouse. Moreover, this recovery support was related to the recipient spouse's life satisfaction via relaxation and mastery experiences. Unexpectedly, psychological detachment was negatively related to life satisfaction, possibly indicating a suppression effect. Life satisfaction crossed over between working spouses. No gender differences were found in the hypothesized paths. Based on these findings, theoretical and practical implications are discussed, and future research directions are presented. PsycINFO Database Record (c) 2015 APA, all rights reserved.

  17. Immigration policy and economic cycle effects on spousal reunification in Spain

    Directory of Open Access Journals (Sweden)

    Francisco Javier Mato Díaz

    2017-09-01

    Full Text Available This paper analyzes the influence of immigration policy and the Great Recession on spousal reunification in Spain. After a significant immigration boom (2000-2008, family-related migration has contributed to the significant flows that continued to arrive in Spain during the economic crisis. But this type of migration was subject to both the crisis and immigration policy changes, such as visa conditions, which may not have been specifically addressed to influence these flows. Using data from the Spanish Labor Force Survey (LFS, the research considers married primary immigrants who came to Spain from the four main countries of origin (Ecuador, Colombia, Romania and Morocco and concludes, first, that tighter conditions to visit the country—particularly tourist border controls—discourage spousal reunification. The reason could be that during the immigration boom, illicit immigration abounded and secondary immigrants were arriving as tourists. Secondly, reunification was slowed down by the Great Recession for the majority of the countries considered, except Ecuador. Unsurprisingly, given the job losses in typical male jobs, the negative influence of the crisis is greater for female primary immigrants. Third, contrary to the expectations that placed secondary immigrants as people with relatively low ties to the labor market, the research shows that because spousal reunification coincided with a deep economic and job crisis, female secondary immigrants increased the family labor supply in order to maintain consumption and/or remittance in what looks like an added-worker effect.

  18. Spousal labor market effects from government health insurance: Evidence from a veterans affairs expansion.

    Science.gov (United States)

    Boyle, Melissa A; Lahey, Joanna N

    2016-01-01

    Measuring the total impact of health insurance receipt on household labor supply is important in an era of increased access to publicly provided and subsidized insurance. Although government expansion of health insurance to older workers leads to direct labor supply reductions for recipients, there may be spillover effects on the labor supply of uncovered spouses. While the most basic model predicts a decrease in overall household work hours, financial incentives such as credit constraints, target income levels, and the need for own health insurance suggest that spousal labor supply might increase. In contrast, complementarities of spousal leisure would predict a decrease in labor supply for both spouses. Utilizing a mid-1990s expansion of health insurance for U.S. veterans, we provide evidence on the effects of public insurance availability on the labor supply of spouses. Using data from the Current Population Survey and Health and Retirement Study, we employ a difference-in-differences strategy to compare the labor market behavior of the wives of older male veterans and non-veterans before and after the VA health benefits expansion. Although husbands' labor supply decreases, wives' labor supply increases, suggesting that financial incentives dominate complementarities of spousal leisure. This effect is strongest for wives with lower education levels and lower levels of household wealth and those who were not previously employed full-time. These findings have implications for government programs such as Medicare and Social Security and the Affordable Care Act. Copyright © 2015 Elsevier B.V. All rights reserved.

  19. 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

  20. 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

  1. 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

  2. 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...

  3. 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

  4. 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.

  5. Marriage and Advance Consent to Sex: A Feminist Judgment in R v JA

    Directory of Open Access Journals (Sweden)

    Jennifer Koshan

    2016-12-01

    Full Text Available This paper is a feminist judgment in R v JA (Supreme Court of Canada 2011, a spousal sexual assault case involving the issue of whether parties can consent in advance to sexual activity that will occur while they are asleep or unconscious. The Supreme Court’s ruling in JA has generated critique and debate amongst feminist and law and sexuality scholars that pits women's equality and security interests against their affirmative sexual autonomy. Using the methodology of a feminist judgment, I endeavour to analyze whether it is possible to adopt an approach to advance consent that protects or at least balances all of these interests. My particular focus is the spousal context, where courts have often interpreted the sexual assault provisions of the Criminal Code to the detriment of women’s sexual integrity and equality, yet where arguments about affirmative sexual autonomy have also predominated. Taking a harm-based approach to criminality that considers both negative and positive sexual autonomy, the judgment concludes that advance consent should not be considered valid without certain legal safeguards being put into place.Este artículo es una sentencia feminista de R v JA (Tribunal Supremo de Canadá 2011, un caso de agresión sexual conyugal que implica la cuestión de si las partes pueden consentir de antemano una actividad sexual que ocurrirá mientras están dormidos o inconscientes. El fallo de la Corte Suprema en JA ha generado críticas y debates entre feministas e investigadores en derecho y sexualidad, que enfrentan los intereses de igualdad y seguridad de la mujer con su autonomía sexual afirmativa. Utilizando la metodología de un juicio feminista, se intenta analizar si es posible adoptar un enfoque de consentimiento anticipado que proteja, o al menos equilibre, todos estos intereses. El enfoque particular es el contexto conyugal, donde los tribunales han interpretado a menudo las disposiciones sobre el asalto sexual del C

  6. 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."

  7. 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

  8. 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

  9. 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

  10. Prevalence and Attitude of Women to Spousal Physical Abuse in Pregnancy in a Niger Delta Community of Nigeria

    Directory of Open Access Journals (Sweden)

    Augustine Vincent Umoh

    2012-12-01

    Full Text Available ABSTRACT Introduction: Spousal physical violence in pregnancy is a major public health and human rights concern. Identifying its prevalence and understanding the women’s attitude towards this phenomenon in our environment is key to developing strategies for effective intervention. Methods: This was a cross sectional study of pregnant women attending antenatal clinics of the University of Uyo Teaching Hospital (UUTH, Uyo in the Niger Delta region of Nigeria. Information was collected using a pre-tested self-administered questionnaire instrument. Results: The mean age of respondents was 28.72 ± 4.47 years with a range of 16 – 48 years. The prevalence of spousal physical violence in the current pregnancy was 10.3%. 45.2% of those who experienced violence in the current pregnancy also experienced violence in other pregnancies while 73.7% of those who reported spousal violence in previous pregnancies also experienced violence in the current pregnancy. There was a significant relationship between spousal physical violence and the woman’s number of deliveries/parity (x2 = 16.145, p=0.025, marital status (x2=11.105, p=0.025 and husband’s occupation (x2=12.786, p=0.047. About half of the respondents expressed the view that spousal violence was not excusable under any circumstance while 22.7% believed that it could be excused under certain circumstances. Also 50.0% of those who experienced physical violence in the current pregnancy expressed the view that physical violence can be excusable. Most of the women (65.8% either kept the incidence of abuse secret or just did nothing. None reported to the police. Conclusion: Spousal physical abuse is still prevalent in our society. There is need to enlighten the women on this phenomenon in order to get their cooperation towards its eradication. [TAF Prev Med Bull 2012; 11(6.000: 731-736

  11. Investigating spousal concordance of diabetes through statistical analysis and data mining.

    Directory of Open Access Journals (Sweden)

    Jong-Yi Wang

    Full Text Available Spousal clustering of diabetes merits attention. Whether old-age vulnerability or a shared family environment determines the concordance of diabetes is also uncertain. This study investigated the spousal concordance of diabetes and compared the risk of diabetes concordance between couples and noncouples by using nationally representative data.A total of 22,572 individuals identified from the 2002-2013 National Health Insurance Research Database of Taiwan constituted 5,643 couples and 5,643 noncouples through 1:1 dual propensity score matching (PSM. Factors associated with concordance in both spouses with diabetes were analyzed at the individual level. The risk of diabetes concordance between couples and noncouples was compared at the couple level. Logistic regression was the main statistical method. Statistical data were analyzed using SAS 9.4. C&RT and Apriori of data mining conducted in IBM SPSS Modeler 13 served as a supplement to statistics.High odds of the spousal concordance of diabetes were associated with old age, middle levels of urbanization, and high comorbidities (all P < 0.05. The dual PSM analysis revealed that the risk of diabetes concordance was significantly higher in couples (5.19% than in noncouples (0.09%; OR = 61.743, P < 0.0001.A high concordance rate of diabetes in couples may indicate the influences of assortative mating and shared environment. Diabetes in a spouse implicates its risk in the partner. Family-based diabetes care that emphasizes the screening of couples at risk of diabetes by using the identified risk factors is suggested in prospective clinical practice interventions.

  12. Spousal Concordance of Diabetes Mellitus among Women in Ajman, United Arab Emirates.

    Science.gov (United States)

    Al-Sharbatti, Shatha S; Abed, Yasmeen I; Al-Heety, Lujain M; Basha, Shaikh A

    2016-05-01

    Spousal concordance is defined as similar behaviours and associated health statuses between spouses. This study aimed to identify the concordance of diabetes mellitus (DM) and related variables among genetically unrelated couples in Ajman, United Arab Emirates (UAE). This cross-sectional study included 270 married women attending either the Mushairef Health Center or the Gulf Medical College Hospital in Ajman between May and November 2012. A validated questionnaire was designed to determine sociodemographic characteristics and a history or family history of DM, hypertension, coronary artery disease or dyslipidaemia among the women and their husbands. The weight, height, body mass index, waist circumference, fasting blood sugar and glycated haemoglobin (HbA1c) levels of all women were measured. Of the women, 39.3% of those with diabetic husbands and 39.9% of those with non-diabetic husbands were diabetic themselves (P >0.050). The prevalence of DM spousal concordance was 17.8%. A history of hypertension, coronary artery disease and dyslipidaemia was significantly more frequent among women whose husbands had a history of the same conditions (P = 0.001, 0.040 and 0.002, respectively). Spousal concordance of abnormal glycaemia among non-diabetic women with diabetic husbands was significant (P = 0.001). Having a diabetic husband (P = 0.006) and being obese (P = 0.009) were the only significant predictors of hyperglycaemia among non-diabetic women after controlling for confounding factors. There was significant concordance of abnormal glycaemia among non-diabetic women with diabetic husbands. The spouses of diabetic patients may therefore be a target population for regular hyperglycaemia and DM screening.

  13. Predictors of Secondary Role Strains Among Spousal Caregivers of Older Adults With Functional Disability.

    Science.gov (United States)

    Polenick, Courtney A; DePasquale, Nicole

    2018-01-08

    Aging spouses commonly care for a partner with functional disability, but little is known about how spousal caregiving may impact different life domains. This study evaluated how caregiving characteristics are associated with secondary role strains among spousal caregivers. This cross-sectional study examined 367 spousal caregivers and their partners from the 2011 National Health and Aging Trends Study and National Study of Caregiving. Hierarchical regressions were estimated to determine how caregiver background factors (sociodemographics, health conditions) along with primary objective (care activities, care recipient health conditions, and dementia status) and subjective (emotional caregiving difficulties, role overload) stressors are linked to care-related valued activity restriction, negative caregiving relationship quality, and care-related family disagreements. Gender differences were considered. After accounting for all predictors, older caregivers and caregivers providing more help with activities of daily living and health system interactions (e.g., scheduling appointments) were more likely to report activity restriction, whereas caregivers with more emotional difficulties reported higher negative caregiving relationship quality. Role overload was positively associated with all three secondary strains. For husbands only, caring for a partner with more chronic conditions was linked to higher negative caregiving relationship quality and caring for a partner with dementia was associated with a greater likelihood of family disagreements. Secondary role strains may develop through similar and unique pathways for caregiving wives and husbands. Further research is needed to identify those who could benefit from support in managing their care responsibilities alongside other life areas. © The Author(s) 2018. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  14. Medical Care Tasks among Spousal Dementia Caregivers: Links to Care-Related Sleep Disturbances.

    Science.gov (United States)

    Polenick, Courtney A; Leggett, Amanda N; Maust, Donovan T; Kales, Helen C

    2018-05-01

    Medical care tasks are commonly provided by spouses caring for persons living with dementia (PLWDs). These tasks reflect complex care demands that may interfere with sleep, yet their implications for caregivers' sleep outcomes are unknown. The authors evaluated the association between caregivers' medical/nursing tasks (keeping track of medications; managing tasks such as ostomy care, intravenous lines, or blood testing; giving shots/injections; and caring for skin wounds/sores) and care-related sleep disturbances. A retrospective analysis of cross-sectional data from the 2011 National Health and Aging Trends Study and National Study of Caregiving was conducted. Spousal caregivers and PLWDs/proxies were interviewed by telephone at home. The U.S. sample included 104 community-dwelling spousal caregivers and PLWDs. Caregivers reported on their sociodemographic and health characteristics, caregiving stressors, negative caregiving relationship quality, and sleep disturbances. PLWDs (or proxies) reported on their health conditions and sleep problems. Caregivers who performed a higher number of medical/nursing tasks reported significantly more frequent care-related sleep disturbances, controlling for sociodemographic and health characteristics, caregiving stressors, negative caregiving relationship quality, and PLWDs' sleep problems and health conditions. Post hoc tests showed that wound care was independently associated with more frequent care-related sleep disturbances after accounting for the other medical/nursing tasks and covariates. Spousal caregivers of PLWDs who perform medical/nursing tasks may be at heightened risk for sleep disturbances and associated adverse health consequences. Interventions to promote the well-being of both care partners may benefit from directly addressing caregivers' needs and concerns about their provision of medical/nursing care. Copyright © 2018 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights

  15. Sexual Scripts and Criminal Statutes: Gender Restrictions, Spousal Allowances, and Victim Accountability After Rape Law Reform.

    Science.gov (United States)

    Levine, Ethan Czuy

    2018-03-01

    The author provides a mixed-methods assessment of U.S. rape statutes to assess progress in reform. Contemporary statutes offer restrictive frameworks for distinguishing criminal from noncriminal sexual violence, many of which are grounded in gendered and heterosexist assumptions. Fourteen states retain gender restrictions in rape statutes. Twenty maintain marital distinctions that limit accountability for spousal rape. Furthermore, whereas explicit resistance requirements have been eliminated nationwide, implicit resistance expectations manifest through emphasis on physical force and involuntary intoxication. Analyses conclude with recommendations for further legal reform and a discussion of the potential for legislation to affect broader social perceptions of rape.

  16. Talking about Sexuality and Intimacy with Women Spousal Caregivers: Perspectives of Service Providers.

    Science.gov (United States)

    Brotman, Shari; Drummond, Jennifer; Silverman, Marjorie; Sussman, Tamara; Orzeck, Pam; Barylak, Lucy; Wallach, Isabelle; Billette, Veronique

    2016-11-20

    This article reports the findings of an exploratory study examining service provider perceptions and experiences of addressing sexuality and intimacy with women spousal caregivers. The caregiver-provider encounter is examined, and challenges faced by service providers in addressing sexuality are considered. Themes identified include ambivalence and discomfort, personal and institutional barriers, meanings attributed to sexuality and intimacy, and lack of opportunities to discuss experiences. Strategies to overcome silence and invisibility on the part of service providers in the health and social services system are considered. © 2016 National Association of Social Workers.

  17. 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.

  18. 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....

  19. 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...

  20. 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...

  1. 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.

  2. Is Women's Empowerment Associated With Help-Seeking for Spousal Violence in India?

    Science.gov (United States)

    Rowan, Kathleen; Mumford, Elizabeth; Clark, Cari Jo

    2018-05-01

    Violence against women by their husbands is a problem for women worldwide. However, the majority of women do not seek help. This article presents findings from a national survey in India on empowerment-related correlates of help-seeking behaviors for currently married women who experienced spousal violence. We examined individual-, relationship-, and state-level measures of empowerment on help-seeking from informal and formal sources. Findings indicate that help-seeking is largely not associated with typical measures of empowerment or socio-economic development, whereas state-level indicators of empowerment may influence help-seeking. Although not a target of this study, we also note that injury from violence and the severity of the violence were among the strongest factors related to seeking help. Taken together, the low prevalence of help-seeking and lack of strong individual-level correlates, apart from severe harm, suggests widespread barriers to seeking help. Interventions that affect social norms and reach women and men across social classes in society are needed in addition to any individual-level efforts to promote seeking help for spousal violence.

  3. The impact of dementia and mild memory impairment (MMI) on intimacy and sexuality in spousal relationships.

    Science.gov (United States)

    Davies, Helen D; Newkirk, Lori A; Pitts, Christiane B; Coughlin, Christine A; Sridhar, Sneha B; Zeiss, L McKenzie; Zeiss, Antonette M

    2010-06-01

    Sexuality and intimacy in couples in which one partner is affected by dementia has been widely researched. Few studies have explored these issues in couples where one partner is affected by mild memory impairment (MMI) or mild cognitive impairment (MCI). The objectives of this study were to (1) identify and contrast issues of intimacy and sexuality that spousal caregivers of persons with MMI and dementia may experience, and (2) identify future lines of research in this population. Fourteen dementia and nine MMI spousal caregivers participated in focus groups conducted between 2008 and 2009 at the Stanford/VA Alzheimer's Research Center. Content analyses were conducted to identify themes. Five themes emerged: communication, marital cohesion, affectional expression, caregiver burden, and ambiguity concerning the future of the relationship. Dementia caregivers reported more difficulties with communication, cohesion, and perceptions of increased burden than their MMI counterparts. Both groups indicated reduced sexual expression due to physical limitations; substitute activities including hand-holding, massaging, and hugging were noted. Both groups reported difficulty anticipating the future of the relationship due to present stressors. While dementia caregivers could consider future romantic relationships with others, MMI caregivers were primarily able to consider future relationships only for companionship and emotional intimacy. Early therapeutic interventions may assist couples in modifying activities, behaviors, and expectations about the future of the relationship. Such modifications may help maintain relationship satisfaction, decrease burden, preserve quality of life, and delay time-to-placement. Extending time-to-placement could have cost savings implications for families and the healthcare system.

  4. Compassionate Love in Individuals With Alzheimer's Disease and Their Spousal Caregivers: Associations With Caregivers' Psychological Health.

    Science.gov (United States)

    Monin, Joan K; Schulz, Richard; Feeney, Brooke C

    2015-12-01

    To examine whether compassionate love in both individuals with Alzheimer's disease (AD) and their spousal caregivers related to less caregiving burden, more positive caregiving appraisals, and less depressive symptoms for caregivers. Fifty-eight individuals with AD and their spousal caregivers participated in interviews in which both partners reported their compassionate love for their partner, and caregivers self-reported burden, positive appraisals of caregiving, and depressive symptoms. As hypothesized, both AD individuals' and caregivers' compassionate love were associated with less burden and more positive appraisals of caregiving. Also, care givers' compassionate love mediated the association between AD individuals' compassionate love and caregivers' burden as well as the association between AD individuals' compassionate love and caregivers' positive appraisals of caregiving. Finally, there was a marginally significant association between caregivers' compassionate love and less caregiver depressive symptoms. Results suggest that AD individuals' compassionate love is related to compassionate love in caregivers, which in turn relates to reduced burden but not significantly less depressive symptoms for caregivers. Assessing caregivers' and AD individuals' feelings of compassionate love may be useful in identifying caregivers who are resilient and those who are at a heightened risk for caregiving burden. Also, interventions that enhance both partners' compassionate love may benefit caregivers. © The Author 2014. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  5. Do Afterlife Beliefs Affect Psychological Adjustment to Late-Life Spousal Loss?

    Science.gov (United States)

    2014-01-01

    Objectives. We explore whether beliefs about the existence and nature of an afterlife affect 5 psychological symptoms (anxiety, anger, depression, intrusive thoughts, and yearning) among recently bereaved older spouses. Method. We conduct multivariate regression analyses using data from the Changing Lives of Older Couples (CLOC), a prospective study of spousal loss. The CLOC obtained data from bereaved persons prior to loss and both 6 and 18 months postloss. All analyses are adjusted for health, sociodemographic characteristics, and preloss marital quality. Results. Bleak or uncertain views about the afterlife are associated with multiple aspects of distress postloss. Uncertainty about the existence of an afterlife is associated with elevated intrusive thoughts, a symptom similar to posttraumatic distress. Widowed persons who do not expect to be reunited with loved ones in the afterlife report significantly more depressive symptoms, anger, and intrusive thoughts at both 6 and 18 months postloss. Discussion. Beliefs in an afterlife may be maladaptive for coping with late-life spousal loss, particularly if one is uncertain about its existence or holds a pessimistic view of what the afterlife entails. Our findings are broadly consistent with recent work suggesting that “continuing bonds” with the decedent may not be adaptive for older bereaved spouses. PMID:23811692

  6. 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.

  7. 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.

  8. 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.

  9. Put Yourself in My Work Shoes: Variations in Work-Related Spousal Support for Professional Married Coworkers

    Science.gov (United States)

    Janning, Michelle

    2006-01-01

    Level and type of spousal shared work has been oversimplified in past research. This research proposes that being similar to a spouse, in the case of paid work, differs depending on whether spouses share workplace, occupation, or both. And this level and type of similarity can influence the level and qualitative characteristics of work-related…

  10. Food Selectivity, Mealtime Behavior Problems, Spousal Stress, and Family Food Choices in Children with and without Autism Spectrum Disorder

    Science.gov (United States)

    Curtin, C.; Hubbard, K.; Anderson, S. E.; Mick, E.; Must, A.; Bandini, L. G.

    2015-01-01

    Mealtime behavior problems and family stress occur frequently among families of children with autism spectrum disorder (ASD). However, it is unknown whether food selectivity is an associated factor. The associations of high food selectivity with mealtime behavior problems, spousal stress, and influence on family members were assessed among 53…

  11. The Effects of Forgiveness Therapy on Depression, Anxiety, and Posttraumatic Stress for Women after Spousal Emotional Abuse

    Science.gov (United States)

    Reed, Gayle L.; Enright, Robert D.

    2006-01-01

    Emotionally abused women experience negative psychological outcomes long after the abusive spousal relationship has ended. This study compares forgiveness therapy (FT) with an alternative treatment (AT; anger validation, assertiveness, interpersonal skill building) for emotionally abused women who had been permanently separated for 2 or more years…

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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 ...

  17. 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.

  18. Examining the relationship between spousal involvement in Gam-Anon and relapse behaviors in pathological gamblers.

    Science.gov (United States)

    Zion, M M; Tracy, E; Abell, N

    1991-06-01

    The present investigation focused on Gamblers Anonymous (GA) members in Ohio to ascertain whether or not spousal participation in Gam-Anon, the companion support group, decreased the gambler's relapse into gambling behavior. A cross-sectional survey of 43 GA members was conducted using a self-administered questionnaire. While no significant difference was found in the relapse of those gamblers with or without a spouse in Gam-Anon, the degree to which the gambler had engaged in other addictive-like behaviors in the past did appear to be related to relapse. Those gamblers who had not relapsed reported significantly more engagement in past addictive-like behaviors (excessive overeating, drinking, and using drugs) than those who had relapsed. Additionally, their spouses had also engaged in addictive-like behaviors in the past. Discussion suggests possible explanations for the findings. Implications are drawn for both outcome measures and research with self-help groups.

  19. Risk Factors for Spousal Physical Violence Against Women in Saudi Arabia.

    Science.gov (United States)

    Eldoseri, Halah M; Sharps, Phyllis

    2017-03-01

    This study aimed to explore selected risk factors for spousal physical violence (SPV) in women frequenting primary health care clinics (PHCs) in Saudi Arabia. A cross-sectional study design was conducted in six PHCs, where one-on-one, private interviews with 200 women were conducted using a standardized World Health Organization (WHO) violence against women questionnaire (v.10.0). SPV was reported by 45.5% of women. Husband-specific risk factors including alcohol or drug addiction, unemployment, control of wealth in the family, and physical aggression toward other men were significant predictors for SPV. A multisectoral approach should be implemented with focus on providers' training, women's safety, and involvement of men in violence prevention and intervention programs.

  20. 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.

  1. Effects of Individual, Spousal, and Offspring Socioeconomic Status on Mortality Among Elderly People in China

    Directory of Open Access Journals (Sweden)

    Lei Yang

    2016-11-01

    Full Text Available Background: The relationship between socio-economic status and health among elderly people has been well studied, but less is known about how spousal or offspring’s education affects mortality, especially in non-Western countries. We investigated these associations using a large sample of Chinese elderly. Methods: The data came from the Chinese Longitudinal Healthy Longevity Survey (CLHLS from the years 2005 to 2011 (n = 15 355, aged 65–105 years at baseline; 5046 died in 2008, and 2224 died in 2011. Educational attainment, occupational status, and household income per capita were used as indicators of socio-economic status. Spousal and offspring’s education were added into the final models. The Cox proportional hazards model was used to study mortality risk by gender. Results: Adjusted for age, highly educated males and females had, on average, 29% and 37% lower mortality risk, respectively, than those with a lower education. Particularly among men, this effect was observed among those whose children had intermediate education only. A higher household income was also associated with lower mortality risk among the elderly. Male elderly living with a well-educated spouse (HR 0.79; 95% CI, 0.64–0.99 had a lower mortality risk than those living with a low-educated spouse. Conclusions: Both the socio-economic status of the individual and the educational level of a co-resident spouse or child are associated with mortality risk in elderly people. The socio-economic position of family members plays an important role in producing health inequality among elderly people.

  2. The self-management balancing act of spousal care partners in the case of Parkinson's disease.

    Science.gov (United States)

    Berger, Sue; Chen, Tiffany; Eldridge, Jenna; Thomas, Cathi A; Habermann, Barbara; Tickle-Degnen, Linda

    2017-12-12

    Living with and caring for someone with chronic illness can lead to limitations in activity and social participation for the care partner. Past research emphasizes the importance of care partners taking care of themselves physically and emotionally so they can stay healthy to support the care recipient. There is little information regarding how the care partner takes care of their own social lives. The purpose of this study was to explore the concept of social self-management from the perspective of spousal care partners of people with Parkinson's disease. Twenty spousal care partners of people with Parkinson's disease were interviewed three times. A grounded theory approach informed data analysis. Findings that emerged from the data focused on balance in activities, support, and emotions and were summarized into three main themes: (1) Activities: Caregiving and beyond; (2) Strategies to support self and spouse; and (3) Emotional impact: Burden and compassion. This research shows that care partners want to retain social participation and provides support for the importance of addressing the socio-emotional needs of care partners of people with a chronic disease. Interventions that guide care partners to take care of their spectrum of needs may lead to healthier, positive relationships. Implications for rehabilitation The focus of rehabilitation is often on the person diagnosed with the chronic condition. Living with and caring for someone with a chronic illness, such as Parkinson's disease, can lead to limitations in activity and social participation for the care partner. Including care partners in the rehabilitation process is key to helping maintain their health and well-being. Learning caregiving and self-management strategies may help care partners support their loved ones while staying socially engaged.

  3. Spousal concordance and reliability of the 'Prudence Score' as a summary of diet and lifestyle.

    Science.gov (United States)

    Parekh, Sanjoti; King, David; Owen, Neville; Jamrozik, Konrad

    2009-08-01

    This paper describes a composite 'Prudence Score' summarising self-reported behavioural risk factors for non-communicable diseases. If proved robust, the 'Prudence score' might be used widely to encourage large numbers of individuals to adopt and maintain simple, healthy changes in their lifestyle. We calculated the 'Prudence Score' based on responses collected in late 2006 to a postal questionnaire sent to 225 adult patients aged 25 to 75 years identified from the records of two general medical practices in Brisbane, Australia. Participants completed the behavioural, dietary and lifestyle items in relation to their spouse as well as themselves. The spouse or partner of each addressee completed their own copy of the study questionnaire. Kappa scores for spousal concordance with probands' reports (n = 45 pairs) on diet-related items varied between 0.35 (for vegetable intake) to 0.77 (for usual type of milk consumed). Spousal concordance values for other behaviours were 0.67 (physical activity), 0.82 (alcohol intake) and 1.0 (smoking habits). Kappa scores for test-retest reliability (n = 53) varied between 0.47 (vegetable intake) and 0.98 (smoking habits). The veracity of self-reported data is a challenge for studies of behavioural change. Our results indicate moderate to substantial agreement from life partners regarding individuals' self-reports for most of the behavioural risk items included in the 'Prudence Score'. This increases confidence that key aspects of diet and lifestyle can be assessed by self-report. The 'Prudence Score' potentially has wide application as a simple and robust tool for health promotion programs.

  4. 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.

  5. Women’s opinion on the justification of physical spousal violence: A quantitative approach to model the most vulnerable households in Bangladesh

    OpenAIRE

    Biswas, Raaj Kishore; Rahman, Nusma; Kabir, Enamul; Raihan, Farabi

    2017-01-01

    Bangladesh is a culturally conservative nation with limited freedom for women. A number of studies have evaluated intimate partner violence (IPV) and spousal physical violence in Bangladesh; however, the views of women have been rarely discussed in a quantitative manner. Three nationwide surveys in Bangladesh (2007, 2011, and 2014) were analyzed in this study to characterize the most vulnerable households, where women themselves accepted spousal physical violence as a general norm. 31.3%, 31....

  6. 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.

  7. 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'.

  8. 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

  9. 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...

  10. 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...

  11. 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.

  12. 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

  13. 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 ...

  14. 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.

  15. 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...

  16. The temporal relationship between change in symptoms of prolonged grief and posttraumatic stress following old age spousal bereavement

    DEFF Research Database (Denmark)

    O Connor, Maja; Nickerson, Angela; Aderka, Idan M.

    2015-01-01

    Background: High levels of both prolonged grief symptoms (PGS) and posttraumatic stress symptoms (PTSS) are relatively common following bereavement, and the two types of bereavement complications share some of the same features. Little research has studied which of the two precedes the other...... following the death of a loved one. The purpose of this study was to examine the temporal relationship between change in high levels of PGS and PTSS during the first four years following old age spousal loss. Methods: Participants were 237 Danes (40% male; mean age = 73 years, SD = 4.4; range 65-81) who....... Results: Lower-level mediation analyses wereas performed. Results indicated that PGS mediated 83% of the relationship between time and PTSS, while PTSS only mediated 17% of the relationship between time and PGS. These results suggest that changes in PGS mediated changes in PTSS following spousal...

  17. Spousal caregivers and persons with dementia: Increasing participation in shared leisure activities among hospital-based dementia support program participants.

    Science.gov (United States)

    DiLauro, Michelle; Pereira, Amanda; Carr, Jennifer; Chiu, Mary; Wesson, Virginia

    2015-02-20

    Spousal caregivers of persons with dementia often have difficulty engaging persons with dementia in leisure activities. This qualitative descriptive study identifies how caregivers perceive their spouses' participation in leisure activities since dementia onset and the professional guidance caregivers require to increase persons with dementia participation in shared leisure activities. Nine spousal caregivers from a hospital-based caregiver intervention attended one of three focus groups. Using symbolic interactionism and selective optimization with compensation theory as guiding frameworks, thematic content analysis was performed. Three major themes were identified: Recognizing and acknowledging changes, Making sense of changes and conflicts, and Embracing changes and forging ahead. Findings can be used by healthcare providers to better understand caregivers' needs for engaging persons with dementia in shared leisure activities, and inform development of feedback protocols to enhance caregiver interventions. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  18. Women's opinion on the justification of physical spousal violence: A quantitative approach to model the most vulnerable households in Bangladesh.

    Science.gov (United States)

    Biswas, Raaj Kishore; Rahman, Nusma; Kabir, Enamul; Raihan, Farabi

    2017-01-01

    Bangladesh is a culturally conservative nation with limited freedom for women. A number of studies have evaluated intimate partner violence (IPV) and spousal physical violence in Bangladesh; however, the views of women have been rarely discussed in a quantitative manner. Three nationwide surveys in Bangladesh (2007, 2011, and 2014) were analyzed in this study to characterize the most vulnerable households, where women themselves accepted spousal physical violence as a general norm. 31.3%, 31.9% and 28.7% women in the surveys found justification for physical violence in household in 2007, 2011 and 2014 respectively. The binary logistic model showed wealth index, education of both women and their partner, religion, geographical division, decision making freedom and marital age as significant household contributors for women's perspective in all the three years. Women in rich households and the highly educated were found to be 40% and 50% less likely to accept domestic physical violence compared to the poorest and illiterate women. Similarly, women who got married before 18 years were 20% more likely accept physical violence in the family as a norm. Apart from these particular groups (richest, highly educated and married after 18 years), other groups had around 30% acceptance rate of household violence. For any successful attempt to reduce spousal physical violence in the traditional patriarchal society of Bangladesh, interventions must target the most vulnerable households and the geographical areas where women experience spousal violence. Although this paper focuses on women's attitudes, it is important that any intervention scheme should be devised to target both men and women.

  19. Role of spousal involvement in continuous positive airway pressure (CPAP adherence in patients with obstructive sleep apnea (OSA

    Directory of Open Access Journals (Sweden)

    Batool-Anwar S

    2017-05-01

    Full Text Available Introduction: Little is known about the impact of spousal involvement on continuous positive airway pressure (CPAP adherence. The aim of this study was to determine whether spouse involvement affects adherence with CPAP therapy, and how this association varies with gender. Methods: 194 subjects recruited from Apnea Positive Pressure Long Term Efficacy Study (APPLES completed the Dyadic Adjustment Scale (DAS. The majority of participants were Caucasian (83%, and males (73%, with mean age of 56 years, mean BMI of 31 kg/m2. & 62% had severe OSA. The DAS is a validated 32-item self-report instrument measuring dyadic consensus, satisfaction, cohesion, and affectional expression. A high score in the DAS is indicative of a person’s adjustment to the marriage. Additionally, questions related to spouse involvement with general health and CPAP use were asked. CPAP use was downloaded from the device and self-report, and compliance was defined as usage > 4 h per night. Results: There were no significant differences in overall marital quality between the compliant and noncompliant subjects. However, level of spousal involvement was associated with increased CPAP adherence at 6 months (p=0.01. After stratifying for gender these results were significant only among males (p=0.03. Three years after completing APPLES, level of spousal involvement was not associated with CPAP compliance even after gender stratification. Conclusion: Spousal involvement is important in determining CPAP compliance in males in the 1st 6 months after initiation of therapy but is not predictive of longer-term adherence. Involvement of the spouse should be considered an integral part of CPAP initiation procedures.

  20. Women's opinion on the justification of physical spousal violence: A quantitative approach to model the most vulnerable households in Bangladesh.

    Directory of Open Access Journals (Sweden)

    Raaj Kishore Biswas

    Full Text Available Bangladesh is a culturally conservative nation with limited freedom for women. A number of studies have evaluated intimate partner violence (IPV and spousal physical violence in Bangladesh; however, the views of women have been rarely discussed in a quantitative manner. Three nationwide surveys in Bangladesh (2007, 2011, and 2014 were analyzed in this study to characterize the most vulnerable households, where women themselves accepted spousal physical violence as a general norm. 31.3%, 31.9% and 28.7% women in the surveys found justification for physical violence in household in 2007, 2011 and 2014 respectively. The binary logistic model showed wealth index, education of both women and their partner, religion, geographical division, decision making freedom and marital age as significant household contributors for women's perspective in all the three years. Women in rich households and the highly educated were found to be 40% and 50% less likely to accept domestic physical violence compared to the poorest and illiterate women. Similarly, women who got married before 18 years were 20% more likely accept physical violence in the family as a norm. Apart from these particular groups (richest, highly educated and married after 18 years, other groups had around 30% acceptance rate of household violence. For any successful attempt to reduce spousal physical violence in the traditional patriarchal society of Bangladesh, interventions must target the most vulnerable households and the geographical areas where women experience spousal violence. Although this paper focuses on women's attitudes, it is important that any intervention scheme should be devised to target both men and women.

  1. 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.

  2. Daily goal progress is facilitated by spousal support and promotes psychological, physical, and relational well-being throughout adulthood

    Science.gov (United States)

    Jakubiak, Brittany K.; Feeney, Brooke C.

    2016-01-01

    In two daily-diary studies, we tested the consequences and precursors of daily goal progress throughout the adult lifespan. Attachment theory posits that exploration—including the pursuit of autonomous goals—promotes well-being across the lifespan and is facilitated by support from close others. For both young-adult newlyweds (Study 1) and married couples in late adulthood (Study 2), daily independent goal progress predicted same-day and next-day improvements in psychological, physical, and relational well-being. Specifically, when participants made more progress on their goals than usual on one day, they reported increases in positive affect, sleep quality, and relationship quality, and decreased physical symptoms, the following day (as well as concurrently). Additionally, spousal support (i.e., availability, encouragement, and noninterference) enabled same-day and next-day goal progress. Mediational analyses showed indirect links between spousal support and well-being through goal progress. Some effects were moderated by attachment orientation in the newlywed sample; individuals with greater insecure attachment benefited most from goal progress, and spousal support enabled goal progress most strongly for individuals with less anxious attachment. Overall, these results support and extend attachment theoretical propositions regarding the importance of the exploration system across the adult lifespan. They contribute to existing literature by demonstrating wide-ranging consequences of successful exploration for well-being and by providing evidence for the importance of both exploration and support for exploration into late adulthood. PMID:27560610

  3. 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.

  4. 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 ...

  5. 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

  6. 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

  7. 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...

  8. 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.

  9. [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.

  10. 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.

  11. 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

  12. 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)

  13. 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.

  14. [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.

  15. 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).

  16. 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.

  17. 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).

  18. 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.

  19. 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.

  20. Protective buffering and emotional desynchrony among spousal caregivers of cancer patients.

    Science.gov (United States)

    Langer, Shelby L; Rudd, Michael E; Syrjala, Karen L

    2007-09-01

    To examine protective buffering and emotional desynchrony among spousal caregivers of cancer survivors. Repeated measures; 42 caregivers engaged in 2 videotaped, oral emotional expression exercises: 1 in the presence of their patient and 1 in the absence of their patient. Felt emotion (self-report) and expressed emotion (lexical expression or words uttered and coder-derived facial expression). Other measures assessed mental and physical health, dyadic satisfaction, and dispositional emotional inhibition. Protective buffering differed by communicative channel (lexical vs. facial). Caregivers' facial expressions were more positive when the patient was present versus absent. In contrast, the valence of caregivers' words did not differ per patient presence. Facial protective buffering was unrelated to health and dyadic outcomes. Lexical protective buffering was inversely related to both caregiver and patient marital satisfaction. Dispositional emotional inhibition was inversely related to caregiver mental health and marital satisfaction. Desynchrony occurred when the patient was present but was counter to prediction; felt emotion was more positive than expressed emotion. Results provide behavioral evidence of facial protective buffering. To the extent that lexical buffering occurs, it poses a dyadic risk, and chronic inhibition poses both psychological and dyadic risks. Future research is needed to refine the operational definition of desynchrony and to examine the biopsychosocial sequelae of buffering. (PsycINFO Database Record (c) 2007 APA, all rights reserved).

  1. Spousal concordance in the use of alternative tobacco products: A multi-country investigation.

    Science.gov (United States)

    Roberts, Megan E; Banse, Rainer; Ebbeler, Christine; Ferketich, Amy K

    2017-02-01

    Married couples often share similar health-related characteristics and behaviors, including cigarette smoking status. Despite their rising popularity in the U.S., little research has examined the patterns of spousal concordance (SC) for alternative tobacco products (ATPs), such as e-cigarettes, cigars, and hookah. The purpose of this project was to examine the roles of age, gender, and culture in the strength of SC for these ATPs. Analyses focused on a diverse community sample of married individuals in Ohio, U.S. (N=278), but also examined patterns in Austria, Greece, Israel, the Netherlands, and Slovakia. All participants completed a survey in which they indicated both their own, and their spouse's ever-use of various tobacco products. For the U.S. sample, SC was highest for e-cigarettes, flavored e-cigarettes, flavored cigarettes, and hookah (ϕs=0.48- 0.61); SC appeared to be stronger among younger couples, and when there was only a small female vs. male differences in use. Similar patterns were found in the other countries, with a few key exceptions. In particular, there was low SC for e-cigarettes and flavored e-cigarettes in the other countries, where e-cigarettes had been federally regulated by the time of data collection. Overall, these findings have implications for the continued spreading popularity of these tobacco use behaviors. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  2. The impact of spousal bereavement on hospitalisations: Evidence from the Scottish Longitudinal Study.

    Science.gov (United States)

    Tseng, Fu-Min; Petrie, Dennis; Wang, Shaolin; Macduff, Colin; Stephen, Audrey I

    2018-02-01

    This paper estimates the impact of spousal bereavement on hospital inpatient use for the surviving bereaved by following the experience of 94,272 married Scottish individuals from 1991 until 2009 using a difference-in-difference model. We also consider the sample selection issues related to differences in survival between the bereaved and non-bereaved using a simple Cox Proportional-Hazard model. Before conducting these estimations, propensity score approaches are used to re-weight the non-bereaved to generate a more random-like comparison sample for the bereaved. We find that those bereaved who survive are both more likely to be admitted and to stay longer in hospital than a comparable non-bereaved cohort. Bereavement is estimated to induce on average an extra 0.24 (95% CI [0.15, 0.33]) hospital inpatient days per year. Similar to previous studies, we estimate the bereaved have a 19.2% (95% CI [12.5%, 26.3%]) higher mortality rate than the comparable non-bereaved cohort. Copyright © 2017 John Wiley & Sons, Ltd.

  3. 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.

  4. Exposure to Spousal Violence in the Family, Attitudes and Dating Violence Perpetration Among High School Students in Port-au-Prince.

    Science.gov (United States)

    Gage, Anastasia J

    2016-09-01

    This study examined the associations of exposure to spousal violence in the family and personal and peer attitudes with dating violence (DV) perpetration among high school students in Port-au-Prince, Haiti. Participants were 342 high school students in Grades 10 to 12 who stated that they had ever been on a date. Multiple linear regression methods were used to examine correlates of the scale of DV perpetration. Findings showed that personal acceptance of DV mediated the association between exposure to wife-perpetrated and husband-perpetrated spousal violence in the family and DV perpetration for girls. Boys who were exposed to husband-perpetrated spousal violence in the family had significantly higher levels of psychological DV perpetration than those who were not. Contrary to expectations, exposure to wife-perpetrated spousal violence in the family was negatively associated with psychological and physical/sexual DV perpetration by boys, after controlling for other factors. Overall, perceived peer tolerance of DV was more strongly associated with DV perpetration than personal tolerance of DV, and was the only significant correlate of psychological DV perpetration for girls. Perceived peer attitudes also moderated the association between boys' exposure to spousal violence in the family and DV perpetration. Implications for future research and policy are discussed. © The Author(s) 2015.

  5. 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

  6. 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.

  7. 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...

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. Role of humoral immune reactions as target for antirejection therapy in recipients of a spousal-donor kidney graft.

    Science.gov (United States)

    Böhmig, G A; Regele, H; Säemann, M D; Exner, M; Druml, W; Kovarik, J; Hörl, W H; Zlabinger, G J; Watschinger, B

    2000-04-01

    Excellent graft outcome has been reported for spousal-donor kidney transplantation. In husband-to-wife transplantation, however, a tendency toward inferior graft survival has been described for recipients who were previously pregnant. In our series of spousal-kidney transplantations (nine transplantations; three female recipients), actual graft survival is 100% (median observation time, 339 days). Five patients experienced early allograft rejection. In four transplant recipients, rejection was easily reversible by conventional antirejection therapy. In a multiparous recipient, however, mild interstitial allograft rejection associated with early graft dysfunction was resistant to anticellular treatment (antilymphocyte antibody, tacrolimus rescue therapy). The particular finding of polymorphonuclear neutrophils in peritubular capillaries and the finding of diffuse capillary deposits of the complement split product, C4d, in a posttransplantation biopsy specimen suggested a role of antibody-mediated graft injury. Retrospective flow cytometry cross-matching showed the presence of preformed immunoglobulin G (IgG) antibodies to HLA class I antigens that were not detectable by pretransplantation lymphocytotoxic cross-match testing or screening for panel reactive antibodies. After transplantation, however, complement-fixing antibodies, also presumably triggered by reexposure to spousal-donor HLA antigens, could be detected in the patient's serum. These findings suggested antibody-mediated allograft rejection and led to the initiation of immunoadsorption therapy (14 sessions) with staphylococcal protein A. Selective removal of recipient IgG resulted in complete reversal of graft dysfunction. Our findings suggest that in husband-to-wife transplantation, donor-specific antibodies, presumably triggered by previous pregnancies, might occasionally induce sustained allograft dysfunction. Thus, in this particular setting, a detailed immunologic and histopathologic work-up regarding

  16. Pathways to Police Contact for Spousal Violence Survivors: The Role of Individual and Neighborhood Factors in Survivors' Reporting Behaviors.

    Science.gov (United States)

    Barrett, Betty Jo; Peirone, Amy; Cheung, Chi Ho; Habibov, Nazim

    2017-09-01

    Rational choice theory proposes that spousal violence survivors engage in a cost-benefit analysis when determining whether to contact the police in the aftermath of violence. Feminist intersectional frameworks contend that the perceived costs and benefits of police intervention differ among survivors based on their intersecting social identities. Normative theory further posits that it is not solely individual factors but also social norms derived from one's neighborhood context that may be related to reporting practices. Consistent with these perspectives, this study assessed the association between spousal violence survivors' sociodemographic, violence, and neighborhood characteristics and (a) police contact, (b) pathways to police contact, (c) motivations for contacting the police, and (d) motivations for not contacting the police. Data were drawn from the 2009 Canadian General Social Survey-Victimization main file, and included male and female survivors ( N = 890). Survivors most commonly contacted the police to stop the violence (89.4%) and most commonly did not contact the police because they did not believe it was important enough (35.3%). Results of multivariate regression analysis indicate that survivors who were visible minority, those who feared for their lives, and those who were injured were significantly more likely to self-report violence to police. Survivors were more likely to say the violence was not important enough to report if there was a police station in their neighborhood, and were less likely to say that violence was not important enough to report if they had experienced multiple incidents of violence. Implications for policing and criminal justice system engagement with spousal violence survivors are provided.

  17. 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.

  18. Relationships among spousal communication, self-efficacy, and motivation among expectant Latino fathers who smoke.

    Science.gov (United States)

    Khaddouma, Alexander; Gordon, Kristina Coop; Fish, Laura J; Bilheimer, Alicia; Gonzalez, Alicia; Pollak, Kathryn I

    2015-10-01

    Cigarette smoking is a prevalent problem among Latinos, yet little is known about what factors motivate them to quit smoking or make them feel more confident that they can. Given cultural emphases on familial bonds among Latinos (e.g., familismo), it is possible that communication processes among Latino spouses play an important role. The present study tested a mechanistic model in which perceived spousal constructive communication patterns predicted changes in level of motivation for smoking cessation through changes in self-efficacy among Latino expectant fathers. Latino males (n = 173) and their pregnant partners participated in a couple-based intervention targeting males' smoking. Couples completed self-report measures of constructive communication, self-efficacy (male partners only), and motivation to quit (male partners only) at 4 time points throughout the intervention. Higher levels of perceived constructive communication among Latino male partners predicted subsequent increases in male partners' self-efficacy and, to a lesser degree, motivation to quit smoking; however, self-efficacy did not mediate associations between constructive communication and motivation to quit smoking. Furthermore, positive relationships with communication were only significant at measurements taken after completion of the intervention. Female partners' level of perceived constructive communication did not predict male partners' outcomes. These results provide preliminary evidence to support the utility of couple-based interventions for Latino men who smoke. Findings also suggest that perceptions of communication processes among Latino partners (particularly male partners) may be an important target for interventions aimed at increasing desire and perceived ability to quit smoking among Latino men. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

  19. Does Spousal Support Can Increase the Women’s Physical Activity?

    Directory of Open Access Journals (Sweden)

    Hajar Rezaee

    2017-04-01

    Full Text Available Background: Numerous benefits of physical activity are well-known for the prevention and treatment of various diseases such as diabetes, cardiovascular disease, obesity, and cancers. However, the status of physical activities among women remains noticeably less than the recommended level. Considering the importance of the spouses’ participation in the promotion of women’s health, this study examined the impact of spousal support on women’s physical activity. Methods: This semi--experimental study was done in February 2015 on 100 couples in reproductive age referred to health centers of Falavarjan city. The participants were randomly divided into intervention and control groups. The information related to women’s physical activity in both groups was collected by aquestionnaire in two steps, before and three months after the intervention. The spouses of women in the intervention group were trained in the field of the importance of physical activity in women’s health in two sessions. The data were analyzed by the software SPSS21 and suitable statistical tests (Independent t, paired t, and Chi-square. Results: The mean and standard deviation of women’s age in the both groups were 28.76±5.51 and 30.38±5.31, respectively. The prevalence of obesity and overweight in the women under the study was generally estimated 44%. Physical activities of women in the intervention group were significantly increased after the intervention (P<0.0001. Also, the Body Mass Index in the intervention group was significantly decreased compared to before the intervention and control group (P<0.001. Conclusion: Spouses could encourage women to perform physical activities. It is recommended that the health care system should implement educational sessions for men to encourage women to exercise.

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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...

  9. 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

  10. 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

  11. Changing spousal roles and their effect on recovery in gamblers anonymous: GamAnon, social support, wives and husbands.

    Science.gov (United States)

    Ferentzy, Peter; Skinner, Wayne; Antze, Paul

    2010-09-01

    This paper examines changing spousal roles and their effects upon recovery in Gamblers Anonymous (GA). It is based upon a qualitative study designed to gage uniformity as well as variations in approaches to recovery in GA. Interviews were conducted with 39 GA members (26 men, 13 women; mean age 56.5 years). Though the study was based in the Toronto area, only 13 interviews involved participants from that region. Phone interviews were conducted with GA members from various regions of both Canada and the US. GamAnon, GA's sister fellowship, has been designed for anyone affected seriously by someone's gambling problem. In practice, GamAnon comprises mostly women--spouses of male GA members--who traditionally have taken a keen interest in the ways in which their husbands achieve and maintain abstinence from gambling. Changing spousal roles have led to fewer women joining GamAnon, as many opt instead to part with troubled spouses. As well, more women are attending GA than in the past, typically with husbands who are disinclined to join GamAnon. All of this has drastically altered how GA members pursue recovery. These changes and their implications are discussed.

  12. Do changes in spousal employment status lead to domestic violence? Insights from a prospective study in Bangalore, India.

    Science.gov (United States)

    Krishnan, Suneeta; Rocca, Corinne H; Hubbard, Alan E; Subbiah, Kalyani; Edmeades, Jeffrey; Padian, Nancy S

    2010-01-01

    The prevalence of physical domestic violence--violence against women perpetrated by husbands--is staggeringly high across the Indian subcontinent. Although gender-based power dynamics are thought to underlie women's vulnerability, relatively little is known about risk and protective factors. This prospective study in southern India examined the association between key economic aspects of gender-based power, namely spousal employment status, and physical domestic violence. In 2005-2006, 744 married women, aged 16-25, residing in low-income communities in Bangalore, India were enrolled in the study. Data were collected at enrollment, 12 and 24 months. Multivariable logistic regression models were used to examine the prospective association between women's employment status, their perceptions of their husband's employment stability, and domestic violence. Women who were unemployed at one visit and began employment by the next visit had an 80% higher odds of violence, as compared to women who maintained their unemployed status. Similarly, women whose husbands had stable employment at one visit and newly had difficulty with employment had 1.7 times the odds of violence, as compared to women whose husbands maintained their stable employment. To our knowledge, this study is the first from a developing country to confirm that changes in spousal employment status are associated with subsequent changes in violence risk. It points to the complex challenges of violence prevention, including the need for interventions among men and gender-transformative approaches to promote gender-equitable attitudes, practices and norms among men and women.

  13. Caregiving burden and psychological distress in Chinese spousal caregivers: gender difference in the moderating role of positive aspects of caregiving.

    Science.gov (United States)

    Wong, Daniel Fu Keung; Ng, Ting Kin; Zhuang, Xiao Yu

    2018-05-21

    This study endeavors to advance the current literature by examining the gender differences in the caregiving experiences and the stress-buffering role of positive aspects of caregiving (PAC) among Chinese spousal caregivers of frail elders in Hong Kong. Forty-nine husband caregivers and 121 wife caregivers of frail elders in Hong Kong (N = 170) responded to the Positive Aspects of Caregiving (PAC) scale, the Zarit Burden Interview (ZBI), the 21-item Depression, Anxiety, and Stress Scales (DASS-21), and demographic questions. These spousal caregivers were diverse in age, and their care receivers were diverse in terms of age and health condition. As predicted, there were significant gender differences in the moderating effects of PAC on the relationships of caregiving burden to depression, anxiety, and overall psychological distress. While PAC significantly buffered the effects of caregiving burden on depression, anxiety, and overall psychological distress for wife caregivers, the moderating effects of PAC were not significant for husband caregivers. Unexpectedly, wife caregivers reported lower PAC, higher caregiving burden, and higher psychological distress. As these findings suggest that PAC is lower but more beneficial for Chinese wife caregivers than Chinese husband caregivers, helping professionals are recommended to use strengths-based interventions that target PAC when working with Chinese wife caregivers.

  14. Spousal Caregiving for Partners With Dementia: A Deductive Literature Review Testing Calasanti's Gendered View of Care Work.

    Science.gov (United States)

    Hong, Sung-Chull; Coogle, Constance L

    2016-07-01

    Spousal caregiving allows stressed couples to continue living in the community rather than seeking institutional solutions. Dr. Toni Calasanti has postulated that there are gender differences in the care work styles and coping strategies used by spousal caregivers dealing with dementia. While caregiving husbands tend to adopt task-oriented (masculine) approaches, caregiving wives are more likely to take an emotionally focused (feminine) orientation. These differences result in the need for varied interventions. Male caregivers tend toward a managerial approach, whereas female caregivers generally adopt a relational approach. This distinction was examined in the course of a literature review through the deductive process. It was determined that the core thesis of such a gender-based view of care work as a tiered entity threaded with masculinity/femininity remains quite plausible in contrast to models based on self-perceived gender identity of caregivers that require more exploration. Recommendations for future investigations are offered as new questions arise. © The Author(s) 2014.

  15. Compassionate Love in Individuals With Alzheimer’s Disease and Their Spousal Caregivers: Associations With Caregivers’ Psychological Health

    Science.gov (United States)

    Monin, Joan K.; Schulz, Richard; Feeney, Brooke C.

    2015-01-01

    Purpose of the Study: To examine whether compassionate love in both individuals with Alzheimer’s disease (AD) and their spousal caregivers related to less caregiving burden, more positive caregiving appraisals, and less depressive symptoms for caregivers. Design and Methods: Fifty-eight individuals with AD and their spousal caregivers participated in interviews in which both partners reported their compassionate love for their partner, and caregivers self-reported burden, positive appraisals of caregiving, and depressive symptoms. Results: As hypothesized, both AD individuals’ and caregivers’ compassionate love were associated with less burden and more positive appraisals of caregiving. Also, care givers’ compassionate love mediated the association between AD individuals’ compassionate love and caregivers’ burden as well as the association between AD individuals’ compassionate love and caregivers’ positive appraisals of caregiving. Finally, there was a marginally significant association between caregivers’ compassionate love and less caregiver depressive symptoms. Implications: Results suggest that AD individuals’ compassionate love is related to compassionate love in caregivers, which in turn relates to reduced burden but not significantly less depressive symptoms for caregivers. Assessing caregivers’ and AD individuals’ feelings of compassionate love may be useful in identifying caregivers who are resilient and those who are at a heightened risk for caregiving burden. Also, interventions that enhance both partners’ compassionate love may benefit caregivers. PMID:24534607

  16. 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...

  17. 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…

  18. 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.

  19. 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.

  20. 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...

  1. 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…

  2. 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 ...

  3. 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...

  4. 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

  5. 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 ...

  6. 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...

  7. Does a wife's education influence spousal agreement on approval of family planning?: Random-effects Modeling using data from two West African Countries.

    Science.gov (United States)

    Hossain, Mian; Ahmed, Saifuddin; Rogers, Laurencia

    2014-05-01

    Spousal approval of family planning is critical for contraceptive use. Both contraceptive use rates and women's education are low in many West-African countries and this study examines the role of wives' education in spousal agreement on approval of family planning in two sub-Saharan West African countries. We used couples' data from Demographic Health Surveys in Senegal and in Niger, conducted in 2005 and 2006, respectively. Multiple logistic regression results using multilevel modeling show that the odds of spousal agreement on approval of family planning were slightly over three times [OR: 3.16; 95% CI: 1.32 to 7.57] in Senegal and were about three times [OR: 3.07; 95% CI: 1.64 to 5.76] in Niger higher for women with more than primary education. Findings suggest that improvement in women's education could lead to spousal agreement on approval of family planning, which may lead to use of family planning in sub-Saharan African countries.

  8. Association between gap in spousal education and domestic violence in India and Bangladesh.

    Science.gov (United States)

    Rapp, Daniel; Zoch, Beate; Khan, M Mobarak H; Pollmann, Thorsten; Krämer, Alexander

    2012-06-21

    Domestic violence (DV) against women is a serious human rights abuse and well recognised global public health concern. The occurrence of DV is negatively associated with the educational level of spouses but studies dealing with educational discrepancies of spouses show contradicting results: Wives with higher education than their husbands were more likely to ever experience DV as compared to equally educated couples. The purpose of this study was to investigate the association between spousal education gap (SEG) and the prevalence and severity of DV in India and Bangladesh. Nationally representative data collected through the 2005/2006 Indian National Family Health Survey (NFHS-3) and 2007 Bangladesh Demographic and Health Survey (BDHS) were used. In total, we analysed data of 69,805 women aged 15-49 years (Bangladesh: 4,195 women, India: 65,610 women). In addition to univariate and bivariable analyses, a multinomial logistic regression model was used to quantify the association between education gap and less severe as well as severe domestic violence. Adjustment was made for age, religion, and family structure. Wives with higher education than their husbands were less likely to experience less severe (OR = 0.83, 95% CI: 0.77-0.89) and severe (OR = 0.79, 95% CI: 0.72-0.87) DV as compared to equally low-educated spouses (reference group). Equally high-educated couples revealed the lowest likelihood of experiencing DV (severe violence: OR 0.43, CI 0.39-0.48; less severe violence: OR 0.59, CI 0.55-0.63). The model's goodness of fit was low (Nagelkerke's R2 = 0.152). Our analysis revealed no increased DV among wives with a higher educational level than their husbands. Moreover, the results point towards a decrease of severe violence with an increase in education levels among spouses. However, the model did not explain a satisfying amount of DV. Therefore, further research should be done to reveal unknown determinants so that suitable interventions to reduce DV can be

  9. 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.

  10. 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.

  11. 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

  12. 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.

  13. 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.

  14. 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...

  15. 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.

  16. [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.

  17. 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...

  18. 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...

  19. 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.

  20. 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.

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Socioeconomic and Demographic Factors for Spousal Resemblance in Obesity Status and Habitual Physical Activity in the United States

    Directory of Open Access Journals (Sweden)

    Hsin-Jen Chen

    2014-01-01

    Full Text Available Studies suggested that the married population has an increased risk of obesity and assimilation between spouses’ body weight. We examined what factors may affect married spouses’ resemblance in weight status and habitual physical activity (HPA and the association of obesity/HPA with spouses’ sociodemoeconomic characteristics and lifestyles. Medical Expenditure Panel Survey data of 11,403 adult married couples in the US during years 2006–2008 were used. Absolute-scale difference and relative-scale resemblance indices (correlation and kappa coefficients in body mass index (BMI and HPA were estimated by couples’ socioeconomic and demographic characteristics. We found that spousal difference in BMI was smaller for couples with a lower household income, for who were both unemployed, and for older spouses. Correlation coefficient between spouses’ BMI was 0.24, differing by race/ethnicity and family size. Kappa coefficient for weight status (obesity: BMI ≥ 30, overweight: 30 > BMI ≥ 25 was 0.11 and 0.35 for HPA. Never-working women’s husbands had lower odds of obesity than employed women’s husbands (OR = 0.69 (95% CI = 0.53–0.89. Men’s unemployment status was associated with wives’ greater odds of obesity (OR = 1.31 (95% CI = 1.01–1.71. HPA was associated with men’s employment status and income level, but not with women’s. The population representative survey showed that spousal resemblance in weight status and HPA varied with socioeconomic and demographic factors.

  11. The role of marital quality and spousal support in behaviour problems of children with and without intellectual disability.

    Science.gov (United States)

    Wieland, Natalie; Baker, B L

    2010-07-01

    Children with intellectual disability (ID) have been found to be at an increased risk for developing behavioural problems. The purpose of this study was to examine the relationship between the marital domain, including marital quality and spousal support, and behaviour problems in children with and without ID. The relationship between the marital domain and child behaviour problems was examined in 132 families of 6-year-olds with and without ID. Using hierarchical regression, these relationships were also studied over time from child ages 6-8 years. Child behaviour problems were assessed with mother-reported Child Behavior Checklist. The marital domain was measured using the Dyadic Adjustment Scale-7 and the Spousal Support and Agreement Scale. Mother-reported parenting stress and observed parenting practices were tested as potential mediators of the relationship between the marital domain and child behaviour problems. Mean levels of the marital domain were not significantly different between typically developing (TD) and ID groups, but there were significantly greater levels of variance in reported marital quality in the ID group at ages 6, 7 and 8. The marital domain score at child age 6 years predicted child behaviour problems at age 8 for the TD group only. This predictive relationship appeared to be a unidirectional effect, as child behaviour problems at age 6 were not found to predict levels of the marital domain at age 8. Parenting stress partially mediated this relationship for the TD group. The marital domain may have a greater impact on behavioural outcomes for TD children. Implications for future research and interventions are discussed.

  12. MHC-Dependent Mate Selection within 872 Spousal Pairs of European Ancestry from the Health and Retirement Study

    Directory of Open Access Journals (Sweden)

    Zhen Qiao

    2018-01-01

    Full Text Available Disassortative mating refers to the phenomenon in which individuals with dissimilar genotypes and/or phenotypes mate with one another more frequently than would be expected by chance. Although the existence of disassortative mating is well established in plant and animal species, the only documented example of negative assortment in humans involves dissimilarity at the major histocompatibility complex (MHC locus. Previous studies investigating mating patterns at the MHC have been hampered by limited sample size and contradictory findings. Inspired by the sparse and conflicting evidence, we investigated the role that the MHC region played in human mate selection using genome-wide association data from 872 European American spouses from the Health and Retirement Study (HRS. First, we treated the MHC region as a whole, and investigated genomic similarity between spouses using three levels of genomic variation: single-nucleotide polymorphisms (SNPs, classical human leukocyte antigen (HLA alleles (both four-digit and two-digit classifications, and amino acid polymorphisms. The extent of MHC dissimilarity between spouses was assessed using a permutation approach. Second, we investigated fine scale mating patterns by testing for deviations from random mating at individual SNPs, HLA genes, and amino acids in HLA molecules. Third, we assessed how extreme the spousal relatedness at the MHC region was compared to the rest of the genome, to distinguish the MHC-specific effects from genome-wide effects. We show that neither the MHC region, nor any single SNPs, classic HLA alleles, or amino acid polymorphisms within the MHC region, were significantly dissimilar between spouses relative to non-spouse pairs. However, dissimilarity in the MHC region was extreme relative to the rest of genome for both spousal and non-spouse pairs. Despite the long-standing controversy, our analyses did not support a significant role of MHC dissimilarity in human mate choice.

  13. The Effects of the MORE Wisdom Resources on Spousal Caregivers' Life Satisfaction: An Application of the Resilience Model.

    Science.gov (United States)

    Kim, Seungyoun; Knight, Bob G

    2017-01-01

    Models of resilience suggest that psychosocial resources and their interactions facilitate resilience while experiencing life challenges of caregiving. The MORE wisdom resources (sense of Mastery, Openness to experience, Reflective attitude, and Emotion regulation) have been suggested as possible personal resources of resilience that predict positive health outcomes of caregivers. Applying a model of resilience, this study examined the direct and indirect effects of the three of the MORE wisdom resources (sense of Mastery, Openness to experience, and Emotion regulation) on caregiving spouses' life satisfaction and perceived physical health. Using data from the survey of Midlife in the United States, caregiving spouses (n = 114) and matched non-caregivers (n = 114) were included. We compared the direct and indirect effects of the wisdom resources on life satisfaction and physical health between the two groups. The simple mediation model proposed in 2008 by Preacher and Hayes revealed that openness to experience was directly associated with better life satisfaction among caregiving spouses. Sense of mastery and emotion regulation had indirect effects on life satisfaction through spousal support. The effects the wisdom resources on caregiving spouses' perceived physical health were not found. This study demonstrated that the three of the MORE wisdom resources are possible personal resilience factors influencing life satisfaction among caregiving spouses. Moreover, the study showed how spousal support mediates the relationship between the wisdom resources and life satisfaction. Interventions aiming to increase life satisfaction among caregiving spouses should focus on increasing both personal and environmental resources and strengthening the relationship of the caregiver and care recipient.

  14. 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.

  15. 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

  16. 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. 

  17. 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.

  18. Factors influencing the health-related quality of life of Chinese advanced cancer patients and their spousal caregivers: a cross-sectional study.

    Science.gov (United States)

    Li, Qiuping; Xu, Yinghua; Zhou, Huiya; Loke, Alice Yuen

    2016-08-02

    Cancer and its treatment have a major impact on the lives of patients and their intimate partners, such as on their health-related quality of life (HRQOL). The aims of this study are to: (i) assess the HRQOL of advanced cancer patients and spousal caregivers, and explore the relationship between the HRQOL of cancer patients and that of their spousal caregivers; (ii) detect factors influencing the HRQOL of cancer patients and spousal caregivers; and (iii) explore the impact of anxiety and depression on the HRQOL of couples. A total of 131 couples where one of the partners was hospitalized for advanced cancer were invited to complete a survey to assess their demographic and background information, HRQOL, and anxiety and depression. HRQOL was measured using the SF-12, while anxiety and depression were measured using the Hospital Anxiety and Depression Scale. Data were analyzed using a T-test, Pearson correlations, multiple linear regressions, and structural equation modeling. In general, the spousal caregivers had higher levels of HRQOL (seven out of eight SF-12 domains and two SF-12 dimensions) p = 0.038-0.000, anxiety (p = 0.002), and depression (p = 0.011) than patients. Correlations of HRQOL between patients and spouses were small to moderate (r = 0.193-0.398). Multiple independent factors influencing the physical component summary (PCS), mental component summary (MCS), vitality (VT), and role emotional (RE) sections of the SF-12 were identified, including: gender, time since diagnosis, levels of education, working status, the extent to which spousal caregivers were informed about the disease, improved marital relationship after the diagnosis of cancer, and anxiety and depression. For both patients and spousal caregivers, the strongest independent factor influencing HRQOL (SF-12 PCS, MCS, VT, and RE) was anxiety and depression. Anxiety and depression may have both actor and partner effects on the HRQOL of couples to various degrees. The findings of

  19. 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

  20. 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.

  1. 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.

  2. [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.

  3. 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.

  4. 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.

  5. Perceptions and receptivity of non-spousal family support: A mixed methods study of psychological distress among older, church-going African American men.

    Science.gov (United States)

    Watkins, Daphne C; Wharton, Tracy; Mitchell, Jamie A; Matusko, Niki; Kales, Helen

    2017-10-01

    The purpose of this study was to explore the role of non-spousal family support on mental health among older, church-going African American men. The mixed methods objective was to employ a design that used existing qualitative and quantitative data to explore the interpretive context within which social and cultural experiences occur. Qualitative data (n=21) were used to build a conceptual model that was tested using quantitative data (n= 401). Confirmatory factor analysis indicated an inverse association between non-spousal family support and distress. The comparative fit index, Tucker-Lewis fit index, and root mean square error of approximation indicated good model fit. This study offers unique methodological approaches to using existing, complementary data sources to understand the health of African American men.

  6. 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.

  7. Spousal overprotection is indirectly associated with poorer dietary adherence for patients with type 2 diabetes via diabetes distress when active engagement is low.

    Science.gov (United States)

    Johnson, Matthew D; Anderson, Jared R; Walker, Ann; Wilcox, Allison; Lewis, Virginia L; Robbins, David C

    2015-05-01

    The current study sought to explore the indirect association of spousal overprotection on patient dietary adherence through the mechanism of diabetes distress and whether the link between overprotection and diabetes distress was moderated by spouse active engagement. Participants were 117 married couples in which one member had been diagnosed with type 2 diabetes and were recruited from a patient registry at a Midwestern (USA) medical centre. Data were gathered from spouses and patients through a self-report survey instrument. The research questions were answered with structural equation modelling using the latent moderated structural equations (LMS) approach and dyadic data analytic procedures. Overprotection was associated with reduced dietary adherence indirectly via increased diabetes distress only at low levels of active engagement. The proposed model also proved superior when compared to two plausible alternatives. These findings highlight the importance of understanding the nuanced associations among the different ways spouses cope with illness to achieve better diabetes outcomes and the mechanisms responsible for linking coping and dietary adherence. Statement of contribution What is already known on this subject? Spousal coping behaviour can influence dietary adherence among patients diagnosed with type 2 diabetes, positively and negatively. Spouses simultaneously engage in different ways of coping with partner illness, but little is known about the interactive nature of coping styles or possible mechanisms that might link coping with illness outcomes. What does this study add? Spousal overprotection is only associated with reduced patient dietary adherence when spouses are also engaging in low levels of active engagement. Diabetes distress is an important mechanism linking spousal coping with patient dietary adherence. © 2014 The British Psychological Society.

  8. Women’s opinion on the justification of physical spousal violence: A quantitative approach to model the most vulnerable households in Bangladesh

    Science.gov (United States)

    2017-01-01

    Bangladesh is a culturally conservative nation with limited freedom for women. A number of studies have evaluated intimate partner violence (IPV) and spousal physical violence in Bangladesh; however, the views of women have been rarely discussed in a quantitative manner. Three nationwide surveys in Bangladesh (2007, 2011, and 2014) were analyzed in this study to characterize the most vulnerable households, where women themselves accepted spousal physical violence as a general norm. 31.3%, 31.9% and 28.7% women in the surveys found justification for physical violence in household in 2007, 2011 and 2014 respectively. The binary logistic model showed wealth index, education of both women and their partner, religion, geographical division, decision making freedom and marital age as significant household contributors for women’s perspective in all the three years. Women in rich households and the highly educated were found to be 40% and 50% less likely to accept domestic physical violence compared to the poorest and illiterate women. Similarly, women who got married before 18 years were 20% more likely accept physical violence in the family as a norm. Apart from these particular groups (richest, highly educated and married after 18 years), other groups had around 30% acceptance rate of household violence. For any successful attempt to reduce spousal physical violence in the traditional patriarchal society of Bangladesh, interventions must target the most vulnerable households and the geographical areas where women experience spousal violence. Although this paper focuses on women’s attitudes, it is important that any intervention scheme should be devised to target both men and women. PMID:29161277

  9. "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…

  10. 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.

  11. 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.

  12. 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.

  13. The difficulty of being a professional, a parent, and a spouse on the same day: Daily spillover of workplace interactions on parenting, and the role of spousal support.

    Science.gov (United States)

    Malinen, Kaisa; Rönkä, Anna; Sevón, Eija; Schoebi, Dominik

    2017-01-01

    Designing parenting interventions and preventions requires knowledge on the factors and processes that shape parenting behaviors. Using data collected over 10 days, during the last hour of work and before going to bed, this study examined the spillover of interpersonal work stresses into positive and negative parenting behaviors. Data were collected among 103 couples who had at least one child between the age of one and eight years. Of particular interest was the role of received emotional spousal support as a moderator of stress spillover. Dyadic variants of multilevel models were used to analyze the data. The results showed that on days on which mothers or fathers reported stressful interpersonal interactions in the workplace, they also reported less positive parenting behaviors. In addition, mothers reported more negative parenting behaviors on days characterized by these kinds of work experiences. Mothers and fathers were found to report more positive parenting behaviors, and mothers less negative parenting behaviors, on the days on which they received more spousal support. Received spousal support also moderated spillover of work stress into parenting behaviors and this finding was found to be gender-specific: for mothers, support enhanced spillover into positive behaviors, and for fathers, it enhanced spillover into negative parenting behaviors.

  14. 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...

  15. 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...

  16. 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...

  17. 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.

  18. 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.

  19. 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

  20. 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.

  1. [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.

  2. 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

  3. 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.

  4. "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.

  5. 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.

  6. 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...

  7. 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…

  8. 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…

  9. 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...

  10. 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...

  11. 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...

  12. 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.

  13. 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...

  14. 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…

  15. 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…

  16. 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

  17. 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. ...

  18. 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 ...

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. 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 ...

  4. 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...

  5. 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 ...

  6. 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…

  7. Avoidant coping partially mediates the relationship between patient problem behaviors and depressive symptoms in spousal Alzheimer caregivers.

    Science.gov (United States)

    Mausbach, Brent T; Aschbacher, Kirstin; Patterson, Thomas L; Ancoli-Israel, Sonia; von Känel, Roland; Mills, Paul J; Dimsdale, Joel E; Grant, Igor

    2006-04-01

    Caring for a loved one with Alzheimer disease is a highly stressful experience that is associated with significant depressive symptoms. Previous studies indicate a positive association between problem behaviors in patients with Alzheimer disease (e.g., repeating questions, restlessness, and agitation) and depressive symptoms in their caregivers. Moreover, the extant literature indicates a robust negative relationship between escape-avoidance coping (i.e., avoiding people, wishing the situation would go away) and psychiatric well-being. The purpose of this study was to test a mediational model of the associations between patient problem behaviors, escape-avoidance coping, and depressive symptoms in Alzheimer caregivers. Ninety-five spousal caregivers (mean age: 72 years) completed measures assessing their loved ones' frequency of problem behaviors, escape-avoidance coping, and depressive symptoms. A mediational model was tested to determine if escape-avoidant coping partially mediated the relationship between patient problem behaviors and caregiver depressive symptoms. Patient problem behaviors were positively associated with escape-avoidance coping (beta = 0.38, p avoidance coping was positively associated with depressive symptoms (beta = 0.33, p avoidance coping. Sobel's test confirmed that escape-avoidance coping significantly mediated the relationship between problem behaviors and depressive symptoms (z = 2.07, p avoidance coping partially mediates the association between patient problem behaviors and depressive symptoms among elderly caregivers of spouses with dementia. This finding provides a specific target for psychosocial interventions for caregivers.

  8. An exploration of spousal separation and adaptation to long-term disability: six elderly couples engaged in a horticultural programme.

    Science.gov (United States)

    Martin, Linda; Miranda, Baldwin; Bean, Michelle

    2008-01-01

    The main objective of the present study was to explore the impact of separation on couples where one spouse lives in a skilled nursing facility and the other spouse lives alone in the community. Six couples participated in a 10-week gardening group. Semi-structured interviews were conducted at the beginning of the study and observations were made and discussions engaged through the 10-week horticultural programme. Thematic analysis of interviews and discussions revealed reduced social participation of community-dwelling spouses in an effort to maintain their marital role. In one or more cases the non-institutionalized spouse adapted to separation by developing social roles and relationships within the skilled nursing facility and continuing as a caregiver to their spouse. Occupational therapists are encouraged to include spouses in programmes to nurture healthy spousal roles. Further research is needed to explore how elderly couples may support each other through purposeful occupation while one spouse is in a long-term care facility. (c) 2007 John Wiley & Sons, Ltd.

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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.

  14. 5 CFR 1650.63 - Executive Director's exception to the spousal notification requirement.

    Science.gov (United States)

    2010-01-01

    ... be submitted to the TSP record keeper on the appropriate TSP paper form, accompanied by the following... spouse, declare the participant's inability to locate the spouse, state the last time the spouse's...

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. Long-term effects of the Family Bereavement Program on spousally bereaved parents: Grief, mental health problems, alcohol problems, and coping efficacy.

    Science.gov (United States)

    Sandler, Irwin; Tein, Jenn-Yun; Cham, Heining; Wolchik, Sharlene; Ayers, Tim

    2016-08-01

    This study reports on the findings from a 6-year follow-up of a randomized trial of the Family Bereavement Program (FBP) on the outcomes for spousally bereaved parents. Spousally bereaved parents (N = 131) participated in the trial in which they were randomly assigned to receive the FBP (N = 72) or literature control (N = 59). Parents were assessed at four time points: pretest, posttest, and 11-month and 6-year follow-up. They reported on mental health problems, grief, and parenting at all four time periods. At the 6-year follow-up, parents reported on additional measures of persistent complex bereavement disorder, alcohol abuse problems, and coping efficacy. Bereaved parents in the FBP as compared to those in the literature control had lower levels of symptoms of depression, general psychiatric distress, prolonged grief, and alcohol problems, and higher coping efficacy (for mothers) at the 6-year follow-up. Multiple characteristics of the parent (e.g., gender, age, and baseline mental health problems) and of the spousal death (e.g., cause of death) were tested as moderators of program effects on each outcome, but only 3 of 45 tests of moderation were significant. Latent growth modeling found that the effects of the FBP on depression, psychiatric distress, and grief occurred immediately following program participation and were maintained over 6 years. Mediation analysis found that improvement in positive parenting partially mediated program effects to reduce depression and psychiatric distress, but had an indirect effect to higher levels of grief at the 6-year follow-up. Mediation analysis also found that improved parenting at the 6-year follow-up was partially mediated by program effects to reduce depression and that program effects to increase coping efficacy at the 6-year follow-up was partially mediated through reduced depression and grief and improved parenting. FBP reduced mental health problems, prolonged grief, and alcohol abuse, and increased coping

  8. Brief Report: Relationships Among Spousal Communication, Self-Efficacy, and Motivation Among Expectant Latino Fathers Who Smoke

    Science.gov (United States)

    Khaddouma, Alexander; Gordon, Kristina Coop; Fish, Laura J.; Bilheimer, Alecia; Gonzalez, Alecia; Pollak, Kathryn I.

    2015-01-01

    Objective Cigarette smoking is a prevalent problem among Latinos, yet little is known about what factors motivate them to quit smoking or make them feel more confident that they can. Given cultural emphases on familial bonds among Latinos (e.g., familismo), it is possible that communication processes among Latino spouses play an important role. The present study tested a mechanistic model in which perceived spousal constructive communication patterns predicted changes in level of motivation for smoking cessation through changes in self-efficacy among Latino expectant fathers. Methods Latino males (n = 173) and their pregnant partners participated in a couple-based intervention targeting males’ smoking. Couples completed self-report measures of constructive communication, self-efficacy (male partners only), and motivation to quit (male partners only) at four time points throughout the intervention. Results Higher levels of perceived constructive communication among Latino male partners predicted subsequent increases in male’s partners’ self-efficacy and, to a lesser degree, motivation to quit smoking; however, self-efficacy did not mediate associations between constructive communication and motivation to quit smoking. Furthermore, positive relationships with communication were only significant at measurements taken after completion of the intervention. Female partners’ level of perceived constructive communication did not predict male partners’ outcomes. Conclusion These results provide preliminary evidence to support the utility of couple-based interventions for Latino men who smoke. Findings also suggest that perceptions of communication processes among Latino partners (particularly male partners) may be an important target for interventions aimed increasing desire and perceived ability to quit smoking among Latino men. PMID:25844907

  9. 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

  10. 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.

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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 ...

  16. 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 ...

  17. 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...

  18. 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 –.

  19. 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.

  20. 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 ...

  1. [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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. THE WORTH OF WIVES: 1950s Corporate America “Discovers” Spousal Social Capital

    Directory of Open Access Journals (Sweden)

    Christiane Diehl Taylor

    2008-01-01

    Full Text Available Social capital is an asset that is generated by the relationship between individuals within a social structure. It allows individuals to achieve goals that are unachievable in its absence or achievable only at higher cost. Wives are a form of social capital, and although they have contributed to the success of their husbands and their firms ever since the nineteenth century, corporations only began to acknowledge their worth during the 1950s. This company recognition arose out of the prevalence of large corporations and bureaucratic practices, corporate decentralization, concerns over frill-employment and unionization, the emphasis on human relations, and the early rumblings of the modern-day womens movement.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

    The aim of this systematic review is to establish the best available evidence of the effectiveness of health literacy interventions on the informed consent process for health care users. The specific review question is:What is the effectiveness of health literacy interventions on health care users' informed consent to health procedures processes? Informed consent is a fundamental principal in the health care context which nowadays includes the patient's capacity to judge and to be involved in the decision making concerning their care that ensures that the care received reflects their goals, preferences and values. The importance of obtaining a valid consent before any medical procedure is well-established. In a US court case in 1914, it was stated that it is the right of any adult with the capability of making decisions concerning his own body, and that any surgical operation without the patient's consent could be considered as an assault. In another US court case, the court stated that it is a doctor's duty to make a reasonable disclosure to his patient of the nature, probable consequences and dangers of the proposed treatment to the patient. The application of the doctrine of informed consent as a legal procedure may slightly differ from country to country or from state to state, and may have different forms even within the same country. For example in the UK, consent can be written, verbal or non-verbal/implied, and a written consent form is not the actual consent itself but merely serves as evidence that consent has been given. If the elements of voluntariness, appropriate information and capacity have not been satisfied, a signed informed consent form will not make the consent valid. Nowadays it is widely accepted that prior to the application of any medical procedure, its benefits, risks and alternatives must have been explained to the patient, and the competent patient should have voluntarily and understandingly consented. Hence, the informed consent refers

  12. "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.

  13. 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

  14. 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.

  15. 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.

  16. 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

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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...

  8. A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting.

    Science.gov (United States)

    Addissie, Adamu; Davey, Gail; Newport, Melanie J; Addissie, Thomas; MacGregor, Hayley; Feleke, Yeweyenhareg; Farsides, Bobbie

    2014-05-02

    Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia. Mixed methods research using a sequential explanatory approach was conducted from July to September 2012, including 241 cross-sectional, self-administered and 19 qualitative, in-depth interviews among health researchers and regulators including ethics committee members in Ethiopian health research institutions and universities. In their evaluation of the consent process, only 40.2% thought that the consent process and information given were adequately understood by study participants; 84.6% claimed they were not satisfied with the current consent process and 85.5% thought the best interests of study participants were not adequately considered. Commonly mentioned consent-related problems included lack of clarity (48.1%), inadequate information (34%), language barriers (28.2%), cultural differences (27.4%), undue expectations (26.6%) and power imbalances (20.7%). About 95.4% believed that consent should be contextualized to the study setting and 39.4% thought REA would be an appropriate approach to improve the perceived problems. Qualitative findings helped to further explore the gaps identified in the quantitative findings and to map-out concerns related to the current research consent process in Ethiopia. Suggestions included, conducting REA during the pre-test (pilot) phase of studies when applicable. The need for clear guidance for researchers on issues such as when and how to apply the REA tools was stressed. The study findings clearly indicated that there are perceived to be correctable gaps in the consent process of medical research in Ethiopia. REA is considered relevant by researchers and stakeholders

  9. Development of a Web-based surgical booking and informed consent system to reduce the potential for error and improve communication.

    Science.gov (United States)

    Siracuse, Jeffrey J; Benoit, Eric; Burke, Janet; Carter, Steven; Schwaitzberg, Steven D

    2014-03-01

    The decision to perform an elective procedure often originates during an office visit between surgeon and patient. Several administrative tasks follow, including scheduling or "booking" of the case and obtaining informed consent. These processes require communicating accurate information regarding diagnosis, procedure, and other patient-specific details necessary for the safe and effective performance of an operation. Nonstandardized and paper-based consents pose difficulty with legibility, portability, and consistency, thereby representing a source of potential error and inefficiency. There are numerous barriers to efficiently booking elective surgical procedures and obtaining a legible, complete, and easily retrievable informed consent. An integrated Web-based booking and consent system was developed at a multisite university-affiliated community hospital system to improve the speed and quality of work flow, as well as communication with both the patients and staff. A booking and consent system was developed and made available over the intranet. This customized system was created by leveraging existing information systems. The electronic consent system uses surgeon-specific templates and allows for a consistent approach to each procedure. A printed consent form can be generated at any time from any of the health care system's three campuses and is commonly stored in the electronic medical record. Integration into our perioperative system allows for coordination with the operating room staff, administrative personal, financial coordinators, and central supply. Total systems expenditure for development was estimated at $40,000 (US). Organizations considering standardizing their own consent and operating room booking processes can review this experience in making their own "make or buy" decision for their own settings.

  10. [Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

    Science.gov (United States)

    Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

    2018-01-01

     Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

  11. Informed consent for clinical trials of deep brain stimulation in psychiatric disease: challenges and implications for trial design.

    Science.gov (United States)

    Lipsman, Nir; Giacobbe, Peter; Bernstein, Mark; Lozano, Andres M

    2012-02-01

    Advances in neuromodulation and an improved understanding of the anatomy and circuitry of psychopathology have led to a resurgence of interest in surgery for psychiatric disease. Clinical trials exploring deep brain stimulation (DBS), a focally targeted, adjustable and reversible form of neurosurgery, are being developed to address the use of this technology in highly selected patient populations. Psychiatric patients deemed eligible for surgical intervention, such as DBS, typically meet stringent inclusion criteria, including demonstrated severity, chronicity and a failure of conventional therapy. Although a humanitarian device exemption by the US Food and Drug Administration exists for its use in obsessive-compulsive disorder, DBS remains a largely experimental treatment in the psychiatric context, with its use currently limited to clinical trials and investigative studies. The combination of a patient population at the limits of conventional therapy and a novel technology in a new indication poses interesting challenges to the informed consent process as it relates to clinical trial enrollment. These challenges can be divided into those that relate to the patient, their disease and the technology, with each illustrating how traditional conceptualisations of research consent may be inadequate in the surgical psychiatry context. With specific reference to risk analysis, patient autonomy, voluntariness and the duty of the clinician-researcher, this paper will discuss the unique challenges that clinical trials of surgery for refractory psychiatric disease present to the consent process. Recommendations are also made for an ethical approach to clinical trial consent acquisition in this unique patient population.

  12. Spousal Conflicts of Interest

    Science.gov (United States)

    Lewis, Shana R.

    2005-01-01

    Romantic relationships bud and sometimes bloom in the school district workplace. When those relationships involve a sitting member of a school board or an administrator with responsibility for managing other employees, questions about a conflict of interest will be raised. Most states have laws prohibiting a public official from taking official…

  13. The two-year incidence of depression and anxiety disorders in spousal caregivers of persons with dementia: who is at the greatest risk?

    Science.gov (United States)

    Joling, Karlijn J; van Marwijk, Harm W J; Veldhuijzen, Aaltje E; van der Horst, Henriëtte E; Scheltens, Philip; Smit, Filip; van Hout, Hein P J

    2015-03-01

    Caregivers of persons with dementia play an important and economically valuable role within society, but many may do so at a considerable cost to themselves. Knowing which caregivers have the highest risk of developing a mental disorder may contribute to better support of ultra-high-risk groups with preventive interventions. This study aims to describe the incidence of depression and anxiety disorders in caregivers and to identify its significant predictors. Prospective cohort study with a follow-up of 24 months. 181 spousal caregivers of persons with dementia without a clinical depression or anxiety disorder at baseline. Memory clinics, case management services, and primary care settings in the Netherlands. The onset of depression and anxiety was measured every 3 months with the MINI International Neuropsychiatric Interview, a structured diagnostic instrument for DSM-IV mental disorders. Potential predictors were assessed at baseline. 60% of the caregivers developed a depressive and/or anxiety disorder within 24 months: 37% a depression, 55% an anxiety disorder, and 32% both disorders. Sub-threshold depressive symptoms (Wald χ2=6.20, df=1, OR: 3.2, 95% CI: 1.28-8.03, p=0.013) and poor self-reported health of the caregiver (Wald χ2=5.56, df=1, OR: 1.17, 95% CI: 1.03-1.34, p=0.018) at baseline were significant predictors of disorder onset. Spousal caregivers of persons with dementia have a high risk to develop a mental disorder. Indicators related to the caregiver's (mental) health rather than environmental stressors such as patient characteristics or interruption of caregivers' daily activities predict disorder onset and can be used to identify caregivers for whom supporting preventive interventions are indicated. Copyright © 2015 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

  14. Long-term outcomes of renal transplants from spousal and living-related and other living-unrelated donors: a single center experience.

    Science.gov (United States)

    Kute, Vivek B; Shah, Pankaj R; Vanikar, Aruna V; Gumber, Manoj R; Goplani, Kamal R; Patel, Himanshu V; Munjappa, Bipin C; Trivedi, Hargovind L; Modi, Pranjal R; Shah, Veena R

    2012-07-01

    Deceased donor organ shortage has made living donors (LD) major source for renal transplantation (RTx) in India. Spouses represent an important source of allograft. We carried out a retrospective study of spousal RTx vs. other LDRTx to compare long-term results. This retrospective single-center study was undertaken to evaluate demographic, patient survival, graft survival, function vis-à-vis serum creatinine (SCr) and rejection episodes in 1523 living donor renal allograft recipients from 1998 to 2009. It included spouse donors (n=337) (group 1), living related donors (LRD) (n=969) (group 2), and living unrelated donors (LUD) (n=217) (group 3). Mean recipient age (years +/- SD)) was 41.48 +/- 8.87, 30.49 +/- 10.61, and 37.13 +/- 13.25, respectively for the three groups who were followed for 4.47 +/- 3.03, 4.47 +/- 3.0 and 5.15 +/- 3.28 years respectively. Female donors were 92.6%, 66.4%, and 41%, mean HLA match was 1.15 +/- 0.93, 3 +/- 1.05 and 1.30 +/- 1.08 respectively. One, 5 and 12 year graft survivals among group 1 were 91.39%, 75.49%, and 73.13%; 90.98%, 74.10% and 64.57% in group 2 and 94.92%, 82.86% and 70.31% in group 3. Patient survival for 1, 5 and 12 years were 89.31%, 72.55% and 66.58% in group 1, 93.57%, 82.25% and 72.23% in group 2, and 92.62%, 79.76% and 66.79% in group 3. Acute rejections were noted in 16.6%, 15.8% and 17% respectively. In circumstances of organ shortage andunavailability of well developed ABO incompatible transplants, spousal donation is viable option.

  15. Facing Spousal Cancer During Child-Rearing Years: Do Social Support and Hardiness Moderate the Impact of Psychological Distress on Quality of Life?

    Science.gov (United States)

    Senneseth, Mette; Hauken, May A; Matthiesen, Stig B; Gjestad, Rolf; Laberg, Jon C

    Partners of cancer patients report psychological distress and reduced quality of life. However, partners' mental health status and quality of life during child-rearing years and the influence of social support and hardiness on their well-being have not yet been studied. The aim of this study was to describe psychological distress, quality of life, social support, and hardiness of the partners facing spousal cancer during child-rearing years and investigate whether social support or hardiness moderated the relationship between psychological distress and quality of life. Cross-sectional data were collected in Norway from December 2013 to July 2015 as part of the Cancer-PEPSONE study. Five questionnaires were administered to 14 females and 21 males (n = 35). Participants reported more psychological distress and lower quality-of-life scores than other healthy Norwegian populations. Psychological distress seemed to be associated with their not being in control of their futures. Received social support moderated the effect of psychological distress on quality of life. Facing spousal cancer during child-rearing years seemed to have a substantial impact on partners' mental health and an adverse impact on their quality of life. Accordingly, these partners' self-care abilities may be reduced. Received social support may reduce the multiple burdens and consequently allow for enhancement of self-care. Interventions should aim to improve the social support provided to child-rearing partners, which may improve their quality of life. Providing adequate information about their partner's cancer illness and treatment may enhance their feelings of control, which may be beneficial for their mental health status.

  16. Consent to research by mentally ill children and adolescents: The ...

    African Journals Online (AJOL)

    2013-03-01

    Mar 1, 2013 ... permissible in minors be stated in terms of well-defined risk standards. Finally, the ... The assessment of a mentally ill child's or adolescent's capacity to consent to ... 'mental healthcare' may include research; furthermore its repeated ..... Clinical response and risk of reported suicidal ideation and suicide ...

  17. 41 CFR 60-30.13 - Consent findings and order.

    Science.gov (United States)

    2010-07-01

    ... Administrative Law Judge after consideration of the nature of the proceeding, the requirments of the public... to the Administrative Law Judge for his consideration; (2) Inform the Administrative Law Judge that... 41 Public Contracts and Property Management 1 2010-07-01 2010-07-01 true Consent findings and...

  18. Towards guidelines for informed consent for prospective stem cell ...

    African Journals Online (AJOL)

    2015-08-02

    Aug 2, 2015 ... of genes that reactivate the embryonic genetic programme.[5,6]. We, and many ... ever more complex and multifaceted ethical issues, many of which require new guidelines, consent protocols and even change in legislation, since they do not ..... Progress and prospects in stem cells therapy. Acta. Pharmacol ...

  19. 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.

  20. Informed consent and medical ordeal: a qualitative study.

    Science.gov (United States)

    Little, M; Jordens, C F C; McGrath, C; Montgomery, K; Lipworth, W; Kerridge, I

    2008-08-01

    Informed consent is a mainstay of clinical practice, with both moral and legal forces. Material disclosure about extreme treatments, however, is unlikely to convey the full impact of the experience of treatment. Informed consent may be flawed under such circumstances. The aims of this study were to compare expressed satisfaction with pretreatment information to satisfaction after experiencing autologous stem cell transplantation for recurrent lymphoma. A qualitative, narrative-based cohort study was conducted in a bone-marrow transplant unit of a teaching hospital at Westmead Hospital, Sydney, Australia. The cohort consisted of 10 transplant recipients and 9 of their nominated lay carers. The outcome measure was satisfaction expressed in narrative interviews at the time of transplantation and 3 months later. We used discourse-analytic techniques to examine the narratives. Both patients and carers expressed high satisfaction with the information given by individual clinicians and by speakers at a formal Information Day held before transplantation. At the first interview, neither patients nor carers commented much on the forthcoming ordeal of chemotherapy and bone marrow ablation, although all patients had undergone previous chemotherapy. At the second interview, the ordeal dominated the narratives and retrospective dissatisfaction with information was common. This study suggests that information about treatment theories and protocols can be satisfactorily communicated, but personal experience of suffering defies communication. This finding has serious implications for the practices involved in obtaining informed consent and for the very notion of informed consent.

  1. 40 CFR 26.1116 - General requirements for informed consent.

    Science.gov (United States)

    2010-07-01

    ... PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides... informed consent. No investigator may involve a human being as a subject in research covered by this... subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution...

  2. An ethical framework for sharing patient data without consent

    Directory of Open Access Journals (Sweden)

    Robert Navarro

    2008-12-01

    Discussion The hard problem of non-consented data sharing should be divided into the easier (though non-trivial ones of data and recipient breach risk measurement. Directed research in these two areas will help move the data sharing problem into the 'solved' pile.

  3. 16 CFR 1605.13 - Procedures for Consent Order Agreements.

    Science.gov (United States)

    2010-01-01

    ... executed by a person, sole proprietorship, partnership, or corporation (Consenting Party) and a Commission... staff, with the approval of the Commission may propose to the person, sole proprietorship, partnership..., sole proprietorship, partnership, or corporation. (c) Upon receiving an executed agreement, the...

  4. Informed consent in Croatia. A work in progress.

    Science.gov (United States)

    Vučemilo, Luka; Borovečki, Ana

    2014-07-01

    As Croatia makes the transition from one political system and type of economy to another, there are inevitable social and political changes that have a profound affect on the healthcare system. This article charts some of the progress of change with respect to patients' rights and informed consent.

  5. 77 FR 29983 - Federal Acquisition Regulation; Information Collection; Subcontract Consent

    Science.gov (United States)

    2012-05-21

    ... performance of functions of the Federal Acquisition Regulation (FAR), and whether it will have practical... The objective of consent to subcontract, as discussed in FAR Part 44, is to evaluate the efficiency and effectiveness with which the contractor spends Government funds, and complies with Government...

  6. 21 CFR 1316.08 - Consent to inspection.

    Science.gov (United States)

    2010-04-01

    ... constitutional right not to have an administrative inspection made without an administrative inspection warrant; (2) That he has right to refuse to consent to such an inspection; (3) That anything of an incriminating nature which may be found may be seized and used against him in a criminal prosecution; (4) That...

  7. The regulation of informed consent to participation in clinical ...

    African Journals Online (AJOL)

    participation in clinical research by mentally ill persons – the discussion on informed consent .... usually lay persons without scientific and medical knowledge. It is .... is not defined by the Mental Health Care Act; nor is it stated anywhere in the ...

  8. Should informed consent be based on rational beliefs?

    Science.gov (United States)

    Savulescu, J; Momeyer, R W

    1997-10-01

    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 relevant information regarding the medical procedures prior to patients consenting to have those procedures, they should also assist patients to think more rationally. We distinguish between rational choice/action and rational belief. While autonomous choice need not necessarily be rational, it should be based on rational belief. The implication for the doctrine of informed consent and the practice of medicine is that, if physicians are to respect patient autonomy and help patients to choose and act more rationally, not only must they provide information, but they should care more about the theoretical rationality of their patients. They should not abandon their patients to irrationality. They should help their patients to deliberate more effectively and to care more about thinking rationally. We illustrate these arguments in the context of Jehovah's Witnesses refusing life-saving blood transfusions. Insofar as Jehovah's Witnesses should be informed of the consequences of their actions, they should also deliberate rationally about these consequences.

  9. Tacitly consenting to donate one’s organs

    NARCIS (Netherlands)

    den Hartogh, G.

    2011-01-01

    The common objection to opt-out systems of postmortal organ procurement is that they allow removal of a deceased person's organs without their actual consent. However, under certain conditions it is possible for ‘silence’—failure to register any objection—conventionally and/or legally to count as

  10. Ethical reasoning and informed consent in occupational therapy.

    Science.gov (United States)

    Kyler-Hutchison, P

    1988-05-01

    Two major ethical theories, the teleological and the deontological, are defined and briefly discussed. A subsequent discussion explores how the ethical principles of informed consent and patient autonomy operate in medical decisions. The application to occupational therapy is left for the reader's judgment.

  11. Impact of informed consent on patient decisions regarding third ...

    African Journals Online (AJOL)

    2015-06-22

    Jun 22, 2015 ... patient is central to the ability to grant informed consent. A verbal ... Access this article online .... which only the relationship with the level of the second .... is the best way to relieve the patient's anxiety, but the doctor.

  12. RESEARCH Voluntary informed consent and good clinical practice ...

    African Journals Online (AJOL)

    of South Africa (1996) and applicable legislation, it is apparent that voluntary informed ... Seoul, 2008);4 Ethics in Health Research: Principles, Structures and. Processes (Department of Health 2004 – 'ethical guidelines' for the purpose of this ... workers have a legal duty to obtain a patient's informed consent for any medical ...

  13. 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. ... Arab Journal of Nephrology and Transplantation ... in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of whether to ...

  14. 17 CFR 230.437a - Written consents.

    Science.gov (United States)

    2010-04-01

    ...) Are filing a registration statement containing financial statements in which Arthur Andersen LLP (or a foreign affiliate of Arthur Andersen LLP) had been acting as the independent public accountant. (b... dispense with the requirement for the registrant to file the written consent of Arthur Andersen LLP (or a...

  15. 29 CFR 801.66 - Consent findings and order.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 3 2010-07-01 2010-07-01 false Consent findings and order. 801.66 Section 801.66 Labor Regulations Relating to Labor (Continued) WAGE AND HOUR DIVISION, DEPARTMENT OF LABOR OTHER LAWS APPLICATION... Administrative Law Judge; and (4) A waiver of any right to challenge or contest the validity of the findings and...

  16. 29 CFR 500.232 - Consent findings and order.

    Science.gov (United States)

    2010-07-01

    ... Administrative Law Judge; and (4) A waiver of any right to challenge or contest the validity of the findings and... 29 Labor 3 2010-07-01 2010-07-01 false Consent findings and order. 500.232 Section 500.232 Labor Regulations Relating to Labor (Continued) WAGE AND HOUR DIVISION, DEPARTMENT OF LABOR REGULATIONS MIGRANT AND...

  17. 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 ...

  18. Optimizing Opt-Out Consent for Record Linkage

    Directory of Open Access Journals (Sweden)

    Das Marcel

    2014-09-01

    Full Text Available This article reports on a study testing the effects of different ways of administering an opt-out consent for record linkage in a probability-based Internet panel. First, we conducted cognitive interviews to explore reactions to a draft version of the opt-out consent text. Second, we conducted a two-factor experiment to test the effects of content manipulations and mode. The results indicate that the way in which respondents were informed did not have much effect on opting out. Results from a follow-up survey on attitudes regarding privacy, confidentiality, and trust, along with knowledge questions about the process of linking, showed no evidence that presenting the opt-out consent statement makes respondents more concerned about privacy. Knowledge about the aspects of record linkage is generally not high. When looking at long-term effects of sending an opt-out consent statement, we found no evidence that this leads to higher attrition or lower participation rates.

  19. 78 FR 5837 - Notice of Lodging Proposed Consent Decree

    Science.gov (United States)

    2013-01-28

    ... Policy, 28 CFR 50.7, notice is hereby given that a proposed Consent Decree in United States v. Porter... complaint filed by the United States against Wesley Porter, Wes Porter Development Company, LLC, Temple and... Division, P.O. Box 7611, Washington, DC 20044, and refer to United States v. Porter, DJ 90-5-1-1-18341. The...

  20. 42 CFR 50.204 - Informed consent requirement.

    Science.gov (United States)

    2010-10-01

    ... APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent... available alternative methods of family planning and birth control; (3) Advice that the sterilization... effectively communicated to any individual to be sterilized who is blind, deaf or otherwise handicapped. (d) A...

  1. Informed consent in oral health care | Tsotsi | East African Medical ...

    African Journals Online (AJOL)

    Background: Informed consent and autonomy are the major ethical principles that define the relationship between health workers and the patient. ... Objectives: To investigate what and how much information dental patients perceived to had been given by oral health workers about treatment, benefits, risks and management ...

  2. Consent: a Cartesian ideal? Human neural transplantation in Parkinson's disease.

    Science.gov (United States)

    Lopes, Manuel; Meningaud, Jean-Paul; Behin, Anthony; Hervé, Christian

    2003-01-01

    The grafting of human embryonic cells in Parkinson's disease is an innovative and hopefully useful therapeutic approach. However, it still concerns a very small number of patients and is only suggested as a research protocol. We present here a study of the problems of information and consent to research within the framework of this disease in which the efficacy of medical treatment is shortlived. The only French center to use this treatment (Hôpital H. Mondor in Créteil) has received authorization from the Comité Consultatif National d'Ethique (Consultative National Committee on Ethics). Eleven patients were treated between 1991 and 1998. The study of the results of a questionnaire sent to those patients showed the difficulties met in evaluating the perception of information despite intact intellectual capacities in people "prepared to risk everything." In France, the duty to inform patients during research procedures is regulated by the Huriet Act. However, it is not easy to guarantee genuine consent when preliminary information is given to patients psychologically impaired by the slow and ineluctable course of their disease. In these borderline cases, a valid consent seems to be a myth in terms of pure autonomy when considered with the Cartesian aim of elimination of uncertainty. The relevance of this concept of genuine consent probably makes more sense as aiming at a Cartesian ideal which is perhaps more in the spirit rather than in the letter. It is in that same spirit that, from the outset, we propose to define t he practical ways of answering the patients' request for information, even sometimes after consent has been given.

  3. 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

  4. 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.

  5. Robot sex and consent : Is consent to sex between a robot and a human conceivable, possible, and desirable?

    NARCIS (Netherlands)

    Frank, L.; Nyholm, S.

    2017-01-01

    The development of highly humanoid sex robots is on the technological horizon. If sex robots are integrated into the legal community as “electronic persons”, the issue of sexual consent arises, which is essential for legally and morally permissible sexual relations between human persons. This paper

  6. Tailoring consent to context: designing an appropriate consent process for a biomedical study in a low income setting.

    Directory of Open Access Journals (Sweden)

    Fasil Tekola

    2009-07-01

    Full Text Available Currently there is increasing recognition of the need for research in developing countries where disease burden is high. Understanding the role of local factors is important for undertaking ethical research in developing countries. We explored factors relating to information and communication during the process of informed consent, and the approach that should be followed for gaining consent. The study was conducted prior to a family-based genetic study among people with podoconiosis (non-filarial elephantiasis in southern Ethiopia.We adapted a method of rapid assessment validated in The Gambia. The methodology was entirely qualitative, involving focus-group discussions and in-depth interviews. Discussions were conducted with podoconiosis patients and non-patients in the community, fieldworkers, researchers, staff of the local non-governmental organisation (NGO working on prevention and treatment of podoconiosis, and community leaders. We found that the extent of use of everyday language, the degree to which expectations of potential participants were addressed, and the techniques of presentation of information had considerable impact on comprehension of information provided about research. Approaching podoconiosis patients via locally trusted individuals and preceding individual consent with community sensitization were considered the optimal means of communication. Prevailing poverty among podoconiosis patients, the absence of alternative treatment facilities, and participants' trust in the local NGO were identified as potential barriers for obtaining genuine informed consent.Researchers should evaluate the effectiveness of consent processes in providing appropriate information in a comprehensible manner and in supporting voluntary decision-making on a study-by-study basis.

  7. Audit of the informed consent process as a part of a clinical research quality assurance program.

    Science.gov (United States)

    Lad, Pramod M; Dahl, Rebecca

    2014-06-01

    Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication of the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process.

  8. Efficacy of a separate informed consent for anesthesia services: A prospective study from the Caribbean

    Directory of Open Access Journals (Sweden)

    Kavi Rampersad

    2016-01-01

    Conclusions: A separate written consent for anesthesia improved the efficacy of the informed consent process with respect to better information about the nature and purpose of anesthesia, common side effects, and rare but serious complications.

  9. Description of a Mobile-based Electronic Informed Consent System Development.

    Science.gov (United States)

    Hwang, Min-A; Kwak, In Ja

    2015-01-01

    Seoul National University Hospital constructed and implemented a computer-based informed consent system in December 2011. As of 2013, 30% of the informed consents were still filled out manually on paper. Patients and medical staff continuously suggested the implementation of a system for electronic informed consent using portable devices. Therefore, a mobile-based system for electronic informed consent was developed in 2013 to prevent the issues that arise with computer-based systems and paper informed consent. The rate of filling out electronic informed consent increased from 69% to 95% following the implementation of the mobile-based electronic informed consent. This construction of a mobile-based electronic informed consent system would be a good reference point for the development of a mobile-based Electronic Medical Record and for various mobile system environments in medical institutions.

  10. 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

  11. Informed consent prior to coronary angiography in a real world scenario: what do patients remember?

    Directory of Open Access Journals (Sweden)

    Aslihan Eran

    Full Text Available BACKGROUND: Patients' informed consent is legally essential before elective invasive cardiac angiography (CA and successive intervention can be done. It is unknown to what extent patients can remember previous detailed information given by a specially trained doctor in an optimal scenario as compared to standard care. METHODOLOGY/PRINCIPAL FINDINGS: In this prospective cohort study 150 consecutive in-patients and 50 out-patients were included before elective CA was initiated. The informed consent was provided and documented in in-patients by trained and instructed physicians the day before CA. In contrast, out-patients received standard information by different not trained physicians, who did not know about this investigation. All patients had to sign a form stating that enough information had been given and all questions had been answered sufficiently. One hour before CA an assessment of the patients' knowledge about CA was performed using a standard point-by-point questionnaire by another independent physician. The supplied information was composed of 12 potential complications, 3 general, 4 periprocedural and 4 procedural aspects. 95% of the patients felt that they had been well and sufficiently informed. Less than half of the potential complications could be remembered by the patients and more patients could remember less serious than life-threatening complications (27.9±8.8% vs. 47.1±11.0%; p<0.001. Even obvious complications like local bleeding could not be remembered by 35% of in-patients and 36% of out-patients (p = 0.87. Surprisingly, there were only a few knowledge differences between in- and out-patients. CONCLUSIONS: The knowledge about CA of patients is vague when they give their informed consent. Even structured information given by a specially trained physician did not increase this knowledge.

  12. 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

  13. 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...

  14. 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

  15. 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

  16. Selections from Unequal Partners: Teaching about Power, Consent, and Healthy Relationships

    Science.gov (United States)

    deFur, Kirsten

    2016-01-01

    The Center for Sex Education recently published the fourth edition of "Unequal Partners: Teaching about Power, Consent, and Healthy Relationships, Volumes 1 and 2." Included here are two lesson plans about sexual consent selected from each volume. "What does it take … to give sexual consent?" [Sue Montfort and Peggy Brick] is…

  17. 78 FR 57176 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Science.gov (United States)

    2013-09-17

    ... model of the system to plan for future needs. The consent decree also provides for the payment of a....html . We will provide a paper copy of the consent decree upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ--ENRD, P.O. Box...

  18. Non-Informed Consent Cultures: Privacy policies and app contracts on Facebook

    DEFF Research Database (Denmark)

    Bechmann, Anja

    2014-01-01

    of consent practices on Facebook, the article argues that with the growing importance and use of these services the consent culture of the internet has turned into a blind non-informed consent culture, heavily relying on social incentives and group dynamics in decision-making that are not adequately...

  19. 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

  20. 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