WorldWideScience

Sample records for spousal consent form

  1. Constitutional Law: Abortion, Parental and Spousal Consent Requirements, Right to Privacy

    Science.gov (United States)

    Long, Sharon L.; Ravenscraft, Patricia

    1976-01-01

    The constitutionality of the Missouri abortion statute was challenged by two physicians and Planned Parenthood of Central Missouri in the Danforth case. The Supreme Court reversed a district court decision in part, ruling that parental and spousal consent requirements are unconstitutional. For journal availability see HE 508 875. (LBH)

  2. 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 < 0.0001) and the AMA/NIH recommended readability guidelines for patient materials of 6th grade (p < 0.0001). Invasive procedure consent forms have 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.

  3. 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...

  4. 42 CFR Appendix to Subpart F of... - Required Consent Form

    Science.gov (United States)

    2010-10-01

    ... Sterilizations Pt. 441, Subpt. F, App. Appendix to Subpart F of Part 441—Required Consent Form Notice: Your... Hispanic origin); Hispanic; Asian or Pacific Islander; American Indian or Alaskan native; or White (not of...

  5. 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.

  6. [How to make consent forms easier to read?].

    Science.gov (United States)

    Araujo, Diego Vinicius Pacheco de; Zoboli, Elma Lourdes Campos Pavone; Massad, Eduardo

    2010-01-01

    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. Quantitative cross sectional study with 399 subjects. The sample was intentional, selected from different outpatient care units of HCFMUSP. Data collection used an instrument that contained a text with prose compatible for assessment of reading skills needed for comprehension of the consent form. More than 46.6% of the interviewees were classified as functionally illiterate, of these, 12.7% were even unable to understand the proposed task in the text they read. Nevertheless, nearly 50% of the interviewees reported having at least started high school. The results and the orientations for the text writing centered on the reader allowed us to make recommendations to render the consent form easier to read. We recommend that the researcher modifies the text to a structural narrative, addressed to the reader, using terms that are familiar. In other words, with terms common to the subjects' and to the medical language. In addition to improving the relationship between the subject and researcher, it is believed that these recommendations may reduce the time taken for the proceeding of research projects, since problems in the wording of consent forms contribute significantly to project delays.

  7. 42 CFR Appendix to Subpart B of... - Required Consent Form

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Required Consent Form Appendix to Subpart B of Part 50 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF... displays the currently valid OMB control number. Public reporting burden for this collection of information...

  8. 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.

  9. 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.

  10. [Introduction of an accreditation system for hospital informed consent forms].

    Science.gov (United States)

    López-Picazo, J J; Tomás-Garcia, N; Calle-Urra, J E; Parra-Hidalgo, P; Valverde-Iniesta, J J

    2015-01-01

    To describe an accreditation system for informed consent forms (ICF) in a tertiary hospital, as an intervention to improve their quality, and to check the improvements achieved. Following an external evaluation of the ICF quality in a public hospital in Murcia (Spain), an accreditation committee set the ICF requirements and associated procedures. Effectiveness is assessed by comparing two external evaluations carried out by the EMCA Program (2011 and 2013) and based on 19 criteria and a sample of 60 ICF for every public hospital in Murcia Region. To be accredited, every ICF must meet the 19 external criteria plus 5 based on legibility, readability and scientific and technical validity. A form to fill in the contents of every ICF was agreed, which would be reviewed, approved and validated for five years. Before the implementation, 8.2 defects/ICF were detected. The accreditation system obtained an 89% improvement (0.9 defects/ICF) and achieved significant improvements in 18 criteria, 16 of which are benchmarked. The accreditation system achieved a substantial improvement in the ICF (obtaining a better result in external evaluations) and guarantees their contents, legibility and readability. This system needs to be extended to other hospitals, since it is not clear whether common ICFs would be suitable. However, this improvement is structural and does not guarantee that the overall information/consent procedure is done properly, thus complementary strategies for measurement and improvement are required. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.

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

    Science.gov (United States)

    Shafiq, Nusrat; Malhotra, Samir

    2011-03-01

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

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

    Science.gov (United States)

    Leng, Catherine; Sharma, Kavita

    2016-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Catherine Leng

    2016-01-01

    Full Text Available Background: 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. Methods: 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. Results: 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. Conclusion: 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.

  14. UMTRA consent form acquisition: a survey of nonrespondents

    International Nuclear Information System (INIS)

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

    1986-01-01

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

  15. Medicaid Consent to Sterilization forms: historical, practical, ethical, and advocacy considerations.

    Science.gov (United States)

    Block-Abraham, Dana; Arora, Kavita S; Tate, Danielle; Gee, Rebekah E

    2015-06-01

    The US government developed a Medicaid Consent to Sterilization form in the mid-1970s to protect vulnerable populations from coerced sterilization. US health care practices have evolved significantly since that time. The form, however, has not changed, and may be preventing access to desired services for the same vulnerable populations it was originally created to protect. This paper discusses the relevant historical, practical use, ethical, and advocacy considerations of the Medicaid sterilization consent form and proposes changes to make the form more pertinent to today's medical environment.

  16. Do undergraduate student research participants read psychological research consent forms? Examining memory effects, condition effects, and individual differences.

    Science.gov (United States)

    Pedersen, Eric R; Neighbors, Clayton; Tidwell, Judy; Lostutter, Ty

    2011-01-01

    While research has examined factors influencing understanding of informed consent in biomedical and forensic research, less is known about participants' attention to details in consent documents in psychological survey research. The present study used a randomized experimental design and found the majority of participants were unable to recall information from the consent form in both in-person and online formats. Participants were also relatively poor at recognizing important aspects of the consent form including risks to participants and confidentiality procedures. Memory effects and individual difference characteristics also appeared to influence recall and recognition of consent form information.

  17. Do undergraduate student research participants read psychological research consent forms? Examining memory effects, condition effects, and individual differences

    OpenAIRE

    Pedersen, Eric R.; Neighbors, Clayton; Tidwell, Judy; Lostutter, Ty

    2011-01-01

    While research has examined factors influencing understanding of informed consent in biomedical and forensic research, less is known about participants’ attention to details in consent documents in psychological survey research. The present study used a randomized experimental design and found the majority of participants were unable to recall information from the consent form in both in-person and online formats. Participants were also relatively poor at recognizing important aspects of the ...

  18. 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.

  19. Spousal veto over family planning services.

    Science.gov (United States)

    Cook, R J; Maine, D

    1987-01-01

    In many countries a spouse, usually the husband, can veto a partner's use of family planning services. Where spousal veto acts as a barrier to family planning services it represents a serious threat to the lives and health of women and children. Removal of spousal authorization requirements has been shown to increase the use of family planning services. The Family Guidance Association of Ethiopia, for example, removed their requirement in 1982 and clinic utilization increased by 26 per cent within a few months. Courts of several countries have held that spousal veto practices violate principles of personal privacy and autonomy and the right to health care. The effect of such judgements has been to reinforce rights to sexual nondiscrimination found, for example, in national constitutions and the Convention on the Elimination of All Forms of Discrimination against Women. This article discusses the nature and application of spousal veto practices, explains how such requirements can violate certain human rights, and explores possible remedies to this problem, including ministerial, legislative, and judicial initiatives. PMID:3812842

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

    Directory of Open Access Journals (Sweden)

    Ihnsook Jeong, RN, PhD

    2013-03-01

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

  1. 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.

  2. The definition of placebo in the informed consent forms of clinical trials.

    Science.gov (United States)

    Hernández, Astrid; Baños, Josep-E; Llop, Cristina; Farré, Magí

    2014-01-01

    Lack of knowledge concerning the nature of placebo and why it is necessary may influence the participation of patients in clinical trials. The objective of the present study is to review how placebo is described in written information for participants in clinical trials to be evaluated by a Human Research Ethics Committee. All research protocols submitted for evaluation in a Spanish hospital during 2007-2013 were reviewed. The main characteristics of the studies using a placebo were collected. Three authors read each of them to determine how the term "placebo" was explained and if there was any comment on its efficacy and safety. Two thousand seven-hundred and forty research protocols were evaluated, of which three hundred and fifty-nine used a placebo. Pharmaceutical companies sponsored most placebo-controlled clinical trials (91.9%), and phase III studies were the commonest (59.9%). Oncology (15.0%), cardiology (14.2%), and neurology (13.1%) made the greatest contributions. A review of the informed consent forms showed that placebo was described in a similar manner in most studies: the explanation was limited to between four and eight words. Very few gave information about the risks of its use or adverse reactions from its administration. None of the studies provided details about the placebo effect. And 23 lacked any information about placebo at all. Explanations about placebo in informed consent forms is often scarce, and information about the placebo effect and associated risks are absent. This situation may influence a full understanding of placebo by participants in clinical trials and might reduce their informed decision to participate.

  3. Overcoming language barriers in the informed consent process: regulatory and compliance issues with the use of the "short form".

    Science.gov (United States)

    Lad, Pramod M; Dahl, Rebecca

    2014-01-01

    Language barriers in the informed consent process can be a significant impediment when recruiting non-English speaking subjects into clinical research studies. Regulatory guidelines indicate that the short form procedure be utilized in such circumstances. In this paper, we examine some of the ambiguities in the regulatory framework, the resulting need for institutional policy guidelines, and compliance issues with the short form process.

  4. 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

  5. Exploring the Readability of Consent Forms in Human Research in the United States Air Force

    National Research Council Canada - National Science Library

    Kruse, Clemens S

    2005-01-01

    Informed consent documents used in human subject research within the United States Air Force appear increasingly complex and lengthy based on the level of risk, or potential harm to a human research...

  6. 10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form

    Science.gov (United States)

    2010-01-01

    ..., I may be requested to release my medical records to a future employer or an insurance company. I... required by a court order or under other law. I understand that the results of my medical tests for... identified. I consent to having the following medical evaluations: / / Physical examination concentrating on...

  7. 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…

  8. Spousal Adjustment to Myocardial Infarction.

    Science.gov (United States)

    Ziglar, Elisa J.

    This paper reviews the literature on the stresses and coping strategies of spouses of patients with myocardial infarction (MI). It attempts to identify specific problem areas of adjustment for the spouse and to explore the effects of spousal adjustment on patient recovery. Chapter one provides an overview of the importance in examining the…

  9. 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.

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

    African Journals Online (AJOL)

    Methods: Data on spousal violence among ever married women was extracted from the 2013 Nigeria Demographic and Health Survey. The outcome variable is pregnancy termination. The explanatory variables were the type of spousal violence experienced by the women in the last 12 months preceding the survey.

  11. 'Killing the beloved': psychosocial factors precipitating spousal ...

    African Journals Online (AJOL)

    The prevalence of spousal homicide in Nigeria appears to have been on the increase in recent years, sparking criminological and public health concerns. Meanwhile, research on family violence has vigorously focused on spousal abuse, trends and prevalence of domestic violence, and risk factors, while the most severe of ...

  12. 5 CFR 1620.23 - Spousal rights.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Spousal rights. 1620.23 Section 1620.23... and Judges § 1620.23 Spousal rights. (a) The current spouse of a justice or judge of the United States (as defined in 28 U.S.C. 451), or of a Court of Veterans Appeals judge, possesses the rights described...

  13. 5 CFR 1655.18 - Spousal rights.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Spousal rights. 1655.18 Section 1655.18 Administrative Personnel FEDERAL RETIREMENT THRIFT INVESTMENT BOARD LOAN PROGRAM § 1655.18 Spousal rights. (a) Spouse of CSRS participant. (1) Before a loan is disbursed to a CSRS participant, the TSP record keeper...

  14. Association between spousal emotional abuse and reproductive outcomes of women in India: findings from cross-sectional analysis of the 2005-2006 National Family Health Survey.

    Science.gov (United States)

    Tiwari, Sucheta; Gray, Ron; Jenkinson, Crispin; Carson, Claire

    2018-03-09

    Spousal violence against women is a global public health problem. In India, approximately 40% of women report spousal violence. Like physical and sexual violence, emotional violence may be a determinant of women's health. This study explores the association between exposure to spousal emotional abuse and poor reproductive outcomes in Indian women. Data on 60,350 women, collected in the Third Indian National Family Health Survey were analysed to assess the impact of spousal emotional abuse on seven reproductive outcomes: age at first birth, number of children, terminated pregnancies, unwanted pregnancies, access to prenatal and skilled delivery care, and breastfeeding. Spousal emotional abuse was assessed using two overlapping constructs: emotional violence and controlling behaviour. Multivariable logistic regression was used for analysis. Spousal emotional violence and controlling behaviour was reported by 16 and 38% of the women, respectively. In unadjusted analyses, spousal emotional violence was associated with all adverse reproductive outcomes, except breastfeeding. Controlling for socio-demographic risk factors attenuated the association, and further adjustment for other forms of violence removed all significant associations. Spousal controlling behaviour was significantly associated with all outcomes, except breastfeeding. The effects remained statistically significant in multivariable regression. Women's experience of violence may be under-reported. When other forms of violence were adjusted for, emotional violence was not associated with adverse reproductive outcomes, whereas controlling behaviour remained associated with all but one adverse reproductive outcome. Therefore, spousal controlling behaviour requires further investigation as a determinant of reproductive health.

  15. "I understood…but some parts were confusing and hard to grasp": Patients′ perception of informed consent forms and clinical trials in Eldoret, Kenya

    Directory of Open Access Journals (Sweden)

    Violet Naanyu

    2014-01-01

    Full Text Available Background: A signed informed consent (IC form proves voluntary participation in a study. Yet the development of accessible and understandable IC forms comes with its own set of challenges, particularly when conducting international research. Purpose: This study explores understanding by participants in an Eldoret-based clinical trial of IC and its implications as well as whether they will volunteer for future trials. Materials and Methods: In mid-2010, in-depth interviews with trial participants were recorded in audio format. Content analysis provides a description of trial participants′ experiences and thoughts. Results: All participants were informed about the trial and its voluntariness and they consented. However, some were too ill to scrutinize trial details. Thus, they relied on their health care provider′s advice, or on their guardians. In general, participants understood their role and were happy to volunteer or invite others to participate in future trials. They also emphasised the importance of an open on-going dialogue in order for participants to be able to ask questions. Conclusion: Clinical trial participants in Eldoret seem to understand their role, but rely on providers and guardians when consenting. They are very willing to participate in future trials. Evaluation of research participants′ opinions may improve trial protocols, increase comprehension and guard against manipulation of study participants. In addition, this research focus should guide development of consent forms and process that facilitates a truly IC.

  16. Spousal Caregiver Narratives and Credible Authority: Uncertainty in Illness of Spousal Caregivers

    Science.gov (United States)

    Sodowsky, Karen

    2012-01-01

    This article is taken from a larger longitudinal study that used caregiver interviews, caregiver surveys, and caregiver statistical information of one community. The interviews were conducted with six spousal caregivers to examine the narratives produced by spouses actively caring for their partners with dementia. The spousal caregivers were…

  17. 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.

  18. [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.

  19. 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.

  20. Meta consent

    DEFF Research Database (Denmark)

    Ploug, Thomas; Holm, Søren

    2015-01-01

    With the ever increasing focus on collecting and conducting research in to ‘Big Data’, there is growing pressure on the protection of the individual’s autonomy and privacy. Current debate on the protection of the individual has presented what we believe to be a false dichotomy between ‘dynamic......’ and ‘broad’ models of consent. In this paper we propose a new model of consent – meta consent – for secondary research use of data and tissue. We believe it represents a new and better approach to consent that is more sensitive to the preferences and interests of the individual....

  1. 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.

  2. 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.

  3. 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.

  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. Spousal violence and pregnancy termination among married ...

    African Journals Online (AJOL)

    Descriptive statistical analysis and binary logistic regression were ap- plied using stata version 12. Results: Results show that 13.8% of women had ever terminated pregnancy; 19.9% had ever experienced at least one type of spousal violence; and women who had ever terminated pregnancy had higher prevalence of all ...

  6. influence of spousal communication on marital stability

    African Journals Online (AJOL)

    Engr E. Egbochukwu

    become a slave to it. The assumption for its social necessity is rested on the premise that through it, families are established and the family is the fundamental unit .... problems. This research deems it necessary to investigate the Influence of spousal communication on marital stability. This is because divorce is becoming a ...

  7. 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.

  8. Is Spousal Violence Being "Vertically Transmitted" through Victims? Findings from the Pakistan Demographic and Health Survey 2012-13.

    Directory of Open Access Journals (Sweden)

    Syeda Kanwal Aslam

    Full Text Available Violence against women is regarded as a major violation of human rights, and several socio-behavioral aspects among victims have been identified as important determinants of spousal violence experience. Pakistani nationally representative contextual evidence is scarce in this regard. We aimed to estimate prevalence of spousal violence, and explore its association with intergenerational transfer, and attitudinal acceptance of violence, among Pakistani ever-married women.Data of 3,687 ever-married women from Pakistan Demographic and Health Survey, 2012-13 was used to perform secondary analysis. Logistic regression analyses were conducted. Association between the different forms of spousal violence and the independent variables: intergenerational transfer of spousal violence (mother also beaten up by father; and attitudinal acceptance of spousal violence (beating is justifies if wife argues with husband were reported as Odds ratios with 95% confidence intervals (CI.Overall, more than a third (n=1344, 37.9%of ever-married women reported that they experienced spousal violence. Almost 68% (n=539 of the women who reported that their mothers were also beaten up by their fathers, were victims of spousal violence; and almost 47% (n=603 of the women who agreed that beating was justified if the wife argues with her husband, also suffered spousal violence. Intergenerational transfer (OR =5.71, 95%CI 4.40-7.41, p-value <0.01, and attitudinal acceptance (OR =1.66, 95%CI 1.27-2.15, p-value <0.01 were significantly associated with experience of physical violence even after adjusting for respondents' age at marriage, education level, wealth index, parity, employment status, and empowerment status.Spousal violence continues to haunt the lives of women in Pakistan, and is being transmitted as a learned behavior from mothers to daughters who tend to accept such violation of human rights. Girl children from such unfortunate homes may continue to transmit such

  9. Spousal Caregiver Burden and Its Relation with Disability in Schizophrenia.

    Science.gov (United States)

    Arun, R; Inbakamal, S; Tharyan, Anna; Premkumar, Prasanna S

    2018-01-01

    Schizophrenia, a chronic psychiatric disorder, can affect one's productivity and psychosocial functioning. In Indian context, the responsibility of caring persons with schizophrenia is increasingly on their spouses. Spousal caregiver experience and its relation with disability in schizophrenia need to be studied. We conducted a cross-sectional study among 52 outpatients with schizophrenia and their spouses attending a tertiary psychiatric center. The objectives were: (a) to explore spousal caregiver burden in schizophrenia and (b) to assess the relation between disability and spousal caregiver burden. The study adopted recommended ethical principles. Scales such as Burden Assessment Schedule, Indian Disability Evaluation and Assessment Scale (IDEAS), and Positive and Negative Syndrome Scale were used to collect appropriate data. Descriptive analysis, bivariate analysis, and multivariate analysis were done in SPSS software version 16.0. The mean spousal caregiver burden score was 73.5 (standard deviation: 14.0). In bivariate analysis, disability, duration of schizophrenia, severity of schizophrenia, place of residence, and socioeconomic status had statistically significant relation with spousal caregiver burden. Adjusted for spouses' age, gender, and other significant factors in bivariate analysis, the IDEAS global disability score (2.6, [confidence interval 0.5-3.8, P = 0.013]) retained statistically significant association with spousal caregiver burden. Spouses of persons with schizophrenia experience significant caregiver burden. Disability was found to be the most powerful determinant of spousal caregiver burden in the sample. Focus on disability alleviation in the management of schizophrenia may help reduce spousal caregiver burden.

  10. 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…

  11. 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

  12. SPOUSAL VIOLENCE IN THE CONTEXT OF WOMEN’S VICTIMIZATION

    Directory of Open Access Journals (Sweden)

    T. V. Shipunova

    2016-01-01

    Full Text Available The article deals with spousal violence against women. Criminal and everyday aspects of conjugal violence highlighted. Criminal violence is reflected in the crime statistics. Everyday aspect includes impostored and indifference violence. The author distinguishes four contexts in which spousal violence is unfolding: sociocultural (class structure of society, settings and attitudes towards violence, etc.; family (the modern family structure, family relationships and their dynamics, and others; individual (prescribed cultural understanding of the strengths and weaknesses, self-esteem and self-control, etc.; crisis (means and opportunities to establish and maintain non-conflict situation in the family, reduced resistance to the couple in crisis situations, etc.. The article presents the results of empirical research of problem of spousal violence youth too. The study found gender differences in the perception and evaluation of the problem of conjugal violence, the differences in the assessment methods of spousal violence, etc. 

  13. The link among self-esteem, differentiation, and spousal intimacy in deaf and hearing adults.

    Science.gov (United States)

    Levinger, Miriam; Ronen, Tammie

    2010-01-01

    Family, as the most important human support system, is the major component that clinicians can use to help people in their struggle to cope, adjust, and adapt to society. The ability to form a family and intimate relations with a spouse comprises a central measure of normative adult functioning and a critical stage of adult development. This study examined a personal component (self-esteem), an original family component (differentiation), and the capacity for spousal intimacy among 101 deaf adults (comprising about one fourth of the Israeli deaf population) and 57 normally hearing adults matched to the deaf sample according to age, gender, place of birth, and marital status. As expected, correlations emerged between higher levels of self-esteem, greater emotional differentiation from parents, and higher spousal intimacy within each group. Also, intergroup differences emerged, with deaf participants lower than their hearing peers both in self-esteem and ability for spousal intimacy. Contrary to expectations, differentiation from original family was similar in both groups. Results emphasized the significant contribution of self-esteem to adult functioning. Outcomes pinpoint the need for social workers and other clinicians to increase these clients' self-esteem to improve functioning.

  14. 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.

  15. Informed Consent (Clinical Trials)

    Science.gov (United States)

    ... Health Professionals Questions to Ask about Your Treatment Research Informed Consent Credit: National Cancer Institute Informed consent is a ... of ensuring patient safety in research. During the informed consent process, the research team, which is made up of doctors and ...

  16. Physical spousal violence against women in India: some risk factors.

    Science.gov (United States)

    Jeyaseelan, L; Kumar, Shuba; Neelakantan, Nithya; Peedicayil, Abraham; Pillai, Rajamohanam; Duvvury, Nata

    2007-09-01

    Domestic spousal violence against women in developing countries like India, is now beginning to be recognized as a widespread health problem impeding development. This study aimed to explore the risk and protective factors for lifetime spousal physical violence. A cross-sectional household survey was carried out in rural, urban and urban-slum areas across seven sites in India, among women aged 15-49 years, living with a child less than 18 years of age. The sample was selected using the probability proportionate to size method. Trained field workers administered a structured questionnaire to elicit information on spousal physical violence. The main hypothesized variables were social support, witnessed father beating mother and experience of harsh physical violence during childhood, alcohol abuse by spouse and socioeconomic variables. The outcome variables included three physical violence behaviours of hit, kick and beat. Odds ratios were calculated for risk and protective factors of violence using logistic regression. Of 9938 women surveyed, 26% reported experiencing spousal physical violence during the lifetime of their marriage. Adjusted odds ratios calculated using multiple logistic regression analysis suggest that women whose husbands regularly consumed alcohol (OR 5.6; 95% CI 4.7-6.6); who experienced dowry harassment (OR 3.2; 95% CI 2.7-3.8); had reported experiencing harsh physical punishment during childhood (OR 1.6; 95% CI 1.4-1.8) and had witnessed their fathers beat their mothers (OR 1.9; 95% CI 1.6-2.1), were at increased risk of spousal physical violence (beat, hit and kick). Higher socioeconomic status and good social support acted as protective buffers against spousal physical violence. The findings provide compelling evidence of the potential risk factors for spousal physical violence, which in turn could help in planning interventions.

  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. Spousal resemblance in psychopathology: A comparison of parents of children with and without psychopathology

    NARCIS (Netherlands)

    Wesseldijk, L. W.; Dieleman, G. C.; Lindauer, R. J. L.; Bartels, M.; Willemsen, G.; Hudziak, J. J.; Boomsma, D. I.; Middeldorp, C. M.

    2016-01-01

    Spouses resemble each other for psychopathology, but data regarding spousal resemblance in externalizing psychopathology, and data regarding spousal resemblance across different syndromes (e.g. anxiety in wives and attention deficit/hyperactivity disorder [ADHD] in husbands) are limited. Moreover,

  19. 40 CFR 26.117 - 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... EPA § 26.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and...

  20. 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.

  1. Modeling the Distress of Spousal Caregivers of People with Dementia.

    Science.gov (United States)

    Wawrziczny, Emilie; Berna, Guillaume; Ducharme, Francine; Kergoat, Marie-Jeanne; Pasquier, Florence; Antoine, Pascal

    2017-01-01

    The progressive mobilization of spouse caregivers who take care of a person with dementia (PWD) can lead to situations of distress. The current study sought to investigate the influence of the characteristics of the caregiving context on spousal caregiver distress. 125 spousal caregivers participated in this study. The characteristics of the caregiving context were assessed using questionnaires. We examined a moderated-mediator model (Step 1) in which we hypothesized that PWD and caregiver characteristics and dyadic determinants contribute to spousal caregiver distress. This model was compared based on the age at onset of the disease and the gender of the caregiver (Step 2). The model revealed that poor self-rated health and a lack of family support accentuated spousal caregiver distress, whereas the feeling of being prepared and level of confidence decreased spousal caregiver distress. Moreover, the quality of couple adjustment affected spousal caregiver distress, and this effect was mediated by the severity of the PWD's symptoms. Regarding the age at onset of the disease, the path between Couple Adjustment and the Care recipient's impairments was more important for caregivers of person with early-onset dementia (PEOD). Female caregivers who reported poor self-rated health experienced greater distress. It would be interesting to create a support program that would incorporate these three areas of intervention regarding the progression of the disease: first, "preparedness modules"; second, "dyadic modules" (especially for caregivers of PEOD); and third, "family modules". Specific attention should be given to female caregivers who report poor self-rated health.

  2. 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…

  3. 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.

  4. 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 ...

  5. Owners' Dynamic Capabilities and Spousal Resources in Small ...

    African Journals Online (AJOL)

    The study explores the relationship between spousal resources and franchisees' dynamic capabilities using both in-depth interviews and questionnaires from the convenience store franchisees in Taiwan. Franchising is recognized as one of the fastest paths to success for a small business, and many owners of the franchise ...

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

    African Journals Online (AJOL)

    Background: As efforts continue to increase contraceptive uptake, male partner support remains important in spousal modern contraceptive use. Methods: A prospective cross-sectional survey involving women on modern contraception was conducted at the family planning clinic of the University of Ilorin Teaching Hospital, ...

  7. 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,

  8. 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

  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. Informed consent in pediatric research.

    Science.gov (United States)

    Leibson, Tom; Koren, Gideon

    2015-02-01

    Pediatric drug research is gradually becoming more and more accepted as the norm for assessing whether a drug is safe and efficacious for infants and children. The process of informed consent and assent for these trials presents a major challenge. The aim of this review is to map historical, ethical and legal aspects relevant to the challenges of informed consent in the setting of pediatric drug research. The impact of age, level of maturity and life circumstances on the process of obtaining informed consent as well as the relations between consent and assent are discussed. There appears to be a lack of regulatory clarity in the area of pediatric clinical trials; while numerous statements have been made regarding children's rights to autonomy and their ability to care for themselves and for younger ones, the ever changing status of adolescence is still difficult to translate to informed consent. This may delay scientific and clinical advancement for children who are at the very junction of being independent and not needing parental permission. Obtaining consent and assent for pediatric clinical trials is a delicate matter, as both parent and child need to agree to participate. The appropriate transfer of information to guardians and the children, especially concerning potential risks and benefits, is at the heart of informed consent, as it serves to protect both patient and physician. As many adults lack health literacy, one must ensure that guardians receive relevant information at a level and in forms they can understand regarding the trials their children are asked to participate in.

  12. 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...

  13. 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.

  14. The nature and scope of stressful spousal caregiving relationships.

    Science.gov (United States)

    Davis, Linda Lindsey; Gilliss, Catherine L; Deshefy-Longhi, Tess; Chestnutt, Deborah H; Molloy, Margory

    2011-05-01

    The caregiving literature provides compelling evidence that caregiving burden and depressive symptoms are linked with stressful care relationships, however, relational difficulties around caregiving are seldom described in the literature. This article presents findings from content analysis of baseline interviews with 40 Alzheimer's disease (AD) and Parkinson's disease (PD) spousal caregivers enrolled in a home care skill-training trial who identified their care relationship as a source of care burden. Disappointment and sadness about the loss of the relationship; tension within the relationship; and care decision conflicts within the relationship were recurrent themes of relational stress in caregiving. These spousal caregivers had relationship quality scores below the mean and burden and depressive symptom scores above the means of other caregivers in the study. These findings provide support for developing dyadic interventions that help spouses manage relational losses, care-related tensions, and care decision-making conflicts.

  15. 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.

  16. 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....

  17. The use of a low-literacy version of the Medicaid sterilization consent form to assess sterilization-related knowledge in Spanish-speaking women: results from a randomized controlled trial.

    Science.gov (United States)

    Natavio, Melissa F; Cortessis, Victoria K; Zite, Nikki B; Ciesielski, Katharine; Eggers, Hilary; Brown, Niquelle; Segall-Gutierrez, Penina

    2018-02-22

    To learn whether a version of the Medicaid Sterilization Consent Form (SCF) adapted for populations of low-literacy can help Spanish-speaking women better understand the process and consequences of tubal sterilization. We randomly assigned Spanish-speaking women, ages 21-45 years, to review either a "standard" or "low-literacy" version of the Medicaid SCF. We assessed sterilization-related knowledge using items from the Postpartum Tubal Sterilization Knowledge questionnaire, using as the primary outcome correct identification of least 4 or more knowledge items and as secondary outcome participants' preferred version of the SCF. Overall sterilization-related knowledge was low in both groups, with 33% of women (n=100) who reviewed the standard SCF form and 42% of those who reviewed the low-literacy form (n=100) correctly identifying four or more knowledge-related items (p=0.19). Regarding specific items, women in the low-literacy SCF group were more likely than those in the standard SCF group to understand the permanence of sterilization (69% versus 49%, plow-literacy form. In our patient population, characterized by low educational attainment and inadequate health literacy skills, a low-literacy SCF did not improve overall sterilization-related knowledge when compared to the standard SCF. The low-literacy version did improve understanding of the permanence of sterilization and time requirements to undergo the procedure. Neither form conveyed an adequate level of knowledge to this vulnerable Spanish-speaking population. Therefore, a considerable need persists for detailed education regarding availability of equally effective reversible contraceptive options, procedure-related risks, and permanence of sterilization throughout the process of informed consent. Copyright © 2018. Published by Elsevier Inc.

  18. Effect of Marriage and Spousal Criminality on Recidivism

    OpenAIRE

    Andersen, Signe Hald; Andersen, Lars H?jsgaard; 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 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 tha...

  19. 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.

  20. 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.

  1. 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

  2. Culture clash on consent.

    Science.gov (United States)

    2010-07-01

    All research on human subjects requires their informed consent. Obtaining valid consent from isolated minorities can be particularly challenging, but scientists need to avoid the temptingly easy way out, so as to prevent further exclusion of these vulnerable populations from biomedical research.

  3. 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 =…

  4. U.S. spousal homicide rates by racial composition of marriage.

    Science.gov (United States)

    Roberts, John M

    2015-09-01

    American spousal homicide rates persistently and substantially vary by racial composition of the married couple. Analyses examined different racial couple types' spousal homicide rates in light of nonspousal homicide victimization and offending rates and couple types' average social, demographic, and economic characteristics. Analyses used 2003 to 2007 spousal homicide data from Supplementary Homicide Reports for which missing data have been multiply imputed. Current Population Survey data provided estimates of the number and average characteristics of different couple types. Log-linear models related couple types' differing spousal homicide rates to different race-sex groups' general rates of homicide victimization and offending and couple types' average characteristics. Among couple types with at least 50,000 couples, annual rates of male-on-female spousal homicide ranged from 0.95 to 8.76 per 100,000 couples; for female-on-male spousal homicide, this range was 0.13 to 2.29. Rates somewhat reflect different race-sex groups' nonspousal homicide activity, but with greater gender disparity and an excess of spousal homicide in some couple types. The association between victim's and offender's race is parsimoniously described by models using couple types' average characteristics (proportion with female's education exceeding the male's, proportion in central cities, and relative frequency). General homicidal-violence reduction strategies may partly apply to spousal homicide, but specifically targeted efforts are required too. Interventions must address different couple types' particular social, economic, and cultural experiences. Copyright © 2015 Elsevier Inc. All rights reserved.

  5. 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

  6. Effect of Marriage and Spousal Criminality on Recidivism.

    Science.gov (United States)

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

    2015-04-01

    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 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.

  7. Legal briefing: Informed consent.

    Science.gov (United States)

    Pope, Thaddeus Mason

    2010-01-01

    This issue's "Legal Briefing" column covers legal developments pertaining to informed consent. Not only has this topic been the subject of recent articles in this journal, but it also been the subject of numerous public and professional discussions over the past several months. Legal developments concerning informed consent can be usefully grouped into nine categories: 1. General disclosure standards in the clinical context; 2. Shared decision making; 3. Staturorily mandated abortion disclosures; 4. Staturorily mandated end-of-life counseling; 5. Other staturorily mandated subject-specific disclosures; 6. U.S. Food and Drug Administration (FDA) labeling and federal pre-emption of state informed consent law; 7. Relaxed informed consent for HIV testing; 8. General disclosure standards in the research context; 9. Issues on the horizon.

  8. 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

  9. 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

  10. 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

  11. [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.

  12. Informed consent for photography in dental practice.

    Science.gov (United States)

    Naidoo, S

    2009-10-01

    There are many reasons why patient images are used in dental practice. They are incorporated into the dental record as an adjunct to clinical care, displayed to colleagues, students and other audiences in educational settings, and published in scientific journals or other media as part of dental research. In each case it is not only prudent, but necessary for the patients' protection and interest that appropriate consent be obtained. While scientific journals invariably require written consent for photographs that may identify the patient, the format of the photograph consent form is usually not specified, nor is it always clear which images require consent. With the proliferation of published images on the Internet it has become particularly important to obtain permission for all uses that will be made of dental images, including worldwide distribution through various electronic media.

  13. A linguistic model of informed consent.

    Science.gov (United States)

    Marta, J

    1996-02-01

    The current disclosure model of informed consent ignores the linguistic complexity of any act of communication, and the increased risk of difficulties in the special circumstances of informed consent. This article explores, through linguistic analysis, the specificity of informed consent as a speech act, a communication act, and a form of dialogue, following on the theories of J.L. Austin, Roman Jakobson, and Mikhail Bakhtin, respectively. In the proposed model, informed consent is a performative speech act resulting from a series of communication acts which together constitute a dialogic, polyphonic, heteroglossial discourse. It is an act of speech that results in action being taken after a conversation has happened where distinct individuals, multiple voices, and multiple perspectives have been respected, and convention observed and recognized. It is more meaningful and more ethical for both patient and physician, in all their human facets including their interconnectedness.

  14. 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 ...

  15. 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.

  16. 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...... 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...

  17. 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

  18. 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.

  19. 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, ...

  20. Het preoperatief informed consent

    NARCIS (Netherlands)

    Legemate, Dink A.; Legemate, Johan

    2009-01-01

    Regarding the preoperative informed consent procedure (ICP), a considerable gap exists between legal requirements and current clinical practice. Although it is often thought that the ICP just has a legal background, the ICP is also important for shared decision making. Physicians are insufficiently

  1. Visual informed consent

    NARCIS (Netherlands)

    Lie, Rico; Witteveen, Loes

    2017-01-01

    The notion of visual informed consent (VIC) is developed in the context of capturing on film the clarification of the purpose of data collection, the use of information obtained, and the rights, risks and benefits of participation on the one hand, and the registration of the participant’s

  2. Informed Consent Process: Foundation of the Researcher-participant Bond.

    Science.gov (United States)

    Sil, Amrita; Das, Nilay Kanti

    2017-01-01

    Consenting to participate in a clinical research study after being properly and correctly informed upholds the basic ethical principle of "autonomy" in human research. The informed consent is a process by which the physician sensitizes the patient about the nature, procedures, risks benefits, treatment schedules, etc of the study in a language that is non-technical and understandable by the study participant. Informed consent document (ICD) has got two parts: the 'Subject Information Sheet' and the 'Informed Consent Form' (ICF); and they have to be approved by the Institutional Ethics Committee (IEC) before administration. Consent should be obtained without any coercion. In case of a situation where a participant is not able to give informed consent (e.g. unconscious, minor or those suffering from severe mental illness or disability) or is illiterate, it has be obtained from a legally acceptable representative (LAR). If the participant or LAR is unable to read/write, then an impartial witness should be present during the entire informed consent process and must append his/her signatures to the consent form. For children consent is essential and for mature minors (age group 7 to 18 years) informed assent should be obtained.

  3. 34 CFR 97.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Documentation of informed consent. 97.117 Section 97...) § 97.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section... required by § 97.116. This form may be read to the subject or the subject's legally authorized...

  4. Voluntary Informed Consent in Paediatric Oncology Research.

    Science.gov (United States)

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

    2016-07-01

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

  5. 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.

  6. Practice variation across consent templates for biobank research. a survey of German biobanks.

    Science.gov (United States)

    Hirschberg, Irene; Knüppel, Hannes; Strech, Daniel

    2013-01-01

    Informed, voluntary, and valid consent from biomaterial donors is a precondition for biobank research. Valid consent protects donors' rights and helps maintain public trust in biobank research. Harmonization of consent procedures in biobank research is needed, because of the widely shared vision on national and international networking of biobanks including data and sample sharing. So far, no study has assessed and compared the content of current consent forms especially for biobank research. The objective of this study was to perform a content analysis of consent forms in German biobanks. Based on ten guidelines for biomedical research, we developed an assessment matrix 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. 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 information/consent to genetic analyzes" 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 (22-88% out of 41 items). Our findings serve as a starting point to reflect upon the spectrum of consent issues that must be addressed in biobank research. The findings show that the majority of consent forms for German biobanks, if not all, should be improved and harmonized to better support an informed and balanced choice of potential donors and to facilitate networking of biobanks. Best practice models for consent forms in biobank research should be developed and biobank operators need to be more aware of relevant consent issues.

  7. Open consent, biobanking and data protection law: can open consent be 'informed' under the forthcoming data protection regulation?

    Science.gov (United States)

    Hallinan, Dara; Friedewald, Michael

    2015-01-01

    This article focuses on whether a certain form of consent used by biobanks--open consent--is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent--in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context--exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of 'data'. The authors argue that these assumptions are difficult to apply to genetic data

  8. [Toward dynamic informed consent].

    Science.gov (United States)

    Stoeklé, Henri-Corto; Deleuze, Jean-François; Vogt, Guillaume; Hervé, Christian

    2017-02-01

    "Personalized medicine" or "data medicine" should make it possible to use mass data to tailor patient treatment. These data are collected from analyses of biological samples, combined with clinical data. At a time when all sorts of information are instantly available via the Internet, the protection of genetic data, in particular, raises new issues with regard to the nature, means, status and usage of these data. Solutions to these problems are required, together with a clear, unambiguous legal, moral and ethical stance, to facilitate the spatial and temporal development of personalized medicine. At the forefront of these issues is the model of informed consent, which consent that has not been modified, despite many advances in technology. Medicine is now much more dynamic, and the possibilities for the real-time exchange and sharing of information, genetic data, or even biological samples, between patients, clinicians, researchers and industrial partners, must now be considered. We describe herein the particular advantages of a so-called "dynamic" and "enriched" consent, given via electronic means, in the context of the development of personalized medicine. © 2017 médecine/sciences – Inserm.

  9. 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.

  10. 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.

  11. Record linkage research and informed consent: who consents?

    Science.gov (United States)

    Huang, Nicole; Shih, Shu-Fang; Chang, Hsing-Yi; Chou, Yiing-Jenq

    2007-02-12

    Linking computerized health insurance records with routinely collected survey data is becoming increasingly popular in health services research. However, if consent is not universal, the requirement of written informed consent may introduce a number of research biases. The participants of a national health survey in Taiwan were asked to have their questionnaire results linked to their national health insurance records. This study compares those who consented with those who refused. A national representative sample (n = 14,611 adults) of the general adult population aged 20 years or older who participated in the Taiwan National Health Interview Survey (NHIS) and who provided complete survey information were used in this study. At the end of the survey, the respondents were asked if they would give permission to access their National Health Insurance records. Information given by the interviewees in the survey was used to analyze who was more likely to consent to linkage and who wasn't. Of the 14,611 NHIS participants, 12,911 (88%) gave consent, and 1,700 (12%) denied consent. The elderly, the illiterate, those with a lower income, and the suburban area residents were significantly more likely to deny consent. The aborigines were significantly less likely to refuse. No discrepancy in gender and self-reported health was found between individuals who consented and those who refused. This study is the first population-based study in assessing the consent pattern in a general Asian population. Consistent with people in Western societies, in Taiwan, a typical Asian society, a high percentage of adults gave consent for their health insurance records and questionnaire results to be linked. Consenters differed significantly from non-consenters in important aspects such as age, ethnicity, and educational background. Consequently, having a high consent rate (88%) may not fully eliminate the possibility of selection bias. Researchers should take this source of bias into

  12. Spousal violence and paternal disinvestment among Tsimane' forager-horticulturalists.

    Science.gov (United States)

    Stieglitz, Jonathan; Kaplan, Hillard; Gurven, Michael; Winking, Jeffrey; Tayo, Basilio Vie

    2011-01-01

    We develop and test a conceptual model of factors influencing the likelihood of physical wife abuse. The paternal disinvestment model emphasizes that spousal conflict over resource use results from men's attempts to increase individual fitness at a cost to the family (e.g., through pursuit of extramarital affairs). We propose that men use violence to control women's responses to the diversion of resources away from the family: to quell women's objections to male disinvestment, maintain women's parental investment, and to dissuade women from pursuing relationships with other men. Interviews were conducted among men and women to determine rates of violence and demographic and behavioral covariates. Structural equation modeling and generalized estimating equations analyses were used to test predictions derived from the model. We also collected data on frequent complaints in marriage and women's perceptions of arguments precipitating violence. Over 85% of women experienced physical wife abuse (n = 49). Indicators of paternal disinvestment positively covary with indicators of marital strife and with rates of wife abuse. The wife's age, matrilocal residence, and presence of joint dependent offspring decrease the likelihood of violence through direct and indirect routes. Wife abuse is linked to the importance of paternal investment in human families, and is a means by which men control women's responses to a dual reproductive strategy of familial investment and pursuit of extramarital sexual relationships. This framework is more general than traditional sociological and evolutionary perspectives emphasizing patriarchy and men's sexual jealousy, respectively. Copyright © 2011 Wiley-Liss, Inc.

  13. [The influence of attitude of inhibiting spousal disclosure about stress on the mental health of firefighters].

    Science.gov (United States)

    Yoo, Seonyoung; Matsui, Yutaka

    2012-12-01

    The present study focused on attitudes related to inhibiting spousal disclosure about stress as an influential factor for the mental health of firefighters. In a pilot study using semi-structured interviews (N = 14), we found that some firefighters usually did not talk about their stresses with their spouses. Some reasons were that they were hiding their weakness, were feeling sure of controlling their stress, out of consideration for their spouse, were giving up on the possibility for improving the situation after spousal disclosure, or hoped to distract themselves. In a subsequent questionnaire survey (N = 554), the results showed that attitudes about inhibiting spousal disclosure of stress have an effect on spousal disclosure about stress and the mental health of firefighters. The findings of the present study imply that spousal disclosure about interpersonal stress can be regarded as an effective factor, along with the disclosure to colleagues, for relieving stress. It is necessary to consider the importance of attitudes about inhibiting disclosure for stress as part of stress management for firefighters.

  14. Feasibility of a pocket-PC based cognitive control intervention in dementia spousal caregivers.

    Science.gov (United States)

    Callan, Judith A; Siegle, Greg J; Abebe, Kaleab; Black, Beverly; Martire, Lynn; Schulz, Richard; Reynolds, Charles; Hall, Martica H

    2016-01-01

    Spousal caregivers of patients with dementia are in need of interventions to bolster their quality of life. Computer-based, self-administered cognitive training is an innovative approach to target spousal caregiver distress and coping. We tested the feasibility of administering one such intervention with minimal clinician intervention. Twenty-seven elderly adults (>64 years old), who each were the primary caregiver for a spouse with dementia, were recruited through the Memory Disorders Clinic of the Alzheimer Disease Research Center in Pittsburgh, PA. Spousal caregivers were instructed to use a handheld computer version of the Adaptive Paced Visual Serial Attention Task (APVSAT) at least three times per week for four weeks as part of a larger caregiver intervention trial (P01 AG020677). Feasibility was explored by examining the frequency of APVSAT usage. Results suggest that self-directed cognitive training is feasible for spousal caregivers of dementia patients. The mean usage of the APVSAT was 42 (SD = 28.58). Performance increased from the beginning to the end of the trial, and usage was not affected by stress, worry, or poor sleep quality. Findings suggest the potential utility of cognitive training via handheld computer for spousal caregivers of dementia patients to improve problem solving, coping and adaptation, planning, and persevering with goal-directed tasks.

  15. 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.

  16. Spousal caregiving and financial strain among middle-aged and older adults.

    Science.gov (United States)

    Lee, Yeonjung; Zurlo, Karen A

    2014-01-01

    We examine whether spousal caregivers face difficulties in meeting their basic household expenses compared to nonspousal caregivers and whether social support mechanisms ameliorate any financial strain from caregiving responsibilities. We use data for caregivers aged 45 and over drawn from a nationally representative, cross-sectional Canadian Community Health Survey--Healthy Aging (N = 5,067). Spousal caregiving is associated with a 35% increase in the likelihood of experiencing difficulties in meeting basic expenses compared to other types of caregiving. Each of social support mechanisms (affectionate, emotional/informational, and positive social interaction), singularly and combined, lessens financial strain from caregiving. Our findings suggest that spousal caregivers are particularly vulnerable because they have fewer resources to draw on for support and perform much more intensive care. Our results highlight the importance of developing appropriate policies and programs to support caregivers. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  17. 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.

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

    DEFF Research Database (Denmark)

    Adjei, Stephen Baffour

    2015-01-01

    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......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......, 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...

  19. 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.

  20. Informed Consent in Adult Psychiatry

    Directory of Open Access Journals (Sweden)

    Ahmed Bait Amer

    2013-07-01

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

  1. 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.

  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. 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

  4. Intelligence by consent

    DEFF Research Database (Denmark)

    Diderichsen, Adam; Rønn, Kira Vrist

    2017-01-01

    for all intelligence activities is inadequate, in particular in relation to the collection and use of intelligence for preventive purposes. In the second part of the paper, we tentatively suggest an alternative moral framework for preventive intelligence, understood as intelligence activities......This article contributes to the current discussions concerning an adequate framework for intelligence ethics. The first part critically scrutinises the use of Just War Theory in intelligence ethics with specific focus on the just cause criterion. We argue that using self-defence as justifying cause...... with no specific suspicion or aggressor. We suggest that the moral permissibility of such activities requires a civilised moral framework, in which openness, transparency and informed consent constitute crucial elements....

  5. Human Subjects and Informed Consent.

    Science.gov (United States)

    Smith, Arthur A.

    1988-01-01

    The doctrine of informed consent has been enumerated to protect the rights of human subjects involved in biomedical research. The elements of informed consent are summarized along with the changes of emphasis that have evolved. The issue of liability and means for minimizing its impact are discussed. (Author/MLW)

  6. Record linkage research and informed consent: who consents?

    Directory of Open Access Journals (Sweden)

    Chou Yiing-Jenq

    2007-02-01

    Full Text Available Abstract Background Linking computerized health insurance records with routinely collected survey data is becoming increasingly popular in health services research. However, if consent is not universal, the requirement of written informed consent may introduce a number of research biases. The participants of a national health survey in Taiwan were asked to have their questionnaire results linked to their national health insurance records. This study compares those who consented with those who refused. Methods A national representative sample (n = 14,611 adults of the general adult population aged 20 years or older who participated in the Taiwan National Health Interview Survey (NHIS and who provided complete survey information were used in this study. At the end of the survey, the respondents were asked if they would give permission to access their National Health Insurance records. Information given by the interviewees in the survey was used to analyze who was more likely to consent to linkage and who wasn't. Results Of the 14,611 NHIS participants, 12,911 (88% gave consent, and 1,700 (12% denied consent. The elderly, the illiterate, those with a lower income, and the suburban area residents were significantly more likely to deny consent. The aborigines were significantly less likely to refuse. No discrepancy in gender and self-reported health was found between individuals who consented and those who refused. Conclusion This study is the first population-based study in assessing the consent pattern in a general Asian population. Consistent with people in Western societies, in Taiwan, a typical Asian society, a high percentage of adults gave consent for their health insurance records and questionnaire results to be linked. Consenters differed significantly from non-consenters in important aspects such as age, ethnicity, and educational background. Consequently, having a high consent rate (88% may not fully eliminate the possibility of selection

  7. SPOUSAL INTRUSION AS A PREDICTOR OF WIVES' MARITAL SATISFACTION IN THEIR SPOUSES' RETIREMENT.

    Science.gov (United States)

    Bozoglan, Bahadir

    2015-06-01

    Retirement of men changes their roles and participation and affects their spouses' daily routines, roles, and participation. This study assessed the effects of spousal intrusion on marital satisfaction in retirement. Questionnaires assessing demographics, spousal intrusion, shared couple activities, feelings, and marital satisfaction were administered to a group of 151 volunteer women whose husbands were retired in two cities in Turkey. The women were recruited among those who were willing to share their feelings and thoughts about their husbands' retirement process as a result of one-on-one interviews. Hierarchical regression analysis indicated that the perception of spousal intrusion, education status, frequency of shared activities, and dyadic adjustment predicted women's marital satisfaction in retirement. However, spousal intrusion did not significantly predict women's marital satisfaction when dyadic adjustment was entered in the second model. In the third model, final variables together predicted 19% of women's marital satisfaction in their spouse's retirement. These findings are important as they underline the factors affecting women's marital satisfaction in their spouses' retirement period.

  8. Spousal Caregivers of Persons with Alzheimer's and Parkinson's Disease Dementia: A Preliminary Comparison.

    Science.gov (United States)

    Dura, Jason R.; And Others

    1990-01-01

    Compared self- and other-rated depression in spousal caregivers for 23 Alzheimer's patients, 23 Parkinsons' Disease patients, and 23 control subjects. Two caregiver groups were similar in length of time they had been giving care and in caregiver distress and both caregiver groups were more depressed than control subjects. (Author/NB)

  9. Relationship satisfaction in couples confronted with colorectal cancer : the interplay of past and current spousal support

    NARCIS (Netherlands)

    Hagedoorn, Mariet; Dagan, Meirav; Puterman, Eli; Hoff, Christiaan; Meijerink, W. J. H. Jeroen; DeLongis, Anita; Sanderman, Robbert

    Based on attribution theory, this study hypthesized that past spousal supportiveness may act as a moderator of the link between one partner's current support behavior and the other partner's relationship satisfaction. A sample of 88 patients with colorectal cancer and their partners completed

  10. 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.

  11. 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…

  12. Voices of Strength and Struggle: Women's Coping Strategies against Spousal Violence in Pakistan

    Science.gov (United States)

    Zakar, Rubeena; Zakar, Muhammad Zakria; Kramer, Alexander

    2012-01-01

    This article documents the coping strategies adopted by women victims of spousal violence in Pakistan. By drawing on 21 in-depth interviews conducted in Lahore and Sialkot (Pakistan), we found that the women tried to cope with violence by using various strategies, both emotion focused (e.g., use of religion, placating the husband, etc.) and…

  13. Alcohol Involvement and Family Violence in a High Risk Sample: I. Spousal Violence.

    Science.gov (United States)

    Reider, Eve E.; And Others

    This report presents cross-sectional data on the relationships of alcohol difficulties, antisocial behavior, family conflict, family violence, and, particularly, spousal violence. The data were derived from a large-scale, longitudinal study of causes of alcohol abuse and the development of patterns of family violence. Subjects in the part of the…

  14. May I Recruit through Your Agency? Considerations for Researchers of Spousal Caregivers

    Science.gov (United States)

    Pote, Steven

    2016-01-01

    Few resources within social science literature provide helpful information related to participant recruitment for research on spousal caregivers of individuals with dementia. Independent researchers with limited resources may not have access to large databases or centers in which access to caregivers is readily available. As a result, these…

  15. 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…

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

    Science.gov (United States)

    Adjei, Stephen Baffour

    2015-12-16

    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. © The Author(s) 2015.

  17. The Vehemence of Self Elements for a Philosophy of Consent

    Directory of Open Access Journals (Sweden)

    Patricio Andrés Mena Malet

    2014-04-01

    Full Text Available By inquiring into the privilege granted by Paul Ricoeur to affirmation with respect to the multiple forms of negativity inscribed in human beings and their actions, the article seeks to contribute conceptual elements for a philosophy of consent. To this effect, it proposes an analysis of consent along the lines of Le volontaire et l’involontaire, bearing in mind the hermeneutics of self and of homo capax, developed by Ricoeur since 1990. The paper argues that consent goes hand in hand with patience, and that both can and should be thought as structural elements that constitute the oneself.

  18. 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

  19. [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

  20. 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

  1. Consent in medicine and sport.

    Science.gov (United States)

    McConnell, A A; Mackay, G M

    1995-08-01

    Last year's football World Cup serves to highlight the confusion now surrounding the classical aim of both sport and sports medicine, namely a healthy mind in a healthy body. The recent focus on violent injuries and the exponential increase in medical litigation suggests that this relationship is not so clearly defined. One cornerstone of this traditional relationship is the concept of informed consent. We review the legal position of consent in sport, especially soccer, which still awaits clarification and draw clear parallels with surgical consent.

  2. 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

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

    Science.gov (United States)

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

    2017-11-01

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

  4. A fundamental problem of consent.

    OpenAIRE

    Mitchell, J.

    1995-01-01

    A consultant anaesthetist gave a diclofenac suppository for postoperative pain to a patient having four teeth extracted under general anaesthesia in the dental surgery. He did not seek the patient's specific consent preoperatively for use of the suppository but told her afterwards what he had done. Charged before the professional conduct committee of the General Medical Council with failure to obtain informed consent and assault, the anaesthetist was found guilty of serious professional misco...

  5. The Origin of Spousal Resemblance for Alcohol Use Disorder.

    Science.gov (United States)

    Kendler, Kenneth S; Lönn, Sara Larsson; Salvatore, Jessica; Sundquist, Jan; Sundquist, Kristina

    2018-03-01

    Although spouses strongly resemble one another in their risk for alcohol use disorder (AUD), the causes of this association remain unclear. To examine longitudinally, in first marriages, the association of a first registration for AUD in one spouse with risk of registration in his or her partner and to explore changes in the risk for AUD registration in individuals with multiple marriages as they transition from a spouse with AUD to one without or vice versa. Population-wide Swedish registries were used to identify individuals born in Sweden between 1960 and 1990 who were married before the end of study follow-up on December 31, 2013. The study included 8562 marital pairs with no history of AUD registration prior to their first marriage and an AUD registration in 1 spouse during marriage and 4891 individuals with multiple marriages whose first spouse had no AUD registration and second spouse did or vice versa. Final statistical analyses were conducted from August 15 to September 1, 2017. A spousal onset or history of AUD registration. Alcohol use disorder registration in national medical, criminal, or pharmacy registries. Among the 8562 marital pairs (5883 female probands and 2679 male probands; mean [SD] age at marriage, 29.2 [5.7] years) in first marriages, the hazard ratio of AUD registration in wives immediately after the first AUD registration in their husbands was 13.82, which decreased 2 years later to 3.75. The hazard ratio of AUD registration in husbands after the first AUD registration in their wives was 9.21, which decreased 2 years later to 3.09. Among the 4891 individuals with multiple marriages (1439 women and 3452 men; mean [SD] age at first marriage, 25.5 [4.2] years), when individuals transitioned from a first marriage to a spouse with AUD to a second marriage to a spouse without AUD, the hazard ratio for AUD registration was 0.50 (95% CI, 0.42-0.59) in women and 0.51 (95% CI, 0.44-0.59) in men. After a first marriage to a spouse without AUD, the

  6. Clinical research before informed consent.

    Science.gov (United States)

    Miller, Franklin G

    2014-06-01

    Clinical research with patient-subjects was routinely conducted without informed consent for research participation prior to 1966. The aim of this article is to illuminate the moral climate of clinical research at this time, with particular attention to placebo-controlled trials in which patient-subjects often were not informed that they were participating in research or that they might receive a placebo intervention rather than standard medical treatment or an experimental treatment for their condition. An especially valuable window into the thinking of clinical investigators about their relationship with patient-subjects in the era before informed consent is afforded by reflection on two articles published by psychiatric researchers in 1966 and 1967, at the point of transition between clinical research conducted under the guise of medical care and clinical research based on consent following an invitation to participate and disclosure of material information about the study. Historical inquiry relating to the practice of clinical research without informed consent helps to put into perspective the moral progress associated with soliciting consent following disclosure of pertinent information; it also helps to shed light on an important issue in contemporary research ethics: the conditions under which it is ethical to conduct clinical research without informed consent.

  7. 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.

  8. Consented Autopsy and the Middle-East.

    Science.gov (United States)

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

    2017-02-01

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

  9. Why Does Spousal Education Matter for Earnings? Assortative Mating or Cross-productivity

    OpenAIRE

    Chong Huang; Hongbin Li; Pak Wai Liu; Junsen Zhang

    2006-01-01

    In interpreting the positive relationship between spousal education and one's earnings, economists have two major hypotheses: cross-productivity between couples and assortative mating. However, no prior empirical study has been able to separate the two effects. This paper empirically disentangles the two effects by using twins data that we collected from urban China. We have two major innovations: we use twins data to control for the unobserved mating effect in our estimations, and we estimat...

  10. Spousal Effects in Smoking Cessation: Matching, Learning, or Bargaining?

    OpenAIRE

    Kerry Anne McGeary

    2015-01-01

    Previous research studying the correlation in smoking behavior between spouses has discounted the role of bargaining or learning. Using the Health and Retirement Study, which contains information on smoking cessation and spouse’s preferences, this paper presents an essential investigation of the impact of spousal bargaining or learning on the decision to cease smoking. We find that, regardless of gender, when one member of a couple ceases smoking this induces the other member to cease smoking...

  11. Spousal concordance for overall health risk status and preventive service compliance.

    Science.gov (United States)

    Pai, Chih-Wen; Godboldo-Brooks, Ambyr; Edington, Dee W

    2010-07-01

    In this study we examined spousal concordance for two aggregate measures of health risk status and compliance with preventive service recommendations among 9620 pairs of cohabitating, opposite-sex married couples. Health risk appraisals were the primary data source to measure two outcome variables. Health risk status was compiled from 12 health risks and categorized into three levels (low-, medium-, and high-risk status). Overall preventive service compliance status was estimated by seven age-sex specific preventive service recommendations and dichotomized into lower and higher compliance status. For each of the husband and wife populations, we conducted proportional odds models and logistic regression models to assess spousal concordance for the two aggregate measures respectively. All models were adjusted for household income, one's characteristics (age, race, education, disease burden), and the same set of characteristics and the corresponding outcome variable from the spouse. A positive correlation within spousal pairs was statistically significant for both health risk status and compliance status (p education. 2010 Elsevier Inc. All rights reserved.

  12. 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.

  13. 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.

  14. To Love is to Suffer: Older Adults' Daily Emotional Contagion to Perceived Spousal Suffering.

    Science.gov (United States)

    Monin, Joan K; Levy, Becca R; Kane, Heidi S

    2017-05-01

    For older adults coping with a spouse's chronic condition, greater marital satisfaction may not be entirely protective for psychological health. We examined marital satisfaction and gender as moderators of the association between perceived spousal suffering and daily emotional contagion. Based on empathy-altruism and interdependent self-construal theories, we hypothesized that high marital satisfaction and being female would heighten daily emotional contagion, or within-person associations between perceived spouse suffering and distress to spouse suffering. Forty-five older adults who had a spouse with a musculoskeletal condition completed daily interviews. Participants reported their marital satisfaction once in the laboratory and then daily perceptions of their spouse's physical suffering and their own distress to spouse suffering via phone at home for 7 days. Consistent with hypotheses, there were significant within-person effects such that highly satisfied wives experienced heightened emotional contagion on days when they perceived higher than average spouse suffering. Unexpectedly, men who were high in marital satisfaction experienced heightened daily distress irrespective of their perceptions of level of spousal suffering. Marital satisfaction can increase daily emotional contagion to spousal suffering among older couples dealing with chronic conditions. Wives' distress may be more dependent on perceiving high levels of partner suffering compared with husbands' distress.

  15. 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.

  16. Spousal violence against pregnant women from a Bedouin community in Jordan.

    Science.gov (United States)

    Okour, Abdelhakeem M; Badarneh, Raja

    2011-12-01

    The objective of this study was to estimate the prevalence of spousal violence against pregnant women during their current pregnancy and investigate factors related to violence. A cross-sectional survey was performed with 303 pregnant women who attended antenatal clinics in Al-Mafraq, northern desert of Jordan. The prevalence of violence (any type) during pregnancy was 40.9%. Physical violence was the highest (34.7 %), followed by psychologic violence (28.1%) and sexual violence (15.5%). Women who resided in the city (odds ratio [OR] 1.77, 95% confidence interval [CI] 1.05-2.79), had six or more pregnancies including the current one (OR 5.4, 95% CI 1.45-20.0), had four or more female children (OR 4.03, 95% CI 1.3- 11.9) and were under pressure to have a male child (OR 1.82, 95% CI 1.07- 3.08) were more likely to be exposed to violence during pregnancy. This study attempted to shed light on some of the cultural dimensions behind spousal violence, especially preference for male children. This study is important to the Jordanian and Arab communities in their efforts to protect women's rights and in designing interventions against domestic and spousal violence.

  17. 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

  18. Signed consent is required if infected man seeks sex.

    Science.gov (United States)

    1998-02-20

    As part of a plea bargain, a Florida man agreed to have future sex partners sign a consent form. [Name removed] pleaded no contest to having sex with a 16-year-old girl who later tested positive for HIV, and the judge placed him on probation for a year and required the consent forms. The agreement will protect [name removed] from future prosecution. At the time of his arrest, the crime of not telling a partner about HIV infection was a misdemeanor. That law has been changed to make it a third-degree felony.

  19. Consent: statutory Provisions in Eritrea

    African Journals Online (AJOL)

    MBY

    If the law gives a person/patient the right to refuse treatment, then such right is a duty to the care provider to first obtain permission from the patient before conducting any medical or surgical intervention. This permission is what we meant by consent; A permission to do something on the other's body. Note that the refusal may ...

  20. Informed consent plays key role.

    Science.gov (United States)

    Blaney, C L

    1994-08-01

    Contraceptive research is conducted in developed and developing countries with the objective of developing safe and acceptable contraceptive methods and improved family planning programs. Volunteers who participate in biomedical and social science research in the field of family planning may, however, be at risk since some of the effects of new drugs, devices, or programs are unknown. It is imperative in such research that volunteers be informed and protected in terms of their health, safety, well-being, rights, and privacy. The responsibility for conferring such protection lies with the organizations which are sponsoring the research. International guidelines and safeguards exist to prevent research participants from being taken advantage of, but the integrity and commitment of researchers is the most essential element. Experts say that communicating all necessary information about the research to participants and obtaining their voluntary informed consent are important protection measures. Ethical review before research and communication between investigators and staff who conduct studies are also important. Contraceptive research, informed consent, the history of consent arising in response to Nazi experimentation upon prisoners in concentration camps during World War II, consent in practice, and improving the protection of volunteers are discussed.

  1. 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

  2. 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

  3. Assessing the benefit of a personalized EHR-generated informed consent in a dental school setting.

    Science.gov (United States)

    Valenza, John A; Taylor, David; Walji, Muhammad F; Johnson, Craig W

    2014-08-01

    Informed consents are routinely used as an important source of information to help patients make appropriate clinical decisions. However, current standard consent forms may not accomplish their intended purpose due to the variety of patient literacy and experiences and, in the dental school setting, the developing competence of students. The purpose of this pilot study was to test the efficacy of a personalized informed consent generated through an electronic health record (EHR) at one dental school and its role in patient decision making. In the study, a set of informed consents, or SmartConsents, were developed for specific diagnoses and procedures, enhanced with graphics, and delivered through the school's EHR. Fifty patients were recruited in the school's Urgent Care Clinic and divided evenly into two groups: one (control) receiving the standard consent, with the second receiving a SmartConsent. Following treatment, patients were assessed based on demographics, decisional conflict, satisfaction, health literacy, and knowledge. Overall, there were no significant differences in main effects between SmartConsent and standard informed consents for decisional conflict and satisfaction, although significant differences were identified during secondary analysis of satisfaction, gender, and ethnicity. The study also demonstrated the potential for consents to aid the student provider in better communicating with patients.

  4. Achieving high rates of consent for genetic testing among African American smokers.

    Science.gov (United States)

    Cox, Lisa Sanderson; Bronars, Carrie A; Thomas, Janet L; Okuyemi, Kolawole S; King, Gary; Mayo, Matthew S; Ahluwalia, Jasjit S

    2007-06-01

    Genetic factors play an important role in smoking behavior. Although African Americans are at disproportionately increased risk for tobacco-related morbidity and mortality, limited attention has been given to genetic investigation of tobacco use in this population. The present study examined consent for genetic testing among African American smokers enrolled in a smoking cessation clinical trial. African American light smokers (genetic analysis related to smoking. Participants completed assessment of demographic, psychosocial, and tobacco-related variables. Of 755 clinical trial participants, 745 (99%) responded to the genetic consent form. Of participants who responded, 620 (83%) provided consent for blood collection for genetic analysis. No significant differences were identified between individuals who consented to genetic analysis and those who denied consent. This study demonstrated the feasibility of obtaining consent for genetic analysis for smoking-related investigation among African American smokers. Findings support the inclusion of African Americans within genetic investigation of tobacco use and treatment.

  5. 42 CFR 441.257 - Informed consent.

    Science.gov (United States)

    2010-10-01

    ... otherwise entitled. (ii) A description of available alternative methods of family planning and birth control... Sterilizations § 441.257 Informed consent. (a) Informing the individual. For purposes of this subpart, an individual has given informed consent only if— (1) The person who obtained consent for the sterilization...

  6. 28 CFR 512.16 - Informed consent.

    Science.gov (United States)

    2010-07-01

    ... RESEARCH Research § 512.16 Informed consent. (a) Before commencing a research project requiring... the research. (b) A researcher who is an employee of the Bureau shall include in the informed consent... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Informed consent. 512.16 Section 512.16...

  7. Informed Consent, Research, and the Elderly

    Science.gov (United States)

    Berkowitz, Sandra

    1978-01-01

    Informed consent is a legal doctrine designed to protect an individual from unwarranted medical intrusions upon his body. Because the processes of aging may affect the elderly subject's capacity to give competent, knowing, and voluntary consent, the securing of informed consent from the elderly will often require special procedural safeguards.…

  8. Informed consent in clinical trials using stem cells: Suggestions and ...

    African Journals Online (AJOL)

    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 ...

  9. 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

  10. Influence of knowledge of spousal fertility cycles on male ...

    African Journals Online (AJOL)

    Men who were knowledgeable of spouse‟s menstrual cycles and ovulation dates were significantly more likely to have supported some form of public health intervention before (p<0.001). Age over 30, above secondary education, and men aware of menstrual dates of spouse were significant predictors of reproductive ...

  11. 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

    2018-02-01

    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

  12. Informed consent for MRI and fMRI research: Analysis of a sample of Canadian consent documents

    Directory of Open Access Journals (Sweden)

    Pike Bruce

    2011-01-01

    Full Text Available Abstract Background Research ethics and the measures deployed to ensure ethical oversight of research (e.g., informed consent forms, ethics review are vested with extremely important ethical and practical goals. Accordingly, these measures need to function effectively in real-world research and to follow high level standards. Methods We examined approved consent forms for Magnetic Resonance Imaging (MRI and functional Magnetic Resonance Imaging (fMRI studies approved by Canadian research ethics boards (REBs. Results We found evidence of variability in consent forms in matters of physical and psychological risk reporting. Approaches used to tackle the emerging issue of incidental findings exposed extensive variability between and within research sites. Conclusion The causes of variability in approved consent forms and studies need to be better understood. However, mounting evidence of administrative and practical hurdles within current ethics governance systems combined with potential sub-optimal provision of information to and protection of research subjects support other calls for more scrutiny of research ethics practices and applicable revisions.

  13. 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.

  14. 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.

  15. 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.

  16. To What did They Consent? Understanding Consent Among Low Literacy Participants in a Microbicide Feasibility Study in Mazabuka, Zambia.

    Science.gov (United States)

    Munalula-Nkandu, Esther; Ndebele, Paul; Siziya, Seter; Munthali, J C

    2015-12-01

    We conducted a study to review the consenting process in a vaginal microbicide feasibility study conducted in Mazabuka, Zambia. Participants were drawn from those participating in the microbicide study. A questionnaire and focus group discussion were used to collect information on participants' understanding of study aims, risks and benefits. Altogether, 200 participants took part in this study. The results of the study showed that while all participants signed or endorsed their thumbprints to the consent forms, full informed consent was not attained from most of the participants since 77% (n = 154) of the participants had numerous questions about the study and 34% (n = 68) did not know who to get in touch with concerning the study. Study objectives were not fully understood by over 61% of the participants. Sixty four percent of the participants were not sure of the risks of taking part in the microbicide study. A significant number thought the study was all about determining their HIV status. Some participants were concerned that their partners were not on the trial as they were convinced that being on the study meant that that they had a lifetime protection from HIV infection. The process of obtaining consent was inadequate as various phases of the study were not fully understood. We recommend the need for researchers to reinforce the consenting process in all studies and more so when studies are conducted in low literacy populations. © 2014 John Wiley & Sons Ltd.

  17. 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.

  18. 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.

  19. Informed consent for obstetric anesthesia research: factors that influence parturients' decisions to participate.

    Science.gov (United States)

    Dorantes, D M; Tait, A R; Naughton, N N

    2000-08-01

    Patients who are approached to participate in clinical studies just before delivery may have insufficient time to make an informed decision and/or may feel pressured into participation. This study was designed to examine factors that influence parturients to consent or decline participation in an anesthesia study related to their delivery. Parturients who had been approached to participate in a continuing clinical obstetric anesthesia study were subsequently given a questionnaire that documented their reasons for consenting or declining participation. There were no demographic differences among the consenters (n = 166) and nonconsenters (n = 109). The most important factors in the patient's decision to consent were related to their understanding and perceived importance of the study and the potential benefit to other women. Forty-one (40. 6%) nonconsenters strongly considered their pain/discomfort a factor in declining participation. Only one patient felt some pressure to consent, suggesting that the overall environment was noncoercive. Logistic regression analysis demonstrated that patients who read the consent form completely, those who had participated in a previous research study, and those who were less anxious about participating were more likely to consent. Obtaining informed consent for obstetric anesthesia studies presents a challenge to the anesthesiologist. Results from this study suggest that the environment in which consent for obstetric studies is sought is not coercive. However, it is important that the anesthesiologist ensures that the patient fully understands the study and develops a rapport with the patient to allay any anxiety associated with her participation as a potential research subject.

  20. 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.

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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…

  6. 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…

  7. Marital satisfaction of advanced prostate cancer survivors and their spousal caregivers: the dyadic effects of physical and mental health.

    Science.gov (United States)

    Zhou, Eric S; Kim, Youngmee; Rasheed, Mikal; Benedict, Catherine; Bustillo, Natalie E; Soloway, Mark; Kava, Bruce R; Penedo, Frank J

    2011-12-01

    Coping with the physical and mental side effects of diagnosis and treatment for advanced prostate cancer (APC) is a challenge for both survivors and their spousal caregivers. There is a gap in our current understanding of the dyadic adjustment process on marital satisfaction in this population. The current study sought to: (1) document levels of physical and mental health, and marital satisfaction, and (2) evaluate the relationship between physical and mental health with marital satisfaction in this understudied population. APC survivors who had undergone androgen deprivation therapy within the past year and their spousal caregiver participated in the study (N = 29 dyads). Physical and mental health was assessed using the MOS SF-36 Health Survey and marital satisfaction was evaluated using the Dyadic Adjustment Scale. The Actor-Partner Interdependence Model revealed strong relations between physical and mental health with marital satisfaction for both survivor and caregiver (actor effects). Furthermore, caregiver physical and mental health was related with the survivor's marital satisfaction (partner effect). Levels of mental health and marital satisfaction were comparable to community-based and prostate cancer samples, while physical health was higher. Marital satisfaction between APC survivors and their spousal caregivers may be influenced by both physical and mental health functioning. In particular, APC survivor functioning may affect his marital satisfaction as well as his spousal caregiver's. This has implications for psychosocial interventions for APC dyads. Further evaluation of the complex nature of survivor/caregiver dyadic adjustment in dealing with APC is necessary. Copyright © 2010 John Wiley & Sons, Ltd.

  8. Spousal Interrelations in Happiness in the Seattle Longitudinal Study: Considerable Similarities in Levels and Change over Time

    Science.gov (United States)

    Hoppmann, Christiane A.; Gerstorf, Denis; Willis, Sherry L.; Schaie, K. Warner

    2011-01-01

    Development does not take place in isolation and is often interrelated with close others such as marital partners. To examine interrelations in spousal happiness across midlife and old age, we used 35-year longitudinal data from both members of 178 married couples in the Seattle Longitudinal Study. Latent growth curve models revealed sizeable…

  9. Caregiver Burden in Alzheimer's Disease: Differential Associations in Adult-Child and Spousal Caregivers in the GERAS Observational Study

    Directory of Open Access Journals (Sweden)

    Catherine Reed

    2014-02-01

    Full Text Available Background/Aims: To examine factors influencing the caregiver burden in adult-child and spousal caregivers of community-dwelling patients with Alzheimer's disease (AD. Methods: Baseline data from the 18-month, prospective, observational GERAS study of 1,497 patients with AD in France, Germany, and the UK were used. Analyses were performed on two groups of caregivers: spouses (n = 985 and adult children (n = 405. General linear models estimated patient and caregiver factors associated with subjective caregiver burden assessed using the Zarit Burden Interview. Results: The caregiver burden increased with AD severity. Adult-child caregivers experienced a higher burden than spousal caregivers despite spending less time caring. Worse patient functional ability and more caregiver distress were independently associated with a greater burden in both adult-child and spousal caregivers. Additional factors were differentially associated with a greater caregiver burden in both groups. In adult-child caregivers these were: living with the patient, patient living in an urban location, and patient with a fall in the past 3 months; in spouses the factors were: caregiver gender (female and age (younger, and more years of patient education. Conclusion: The perceived burden differed between adult-child and spousal caregivers, and specific patient and caregiver factors were differentially associated with this burden.

  10. Caregiver Burden in Alzheimer's Disease: Differential Associations in Adult-Child and Spousal Caregivers in the GERAS Observational Study

    Science.gov (United States)

    Reed, Catherine; Belger, Mark; Dell'Agnello, Grazia; Wimo, Anders; Argimon, Josep Maria; Bruno, Giuseppe; Dodel, Richard; Haro, Josep Maria; Jones, Roy W.; Vellas, Bruno

    2014-01-01

    Background/Aims To examine factors influencing the caregiver burden in adult-child and spousal caregivers of community-dwelling patients with Alzheimer's disease (AD). Methods Baseline data from the 18-month, prospective, observational GERAS study of 1,497 patients with AD in France, Germany, and the UK were used. Analyses were performed on two groups of caregivers: spouses (n = 985) and adult children (n = 405). General linear models estimated patient and caregiver factors associated with subjective caregiver burden assessed using the Zarit Burden Interview. Results The caregiver burden increased with AD severity. Adult-child caregivers experienced a higher burden than spousal caregivers despite spending less time caring. Worse patient functional ability and more caregiver distress were independently associated with a greater burden in both adult-child and spousal caregivers. Additional factors were differentially associated with a greater caregiver burden in both groups. In adult-child caregivers these were: living with the patient, patient living in an urban location, and patient with a fall in the past 3 months; in spouses the factors were: caregiver gender (female) and age (younger), and more years of patient education. Conclusion The perceived burden differed between adult-child and spousal caregivers, and specific patient and caregiver factors were differentially associated with this burden. PMID:24711814

  11. The influence of stressors, appraisal and personal conditions on the burden of spousal caregivers of persons with dementia

    NARCIS (Netherlands)

    Wijngaart, M.A.G. van den; Vernooij-Dassen, M.J.F.J.; Felling, A.J.A.

    2007-01-01

    Objectives: The aim of this study was to explore the main and mediating influences of stressors, a caregiver's appraisal, coping, personal conditions and social resources on the burden of dementia caregivers. Method: The study sample consisted of 95 spousal caregivers of non-institutionalized

  12. The effect of spousal violence on women′s health: Findings from the Stree Arogya Shodh in Goa, India

    Directory of Open Access Journals (Sweden)

    Chowdhary N

    2008-01-01

    Full Text Available Background: Spousal violence has wide-ranging effects on the physical, reproductive, sexual and psychological health of women. There are few longitudinal studies that describe this association in developing countries. Aim: To test the hypothesis that spousal violence is an independent risk factor for a broad range of adverse health outcomes in women. Setting and Design: A population-based cohort study of women living in the catchment area of a primary health center in north Goa. Two thousand four hundred and ninety-four of 3000 randomly selected women were recruited of whom 1750 married women were included for this paper. Materials and Methods: Each participant was assessed at baseline with a structured interview for the assessment of exposure to spousal violence (verbal, physical, sexual over two time periods (lifetime; recent in the past three months. The interview collected data on gynecological complaints and the Revised Clinical Interview Schedule was used for the diagnosis of depressive disorder. Laboratory tests for anemia and sexually transmitted infections (STI were carried out. Longitudinal data was collected after six and 12 months on these outcomes. In addition, baseline measures for nutritional status and menstrual health were also obtained. Statistical Analysis: Univariate analyses were carried out on the cross-sectional and longitudinal data to assess the association between each type of spousal violence and each health outcome. Multivariate analyses adjusted for age, literacy, household per capita income. Logistic regression was used for all analyses in Stata (Version 10. Results: Lifetime spousal violence was reported by 290 (16.6%, 95%CI=14.9-18.4 women; recent violence was reported by 230 (13.0%, 95%CI=11.6-14.8. The cross-sectional data showed an association between violence and a range of self-reported gynecological complaints, low Body Mass Index, depressive disorder and attempted suicide. The longitudinal analyses

  13. Identity change and informed consent.

    Science.gov (United States)

    Witt, Karsten

    2017-06-01

    In this paper, I focus on a kind of medical intervention that is at the same time fascinating and disturbing: identity-changing interventions. My guiding question is how such interventions can be ethically justified within the bounds of contemporary bioethical mainstream that places great weight on the patient's informed consent. The answer that is standardly given today is that patients should be informed about the identity effects, thus suggesting that changes in identity can be treated like 'normal' side effects. In the paper, I argue that this approach is seriously lacking because it misses important complexities going along with decisions involving identity changes and consequently runs into mistakes. As a remedy I propose a new approach, the 'perspective-sensitive account', which avoids these mistakes and thus provides the conceptual resources to systematically reflect on and give a valid consent to identity-changing interventions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  14. College students and sexual consent: unique insights.

    Science.gov (United States)

    Jozkowski, Kristen N; Peterson, Zoë D

    2013-01-01

    Sexual assault continues to be a salient health concern, especially among college women. Because assault is often defined in terms of consent, prevention efforts hinge on promoting the definition and the obtainment of consent as a mechanism to reduce assault. Despite the focus on consent promotion, research specifically examining consent in general and among college students specifically is limited. College students (n = 185) were recruited to participate in an open-ended survey in which they were asked to report how they indicated consent and interpreted their partners' consent to engage in a range of sexual behaviors. Content analysis was utilized to qualitatively analyze responses. In the current study, data were assessed for emerging themes across all items. In examining participants' responses, four distinct themes emerged: (a) endorsement of the traditional sexual script; (b) women are responsible for performing oral sex; (c) men's consent to sex can be aggressive; and (d) men utilize deception to obtain consent to sex. Findings suggest that men are conceptualized as sexual initiators and women as sexual gatekeepers, and that men's sexual pleasure is primary whereas women's experience of pleasure is secondary. Findings articulate the need for more pointed research aimed at assessing sexual consent among college students.

  15. Multimedia Consent for Research in People With Schizophrenia and Normal Subjects: a Randomized Controlled Trial

    Science.gov (United States)

    Jeste, Dilip V.; Palmer, Barton W.; Golshan, Shahrokh; Eyler, Lisa T.; Dunn, Laura B.; Meeks, Thomas; Glorioso, Danielle; Fellows, Ian; Kraemer, Helena; Appelbaum, Paul S.

    2009-01-01

    Limitations of printed, text-based, consent forms have long been documented and may be particularly problematic for persons at risk for impaired decision-making capacity, such as those with schizophrenia. We conducted a randomized controlled comparison of the effectiveness of a multimedia vs routine consent procedure (augmented with a 10-minute control video presentation) as a means of enhancing comprehension among 128 middle-aged and older persons with schizophrenia and 60 healthy comparison subjects. The primary outcome measure was manifest decisional capacity (understanding, appreciation, reasoning, and expression of choice) for participation in a (hypothetical) clinical drug trial, as measured with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and the University of California San Diego (UCSD) Brief Assessment for Capacity to Consent (UBACC). The MacCAT-CR and UBACC were administered by research assistants kept blind to consent condition. Additional assessments included standardized measures of psychopathology and cognitive functioning. Relative to patients in the routine consent condition, schizophrenia patients receiving multimedia consent had significantly better scores on the UBACC and on the MacCAT-CR understanding and expression of choice subscales and were significantly more likely to be categorized as being capable to consent than those in the routine consent condition (as categorized with several previously established criteria). Among the healthy subjects, there were few significant effects of consent condition. These findings suggest that multimedia consent procedures may be a valuable consent aid that should be considered for use when enrolling participants at risk for impaired decisional capacity, particularly for complex and/or high-risk research protocols. PMID:18245061

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

    Science.gov (United States)

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

    2014-03-01

    To assess the readability of informed consent documents (IC) of the different national surgical societies. During January 2012 we collected 504 IC protocols of different specialties. To calculate readability parameters the following criteria were assessed: number of words, syllables and phrases, syllables/word and word/phrase averages, Word correlation index, Flesch-Szigriszt index, Huerta Fernández index, Inflesz scale degree and the Gunning-Fog index. The mean Flesch-Szigriszt index was 50.65 ± 6,72, so readability is considered normal. There are significant differences between specialties such as Urology (43.00 ± 4.17) and Angiology and Vascular Surgery (63.00 ± 3.26, PVascular Surgery were the closest ones (67.85 ± 3.20). Considering the Inflesz scale degree (total mean of 2.84 ± 3,23), IC can be described as «somewhat difficult». There are significant differences between the IC of Angiology and Vascular Surgery (3.23 ± 0.47) that could be qualified as normal, or Cardiovascular Surgery (2.79 ± 0.43) as «nearly normal readability»; and others such as Urology (1, 70 ± 0.46, P<.001) and Thoracic Surgery (1.90 ± 0.30, P<.001), with a readability between «very» and «somewhat» difficult. The Gunning-Fog indexes are far from the readability for a general audience (total mean of 26.29 ± 10,89). IC developed by scientific societies of different surgical specialties do not have an adequate readability for patients. We recommend the use of readability indexes during the writing of these consent forms. Copyright © 2012 AEC. Published by Elsevier Espana. All rights reserved.

  17. Informed Consent in the Changing Landscape of Research.

    Science.gov (United States)

    Hammer, Marilyn J

    2016-09-01

    The history of informed consent dates back as early as the 16th century (Selek, 2010). The current tenets of informed consent pertaining to the ethical conduct of research on human participants predominately stems from the 1947 Nuremberg Code (National Institutes of Health, 2016), which was created following the Nuremberg trials at the end of World War II. The unethical conduct of research on human participants during the Holocaust, coupled with experiments (e.g., the Tuskegee syphilis study), prompted a more formalized structure for ensuring the well-being and autonomy of human participants in research studies. The World Medical Association (2013) created the Declaration of Geneva in 1948 (Fischer, 2006), followed by the Declaration of Helsinki in 1964, to apply ethical principles to medical research involving human participants (Fischer, 2006; Rickham, 1964). A decade later, on July 12, 1974, the National Research Act was signed into law (U.S. Department of Health and Human Services [HHS], 1979). Through this act, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed and charged with developing guidelines for the conduct of biomedical and behavioral research. The guidelines were established in the Belmont Report (HHS, 1979; U.S. Department of Health, Education, and Welfare, 1979), which continues to be periodically updated. The Belmont Report describes the general principles of respect for persons, beneficence, and justice, and it outlines the process of obtaining informed consent to ensure that these principles are followed (HHS, 1979). In 1998, an informed consent checklist was instituted (HHS, 1998). Although clearly outlined, defined, and described in consent forms, it is beneficial to revisit how informed participants are when they enter research studies, particularly for patients undergoing treatment for cancer. This article will provide an overview of several areas for consideration. 
.

  18. 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.

  19. 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

  20. 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.

  1. Positive affect and sleep in spousal Alzheimer caregivers: a longitudinal study.

    Science.gov (United States)

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

    2014-09-03

    This article examines the longitudinal relation between positive affect (PA) and sleep in 126 spousal Alzheimer's disease caregivers. Caregivers underwent 4 yearly assessments for the Positive and Negative Affect Schedule, the self-rated Pittsburgh Sleep Quality Index, and actigraphy to objectify nighttime total sleep time, wake after sleep onset, and percentage of sleep. Increased levels of PA and a greater positivity (i.e., positive-to-negative affect) ratio were significantly associated with better subjective sleep over the entire study period. Yearly increases in PA-even when controlling for negative affect (NA)-and in the positivity ratio were also associated with better subjective sleep. PA and actigraphy measures showed no significant relations. Increased PA is longitudinally associated with better sleep in dementia caregivers largely independent of NA.

  2. Relationship satisfaction and emotional language in frontotemporal dementia and Alzheimer disease patients and spousal caregivers.

    Science.gov (United States)

    Ascher, Elizabeth A; Sturm, Virginia E; Seider, Benjamin H; Holley, Sarah R; Miller, Bruce L; Levenson, Robert W

    2010-01-01

    We studied the impact of 2 types of dementia on marital satisfaction and on the emotional language that spouses use during conflictive marital interactions. Fifteen frontotemporal dementia (FTD) and 16 Alzheimer disease (AD) patient-caregiver couples, and 21 control couples, discussed a relationship problem in a laboratory setting. Marital satisfaction was assessed through questionnaire, and emotion language was quantified using text analysis. FTD couples reported lower marital satisfaction than AD and control couples. During the interactions, FTD and AD caregivers used significantly more negative emotion words than their patient spouses (no spousal differences were found in control couples). FTD caregivers also used more negative words than AD caregivers and controls. We interpret these findings as reflecting challenges that the behavioral changes in FTD create for maintaining a healthy marital bond.

  3. Early father–daughter relationship and demographic determinants of spousal marital satisfaction

    Directory of Open Access Journals (Sweden)

    Alsheikh Ali A

    2016-04-01

    Full Text Available Ahmad Alsheikh Ali,1 Fawzi Shaker Daoud2 1Counseling Psychology Program, Faculty of Educational Sciences, Hashemite University, 2Department of Psychology, Faculty of Arts and Sciences, Al-Ahliyya Amman University, Amman, Jordan Abstract: This study examined several dimensions of early father–daughter relationship as predictors of marital satisfaction among 494 respondents. Descriptive comparative approach was used in result analysis. The Father Presence Questionnaire and Marital Satisfaction Questionnaire were used, in addition to a number of demographic variables. Results showed that only physical relationship with the father, and perceptions of father’s influence, had a positive significant impact on wives’ marital satisfaction. Of all domains, only positive feelings about the father had a negative impact on the husband's marital satisfaction. Most demographic variables had statistically significant effect on marital satisfaction. Sociocultural implications for marital satisfaction for wives and husbands are discussed. Keywords: early father–daughter relationship, demographic, spousal marital satisfaction

  4. Spousal Breadwinning Across 30 Years of Marriage and Husbands' Health: A Gendered Life Course Stress Approach.

    Science.gov (United States)

    Springer, Kristen W; Lee, Chioun; Carr, Deborah

    2017-08-01

    Wives increasingly outearn their husbands, and gender relations theory suggests this arrangement may undermine men's well-being. We explore how long-term histories of spousal breadwinning may be associated with older men's self-rated mental and physical health, and risk of nine health diagnoses. Using 30 years of couple-level income data from the Health and Retirement Study ( n = 1,095 couples), we use latent class analyses to identify six classes that differ with respect to the timing and level of wife breadwinning. We link these classes to older husbands' later-life health. Classes that transitioned from husband breadwinning to wife breadwinning in early or later adulthood were associated with husbands' poorer overall physical health and risk of cardiometabolic and stress-related diseases. Patterns persist net of sociodemographics, depressive symptoms, health behaviors, and adolescent health. Violating cultural expectations, such as the masculinity ideal of male breadwinning, is associated with older men's poorer health.

  5. 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.

  6. Alpha-1 couples: interpersonal and intrapersonal predictors of spousal communication and stress.

    Science.gov (United States)

    Smith, Rachel A; Wienke, Sara; Coffman, Donna L

    2014-04-01

    Couples often discuss genetic test results, and then manage their implications together. This interdependence can lead to common, shared experiences, similar intrapersonal processes to manage shared stressors, or interpersonal influences between spouses, leading to different outcomes. This study sought to reveal the intracouple, intrapersonal, and interpersonal influences of genetic stigma and negative feelings on spousal communication and perceived stress with 50 couples in which one spouse is a member of a genetic disease registry. The results were analyzed with dyadic analysis, including multilevel modeling. The findings showed that registered members and their spouses were not statistically different in their mean levels of perceived genetic stigma, negative feelings about alpha-1 antitrypsin deficiency (AATD), conversations with each other about the AATD test results, and their perceived stress. The findings also showed that their intracouple consistencies were not high, and their intrapersonal and interpersonal influences on communication and stress differed. The social implications of genetic research at the interpersonal level are discussed.

  7. Association Between Spousal Caregiver Well-Being and Care Recipient Healthcare Expenditures.

    Science.gov (United States)

    Ankuda, Claire K; Maust, Donovan T; Kabeto, Mohammed U; McCammon, Ryan J; Langa, Kenneth M; Levine, Deborah A

    2017-10-01

    To measure the association between spousal depression, general health, fatigue and sleep, and future care recipient healthcare expenditures and emergency department (ED) use. Prospective cohort study. Health and Retirement Study. Home-dwelling spousal dyads in which one individual (care recipient) was aged 65 and older and had one or more activity of daily living or instrumental activity of daily living disabilities and was enrolled in Medicare Part B (N = 3,101). Caregiver sleep (Jenkins Sleep Scale), depressive symptoms (Center for Epidemiologic Studies Depression-8 Scale), and self-reported general health measures. Primary outcome was care recipient Medicare expenditures. Secondary outcome was care recipient ED use. Follow-up was 6 months. Caregiver depressive symptoms score and six of 17 caregiver well-being measures were prospectively associated with higher care recipient expenditures after minimal adjustment (P care recipient expenditures remained significantly associated with caregiver fatigue (cost increase, $1,937, 95% confidence interval (CI) = $770-3,105) and caregiver sadness (cost increase, $1,323, 95% CI = $228-2,419) after full adjustment. Four of 17 caregiver well-being measures, including severe fatigue, were significantly associated with care recipient ED use after minimal adjustment (P care recipient ED use remained significantly associated with caregiver fatigue (odds ratio (OR) = 1.24, 95% CI = 1.01-1.52) and caregiver fair to poor health (OR = 1.23, 95% CI = 1.04-1.45) after full adjustment. Caregiver total sleep score was not associated with care recipient outcomes. Poor caregiver well-being, particularly severe fatigue, is independently and prospectively associated with higher care recipient Medicare expenditures and ED use. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

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

    Science.gov (United States)

    Yang, Lei; Martikainen, Pekka; Silventoinen, Karri

    2016-11-05

    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. 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. 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. 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.

  9. 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.

  10. Establishing Criteria for Sexual Consent Capacity.

    Science.gov (United States)

    Kennedy, Carrie Hill; Niederbuhl, John

    2001-01-01

    Psychologists (N=305) completed a questionnaire concerning criteria for sexual consent capacity by individuals with mental retardation. Factor analysis identified five factors of which basic sexual knowledge, knowledge of the consequences of sexual behavior, and abilities related to self-protection were most critical for sexual consent capacity.…

  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. Informed Consent In Research | Nnebue | Afrimedic Journal

    African Journals Online (AJOL)

    Background: Ethical problems most often arise in research. One of the most important ethical rules governing research on humans is that participants must give their informed consent before taking part in a study. Informed consent is therefore a vital part of the research process, and as such entails more than obtaining a ...

  13. 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

  14. 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...

  15. 45 CFR 46.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Documentation of informed consent. 46.117 Section... informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be...) A written consent document that embodies the elements of informed consent required by § 46.116. This...

  16. 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....

  17. Association Between Spousal Suicide and Mental, Physical, and Social Health Outcomes: A Longitudinal and Nationwide Register-Based Study.

    Science.gov (United States)

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

    2017-05-01

    Bereavement after spousal suicide has been linked to mental disorders; however, a comprehensive assessment of the effect of spousal suicide is needed. 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. 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. 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. 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 population. Compared with spouses bereaved by other manners of death, those bereaved by

  18. [Formal quality assessment of informed consent documents in 9 hospitals].

    Science.gov (United States)

    Calle-Urra, J E; Parra-Hidalgo, P; Saturno-Hernández, P J; Martínez-Martínez, M J; Navarro-Moya, F J

    2013-01-01

    Informed consent forms are very important in the process of medical information. The aim of this study is to design reliable formal quality criteria of these documents and their application in the evaluation of those used in the hospitals of a regional health service. Criteria have been designed from the analysis of existing regulations, previous studies and consultation with key experts. The interobserver concordance was assessed using the kappa index. Criteria evaluation was performed on 1425 documents of 9 hospitals. A total of 19 criteria used in the evaluation of the quality of informed consent forms have been obtained. Kappa values were higher than 0,60 in 17 of them and higher than 0,52 in the other 2. The average number of defects per document was 7.6, with a high-low ratio among hospitals of 1.84. More than 90% of the documents had defects in the information on consequences and contraindications, and in about 90% it did not mention the copy to the patient. More than 60% did not comply with stating the purpose of the procedure, a statement of having understood and clarified doubts, and the treatment options. A tool has been obtained to reliably assess the formal quality of the informed consent forms. The documents assessed have a wide margin for improvement related to giving a copy to the patient, and some aspects of the specific information that patients should receive. Copyright © 2012 SECA. Published by Elsevier Espana. All rights reserved.

  19. Consenting to sexual activity: the development and psychometric assessment of dual measures of consent.

    Science.gov (United States)

    Jozkowski, Kristen N; Sanders, Stephanie; Peterson, Zoë D; Dennis, Barbara; Reece, Michael

    2014-04-01

    Sexual assault prevention efforts have focused on educating students to obtain consent as a mechanism to reduce sexual assault, yet little is known about how college students consent to sex. Additionally, there are currently no measures available to assess students' consent to sex. The current study aimed to better understand college students consent by using a systematic approach to develop validated measures of sexual consent. This study integrated mixed methods via three phases and two waves of data collection to develop two measures of consent. In Phase 1, qualitative data were collected from college students (n = 185) to inform the design of quantitative measures aimed at assessing sexual consent at last sexual intercourse. In Phase 2, items were written for the closed-ended quantitative instrument and reviewed by a team of experts, educators, and clinicians. In Phase 3, a quantitative survey was administered to college students (n = 660) which included the measures of consent developed from the Phase 1 data; the measures were assessed for their psychometric properties. Exploratory factor analyses were utilized to assess the measures and resulted in five factors each for both consent scales. Both scales had high internal consistency reliability, showed gender differences, and showed differences across relationship status (single vs. in a relationship). The two newly developed measures assess unique constructs of consent and demonstrate assessments of specific concepts. Our findings provide an important contribution to the field of sexuality as these measures can be used in future research to better understand sexual consent.

  20. Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents.

    Science.gov (United States)

    Munung, Nchangwi Syntia; Marshall, Patricia; Campbell, Megan; Littler, Katherine; Masiye, Francis; Ouwe-Missi-Oukem-Boyer, Odile; Seeley, Janet; Stein, D J; Tindana, Paulina; de Vries, Jantina

    2016-02-01

    The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium. A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of test results. Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results. H3Africa research makes use of three consent models-specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  1. Informed consent in field trials of gene-drive mosquitoes.

    Science.gov (United States)

    Kolopack, Pamela A; Lavery, James V

    2017-12-11

    The US National Academies' (NAS) recent report 'Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values' examines the requirements of responsible conduct in research involving gene drives in non-human organisms. Many of the complex ethical issues raised by the introduction of gene drive technologies for mosquito population control have been anticipated during the development and field-testing of earlier-generation genetic engineering approaches with mosquitoes. One issue-the requirement for informed consent in field trials-is not addressed explicitly in the NAS' report. Some commentators have presumed that informed consent should play a role as a protection for research participants in studies of genetically modified mosquitoes. Others have argued that there are no human subjects of field trials, so the informed consent requirement does not apply. It is both ethically and practically important that these presumptions are adequately scrutinized to ensure that any applications of informed consent in these trials are properly justified. We argue that informed consent from individual research participants in gene drive trials may be required: (1) when blood and other forms of clinical data are collected from them, as will likely be the case in some studies involving epidemiological endpoints, such as the incidence of new infections with dengue and malaria; (2) when they participate in social science and/or behavioral research involving the completion of surveys and questionnaires; or (3) when their home or property is accessed and the location recorded as a spatial variable for the release or collection of mosquitoes because the precise location of the household is important for entomological reasons and these data constitute identifiable private information at the household level. Importantly, most regulations and guidelines allow these requirements to be waived or modified, to various degrees, according to the

  2. 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.

  3. Towards better-informed consent: Research with livestock-keepers and informal traders in East Africa.

    Science.gov (United States)

    Cooper, Tarni Louisa; Kirino, Yumi; Alonso, Silvia; Lindahl, Johanna; Grace, Delia

    2016-06-01

    of relationships between humans, animals, and their environment. Also discussed is how a requirement to sign consent forms might limit consent among workers in informal markets, which are commonly studied in One Health research. We suggest expansion of these, and development of further, studies towards improving consent processes in One Health research. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

  4. Comprehensibility of translated informed consent documents used in clinical research in psychiatry.

    Science.gov (United States)

    Jhanwar, Venu Gopal; Bishnoi, Ram Jeevan

    2010-01-01

    Informed consent forms are required in all clinical trials which are approved by an independent Ethics Committee before practical use in the trials. However, how much the average subject actually understands of the information contained in these informed consent forms is uncertain. In a cross sectional study, the translated informed consent forms used in psychiatric clinical trials were assessed with respect to their ease of readability. We analyzed 30 informed consent forms translated from English to Hindi used in multinational and multicentre psychiatric clinical trials sponsored by different sponsors. We examined consent forms for readability scores and factors that might relate to readability. The mean readability score for the informed consent forms, determined by the Flesch-Kincaid Grade Level Index (FKGL) was grade levels of 13.66. The ease of readability assessed by the Flesch Reading Ease Score (FRES) was 46.08 suggesting significant complexity of the texts. These values carry even more significance when the average years of schooling for India as a whole are 6.2 years. Our results show that the most informed consent forms were too complex to understand by an average adult subject. We suggest reducing this complexity and increasing the ease of readability so those average subjects receive the intended information as exactly as it could be. This can be achieved by few simple measures like improving the deficiencies in translation processes, encouraging the investigators to participate while preparing these forms, and enhanced understanding of the site specific requirements, namely culture, language (dialect), general literacy rate, etc.

  5. Assessing a narrated white board animation as part of the consent process for intravenous fluorescein angiography: a randomized educational study.

    Science.gov (United States)

    Mednick, Zale; Irrcher, Isabella; Hopman, Wilma M; Sharma, Sanjay

    2016-12-01

    To determine if a narrated white board animation (nWBA) video as part of the consent process for intravenous fluorescein angiography (IVFA) improves patient comprehension compared with a standard consent process. Prospective, randomized study. Patients undergoing an initial IVFA investigation. Three groups of 26 patients (N = 78) naïve to the IVFA procedure were included. Groups 1 and 2 consisted of patients undergoing IVFA for diagnostic purposes. Group 1 received the IVFA information via standard physician-patient interaction to obtain standard consent. Group 2 received IVFA information by watching an nWBA explaining the purpose, method, and risks of the diagnostic test to obtain informed consent. Group 3 comprised patients who were not scheduled to undergo IVFA. This group was exposed to both the standard and nWBA consent. All groups completed a 6-question knowledge quiz to assess retained information and a survey to reflect on the consent experience. Participants receiving information via standard physician-patient interaction to obtain informed consent had a lower mean knowledge score (4.38 out of 6; 73%) than participants receiving the information to obtain consent via nWBA (5.04 out of 6, 84%; P = 0.023). Of participants receiving both forms of information (group 3) to obtain informed consent, 73% preferred the nWBA to the standard consent process. Participants receiving consent information for an IVFA diagnostic test via nWBA have better knowledge retention regarding the IVFA procedure and preferred this medium compared with participants receiving the standard physician-patient interaction for obtaining consent. Incorporation of multimedia into the informed consent process should be explored for other diagnostic tests. Copyright © 2016 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

  6. First Implementation of Transfusion Consent Policy in Oman; Audit of compliance from a tertiary care university hospital

    Directory of Open Access Journals (Sweden)

    Arwa Z. Al-Riyami

    2016-08-01

    Full Text Available Objectives: Transfusions are a common medical intervention. Discussion of the benefits, risks and alternatives with the patient is mandated by many legislations prior to planned transfusions. At the Sultan Qaboos University Hospital (SQUH, Muscat, Oman, a written transfusion consent policy was introduced in March 2014. This was the first time such a policy was implemented in Oman. This study therefore aimed to assess adherence to this policy among different specialties within SQUH. Methods: The medical records of patients who underwent elective transfusions between June and August 2014 were reviewed to assess the presence of transfusion consent forms. If present, the consent forms were examined for completeness of patient, physician and witness information. Results: In total, the records of 446 transfused patients (299 adult and 147 paediatric patients were assessed. Haematology patients accounted for 50% of adult patients and 71% of paediatric patients. Consent was obtained for 75% of adult and 91% of paediatric patients. The highest adherence rate was observed among adult and paediatric haematology specialists (95% and 97%, respectively. Consent forms were correctly filled out with all details provided for 51% and 52% of adult and paediatric patients, respectively. Among inadequately completed forms, the most common error was a lack of witness details (20–25%. Conclusion: In most cases, the pre-transfusion consent policy was successfully adhered to at SQUH. However, further work is required to ensure full compliance with the consent procedure within different specialties. Implementation of transfusion consent in other hospitals in the country is recommended.

  7. A computer-based education intervention to enhance surrogates' informed consent for genomics research.

    Science.gov (United States)

    Shelton, Ann K; Freeman, Bradley D; Fish, Anne F; Bachman, Jean A; Richardson, Lloyd I

    2015-03-01

    Many research studies conducted today in critical care have a genomics component. Patients' surrogates asked to authorize participation in genomics research for a loved one in the intensive care unit may not be prepared to make informed decisions about a patient's participation in the research. To examine the effectiveness of a new, computer-based education module on surrogates' understanding of the process of informed consent for genomics research. A pilot study was conducted with visitors in the waiting rooms of 2 intensive care units in a Midwestern tertiary care medical center. Visitors were randomly assigned to the experimental (education module plus a sample genomics consent form; n = 65) or the control (sample genomics consent form only; n = 69) group. Participants later completed a test on informed genomics consent. Understanding the process of informed consent was greater (P = .001) in the experimental group than in the control group. Specifically, compared with the control group, the experimental group had a greater understanding of 8 of 13 elements of informed consent: intended benefits of research (P = .02), definition of surrogate consenter (P= .001), withdrawal from the study (P = .001), explanation of risk (P = .002), purpose of the institutional review board (P = .001), definition of substituted judgment (P = .03), compensation for harm (P = .001), and alternative treatments (P = .004). Computer-based education modules may be an important addition to conventional approaches for obtaining informed consent in the intensive care unit. Preparing patients' family members who may consider serving as surrogate consenters is critical to facilitating genomics research in critical care. ©2015 American Association of Critical-Care Nurses.

  8. 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

  9. A Pilot Study of Simple Interventions to Improve Informed Consent in Clinical Research: Feasibility, Approach, and Results

    Science.gov (United States)

    Kass, Nancy; Taylor, Holly; Ali, Joseph; Hallez, Kristina; Chaisson, Lelia

    2014-01-01

    Background Informed consent is intended to ensure that individuals understand the purpose, risks, and benefits of research studies, and then can decide, voluntarily, whether to enroll. However, research suggests that consent procedures do not always lead to adequate participant understanding and may be longer and more complex than necessary. Studies also suggest some consent interventions, including enhanced consent forms and extended discussions with patients, increase understanding, yet methodologic challenges have been raised in studying consent in actual trial settings. This study aimed to examine the feasibility of testing two consent interventions in actual studies and also to measure effectiveness of interventions in improving understanding of trials. Methods Participants enrolling in any of eight ongoing clinical trials (“collaborating studies”) were, for the purposes of this study, sequentially assigned to one of three study arms involving different informed consent procedures (one control and two intervention). Control participants received standard consent form and processes. Participants in the 1st intervention arm received a bulleted fact-sheet providing simple summaries of all study components in addition to the standard consent form. Participants in the 2nd intervention arm received the bulleted fact-sheet and standard consent materials and then also engaged with a member of the collaborating study staff in a feedback Q&A session. Following consent procedures, we administered closed and open ended questions to assess patient understanding and we assessed literacy level. Descriptive statistics, Wilcoxon-Mann-Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of patient understanding. Results 144 participants enrolled. Using regression analysis participants receiving the 2nd intervention, which included a standard consent form, bulleted fact sheet and structured question and answer

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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

  16. Informed consent & ethical issues in paediatric psychopharmacology.

    Science.gov (United States)

    Malhotra, Savita; Subodh, B N

    2009-01-01

    Issues relating to informed consent and ethics in paediatric psychopharmacology limit research in this population. Children vary in their levels of cognitive development, and presence of psychiatric disorder may further impair their ability to give informed consent. In decisional impairment subjects, various methods used for consent are assent/dissent; inclusion of advance directives; and/or alternative decision-makers. India is emerging as a new market for clinical trials in recent years. Moreover, in India the sociocultural realities are different from those in the western countries making it necessary for professionals to be cautious in conducting drug trials. In this review, issues regarding informed consent in children and adolescent with psychiatric diagnosis are discussed for information, discussion and debate by professionals, parents, society and legal experts to create awareness and to facilitate development of guidelines that are appropriate and applicable to the Indian system.

  17. 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.

  18. 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)

  19. 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.

  20. Perceptions of Purpose in Life Within Spousal Care Dyads: Associations With Emotional and Physical Caregiving Difficulties.

    Science.gov (United States)

    Polenick, Courtney A; Kales, Helen C; Birditt, Kira S

    2018-01-05

    Greater feelings of purpose in life are associated with better health and may reduce the negative impact of chronic stress. Yet little is known about how purpose in life may buffer the negative effects of caregiving, a common chronic stressor in middle and later life. This cross-sectional study utilized a U.S. sample of 315 spousal caregivers and their partners with functional disability drawn from the 2011 National Health and Aging Trends Study and National Study of Caregiving to examine how both parties' perceptions of purpose in life are associated with caregivers' emotional and physical caregiving difficulties. We also evaluated whether care recipients' purpose in life moderates the association between caregivers' purpose in life and care-related difficulties. Finally, we considered whether these links differed by caregiver gender. Models controlled for caregivers' sociodemographics, care tasks, support resources, valued activity participation, and each care partner's health conditions. Caregivers' greater purpose in life was significantly linked to fewer physical caregiving difficulties. Caregivers' greater purpose in life was significantly associated with fewer emotional care-related difficulties among caregiving wives and when care recipients' purpose in life was low. Although the associations between purpose in life and care-related difficulties are likely bidirectional, purpose in life may represent an important resource for combating the adverse consequences of caregiving. This study highlights the value of considering personal resources and their implications for caregivers' well-being within a dyadic context.

  1. 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).

  2. Correlates of spousal empathic accuracy for pain-related thoughts and feelings.

    Science.gov (United States)

    Leonard, Michelle T; Issner, Jaclyn Heller; Cano, Annmarie; Williams, Amy M

    2013-04-01

    This study explored correlates of spousal ability to infer the thoughts and feelings of individuals with chronic pain (ICPs). Participant couples (N=57), who consisted of at least 1 couple member with chronic pain, engaged in a videotaped discussion about pain, after which they completed an empathic accuracy procedure where spouses of ICP were asked to infer thoughts/feelings of ICPs. Overall levels of partner empathic accuracy were similar to other studies of couples. Several characteristics of the pain experience and the marital relationship correlated with empathic accuracy for thoughts and feelings. Specifically, partner catastrophizing about the ICP's pain was associated with less empathic accuracy for thoughts, whereas ICP pain severity was related to a greater empathic accuracy for feelings. Several significant interactions were also found, with marital satisfaction and partner's own pain experience acting as moderators. These findings provide support for models of empathy that argue that characteristics of the pain condition and characteristics of the observer are important contributors to observers' understanding of pain. In addition, the findings support previous research that suggests there are different processes for understanding the emotional versus the cognitive experience of others.

  3. Predictive Factors for the Uptake of Coping Strategies by Spousal Dementia Caregivers: A Systematic Review.

    Science.gov (United States)

    Roche, Lauren; MacCann, Carolyn; Croot, Karen

    2016-01-01

    An understanding of spousal dementia caregivers' coping strategies and their predictive factors is imperative for caregivers' well-being. Although several reviews have explored the relationship between coping strategies and outcomes, no review has investigated factors that predict caregivers' use of one type of coping strategy over another. The current review aimed to identify factors that predict caregivers' coping strategies. Within this, we attempted to identify caregivers who are more likely to adopt dysfunctional coping strategies and be at risk of adverse outcomes. Several electronic databases were systematically searched. Twenty-one studies were eligible for review, describing 18 caregiver and care-recipient factors related to the 3 coping strategies. No factors were classified "predictive," however, 16 factors were "potentially predictive." Younger, more highly educated caregivers with greater emotional supports and knowledge of dementia were associated with solution-focused coping. Younger, less educated caregivers were associated with emotional support/acceptance-based coping strategies. Whereas nonwhite caregivers with less emotional supports caregiving for persons with more behavioral problems were associated with dysfunctional coping strategies. Enhancing caregiver self-efficacy, knowledge of dementia, improving social supports, linking to support groups, managing behavioral problems, as well as coaching adaptive coping strategies while flagging caregivers at risk for dysfunctional coping may improve outcomes for caregivers.

  4. Consent for audio-video recording of informed consent process in rural South India

    Directory of Open Access Journals (Sweden)

    Ramesh Chand Chauhan

    2015-01-01

    Full Text Available Introduction and Objectives: In recent times, audio-video (A-V recording of consent process for all the study subjects entering a clinical trial has been made mandatory. A-V recording of informed consent process is a big challenge due to confidentiality and the sociocultural environment in India. It is important to find out the acceptability for A-V recording of the consent process and reasons for refusal, if any to address this new challenge. Materials and Methods: A descriptive survey was done among 150 residents of a rural community of South India. Acceptability for A-V recording of consent process was assessed among those who had given the informed written consent for participation in the study. An attempt to find the factors determining the refusal was also made. Results: More than one-third (34% of the study subjects refused to give consent for A-V recording of consent process. Not interested in recording or don′t like to be recorded (39% were the most common reasons to refuse for A-V recording of consent process. The refusal was higher among female and younger age-group adult subjects. Socioeconomic status was not found to be significantly associated with refusal to consent for A-V recording. Conclusion: Refusal for A-V recording of consent process is high in the South Indian rural population. Before any major clinical trial, particularly a field trial, an assessment of consent for A-V recording would be helpful in recruitment of study subjects.

  5. 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.

  6. Gender vulnerabilities, spousal abuse and the incidence of HIV in Lesotho:a case for an integrative rights-based approach.

    Science.gov (United States)

    Olowu, 'Dejo

    2011-09-01

    The article posits that imbalances in gender relations are influencing two distinctive yet connected crises for women in Lesotho: the HIV epidemic and spousal abuse. The overarching premise is that as spousal abuse is increasingly recognised and as HIV infections spread, responses to the phenomenon do not reflect the related risks and consequences in married women's lives. This article underscores the nexus of connections between HIV and spousal abuse in Lesotho, identifying potential areas for pragmatic state-led responses. Applying a rights-based approach, it assesses women's vulnerability to each problem at the individual, societal and programmatic levels, noting that there are both direct and underlying factors heightening risks for women. The article asks, what is the value added by a rights-based approach to the subject under discourse? And, how can a rights-based approach be translated into practical tools for planning, monitoring and evaluating projects and programmes aimed at tackling the multifaceted risks and challenges of HIV and spousal abuse confronting women in Lesotho? In response to these questions, the author identifies three trajectories of opportunities for an integrated, comprehensive response. The unmistakable anchor of the article's propositions is the rights-based approach. Although the discussion focuses on Lesotho, the implications for the broader African region cannot be overemphasised in light of commonly shared experiences pertaining to the severe difficulties posed by spousal abuse and HIV.

  7. 76 FR 18762 - Google, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Science.gov (United States)

    2011-04-05

    ... FEDERAL TRADE COMMISSION [File No. 102 3136] Google, Inc.; Analysis of Proposed Consent Order To... paper form. Comments should refer to ``Google, File No. 102 3136'' to facilitate the organization of... paper form should include the ``Google, File No. 102 3136'' reference both in the text and on the...

  8. Children and School-based Research: "Informed Consent" or "Educated Consent?"

    Science.gov (United States)

    David, Miriam; Edwards, Rosalind; Alldred, Pam

    2001-01-01

    Discusses informed consent regarding research with children in educational settings. Considers issues that arose in the process of gaining their consent to participate in research on children's understandings of parental involvement in education. Raises questions about distinctions between providing information and teaching and conducting ethical…

  9. 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.

  10. 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.

  11. Unblurring the lines of sexual consent with a college student-driven sexual consent education campaign.

    Science.gov (United States)

    Ortiz, Rebecca R; Shafer, Autumn

    2018-02-06

    To test the effectiveness of a college student-driven sexual consent education campaign to improve college students' sexual consent understanding. Undergraduate students (N = 992) at a large, public Midwestern university between March and December 2015. Three online survey questionnaires assessing relevant outcome measures were distributed to the university's undergraduate student population before, during, and after the campaign's implementation over two consecutive academic semesters. Exposure to the campaign and the sexual consent understanding of the student population improved over time. College men and members of university-affiliated social sororities or fraternities resulted in greater improvement than their respective counterparts (i.e., college women, nonmembers). Sexual consent education campaigns for college students that are student-driven and address relevant sociocultural factors while authentically interacting with students can improve students' sexual consent understanding. These type of campaigns also have the opportunity to reach historically hard-to-reach audiences, such as college men.

  12. 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.

  13. 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.

  14. 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.

  15. Exceptions to the rule of informed consent for research with an intervention.

    Science.gov (United States)

    Rebers, Susanne; Aaronson, Neil K; van Leeuwen, Flora E; Schmidt, Marjanka K

    2016-02-06

    In specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent. Here, we provide a more extensive literature review of possible exceptions to the rule of informed consent and the accompanying arguments based on literature from 1997 onwards, using both Pubmed and PsycINFO in our search strategy. We identified three main categories of arguments for the acceptability of a consent waiver: data validity and quality, major practical problems, and distress or confusion of participants. Approval by a medical ethical review board always needs to be obtained. Further, we provide examples of specific conditions under which consent waiving might be allowed, such as additional privacy protection measures. The reasons legitimized by the authors of the papers in this overview can be used by researchers to form their own opinion about requesting an exception to the rule of informed consent for their own study. Importantly, rules and guidelines applicable in their country, institute and research field should be followed. Moreover, researchers should also take the conditions under which they feel an exception is legitimized under consideration. After discussions with relevant stakeholders, a formal request should be sent to an IRB.

  16. 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

  17. Sleep in Spousal Alzheimer Caregivers: A Longitudinal Study with a Focus on the Effects of Major Patient Transitions on Sleep

    Science.gov (United States)

    von Känel, Roland; Mausbach, Brent T.; Ancoli-Israel, Sonia; Dimsdale, Joel E.; Mills, Paul J.; Patterson, Thomas L.; Ziegler, Michael G.; Roepke, Susan K.; Chattillion, Elizabeth A.; Allison, Matthew; Grant, Igor

    2012-01-01

    Study Objectives: Findings on sleep disturbances in family dementia caregivers are conflicting. We studied the longitudinal effects of dementia caregiving and major transitions in the caregiving situation on caregivers' sleep and the effect of moderating variables. Design and Setting: Community-based longitudinal study with assessments about once a year for up to three years. Participants: A sample of 109 elderly spousal Alzheimer caregivers and 48 non-caregiving age- and gender-matched controls. Measurements and Results: Random regression models with fixed and time-variant effects for covariates known to affect sleep were used to evaluate changes in the Pittsburgh Sleep Quality Index (PSQI) and in four actigraphy measures over time in relation to caregiving status and transitions (i.e., nursing home placement or death of the Alzheimer disease spouse). Multivariate-adjusted sleep characteristics did not significantly differ between caregivers and non-caregivers over time. Spousal death increased caregivers' nighttime wake after sleep onset (WASO) by 23 min (P = 0.002) and daytime total sleep time (TST) by 29 min (P = 0.003), while nighttime sleep percent decreased by 3.2% (P = 0.009) and nighttime TST did not change. Placement of the spouse had no significant effect on caregivers' sleep. Older age, male gender, role overload, depressive symptoms, and proinflammatory cytokines variously emerged as significant moderators of the relationships between caregiving and transitions with poor subjective and objective sleep. Conclusions: Alzheimer caregivers and non-caregiving controls had similar trajectories of sleep. However, there may be subgroups of caregivers who are vulnerable to develop sleep disturbances, including those whose spouses have died. Citation: von Känel R; Mausbach BT; Ancoli-Israel S; Dimsdale JE; Mills PJ; Patterson TL; Ziegler MG; Roepke SK; Chattillion EA; Allison M; Grant I. Sleep in spousal alzheimer caregivers: a longitudinal study with a focus

  18. A template for broad consent in biobank research. Results and explanation of an evidence and consensus-based development process.

    Science.gov (United States)

    Strech, D; Bein, S; Brumhard, M; Eisenmenger, W; Glinicke, C; Herbst, T; Jahns, R; von Kielmansegg, S; Schmidt, G; Taupitz, J; Tröger, H D

    2016-06-01

    Biobanks increasingly presume long-term storage of biomaterials and data that shall be used for future research projects which are today unspecified. Appropriate consent documents for sample donors must therefore explain the breadth of consent and other elements of the biobank governance framework. Recent reviews demonstrated high variability in what issues these documents mention or not and how the issues are explained. This might undermine the protection of sample donors, complicate networked biobank research, create research waste and impact on public trust. A systematic analysis of international research guidelines and existing broad consent templates was performed. Based on this information an interdisciplinary expert group from the AKMEK (Permanent Working Party of German RECs) developed a draft template and organized a comprehensive stakeholder consultation. After revision the final template was consented by all 53 German RECs. This paper briefly explores the spectrum of potentially relevant issues for broad consent forms. It then elaborates the template and how it was designed to be applicable in different types of biobanks. To further improve the validity and applicability of broad consent forms in biobank and other big data research, practice evaluations are needed. We hope that in this regard the presented template supports the development of new consent forms as well as the evaluation and revision of existing ones. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  19. Spousal separation, selectivity and contextual effects: exploring the relationship between international labour migration and fertility in post-Soviet Tajikistan

    Directory of Open Access Journals (Sweden)

    David Clifford

    2009-12-01

    Full Text Available This paper contributes to the sparse literature on the impact of temporary migration on fertility in origin areas. It examines the case of male labour migration from post-Soviet Tajikistan, a significant and relatively recent phenomenon. Fertility and migration models are solved simultaneously to account for cross-process correlation. There is clear evidence for a short-term disruptive effect of spousal separation, but it is too early to assess the implications for completed fertility. While there is no evidence for unobserved selectivity at the couple level, there is a significant positive correlation between the migration and fertility processes at the community level.

  20. 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

    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...... bereavement to a greater extent than vice versa. Conclusions: The findings in the present study indicate that changes in PGS may precede and potentially directly impact changes in PTSS following bereavement. This tentative conclusion points to the potential value of targeting PGS in psychological...

  1. 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).

  2. 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.

  3. Public preferences on written informed consent for low-risk pragmatic clinical trials in Spain.

    Science.gov (United States)

    Dal-Ré, Rafael; Carcas, Antonio J; Carné, Xavier; Wendler, David

    2017-09-01

    Pragmatic randomized clinical trials (pRCTs) collect data that have the potential to improve medical care significantly. However, these trials may be undermined by the requirement to obtain written informed consent, which can decrease accrual and increase selection bias. Recent data suggest that the majority of the US public endorses written consent for low-risk pRCTs. The present study was designed to assess whether this view is specific to the US. The study took the form of a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent vs. verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing two drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. The primary outcome measures were respondents' personal preference and hypothetical recommendation to a research ethics committee regarding the use of written informed consent vs. the alternatives. A total of 2008 adults sampled from a probability-based online panel responded to the web-based survey conducted in May 2016 (response rate: 61%). Overall, 77% of respondents endorsed written consent. In both scenarios, the alternative of general notification received significantly more support (28.7-37.1%) than the alternative of verbal consent (12.7-14.0%) (P = 0.001). Forty per cent of respondents preferred and/or recommended general notification rather than written consent. The results suggested that, rather than attempting to waive written consent, current pRCTs should focus on developing ways to implement written consent that provide sufficient information without undermining recruitment or increasing selection bias. The finding that around 40% of respondents endorsed general notification over written consent raises the possibility that, with educational efforts, the majority of Spaniards might accept general notification for low-risk pRCTs. © 2017 The

  4. 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 ...

  5. 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.

  6. Express consent and full membership in Locke

    NARCIS (Netherlands)

    den Hartogh, G.A.

    1990-01-01

    It seems mysterious why Locke required express consent as a condition of full membership of civil society. It is suggested this requirement be interpreted as a political programme. In a draft of a pamphlet of 1690 Locke criticizes the oath of allegiance required after the Glorious Revolution for not

  7. 34 CFR 300.9 - Consent.

    Science.gov (United States)

    2010-07-01

    ... language, or through another mode of communication; (b) The parent understands and agrees in writing to the... parent revokes consent in writing for their child's receipt of special education services after the child... SERVICES, DEPARTMENT OF EDUCATION ASSISTANCE TO STATES FOR THE EDUCATION OF CHILDREN WITH DISABILITIES...

  8. Consent in escrow: opting to opt in.

    Science.gov (United States)

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

    2015-11-01

    In this paper, we reply to Taylor's (2015) peer commentary on consent-in-escrow. Specifically, we clarify the utility of this novel approach, the way in which it minimizes risks to participants, and how it differs from existing opt-out methods. We further explore its potential use in fields beyond disaster research.

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

    Science.gov (United States)

    Harjunen, Elina

    2011-01-01

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

  10. Informed consent to HIV cure research.

    Science.gov (United States)

    Bromwich, Danielle; Millum, Joseph R

    2017-02-01

    Trials with highly unfavourable risk-benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants' motivations for enrolling in potentially high risk research with no prospect of direct benefit; and third, participants' understanding of the details of the trials in which they enrol. We argue that the communication concern is relevant to the validity of informed consent and the quality of decision making, that the motivation concern does not identify a genuine problem with either the validity of consent or the quality of decision making and that the understanding concern may not be relevant to the validity of consent but is relevant to the quality of decision making. In doing so, we derive guidance points for researchers recruiting and enrolling participants into their HIV cure trials, as well as the research ethics committees reviewing proposed studies. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  11. HIV testing and informed consent - ethical considerations

    African Journals Online (AJOL)

    patient; research; blood, tissue and organ donation; and the protection of third parties, including the health care worker. We contend that in each case there is no good reason for the requirement of informed consent to be significantly waived. S Atr Med J 1994; 84: 669-674. Does testing for HIV infection require the informed ...

  12. 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 ...

  13. 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

  14. 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... vehicle on a military installation involved in a motor vehicle or criminal infraction shall be informed...

  15. EPO or not-EPO? An evidence based informed consent.

    Science.gov (United States)

    Mezza, E; Piccoli, G B; Pacitti, A; Soragna, G; Bermond, F; Burdese, M; Gai, M; Motta, D; Jeantet, A; Merletti, F; Vineis, P; Segoloni, G P

    2004-04-01

    Informed consent is crucial in therapeutic choices; however, the forms presented to patients are often locally developed and information may not be homogeneous. To prepare an evidence-based model for informed consent, applied in the case of erythropoietin therapy (EPO) as a teaching tool for medical students. Methodological tools of Evidence-Based Medicine (EBM) were developed within the EBM Course in the Medical School of Torino, Italy, as problem solving and patient information tools (5th year students work in small groups under the supervision of statisticians, epidemiologists and experts of internal medicine--nephrology in this case). Methodological and ethical problems were identified: in the pre-dialysis field, evidence from randomized clinical trials (RCT) is scant; how to use evidence gathered in dialysis? How to deal with implementation? How with the mass media? Do we need to discuss the drug choice with the patients? How to deal with rare and severe side effects?). The "evidence" was searched for on Medline/Embase, by using key-words and free terms. About 680 papers were retrieved and screened. Forms available on the Internet were retrieved and a general scheme was drawn: it included 5 areas: title, aim and targets (patients and family physicians); search strategies and updating; pros and cons of therapy; alternative options; open questions. EBM may offer valuable tools for systematically approaching patient information; the inclusion of this kind of exercise in the Medical School EBM courses may help enhance the awareness of future physicians of the correct communication with patients.

  16. The informed consent: a study of the efficacy of informed consents and the associated role of language barriers.

    Science.gov (United States)

    Clark, Steven; Mangram, Alicia; Ernest, Dunn; Lebron, Ricardo; Peralta, Lauren

    2011-01-01

    Obtaining informed consent before performing invasive procedures and operations has become a standard practice at all medical institutions in the United States. All agree that patients should be both conscious of and in agreement with their medical care. Though patients routinely sign consent forms with numerous risks and complications detailed, there are only a limited amount of reports that study if these patients have a thorough understanding of those risks and complications. Confounding the issue of the efficacy of informed consents is the growing population of patients who do not speak English. To obtain objective data on the efficacy of informed consents and the role of language barriers we looked at how well patients who consented to have a laparoscopic cholecystectomy understood the complications associated with this procedure. We conducted a randomized prospective study of all patients seen in the General Surgery Resident Outpatient Clinic who presented for an elective cholecystectomy. Fifty patients agreed to participate in our study. Participants were split into two groups. In the first group (the control group) surgical benefits, risks and complications were explained in the usual fashion. In the second group, after hearing the standard explanation of surgical risks, complications and benefits, patients watched a PowerPoint presentation with illustrations on laparoscopic cholecystectomy. Patients from both groups then took a ten question assessment based on the presentations that they encountered. Spanish speaking patients were addressed with an interpreter and given a Spanish PowerPoint presentation with a Spanish assessment. The patients' age, education level, income, and birth country were also studied. Fifty-two percent of the patients in the study were born outside of the United States. All of the non-US born patients were Hispanic and their primary language was Spanish. The average age of the studied patients was 38. Sixty-eight percent of the

  17. 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.

  18. 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.

  19. The longitudinal and dyadic effects of mutuality on perceived stress for stroke survivors and their spousal caregivers.

    Science.gov (United States)

    Godwin, Kyler M; Swank, Paul R; Vaeth, Patrice; Ostwald, Sharon K

    2013-01-01

    Functional impairment resulting from a stroke frequently requires the care of a family caregiver, often the spouse. This change in the relationship can be stressful for the couple. Thus, this study examined the longitudinal, dyadic relationship between caregivers' and stroke survivors' mutuality and caregivers' and stroke survivors' perceived stress. This secondary data analysis of 159 stroke survivors and their spousal caregivers utilized a cross-lagged, mixed models analysis with the actor-partner interdependence model to examine the dyadic relationship between mutuality and perceived stress over the first year post-discharge from inpatient rehabilitation. Caregivers' mutuality showed an actor effect (β = -3.82, p perceived stress but not the stroke survivors' perceived stress. Stroke survivors' perceived stress showed a partner effect and affected caregivers' perceived stress (β = 0.13, p = 0.047). Caregivers' perceived stress did not show a partner effect and did not significantly affect stroke survivors' perceived stress. These findings highlight the interpersonal nature of stress in the context of caregiving for a spouse. Caregivers are especially influenced by perceived stress in the spousal relationship. Couples should be encouraged to focus on positive aspects of the caregiving relationship to mitigate stress.

  20. 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

  1. Parent-child and spousal relationships in families with a young child with end-stage renal disease.

    Science.gov (United States)

    Laakkonen, Hanne; Taskinen, Sara; Rönnholm, Kai; Holmberg, Christer; Sandberg, Seija

    2014-02-01

    End-stage renal disease (ESRD) leads to the need for dialysis and renal transplantation (Tx). Peritoneal dialysis (PD) of young children is normally performed at home by the parents and affects the whole family. We studied the coping of families with a young child with ESRD by interviewing the parents of 19 children. The spousal and parent-child relationships were assessed by using the Psychosocial Assessment of Childhood Experiences (PACE) and the Brief Measure of Expressed Emotion, respectively. A control group of 22 families with a healthy child was used for the parent-child relationship evaluation. The spousal relationship at the start of PD was good or fairly good in most of the families and remained good in half of the families following renal Tx. Lack of support from close relatives and renal Tx were associated with a poorer relationship quality. Almost all parents expressed much or fairly much emotional warmth towards the child throughout the study, but there was a trend towards increased criticism over time. No differences in the degree of expressed warmth or criticism were noted between the index parents and controls. Overall, the study families appeared to cope well despite the serious illness of their child and the demands of the treatments.

  2. Security Paving Company, Inc.: Consent Agreement and Proposed Final Order

    Science.gov (United States)

    Consent Agreement and Proposed Final Order (“Proposed Consent Agreement”), between the U.S. Environmental Protection Agency, Region 9 (“EPA”), and Security Paving Company (“Respondent”) to resolve a civil administrative penalty proceeding.

  3. Risk Management for Chiropractors and Osteopaths. Informed consent

    OpenAIRE

    Walker, Bruce F.; Cameron, Melainie; French, Simon; Pollard, Henry P.; Vitiello, Andrew L.; Reggars, John W.; Werth, Peter D.

    2004-01-01

    Obtaining the informed consent of a patient before undertaking chiropractic or osteopathic treatment is a common law requirement in Australia. This paper outlines the essential elements of informed consent and provides some practice tips on streamlining the process.

  4. 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.

  5. The Concept of Consent under the Sexual Offences Act 2003

    OpenAIRE

    Scott, Jacqueline

    2010-01-01

    The concept of consent is fundamental in considering the crime of rape under the Sexual Offences Act 2003 (SOA). Consent was placed on a statutory footing for the first time by the SOA which defines consent alongside evidential and conclusive presumptions under sections 74-76, respectively. This article explores the position that unfortunately, neither significant clarity nor enhanced protection appears to have been embraced or achieved by the incorporation of consent.

  6. Need and value of case management in multidisciplinary ALS care: A qualitative study on the perspectives of patients, spousal caregivers and professionals

    NARCIS (Netherlands)

    Bakker, Minne; Creemers, Huub; Schipper, Karen; Beelen, Anita; Grupstra, Hepke; Nollet, Frans; Abma, Tineke

    2015-01-01

    Our objective was to explore the needs and value of case management according to patients with amyotrophic lateral sclerosis (ALS), their spousal caregivers, and health care professionals in the context of multidisciplinary ALS care. We undertook semi-structured interviews with 10 patients with ALS,

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

    Directory of Open Access Journals (Sweden)

    Rapp Daniel

    2012-06-01

    Full Text Available Abstract Background 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. Methods 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. Results 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. Conclusions 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

  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. Informed consent for anaesthesiological and intensive care unit ...

    African Journals Online (AJOL)

    2013-03-04

    Mar 4, 2013 ... Keywords/phrases: anaesthesia, ICU research, South Africa, guidelines and regulations, informed consent, surrogate consent, vulnerability. Abstract .... (f) the development or new application of pharmaceuticals, medicines and .... authentic informed consent.22 The vulnerability of critically ill patients is ...

  10. 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...

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

    African Journals Online (AJOL)

    Doctors who treat children were significantly less likely to obtain consent for certain interventions. Conclusion. Doctors meet many, but not all, of the legal requirements for informed consent. The findings question whether informed consent as envisioned by the law exists in reality. Cross-cultural research is needed to clarify ...

  12. 40 CFR 26.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-07-01

    ... obtain informed consent provided the IRB finds and documents that: (1) The research or demonstration... obtain informed consent provided the IRB finds and documents that: (1) The research involves no more than... Supported by EPA § 26.116 General requirements for informed consent. Except as provided elsewhere in this...

  13. ORIGINAL ARTICLES Child consent in South African law ...

    African Journals Online (AJOL)

    Medical treatment. Currently, children can consent independently to medical treatment from the age of 14; those below 14 require consent from a parent, legal guardian or other designated person.2 In the future, children will be able to consent ... have the right to refuse circumcision.11. Health research. Currently, there is no ...

  14. 30 CFR 877.11 - Written consent for entry.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Written consent for entry. 877.11 Section 877... ABANDONED MINE LAND RECLAMATION RIGHTS OF ENTRY § 877.11 Written consent for entry. Written consent from the... to enter lands in order to carry out reclamation activities. Nonconsensual entry by exercise of the...

  15. Informed consent for cord blood donation. A theoretical and empirical study

    Science.gov (United States)

    Petrini, Carlo; Farisco, Michele

    2011-01-01

    Background and objectives Umbilical cord blood (CB) banking and therapeutic use raise several ethical issues: medical indications, legal framework, public versus private biobanks, autologous versus allogeneic use, ownership, commercialisation, quality assurance and many others. Surrogate informed consent is one of the most notable controversial ethical issues. The aim of this study was to analyse and compare informed consent forms for CB collection, storage and use in the 18 accredited biobanks of the Italian Network. Material and methods The first part of the article gives a brief overview of the scientific framework, the comparison of allogeneic and autologous use and Italian regulations. In the second part the contents of the consent forms from the 18 Italian biobanks are compared with the “NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration”. Results Most of the Italian consent forms differ significantly from the NetCord-FACT Standards, with regards both to formal and substantial aspects. Conclusion Italian forms for CB collection, storage and use need standardisation to meet international criteria. PMID:21251456

  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. 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.

  18. [Free will and patient consent during care].

    Science.gov (United States)

    Bréhaux, Karine

    2016-09-01

    Raising the question of a person's free will means questioning their freedom and capacity to make choices. Therefore, being free, means being able to judge between the possibilities which are offered to us, and deciding of our own accord what is acceptable to us. The concept of free will is associated with the notion of consent, in particular during care. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

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

    Science.gov (United States)

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

    2006-01-01

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

  20. Sexual Consent Capacity Assessment with Older Adults.

    Science.gov (United States)

    Syme, Maggie L; Steele, Debora

    2016-09-01

    Many healthcare providers have a limited knowledge of sexual and intimate expression in later life, often due to attitudinal and informational limitations. Further, the likelihood of an older adult experiencing cognitive decline increases in a long-term care (LTC) setting, complicating the ability of the providers to know if the older adult can make his or her own sexual decisions, or has sexual consent capacity. Thus, the team is left to question if and how to support intimacy and/or sexuality among residents with intimacy needs. Psychologists working with LTC need to be aware and knowledgeable about sexual consent capacity in older adulthood to be prepared to conduct evaluations and participate in planning care. Limited research is available to consult for best practices in sexual consent capacity assessment; however, models of assessment have been developed based on the best available evidence, clinical judgment, and practice. Existing models will be discussed and an integrated model will be illustrated via a case study. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  1. Public support and consent preference for biomedical research and biobanking in Jordan.

    Science.gov (United States)

    Ahram, Mamoun; Othman, Areej; Shahrouri, Manal

    2013-05-01

    The success of any biobank depends on a number of factors including public's view of research and the extent to which it is willing to participate in research. As a prototype of surrounding countries, public interest in research and biobanking in addition to the influence and type of informed consent for biobanking were investigated in Jordan. Data were collected as part of a national survey of 3196 individuals representing the Jordanian population. The majority of respondents (88.6%) had a positive perception of the level of research in Jordan and they overwhelmingly (98.2%) agreed to the concept of investing as a country in research. When respondents were asked if the presence of an informed consent would influence their decision to participate in biobanking, more individuals (19.8%) considered having an informed consent mechanism as a positive factor than those who considered it to have negative connotations (13.1%). However, a substantial portion (65%) did not feel it affected their decision. The majority of survey participants (64%) expressed willingness to participate in biobanking and over 90% of them preferred an opt-in consent form whether general (75.2%) or specific for disease or treatment (16.9%). These results indicate a promising ground for research and biobanking in Jordan. Educational programs or mass awareness campaigns to promote participation in biobanking and increase awareness about informed consent and individual rights in research will benefit both the scientific community as well as the public.

  2. Spontaneous decision of organ donation in patients signing informed consent for liver transplantation.

    Science.gov (United States)

    Heits, N; Guenther, R; Kuechler, T; Becker, T; Braun, F

    2013-05-01

    The shortage of postmortem donor organs is a well-known problem in Germany. Willingness in the general population is 80%, but less than 14% have an organ donor card. We evaluated the free decision of liver transplant candidates who filled out a donor card before signing the informed consent for the transplant procedure. We analyzed 122 patients of mean age 55.9 years (range, 15.4-74.1) who signed an informed consent for liver transplantation between January 10, 2007, and January 24, 2012. The patients received the original text of the German organ donor card with tick boxes on the informed consent form for liver transplantation. All patients were informed that their decision had no impact on further management. Patients were able to choose between (1) becoming a donor, (2) refusal, (3) transfer of the decision to another person, or (4) no decision. All patients signed the informed consent to be listed for liver transplantation: 73.8% (n = 90) chose to become a donor; 5.7% (n = 7) refused; 5.7% (n = 7) transferred the decision to another person; and 14.8% (n = 18) did not come to a decision. Interestingly, not all candidates for liver transplantation were willing to become an organ donor in the time of expressed consent. However, willingness to sign the donor card was much higher among liver transplant candidates compared with the general population. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. Consent and medical treatment: The legal paradigm in India

    Directory of Open Access Journals (Sweden)

    Omprakash V Nandimath

    2009-01-01

    Full Text Available The element of consent is one of the critical issues in medical treatment. The patient has a legal right to autonomy and self determination enshrined within Article 21 of the Indian Constitution. He can refuse treatment except in an emergency situation where the doctor need not get consent for treatment. The consent obtained should be legally valid. A doctor who treats without valid consent will be liable under the tort and criminal laws. The law presumes the doctor to be in a dominating position, hence the consent should be obtained after providing all the necessary information.

  4. Legal sanctity of consent for surgical procedures in India

    Directory of Open Access Journals (Sweden)

    Gauri Sharma

    2012-01-01

    Full Text Available As surgeons, we are morally committed to respecting the right of self-determination of patients, thus an informed consent is necessary before any operative intervention. Many neurosurgical patients are incapable of giving consent because of impaired consciousness. Moreover, neurosurgical procedures involve high risks and often are time sensitive; therefore obtaining consent is a challenging job. Patients and their family members need immense courage, understanding, and trust before giving consent for a surgical procedure to a doctor. Lawsuits against doctors are on the rise and it is important to understand "what is consent?" in legal parlance.

  5. Consent and medical treatment: The legal paradigm in India.

    Science.gov (United States)

    Nandimath, Omprakash V

    2009-07-01

    The element of consent is one of the critical issues in medical treatment. The patient has a legal right to autonomy and self determination enshrined within Article 21 of the Indian Constitution. He can refuse treatment except in an emergency situation where the doctor need not get consent for treatment. The consent obtained should be legally valid. A doctor who treats without valid consent will be liable under the tort and criminal laws. The law presumes the doctor to be in a dominating position, hence the consent should be obtained after providing all the necessary information.

  6. Spousal cardiometabolic risk factors and incidence of type 2 diabetes: a prospective analysis from the English Longitudinal Study of Ageing.

    Science.gov (United States)

    Nielsen, Jannie; Hulman, Adam; Witte, Daniel R

    2018-03-08

    In the UK, more than one million people have undiagnosed diabetes and an additional five million are at high risk of developing the disease. Given that early identification of these people is key for both primary and secondary prevention, new screening approaches are needed. Since spouses resemble each other in cardiometabolic risk factors related to type 2 diabetes, we aimed to investigate whether diabetes and cardiometabolic risk factors in one spouse can be used as an indicator of incident type 2 diabetes in the other spouse. We analysed data from 3649 men and 3478 women from the English Longitudinal Study of Ageing with information on their own and their spouse's diabetes status and cardiometabolic risk factors. We modelled incidence rates and incidence rate ratios with Poisson regression, using spousal diabetes status or cardiometabolic risk factors (i.e. BMI, waist circumference, systolic and diastolic BP, HDL- and LDL-cholesterol and triacylglycerols) as exposures and type 2 diabetes incidence in the index individual as the outcome. Models were adjusted for two nested sets of covariates. Spousal BMI and waist circumference were associated with incident type 2 diabetes, but with different patterns for men and women. A man's risk of type 2 diabetes increased more steeply with his wife's obesity level, and the association remained statistically significant even after adjustment for the man's own obesity level. Having a wife with a 5 kg/m 2 higher BMI (30 kg/m 2 vs 25 kg/m 2 ) was associated with a 21% (95% CI 11%, 33%) increased risk of type 2 diabetes. In contrast, the association between incident type 2 diabetes in a woman and her husband's BMI was attenuated after adjusting for the woman's own obesity level. Findings for waist circumference were similar to those for BMI. Regarding other risk factors, we found a statistically significant association only between the risk of type 2 diabetes in women and their husbands' triacylglycerol levels. The main

  7. 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

  8. Research without informed patient consent in incompetent patients.

    Science.gov (United States)

    Dobb, G J

    2015-05-01

    Most patients needing intensive care cannot give informed consent to participation in research. This includes the most acutely and severely ill, with the highest mortality and morbidity where research has the greatest potential to improve patient outcomes. In these circumstances consent is usually sought from a substitute decision maker, but while survivors of intensive care believe substitute decision makers will look after their interests, evidence suggests substitute decision makers are poorly equipped for this task. Various models have been suggested for research without patient informed consent when intervention is urgent and cannot wait until first person consent is possible, including a waiver of consent if conditions are met. A nationally consistent model is proposed for Australia with a robust process for initial waiver of consent followed by first person consent to further research-related procedures or ongoing follow-up when this can be competently provided.

  9. 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

  10. Informed consent practices for surgical care at university teaching hospitals: a case in a low resource setting.

    Science.gov (United States)

    Ochieng, Joseph; Ibingira, Charles; Buwembo, William; Munabi, Ian; Kiryowa, Haruna; Kitara, David; Bukuluki, Paul; Nzarubara, Gabriel; Mwaka, Erisa

    2014-05-19

    Informed consent in medical practice is essential and a global standard that should be sought at all the times doctors interact with patients. Its intensity would vary depending on the invasiveness and risks associated with the anticipated treatment. To our knowledge there has not been any systematic review of consent practices to document best practices and identify areas that need improvement in our setting. The objective of the study was to evaluate the informed consent practices of surgeons at University teaching Hospitals in a low resource setting. A cross-sectional study conducted at three university teaching hospitals in Uganda. Self-guided questionnaires were left at a central location in each of the surgical departments after verbally communicating to the surgeons of the intention of the study. Filled questionnaires were returned at the same location by the respondents for collection by the research team. In addition, 20 in-depth interviews were held with surgeons and a review of 384 patients' record files for informed consent documentation was done. A total of 132 (62.1%) out of 214 questionnaires were completed and returned. Respondents were intern doctors, residents and specialists from General surgery, Orthopedic surgery, Ear, Nose and Throat, Ophthalmology, Dentistry, Obstetrics and Gynaecology departments. The average working experience of respondents was 4.8 years (SD 4.454, range 0-39 years). 48.8% of the respondents said they obtained consent all the time surgery is done while 51.2% did not obtain consent all the time. Many of the respondents indicated that informed consent was not obtained by the surgeon who operated the patient but was obtained either at admission or by nurses in the surgical units. The consent forms used in the hospitals were found to be inadequate and many times signed at admission before diagnosing the patient's disease. Informed consent administration and documentation for surgical health care is still inadequate at

  11. 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.

  12. Managing End-of-Life Uncertainty: Applying Problematic Integration Theory to Spousal Communication About Death and Dying.

    Science.gov (United States)

    Rafferty, Katherine A; Cramer, Emily M; Priddis, DeAnne

    2016-02-01

    A significant number of Americans die in ways that do not reflect their preferences for end-of-life (EOL) care. For married individuals, the spouse often has the legal authority to make decisions at EOL. Many factors, most notably open preemptive communication about care preferences and dying wishes, determine whether such communication is viable and a partner's wishes are respected. We used a mixed method approach, involving a content analysis of spouses' reasons for seeking and avoiding conversations regarding their partners' EOL care preferences, and examined whether certain demographic factors (eg, income, gender, age) more likely contributed to the initiation of EOL conversations. We situate our findings within the broader cultural discourse about death and dying and highlight the influence of uncertainty in spousal EOL communication. © The Author(s) 2014.

  13. Alternatives of informed consent for storage and use of human biological material for research purposes: Brazilian regulation.

    Science.gov (United States)

    Marodin, Gabriela; França, Paulo Henrique Condeixa de; Salgueiro, Jennifer Braathen; Motta, Marcia Luz da; Tannous, Gysélle Saddi; Lopes, Anibal Gil

    2014-12-01

    Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms - Resolution 441/11 of the National Health Council, approved on 12 May 2011, and Ordinance 2.201 (NATIONAL GUIDELINES FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 - state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher. © 2012 John Wiley & Sons Ltd.

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

    Science.gov (United States)

    Qiao, Zhen; Powell, Joseph E; Evans, David M

    2018-01-22

    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.

  15. 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.

  16. Sleep in spousal Alzheimer caregivers: a longitudinal study with a focus on the effects of major patient transitions on sleep.

    Science.gov (United States)

    von Känel, Roland; Mausbach, Brent T; Ancoli-Israel, Sonia; Dimsdale, Joel E; Mills, Paul J; Patterson, Thomas L; Ziegler, Michael G; Roepke, Susan K; Chattillion, Elizabeth A; Allison, Matthew; Grant, Igor

    2012-02-01

    Findings on sleep disturbances in family dementia caregivers are conflicting. We studied the longitudinal effects of dementia caregiving and major transitions in the caregiving situation on caregivers' sleep and the effect of moderating variables. Community-based longitudinal study with assessments about once a year for up to three years. A sample of 109 elderly spousal Alzheimer caregivers and 48 non-caregiving age- and gender-matched controls. Random regression models with fixed and time-variant effects for covariates known to affect sleep were used to evaluate changes in the Pittsburgh Sleep Quality Index (PSQI) and in four actigraphy measures over time in relation to caregiving status and transitions (i.e., nursing home placement or death of the Alzheimer disease spouse). Multivariate-adjusted sleep characteristics did not significantly differ between caregivers and non-caregivers over time. Spousal death increased caregivers' nighttime wake after sleep onset (WASO) by 23 min (P = 0.002) and daytime total sleep time (TST) by 29 min (P = 0.003), while nighttime sleep percent decreased by 3.2% (P = 0.009) and nighttime TST did not change. Placement of the spouse had no significant effect on caregivers' sleep. Older age, male gender, role overload, depressive symptoms, and proinflammatory cytokines variously emerged as significant moderators of the relationships between caregiving and transitions with poor subjective and objective sleep. Alzheimer caregivers and non-caregiving controls had similar trajectories of sleep. However, there may be subgroups of caregivers who are vulnerable to develop sleep disturbances, including those whose spouses have died.

  17. 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.

  18. 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.

  19. Transboundary Resources, Consent and Customary Law - Comment

    Directory of Open Access Journals (Sweden)

    Graham Dutfield

    2013-09-01

    Full Text Available This brief commentary focuses on the unresolved access and benefit sharing (ABS challenges of transboundary resources and situations where getting prior informed consent is not possible. In the absence of the global mechanism envisaged by the Nagoya Protocol, satisfactory ABS deals can still be struck but these are unlikely to be either common or effective in generating substantial benefits for the indigenous peoples. The commentary closes by underlining the moral imperative of ensuring that traditional knowledge and genetic resource users comply with the laws and customary practices established by indigenous groups rather than simply impose their own norms. However, there are many legal and conceptual obstacles to be overcome first.

  20. 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...... and concepts from real designs by studying form in abstract contexts. The challenge for the first approach is how to support students in decoupling form from the work as a whole. The challenge for the second approach is how to translate general form into real design. Hence, choosing between the two approaches...

  1. "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…

  2. Consent by Proxy for Nonurgent Pediatric Care.

    Science.gov (United States)

    Fanaroff, Jonathan M

    2017-02-01

    Minor-aged patients are often brought to the pediatrician for nonurgent acute medical care, physical examinations, or health supervision visits by someone other than their legally authorized representative, which, in most situations, is a parent. These surrogates or proxies can be members of the child's extended family, such as a grandparent, adult sibling, or aunt/uncle; a noncustodial parent or stepparent in cases of divorce and remarriage; an adult who lives in the home but is not biologically or legally related to the child; or even a child care provider (eg, au pair, nanny, private-duty nurse/nurse's aide, group home supervisor). This report identifies common situations in which pediatricians may encounter "consent by proxy" for nonurgent medical care for minors, including physical examinations, and explains the potential for liability exposure associated with these circumstances. The report suggests practical steps that balance the need to minimize the physician's liability exposure with the patient's access to health care. Key issues to be considered when creating or updating office policies for obtaining and documenting consent by proxy are offered. Copyright © 2017 by the American Academy of Pediatrics.

  3. 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.

  4. 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.

  5. REXIC Project: Retrospective Cross-Sectional Study of Documentation of Informed Consent for Research Biobanking in A Public Research and Teaching Hospital.

    Science.gov (United States)

    Nobile, Marta; Garavelli, Elena; Gagliardi, Barbara; Giovanelli, Silvia; Rebulla, Paolo; Caccami, Concetta; Iemmi, Diego; Saibene, Federico; Castaldi, Silvana

    2013-04-28

    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. 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. 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. Progressive adoption of a simple, standard consent model is expected to improve the quality of consent acquisition. Regular audit of the compliance of consent practices with ethical and legal requirements is mandatory to improve the quality of research biobanking.

  6. 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.

  7. 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

  8. 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.

  9. 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.

  10. Depressed Spousal Caregivers Have Psychological Stress Unrelated to the Progression of Alzheimer Disease: A 3-Year Follow-Up Report, Kuopio ALSOVA Study.

    Science.gov (United States)

    Välimäki, Tarja H; Martikainen, Janne A; Hallikainen, Ilona T; Väätäinen, Saku T; Koivisto, Anne M

    2015-12-01

    To explore family caregiver (FC) long-term psychological distress after Alzheimer disease (AD) diagnosis in a family member. FC (n = 236) and patients with AD were prospectively followed up to 36 months after AD diagnosis. FC psychological distress was evaluated using the General Health Questionnaire (GHQ). Furthermore, caregiver depressive symptoms and sense of coherence, along with AD patient measurements, were measured at baseline and annually. Generalized estimating equation models were applied to study associations of these baseline factors to caregiver GHQ. After 36 months of follow-up, spousal caregivers (SCs) GHQ was significantly higher (P caregivers (NSCs). The difference in GHQ scores was associated by depressive symptoms (P caregiving, spousal and depressed caregivers of patients with AD report higher and increasing psychological stress than nonspousal and nondepressed caregivers. Spousal relationship, caregivers' depressive symptoms, and the severity of patients' neuropsychological symptoms at the time of AD diagnosis predict the trajectory of psychological distress. The current study highlights the need for evaluating AD caregiver mental health and level of coping. © The Author(s) 2015.

  11. 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

  12. Effects of financial incentives on the intention to consent to organ donation: a questionnaire survey.

    Science.gov (United States)

    Mayrhofer-Reinhartshuber, D; Fitzgerald, A; Benetka, G; Fitzgerald, R

    2006-11-01

    Shortage of donor organs is a serious problem for transplantation medicine. One controversial suggestion to increase the number of organ donors is financial incentives for consent. The aim of this study was to test whether different forms and amounts of financial incentives were apt to increase the consent to organ donation. Data were collected via questionnaires in urban and rural regions of Austria and randomly assigned to settings with three different amounts of financial incentives. The questionnaire was designed by using the theory of planned behaviour of Ajzen. Parents 69 mothers and 35 fathers; ages 25 to 65 years were evaluated for intention to consent to organ donation, perceived social norm, and positive/ negative aspects of organ donation without and with various financial incentives. The intention to consent to organ donation dropped highly significantly (Z = -7.556 P = .000) from the basic condition (M = 1.13; confidence interval [CIs] 0.78 to 1.51) to the condition with financial incentives (M = -1.58; CI, 1.96 to -1.15). No influence of the amount of financial incentive was observed. Highly significant differences were measured between both conditions for the social norm (Z = -5.638; P organ donation (Z = -1.962; P organ donation seems to be a strict taboo for most people in Austrian society.

  13. US Public Cord Blood Banking Practices: Recruitment, Donation, and the Timing of Consent

    Science.gov (United States)

    Broder, Sherri; Ponsaran, Roselle; Goldenberg, Aaron

    2012-01-01

    BACKGROUND Cord blood has moved rapidly from an experimental stem cell source to an accepted and important source of hematopoietic stem cells. There has been no comprehensive assessment of US public cord blood banking practices since the Institute of Medicine study in 2005. STUDY DESIGN AND METHODS Of 34 US public cord blood banks identified, 16 participated in our qualitative survey of public cord blood banking practices. Participants took part in in-depth telephone interviews in which they were asked structured and open-ended questions regarding recruitment, donation, and the informed consent process at these banks. RESULTS 13 of 16 participants reported a variably high percentage of women who consented to public cord blood donation. 15 banks offered donor registration at the time of hospital admission for labor and delivery. 7 obtained full informed consent and medical history during early labor and 8 conducted some form of phased consent and/or phased medical screening and history. 9 participants identified initial selection of the collection site location as the chief mode by which they recruited minority donors. CONCLUSION Since 2005, more public banks offer cord blood donor registration at the time of admission for labor and delivery. That, and the targeted location of cord blood collection sites, are the main methods used to increase access to donation and HLA diversity of banked units. Currently, the ability to collect and process donations, rather than donor willingness, is the major barrier to public cord blood banking. PMID:22803637

  14. [Prerequisites and limits of informed consent].

    Science.gov (United States)

    Peintinger, M

    2001-01-01

    The process of getting an "informed consent" is based on judicial necessity as well as on the relationship between the patient and his doctor, which has been changing remarkably over the last years. In this alliance the idea of autonomy increases, while the paternal treatment is loosing its influence continuously. Although patients have the right to decide, they also need competence in order to make a decision. Many circumstances may be responsible for a corruption of this competence. A communication based on appreciation, empathy and authenticity is able to discover such circumstances and fight against them. This kind of communication is able to prevent communication gaps, even when severe or dangerous realities have to be verbally expressed. Despite the judicial necessity the healing power of communication should get a more central place in therapy.

  15. Some consent and confidentiality issues regarding the application of ...

    African Journals Online (AJOL)

    The Choice on Termination of Pregnancy Act (Choice Act) allows a female of any age to consent to a termination of pregnancy, but other statutes such as the previous Child Care Act and the present Children's Act provide for different ages of consent for medical and surgical procedures. As a result doctors are not always ...

  16. 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…

  17. 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.

  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. The Social Construction of Consent: Sexual Scripts and Acquaintance Rape.

    Science.gov (United States)

    White, Jacquelyn W.; Niles, Patricia

    The decision whether a woman has consented to sexual intercourse is rarely determined by the woman herself. Often, instead, a woman's consent, and ultimately her sexuality, is determined for her by others--her partner, the community, or the court system. Women in this culture have traditionally had very little power to control their own bodies and…

  20. 16 CFR 1028.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Documentation of informed consent. 1028.117 Section 1028.117 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this...

  1. 42 CFR 50.204 - Informed consent requirement.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Informed consent requirement. 50.204 Section 50.204 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 § 50.204 Informed consent...

  2. 29 CFR 101.19 - Consent adjustments before formal hearing.

    Science.gov (United States)

    2010-07-01

    ... effective. These notices reproduce a sample ballot and outline such election details as location of polls... arrangements are commonly referred to as consent-election agreement followed by Regional Director's determination, stipulated election agreement followed by Board certification, and full consent agreement, in...

  3. Some consent and confidentiality issues regarding the application of ...

    African Journals Online (AJOL)

    The provisions in the Choice Act1 allowing consent to a termination of pregnancy by girls of any age were not affected by the repealed. Child Care Act3 or the newly in force Children's Act.7 In respect of other procedures, the provisions of the Child Care Act8 regard- ing consent to medical treatment by children over the age ...

  4. 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 ...

  5. 28 CFR 29.13 - No new conditions without consent.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false No new conditions without consent. 29.13 Section 29.13 Judicial Administration DEPARTMENT OF JUSTICE MOTOR VEHICLE THEFT PREVENTION ACT REGULATIONS... vehicle may be stopped may only be added to an existing program if the owner consents to the new condition...

  6. 34 CFR 97.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false General requirements for informed consent. 97.116 Section 97.116 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS... Subjects) § 97.116 General requirements for informed consent. Except as provided elsewhere in this policy...

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

    African Journals Online (AJOL)

    Voluntary informed consent for participation in clinical research is the cornerstone of health research ethics and a requirement for clinical research in South Africa. The South African-specific guidance documents concerning voluntary informed consent provisions differ and sometimes contradict international documents.

  8. 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.

  9. 42 CFR 35.15 - Consent to operative procedures.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Consent to operative procedures. 35.15 Section 35.15 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICAL CARE AND... or refusal of consent shall be made a part of the clinical record. ...

  10. 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.

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

    African Journals Online (AJOL)

    Informed consent is a primary precondition of legal and ethical clinical research and is regarded as the ... on the ethical principle of respect for personal autonomy, informed consent flows from the ..... Ethics. Chichester: John Wiley & Sons, 1994: 63-64, where he presents Kant's argument in favour of respecting autonomy.) 3.

  12. 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…

  13. 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 ...

  14. 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…

  15. 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.

    2018-01-01

    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. PMID:25747685

  16. 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.

  17. Impact of Open Data Policies on Consent to Participate in Human Subjects Research: Discrepancies between Participant Action and Reported Concerns.

    Science.gov (United States)

    Cummings, Jorden A; Zagrodney, Jessica M; Day, T Eugene

    2015-01-01

    Research outlets are increasingly adopting open data policies as a requisite for publication, including studies with human subjects data. We investigated whether open data policies influence participants' rate of consent by randomly assigning participants to view consent forms with and without discussion of open data policies. No participants declined to participate, regardless of condition, nor did rates of drop-out vs. completion vary between conditions. Furthermore, no significant change in potential consent rates was reported when participants were openly asked about the influence of open data policies on their likelihood of consent. However, follow-up analyses indicated possible poor attention to consent forms, consistent with previous research. Moreover, thematic analysis of participants' considerations of open data policy indicated multiple considerations such as concerns regarding confidentiality, anonymity, data security, and study sensitivity. The impact of open data policies on participation raises complex issues at the intersection of ethics and scientific innovation. We conclude by encouraging researchers to consider participants as stakeholders in open data policy and by providing recommendations for open data policies in human subjects research.

  18. 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

  19. 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

  20. Specimen Collection for Induced Pluripotent Stem Cell Research: Harmonizing the Approach to Informed Consent

    Science.gov (United States)

    Lowenthal, Justin; Lipnick, Scott; Rao, Mahendra

    2012-01-01

    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. PMID:23197820

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 76 FR 64945 - Teva Pharmaceutical Industries Ltd. and Cephalon, Inc.; Analysis of Agreement Containing Consent...

    Science.gov (United States)

    2011-10-19

    ... Teva Pharmaceutical Industries Ltd. and Cephalon, Inc.; Analysis of Agreement Containing Consent Orders... Consent Orders (``Consent Agreement'') from Teva Pharmaceutical Industries Ltd. (``Teva'') and Cephalon... Pharmaceutical, Inc. (``Par'') all of Teva's rights and assets relating to its generic transmucosal fentanyl...

  7. [Beyond the informed consent: the relationship consensual].

    Science.gov (United States)

    Binetti, Paola

    2011-01-01

    The current paradigm of medicine places the principle of self-determination at the centre of the system of treatment, as an essential condition for the validity of medical action, even from the ethical point of view. But if it is not correctly integrated with the former principle, that of doing good, the principle of self-determination alone cannot guarantee a fully ethical dimension in medical action, among other reasons because it would arrive at a contractual-type way of reasoning, in which the doctor's position would be subordinate to that of the patient. Only a situation where both sides are truly equal protagonists in the decision-making process, and both truly share the assumption of responsibility, can take full account of the centrality of the person in relation to his or her treatment. In this way the quality of the relationship, even from the ethical standpoint, would be the axis of the treatment paradigm, over and above, for instance, informed consent. The demands for euthanasia that could be derived from the application of the principle of self-determination need to be forestalled by a renewed discovery of the value of good in its double dimension: the subjective one of the perceived good, and the objective one of the moral good.

  8. 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.

  9. 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.

  10. National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis.

    Science.gov (United States)

    Mendelson, Scott J; Courtney, D Mark; Gordon, Elisa J; Thomas, Leena F; Holl, Jane L; Prabhakaran, Shyam

    2018-03-01

    No standard approach to obtaining informed consent for stroke thrombolysis with tPA (tissue-type plasminogen activator) currently exists. We aimed to assess current nationwide practice patterns of obtaining informed consent for tPA. An online survey was developed and distributed by e-mail to clinicians involved in acute stroke care. Multivariable logistic regression analyses were performed to determine independent factors contributing to always obtaining informed consent for tPA. Among 268 respondents, 36.7% reported always obtaining informed consent and 51.8% reported the informed consent process caused treatment delays. Being an emergency medicine physician (odds ratio, 5.8; 95% confidence interval, 2.9-11.5) and practicing at a nonacademic medical center (odds ratio, 2.1; 95% confidence interval, 1.0-4.3) were independently associated with always requiring informed consent. The most commonly cited cause of delay was waiting for a patient's family to reach consensus about treatment. Most clinicians always or often require informed consent for stroke thrombolysis. Future research should focus on standardizing content and delivery of tPA information to reduce delays. © 2018 American Heart Association, Inc.

  11. Can informed consent to research be adapted to risk?

    Science.gov (United States)

    Bromwich, Danielle; Rid, Annette

    2015-07-01

    The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential clinical benefits for the individual research participant. Furthermore, current proposals do not address the concern that risk-adapted informed consent may result in enrolling participants into research without their autonomous authorisation. In this paper, we show how the standard view of informed consent--consent as autonomous authorisation--can be adapted to risk even when the research does not have a favourable risk-benefit profile for the participant. Our argument has two important implications: first, it implies that current and proposed consent standards are not adequately calibrated to risk and, second, that consent standards also need to be adapted to factors other than risk. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  12. 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.

  13. Audio-visual presentation of information for informed consent for participation in clinical trials.

    Science.gov (United States)

    Synnot, Anneliese; Ryan, Rebecca; Prictor, Megan; Fetherstonhaugh, Deirdre; Parker, Barbara

    2014-05-09

    Informed consent is a critical component of clinical research. Different methods of presenting information to potential participants of clinical trials may improve the informed consent process. Audio-visual interventions (presented, for example, on the Internet or on DVD) are one such method. We updated a 2008 review of the effects of these interventions for informed consent for trial participation. To assess the effects of audio-visual information interventions regarding informed consent compared with standard information or placebo audio-visual interventions regarding informed consent for potential clinical trial participants, in terms of their understanding, satisfaction, willingness to participate, and anxiety or other psychological distress. We searched: the Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, issue 6, 2012; MEDLINE (OvidSP) (1946 to 13 June 2012); EMBASE (OvidSP) (1947 to 12 June 2012); PsycINFO (OvidSP) (1806 to June week 1 2012); CINAHL (EbscoHOST) (1981 to 27 June 2012); Current Contents (OvidSP) (1993 Week 27 to 2012 Week 26); and ERIC (Proquest) (searched 27 June 2012). We also searched reference lists of included studies and relevant review articles, and contacted study authors and experts. There were no language restrictions. We included randomised and quasi-randomised controlled trials comparing audio-visual information alone, or in conjunction with standard forms of information provision (such as written or verbal information), with standard forms of information provision or placebo audio-visual information, in the informed consent process for clinical trials. Trials involved individuals or their guardians asked to consider participating in a real or hypothetical clinical study. (In the earlier version of this review we only included studies evaluating informed consent interventions for real studies). Two authors independently assessed studies for inclusion and extracted data. We synthesised the findings

  14. 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.

  15. Should the chiropractic profession embrace the doctrine of informed consent?

    Science.gov (United States)

    Lehman, James J.; Conwell, Timothy D.; Sherman, Paul R.

    2008-01-01

    Abstract This commentary provides a narrative review of the literature focusing on the use of a health care informed consent process in the United States. This article reviews the current positions of the World Medical Association, American Medical Association, American Chiropractic Association, Wisconsin and New Jersey State Courts, US Federal Government Office of Health Policy and Clinical Outcomes, and 1 college of chiropractic regarding the doctrine of informed consent. The authors recommend that the chiropractic profession embrace the doctrine of informed consent and promulgate it as a standard of care. The implementation of this doctrine by chiropractic physicians promotes and improves the safety of chiropractic interventions. PMID:19646372

  16. Consenting to counter-normative sexual acts: differential effects of consent on anger and disgust as a function of transgressor or consenter.

    Science.gov (United States)

    Russell, Pascale Sophie; Piazza, Jared

    2015-01-01

    Anger and disgust may have distinct roles in sexual morality; here, we tested hypotheses regarding the distinct foci, appraisals, and motivations of anger and disgust within the context of sexual offenses. We conducted four experiments in which we manipulated whether mutual consent (Studies 1-3) or desire (Study 4) was present or absent within a counter-normative sexual act. We found that anger is focused on the injustice of non-consensual sexual acts, and the transgressor of the injustice (Studies 1 and 3). Furthermore, the sexual nature of the act was not critical for the elicitation of anger--as anger also responded to unjust acts of violence (Study 3). By contrast, we hypothesised and found that disgust is focused on whether or not a person voluntarily engaged in, desired or consented to a counter-normative sexual act (Studies 2-4). Appraisals of abnormality and degradation were the primary appraisals of disgust, and the sexual nature of the act was a critical elicitor of disgust (Study 3). A final study ruled out victimisation as the mechanism of the effect of consent on disgust and indicated that the consenter's sexual desire was the mechanism (Study 4). Our results reveal that anger and disgust have differential roles in consent-related sexual offenses due to the distinct appraisals and foci of these emotions.

  17. 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.

  18. Informed Consent in Health Research: Challenges and Barriers in Low-and Middle-Income Countries with Specific Reference to Nepal.

    Science.gov (United States)

    Regmi, Pramod R; Aryal, Nirmal; Kurmi, Om; Pant, Puspa Raj; van Teijlingen, Edwin; Wasti, Sharada P

    2017-08-01

    Obtaining 'informed consent' from every individual participant involved in health research is a mandatory ethical practice. Informed consent is a process whereby potential participants are genuinely informed about their role, risk and rights before they are enrolled in the study. Thus, ethics committees in most countries require 'informed consent form' as part of an ethics application which is reviewed before granting research ethics approval. Despite a significant increase in health research activity in low-and middle-income countries (LMICs) in recent years, only limited work has been done to address ethical concerns. Most ethics committees in LMICs lack the authority and/or the capacity to monitor research in the field. This is important since not all research, particularly in LMICs region, complies with ethical principles, sometimes this is inadvertently or due to a lack of awareness of their importance in assuring proper research governance. With several examples from Nepal, this paper reflects on the steps required to obtain informed consents and highlights some of the major challenges and barriers to seeking informed consent from research participants. At the end of this paper, we also offer some recommendations around how can we can promote and implement optimal informed consent taking process. We believe that paper is useful for researchers and members of ethical review boards in highlighting key issues around informed consent. © 2016 John Wiley & Sons Ltd.

  19. 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

  20. 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

  1. 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 ...

  2. 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...) The registrant discloses clearly any limitations on recovery by investors posed by the lack of consent...

  3. 40 CFR 26.1117 - Documentation of informed consent.

    Science.gov (United States)

    2010-07-01

    ... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1117 Documentation of informed consent. (a...

  4. Are Patients Informed When They Consent to ERCP?

    Directory of Open Access Journals (Sweden)

    Sinead O’Sullivan

    2002-01-01

    Full Text Available BACKGROUD: Only the British Society of Gastroenterology has published consent guidelines that are inclusive for endoscopic retrograde cholangiopancreatography (ERCP. Previous research has shown that there are variations in the information discussed with patients who are undergoing ERCP.

  5. Informed Consent at Gunpoint: When Psychiatry Affects Gun Ownership.

    Science.gov (United States)

    Candilis, Philip J; Khurana, Gagandeep; Leong, Gregory B; Weinstock, Robert

    2015-06-01

    As states take more steps to connect patients' gun ownership to their mental health, psychiatrists are being asked to provide mental health information after clinical interviews as well as after confiscation. This move into the patient-physician relationship raises new questions about how psychiatrists should obtain informed consent when interviews may result in reports to legal authorities. Consent warnings are already practiced more in the breach than in the observance and informed consent is imperfect at its best. In communities torn by controversies surrounding gun control, vehement political views will further influence these established themes to result in unprecedented pressures on patient confidentiality. This analysis draws on new movements in ethical theory and behavioral medicine that go beyond balancing principles to question the use of psychiatry in firearm reporting, and support a vigorous practice of informed consent to protect both individuals and the communities they live in. Copyright © 2015 John Wiley & Sons, Ltd.

  6. [Informed consent: a dialogic praxis for the research].

    Science.gov (United States)

    Mondragón-Barrios, Liliana

    2009-01-01

    The informed consent is a process in which a person agrees to participate in a research, knowing the risks, benefits, problems or consequences that may arise during developing it. The aim of this study is to collect the characteristics of the informed consent process (ICP) so its understanding and compliance allow an ethical dialog, thoughtful and responsible exercise for the researcher. We present the results of an extensive review of the ICP elements from its components to their legal and ethical foundation, including the myths and realities that exist about the format of informed consent as a legal protection. The informed consent is not an established format that researchers reproduce in their research, but its praxis is a daily task in the research with human subjects as critical, deliberative, and committed communication between two moral agents: the researcher and the researched one.

  7. Informed consent and the Facebook emotional manipulation study

    OpenAIRE

    Flick, Catherine

    2015-01-01

    This article argues that the study conducted by Facebook in conjunction with Cornell University did not have sufficient ethical oversight, and neglected in particular to obtain necessary informed consent from the participants in the study. It establishes the importance of informed consent in Internet research ethics and suggests that in Facebook’s case (and other, similar cases), a reasonable shift could be made from traditional medical ethics ‘effective consent’ to a ‘waiver of normative exp...

  8. 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

  9. Sex Differences in Medication and Primary Healthcare Use before and after Spousal Bereavement at Older Ages in Denmark: Nationwide Register Study of over 6000 Bereavements

    DEFF Research Database (Denmark)

    Oksuzyan, Anna; Jacobsen, Rune; Glaser, Karen

    2011-01-01

    Background. The study aimed to examine sex differences in healthcare use before and after widowhood to investigate whether reduced healthcare use among widowers compared with widows may partially explain excess mortality and more adverse health outcomes among men than women after spousal loss...... use and the average annual number of visits to general physicians (GPs). Results. The average daily use of all-cause and major system-specific medications, as well as the number of GP visits increased over the period from 1 year before and up to 5 years after a spouse's death, but there were no sex...

  10. 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

  11. Rethinking Informed Consent in Research on Heroin-Assisted Treatment.

    Science.gov (United States)

    Uusitalo, Susanne; Broers, Barbara

    2015-09-01

    Can heroin addicts give consent to research on trials in which heroin is prescribed to them? Analyses of addicts and informed consent have been objects of debate in several articles. Informed consent requires the agent not only to be competent but also to give consent voluntarily. This has been questioned because of alleged features of heroin addiction. Until recently the discussion has focused on heroin addicts' desires for heroin, whether these are irresistible and thus pose a problem for giving consent. Still, in light of empirical evidence, there seems to be a consensus more or less that the problem is not whether the addicts can resist their desire for heroin. A recent article concentrates specifically on heroin addicts' false assumptions of options and voluntariness. We argue that the prevailing framing of the options in this discussion in terms of heroin and access to it is problematic. The way in which the options are typically laid out suggests an assumption that participation in the research is allegedly based on the addicts' views on using the drug. We argue that this way of presenting the options is, first, a mismatch to the studies carried out and, second, symptomatic of potential misconceptions about heroin addiction and addicts. Furthermore, we also suggest that the account of voluntariness needs to be realistic in order for subjects to be able to give consent voluntarily in actual situations, and for medical research to carry out studies on improving outcomes in addiction treatment in an ethical way. © 2014 John Wiley & Sons Ltd.

  12. [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.

  13. Informed consent in high-risk renal transplant recipients.

    Science.gov (United States)

    Cocchiara, G; Lo Monte, A I; Romano, G; Romano, M; Buscemi, G

    2009-06-01

    Before performing a clinical, diagnostic, and/or therapeutic action, the doctor is required to provide the patient with a bulk of information defined as informed consent. This expression was used for the first time in 1957 during a court case in California and the two words--informed and consent--are used together to underline the fact that the patient cannot give his or her true consent without first receiving correct information concerning the medical act in question. With regard to the medicolegal aspects governing organ transplants, despite the bulk of detailed work performed by health service workers involved in this surgical field with the aim of preparing adequate informed consent models, this has not yet been accompanied by the necessary legislative development. The informed consent model to be presented to the kidney transplant candidate should include a detailed description of the recipient's comorbidity and should aim at reducing the number of medicolegal actions, which have become more and more frequent in the last few years due to the ever increasing number of patients considered as suitable for transplantation. Informed consent, therefore, should not be a mere bureaucratic formality to be obtained casually, but should be carefully stipulated together with the patient by the transplant surgeon. It is, in fact, an indispensable condition for transforming a potentially illegal action, that is, the violation of an individual's psychophysical integrity, into a legal one.

  14. 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

  15. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials

    Science.gov (United States)

    2013-01-01

    Background 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. Purpose 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. 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. Results 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

  16. 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.

  17. 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.

  18. 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.

  19. Informed consent and registry-based research - the case of the Danish circumcision registry.

    Science.gov (United States)

    Ploug, Thomas; Holm, Søren

    2017-09-15

    Research into personal health data holds great potential not only for improved treatment but also for economic growth. In these years many countries are developing policies aimed at facilitating such research often under the banner of 'big data'. A central point of debate is whether the secondary use of health data requires informed consent if the data is anonymised. In 2013 the Danish Minister of Health established a new register collecting data about all ritual male childhood circumcisions in Denmark. The main purpose of the register was to enable future research into the consequences of ritual circumcision. This article is a study into the case of the Danish Circumcision Registry. We show that such a registry may lead to various forms of harm such as 1) overreaching social pressure, 2) stigmatization, 3) medicalization of a religious practice, 4) discrimination, and 5) polarised research, and that a person may therefore have a strong and legitimate interest in deciding whether or not such data should be collected and/or used in research. This casts doubt on the claim that the requirement of informed consent could and should be waived for all types of secondary research into registries. We finally sketch a new model of informed consent - Meta consent - aimed at striking a balance between the interests in promoting research and at the same time protecting the individual. Research participants may have a strong and legitimate interest in deciding whether or not their data should be collected and used for registry-based research whether or not their data is anonymised.

  20. "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.

  1. Informed consent and nurses' roles: a survey of Indonesian practitioners.

    Science.gov (United States)

    Susilo, Astrid P; van Dalen, Jan; Chenault, Michelene N; Scherpbier, Albert

    2014-09-01

    In Southeast Asia, the process of obtaining informed consent is influenced by both culture and policy at the hospital and national level. Both physicians and nurses play vital roles in this process, but physicians influence the roles of nurses. Since the physicians and nurses often have different perspectives, it is important to investigate their views about the informed consent process and nurses' roles therein and whether there is a difference between ideal and experienced practice (reality), and whether this differs across hospitals. A questionnaire was developed and a survey was conducted among physicians and nurses. Using exploratory factor analysis a three factor structure was determined: 'nurses' roles', 'barriers in informed consent', and 'adequacy of information'. Non-parametric tests were applied to compare nurses and physicians, and hospital setting. Responses were obtained from 129 physicians and 616 nurses from two Indonesian hospitals. Those hospitals differ in ownership, location, and size. The study was reviewed by the hospital ethical committee. Participation was voluntary and confidentiality was ensured by keeping the responses anonymous. Physicians and nurses differ significantly on all three factors. The scores reflecting disparity between ideal and reality regarding nurses' roles varied across professions, while barriers in informed consent differed between hospitals. The differences between ideal and reality indicated that improvement in the informed consent process and nurses' roles therein is called for. Varying views between physicians and nurses on nurses' roles may hinder collaboration. The differences between hospital settings showed interventions may have to be customized for different settings. Views on nurses' roles vary across professions. Views on barriers in informed consent vary across hospitals. Therefore interprofessional education is needed to promote interprofessional collaboration and intervention to improve informed consent

  2. Surgical informed consent in children: a systematic review.

    Science.gov (United States)

    Chotai, Pranit N; Nollan, Richard; Huang, Eunice Y; Gosain, Ankush

    2017-06-01

    The purpose of the article was to analyze current literature on surgeon and parents' understanding and role in the informed consent process for children undergoing surgery. A systematic database search (MEDLINE, EMBASE, PsycINFO, and EBM Reviews) was performed to identify articles concerning any aspect of the surgical informed consent for children undergoing an invasive procedure. Articles analyzing informed consent in research studies, non-English-language articles, review articles, case reports and/or series, letters-commentaries, and dentistry and/or nursing-related articles were excluded. Articles meeting inclusion criteria were analyzed to identify common themes related to the process of informed consent. One hundred seventy-eight articles were identified on primary search, after removing duplicates and screening titles for relevance, 83 abstracts were reviewed. Thirty-two additional abstracts were identified by secondary search. Twelve of 115 articles met inclusion criteria. Analysis identified five different study themes. Information delivered during consent (Content) was studied in five articles (42%), three (25%) studied the mechanics or delivery of the information (Delivery), three (25%) studied parent participation and discussion (Interchange), six articles (50%) discussed surgeons' perceptions or the parents' ability to understand or recall the information (Comprehension), and five articles (42%) evaluated surgeon or parent satisfaction or anxiety (Satisfaction). None of the articles studied all five categories. Studies of the surgical informed consent process in children are scarce. Prospective studies evaluating surgeon and parent perception regarding the Content, Delivery, and Interchange of information as well as Comprehension and Satisfaction are needed to understand barriers to the surgeon-patient relationship and to optimize the informed consent process in children undergoing surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. 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.

  4. 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

  5. Female sexual subjectivity and verbal consent to receiving oral sex.

    Science.gov (United States)

    Satinsky, Sonya; Jozkowski, Kristen N

    2015-01-01

    Women are less likely than men are to report receiving oral sex from their partners. Elements of sexual subjectivity may have implications for women's communication of consent to specific sexual acts. Sexually active women (n = 237) between 18 and 71 years of age (M = 28.85 years) completed an online survey measuring sociodemographic variables, entitlement to pleasure from partner, self-efficacy in achieving sexual pleasure, and consent communication at last receptive oral sex event. Participants were predominantly White (84.8%, n = 201) and in exclusive or monogamous sexual relationships (54.9%, n = 130). The authors used a 4-step test of mediation to determine whether self-efficacy in achieving sexual pleasure mediated the relation between entitlement to pleasure from partner and verbal consent communication. Self-efficacy emerged as a significant predictor of verbal consent communication (p .05), indicating full mediation. Therefore, entitlement to pleasure predicted verbal consent to oral sex as a function of self-efficacy in achieving sexual pleasure. Sex-positive educational interventions may improve disparities between men and women in receiving oral sex from their partners. Results of this study offer insight into the ways in which culture-level forces affect interpersonal and intraindividual sexual health behaviors.

  6. Participants' Understanding of Informed Consent for Biobanking: A Systematic Review.

    Science.gov (United States)

    Eisenhauer, Elizabeth R; Tait, Alan R; Rieh, Soo Young; Arslanian-Engoren, Cynthia M

    2017-07-01

    Nurses are increasingly asked to obtain consent from participants for biobanking studies. Biobanking has added unique complexities to informed consent. The purpose of this systematic review was to evaluate participants' level of understanding of the information presented during the informed consent process unique to the donation of biological specimens for research. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were utilized to conduct the review. PubMed, EMBASE, CINAHL, PsycINFO, Scopus, Web of Science, and ProQuest bibliographic databases were searched. Results indicated that elements of informed consent unique to biobanking were poorly understood. Most studies had authors or funding associated with a biobank. Only one study disclosed and assessed participants' understanding of moral risks. Increased disclosures, values-clarification, and presenting information via multiple modalities may facilitate understanding. There is a need to improve the quality of informed consent for biobanking studies by utilizing standardized instruments, definitions, and encouraging research about informed choice outside the biobanking industry.

  7. 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

  8. 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

  9. 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

    2015-04-01

    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. 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. 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. 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 respondents with degree-level education

  10. 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

  11. 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.

  12. 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.

  13. Reappraising consent: conducting ethical psychiatric research in Singapore.

    Science.gov (United States)

    Rekhi, Gurpreet; Capps, Benjamin; Lysaght, Tamra; Chong, Siow Ann

    2012-09-01

    Singapore is legally restrictive when it comes to research involving minors. The age of majority is 21 and parental consent is required for participation in medical research. This article explores the age of majority and the issues related to obtaining consent for research in Singapore, focusing on "young adults" (17-21 years), using an example of a translational and clinical research project called the Longitudinal Youth at Risk Study (LYRIKS). It describes the unique legal and social conditions pertaining to the age of majority in Singapore, before presenting an argument for consideration as to whether the age of consent to participate in research should be reviewed. It concludes that rather than a set of doctrinaire rules for the age of participation in research, there should be an assessment of the kind of tasks that minors can assume themselves in respect to a specific project, and the degree of parental involvement.

  14. 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.

  15. 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.

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

    Science.gov (United States)

    Tekola, Fasil; Bull, Susan J; Farsides, Bobbie; Newport, Melanie J; Adeyemo, Adebowale; Rotimi, Charles N; Davey, Gail

    2009-07-21

    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.

  17. 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.

  18. An investigation of the efficacy of electronic consenting interfaces of research permissions management system in a hospital setting.

    Science.gov (United States)

    Chalil Madathil, Kapil; Koikkara, Reshmi; Obeid, Jihad; Greenstein, Joel S; Sanderson, Iain C; Fryar, Katrina; Moskowitz, Jay; Gramopadhye, Anand K

    2013-09-01

    Ethical and legal requirements for healthcare providers in the United States, stipulate that patients sign a consent form prior to undergoing medical treatment or participating in a research study. Currently, the majority of the hospitals obtain these consents using paper-based forms, which makes patient preference data cumbersome to store, search and retrieve. To address these issues, Health Sciences of South Carolina (HSSC), a collaborative of academic medical institutions and research universities in South Carolina, is developing an electronic consenting system, the Research Permissions Management System (RPMS). This article reports the findings of a study conducted to investigate the efficacy of the two proposed interfaces for this system - an iPad-based and touchscreen-based by comparing them to the paper-based and Topaz-based systems currently in use. This study involved 50 participants: 10 hospital admission staff and 40 patients. The four systems were compared with respect to the time taken to complete the consenting process, the number of errors made by the patients, the workload experienced by the hospital staff and the subjective ratings of both patients and staff on post-test questionnaires. The results from the empirical study indicated no significant differences in the time taken to complete the tasks. More importantly, the participants found the new systems more usable than the conventional methods with the registration staff experiencing the least workload in the iPad and touchscreen-based conditions and the patients experiencing more privacy and control during the consenting process with the proposed electronic systems. In addition, they indicated better comprehension and awareness of what they were signing using the new interfaces. The results indicate the two methods proposed for capturing patient consents are at least as effective as the conventional methods, and superior in several important respects. While more research is needed, these

  19. 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.

  20. [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.

  1. Participants with schizophrenia retain the information necessary for informed consent during clinical trials

    Science.gov (United States)

    Fischer, Bernard A.; McMahon, Robert P.; Meyer, Walter A.; Slack, Daniel J.; Appelbaum, Paul S.; Carpenter, William T.

    2015-01-01

    Objective Cognitive impairment is a characteristic of schizophrenia. This impairment may affect the retention of information required for ongoing knowledgeable participation in clinical trials. This study monitored retention of study-related knowledge--including assessment of therapeutic misconception--in people with stable, DSM-IV schizophrenia during participation in placebo-controlled clinical trials of adjunctive agents. Stability was defined as being on an antipsychotic with no change in medication or dose over the previous 4 weeks. Method Individuals enrolling in one of seven clinical trials were approached for participation. Participants came from research clinics and community mental health centers. At baseline, clinical trial consent forms were reviewed and study knowledge assessed. Participants were randomized to follow-up assessments at weeks 1, 4, and 8; weeks 4 and 8; or at week 8 only. Clinical trial consent forms were not re-reviewed at any follow-up visit. Results Fifty-nine participants were enrolled; analysis included 52 participants with at least one follow-up visit. Study knowledge did not decrease meaningfully in any group. Therapeutic misconception was not observed in participants during the study. The group assessed most frequently demonstrated significant improvement over baseline (t44= 3.43, p= 0.001). Retention of study knowledge was not related to symptoms, but had a weak correlation with cognitive capacity (R= 0.28, p= 0.07). Performance did not differ between participants from research clinics and those from community mental health centers. Conclusions Clinically-stable people with schizophrenia enrolling in a placebo-controlled adjunctive medication study, once determined to have capacity to consent to a clinical trial, retained appropriate study knowledge for at least 8 weeks. In the absence of a specific reason to suspect a loss of decisional capacity, there appears to be no need to routinely re-evaluate participants during this type

  2. Consent for care in dentistry | Rugarabamu | Tanzania Dental Journal

    African Journals Online (AJOL)

    Tanzania Dental Journal. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 17, No 1 (2011) >. Log in or Register to get access to full text downloads. Username, Password, Remember me, or Register. Consent for care in dentistry. S Rugarabamu, M Gideon. Abstract.

  3. Voluntary informed consent and good clinical practice for clinical ...

    African Journals Online (AJOL)

    Most differences, shortcomings and contradictions regarding voluntary informed consent for participation in clinical research relate to the South African-specific guidance documents, i.e. South African Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa (2006) and Ethics in ...

  4. 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.

  5. Boni mores and consent for child research in South Africa

    African Journals Online (AJOL)

    2015-05-22

    May 22, 2015 ... the consent to harm, or the risk of harm, is permitted or ought to be permitted by the legal order. Recently, it has also become a .... (such as adolescent same-sex activity); or the possible motivation of potential consentors. .... that impact on risky sexual practices of adolescents might be frowned upon by some ...

  6. 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.

  7. 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 ...

  8. 75 FR 7428 - Amendments to Enforceable Consent Agreement Procedural Rules

    Science.gov (United States)

    2010-02-19

    ... Amendments to Enforceable Consent Agreement Procedural Rules AGENCY: Environmental Protection Agency (EPA... Manufacturers Association; several public meetings to discuss the procedures were held before the procedural... formally concluded, or have been terminated. EPA now proposes to revise the ECA procedural rule to increase...

  9. 75 FR 56472 - Amendments to Enforceable Consent Agreement Procedural Rules

    Science.gov (United States)

    2010-09-16

    ... Amendments to Enforceable Consent Agreement Procedural Rules AGENCY: Environmental Protection Agency (EPA... provide procedural safeguards equivalent to those that apply where testing is conducted by rule. B. What... comments indicated support for the ECA procedural changes, and had a few specific suggestions: Comment 1...

  10. 48 CFR 52.227-1 - Authorization and Consent.

    Science.gov (United States)

    2010-10-01

    ... a government regulatory body, of any invention described in and covered by a United States patent (1... 48 Federal Acquisition Regulations System 2 2010-10-01 2010-10-01 false Authorization and Consent. 52.227-1 Section 52.227-1 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION...

  11. 77 FR 63339 - Amended Notice of Lodging Proposed Consent Decree

    Science.gov (United States)

    2012-10-16

    ... Policy, 28 CFR 50.7, notice is hereby given that a proposed Consent Decree in United States v. Snowden... against Guy B. Snowden, Diane P. Snowden, FCF Realty, LLC, and Falls Creek Farm, LLC, pursuant to sections... 7611, Washington, DC 20044, and refer to United States v. Snowden, DJ 90-5-1-1-18622/1. The proposed...

  12. 77 FR 61640 - Notice of Lodging Proposed Consent Decree

    Science.gov (United States)

    2012-10-10

    ... Policy, 28 CFR 50.7, notice is hereby given that a proposed Consent Decree in United States v. Snowden... against Guy B. Snowden, Diane P. Snowden, FCF Realty, LLC, and Falls Creek Farm, LLC, pursuant to sections... 7611, Washington, DC 20044, and refer to United States v. Snowden, DJ 90-5-1-1-18622/1. The proposed...

  13. 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. ... Results: The majority of the students were treated in the private sector (85.0%) by male oral health workers (61.6%) and dentists (89.5%) as opposed to dental therapists or oral ...

  14. 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.

  15. 12 CFR 333.101 - Prior consent not required.

    Science.gov (United States)

    2010-01-01

    ... extension by any State nonmember insured bank of its business to include personal, character or installment... bank, is not a change in the general character or type of business requiring the prior written consent... and Coverdell Education Savings Accounts established pursuant to the Taxpayer Relief Act of 1997 (26 U...

  16. Stability under Unanimous Consent, Free Mobility and Core

    OpenAIRE

    Bogomolnaia, Anna; Le Breton, Michel; Savvateev, Alexei; Weber, Shlomo

    2006-01-01

    In this paper we consider an urban population represented by a continuum of individuals uniformly distributed over the real line that faces a problem of location and financing of multiple public facilities. We examine three notions of stability of emerging jurisdiction: stability under unanimous consent, free mobility and core and provide a characterization of stable partitions under these notions of stability.

  17. 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...

  18. 21 CFR 1316.08 - Consent to inspection.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Consent to inspection. 1316.08 Section 1316.08 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS... constitutional right not to have an administrative inspection made without an administrative inspection warrant...

  19. Consent in cyberspace: Internet-based research involving young people.

    Science.gov (United States)

    Spriggs, Merle

    2009-12-01

    Social networking sites such as MySpace and virtual communities such as on-line support groups can be a rich source of data for researchers. These sites can be an effective way of reaching and researching young people in order to address their particular health needs. Internet-based research is also potentially risky and exploitative. There is some guidance for conducting research online, but there are no detailed or universally accepted ethics guidelines for research of webspaces such as MySpace or virtual communities in which young people participate. One question that arises is--If MySpace is a public webspace, can research be done without consent? In this paper I investigate ethical issues surrounding young people's consent in cyber research. I identify issues that help determine whether consent is needed, offer suggestions for dealing with consent in cyberspace and add my voice to the call for a resource of case studies--indispensible in the development of guidelines and the education of researchers and research ethics committees.

  20. Demographic factors influencing consent for cadaver organ donation

    African Journals Online (AJOL)

    Suicide, mainly due to gunshot wounds to the head, was the cause of death in 38 of the donor referrals (6,7%). Data collection. Each donor referral is documented and data including the age, sex, race, cause of death and whether consent was given are recorded by the transplant co-ordinator. Initially these details were ...

  1. Written informed consent in health research is outdated

    NARCIS (Netherlands)

    Broekstra, R.; Maeckelberghe, E. L. M.; Stolk, R. P.

    2017-01-01

    Reference to the Declaration of Helsinki as assurance for ethical principles for medical research involving human subjects has become a meaningless mantra. The participants’ relationship with researchers has been distrusted-based with Written Informed Consent (WIC) hereinafter referred to as WIC)

  2. Informed Consent in Educational Settings and the Novice Researcher

    Science.gov (United States)

    Sanderson, Lara

    2010-01-01

    Research ethics are of fundamental importance to any research. They define and shape the research process from the very beginning as they are the code on which academics rely on as guiding practice in the field (Hopf, 2004). Informed consent is an interesting concept as it is interwoven with other ethical issues that include power, privacy and…

  3. Free and Informed Consent in Research Involving Native American Communities.

    Science.gov (United States)

    Piquemal, Nathalie

    2001-01-01

    Participant observers conducting research among other cultures must use what is learned without betraying the confidence of those with whom they interact. Two Native American examples illustrate how current protocols are insufficient in cross-cultural situations. Recommendations include negotiating responsibilities before seeking consent,…

  4. 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...

  5. One Criteria of Consent of Normal Distribution Law

    Directory of Open Access Journals (Sweden)

    Serezha N. Sandryan

    2013-01-01

    Full Text Available According to the Central limit theorem, normal probability distribution law is most often found in random phenomena. In this work the linear criteria of consent is developed for the verification of statistical hypotheses of the normal distribution law of the statistical population

  6. Informed consent for telemedicine in South Africa: A survey of ...

    African Journals Online (AJOL)

    2013-11-02

    Nov 2, 2013 ... therefore important to know doctors' and nurses' current approach to consent in everyday practice and when using information and communication technologies. Objective. This study aims to survey the habits and practices of health professionals working in the private and public sectors in Durban,.

  7. Demographic factors influencing consent for cadaver organ donation

    African Journals Online (AJOL)

    The records of all donor referrals to Groote Schuur Hospital over a 5½-year period were retrospectively examined to determine which factors influenced the families' decision on organ donation. In 35% of these referrals the families were not approached for consent. The reasons for this included the potential donor being ...

  8. 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 ...

  9. Consent procedures and electroconvulsive therapy in South Africa ...

    African Journals Online (AJOL)

    Adele

    The introduction of the new Mental Health Care Act (MHCA) No 17 of 2002 has highlighted the ethical treatment in least restrictive environments for patients suffering from mental illness. The legislation has highlighted several shortcomings in the consent procedures that were previously utilised for psychiatric patients.

  10. Human dignity and consent in research biobanking | Kirchhoffer ...

    African Journals Online (AJOL)

    Biobanking policy needs to take into account the concept of human dignity, because this concept is enshrined in both international and South African law. The accepted understanding of informed consent, which is also required by law, is inadequate for biobanking because it is often not possible to inform people of possible ...

  11. 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...

  12. Informed consent for surgery in Nigeria: Is the practice adequate ...

    African Journals Online (AJOL)

    To evaluate the adequacy of the use of informed consent in surgical practice from the patients' perspective. The study was carried out in the department of Surgery, University of Calabar Teaching Hospital, Calabar, over a six-month period. A structured questionnaire was administered post operatively on patients, and ...

  13. 42 CFR 486.342 - Condition: Requesting consent.

    Science.gov (United States)

    2010-10-01

    ... consented to donation before his or her death in a manner that satisfied applicable State law requirements... SUPPLIERS Requirements for Certification and Designation and Conditions for Coverage: Organ Procurement Organizations Organ Procurement Organization Process Performance Measures § 486.342 Condition: Requesting...

  14. 75 FR 26275 - Notice of Lodging of Proposed Consent Decree

    Science.gov (United States)

    2010-05-11

    ... Oceanic and Atmospheric Administration and the Department of the Interior; the State of Washington; the.... 9607(a); section 311 of the Clean Water Act (CWA), 33 U.S.C. 1321; section 1002(b) of the Oil Pollution... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree In accordance with Departmental...

  15. 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 ...

  16. 32 CFR 634.23 - Specified consent to impoundment.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 4 2010-07-01 2010-07-01 true Specified consent to impoundment. 634.23 Section 634.23 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) LAW ENFORCEMENT AND CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Motor Vehicle Registration § 634.23...

  17. An audit of the informed consent process in postgraduate ...

    African Journals Online (AJOL)

    Background: Informed consent ensures respect for individual autonomy and safeguards against abuses of human participants. However, the high prevalence of poverty, inaccessibility of healthcare services, diseases, social insecurity and low literacy in developing countries such as Kenya increases participants' ...

  18. The Use of Multimedia in the Informed Consent Process

    Science.gov (United States)

    Jimison, Holly B.; Sher, Paul P.; Appleyard, Richard; LeVernois, Yvonne

    1998-01-01

    Abstract Objective: The goal of the project was to create recommendations and design specifications for a multimedia tool to enhance the informed consent process for clinical trials. The authors focused on the needs of patients with potential cognitive impairment. Design: The authors first performed a needs assessment using focus groups and interviews with health care researchers, institutional review board members, and three groups of patients (who had depression, breast cancer, or schizophrenia). Their feedback was incorporated into the design of a prototype multimedia tool. The design included general modules with information about clinical trials and informed consent as well as trial-specific modules. The authors then used the resulting prototype multimedia tool for informed consent in follow-up focus groups and interviews to obtain feedback on the feasibility and potential effectiveness of using such a tool routinely for clinical trials. Results: The authors showed that it was feasible to adapt a structured multimedia informed consent system to a specific clinical trial and to incorporate techniques to improve the understandability of informed consent content. Patients generally felt the prototype system was useful and could replace the paper document. They felt using the system would be less stressful, because they would have a greater sense of control and could proceed at their own pace. They liked the hierarchic and modular approach to providing information and felt that the use of video made information more understandable. Researchers and institutional review board members also found the system to be valuable in these ways but had concerns about how to review the system for potential biases in presentation and about the legal issues associated with replacing the paper document. PMID:9609494

  19. Dyadic analysis of self-efficacy and perceived support: the relationship of individual and spousal characteristics with physical activity among middle-aged and young-older adults.

    Science.gov (United States)

    Ayotte, Brian J; Margrett, Jennifer A; Patrick, Julie Hicks

    2013-06-01

    The purpose of this study was to examine the associations among self-efficacy, perceived support, and physical activity in middle-aged and older married couples. A total of 116 middle-aged and older couples (M = 58.86 years, SD = 7.16, range 50-74) participated in the study. A dyadic approach to path modeling was taken. The final model indicated that for both husbands and wives, one's own self-efficacy was directly related to physical activity. In addition, husband self-efficacy was positively related to wive physical activity and indirectly related to wife physical activity through wife self-efficacy. Wife self-efficacy was indirectly related to husband physical activity via the level of husband perceived support. These results provide evidence for the importance of incorporating spousal characteristics in addition to individual characteristics when investigating physical activity during middle and later married life. PsycINFO Database Record (c) 2013 APA, all rights reserved.

  20. 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.

  1. Defining "coercion" and "consent" cross-culturally.

    Science.gov (United States)

    Heise, L; Moore, K; Toubia, N

    1996-01-01

    Excerpts are presented from a book entitled Sexual Coercion and Reproductive Health: A Focus on Research published by the Population Council in 1995. All societies have forms of sexual violence that are socially proscribed and others that are tolerated by social customs. Some argue that there is no such thing as marital rape because of the very meaning of marriage. Most societies condemn sex between adults and children and forced sexual intercourse with an unmarried virgin. However, in many societies forced sex within marriage is accepted. Most cultural definitions of abuse are devoid of the volition, perceptions, and feelings of the woman. Coercive sex can be conceived as a continuum from transgressive to tolerated coercive sex. Some types of coercive sex are in transition, for instance, in the United States acts for which the girl would have been blamed 20 years ago are increasingly being termed date rape. The psychologist Patricia Rozee suggests that female choice should the benchmark for the definition of rape. At a seminar on sexual coercion participants endorsed the idea of a universal standard for identifying coerced sex across cultures. The ultimate goal is to make possible voluntary, safe sexuality for all people. Although male dominance has persisted in sexual matters, no major religion or social code of ethics condones sexual violence. The appropriate definition of rape or coerced sex was also discussed in situations when the word itself was not used by the victim. When interviewed, exiled Iranian women living in the United States revealed that for most of them their wedding nights in Iran had been violent and traumatic; many had been held down by relatives for what they now (but not at the time) described as rape and torture.

  2. The sexual consent scale-revised: development, reliability, and preliminary validity.

    Science.gov (United States)

    Humphreys, Terry P; Brousseau, Mélanie M

    2010-09-01

    The Sexual Consent Scale-Revised (SCS-R) measures an individual's beliefs, attitudes, and behaviors with respect to how sexual consent should be and is negotiated between sexual partners. This study extends previous research on sexual consent by revising a scale using the Theory of Planned Behavior (Ajzen, 1991, 2001, 2005) as its theoretical foundation. The psychometric properties of the SCS-R were established using factor analysis, construct validity tests, as well as internal consistency and test-retest reliability. Five factors emerged: perceived behavioral control, positive attitude toward establishing consent, sexual consent norms, indirect consent behaviors, and awareness of consent. Results indicated that the SCS-R can be useful for examining a variety of research questions relating to sexual consent.

  3. 78 FR 59943 - Submission for OMB Review; 30-Day Comment Request; Interactive Informed Consent for Pediatric...

    Science.gov (United States)

    2013-09-30

    ... compared with the standard paper consent document. Given that many individuals have difficulty reading and... clinical trial presented using either a standard paper consent document or an interactive computer-based...

  4. 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.

  5. Legal and Ethical Aspects of Informed Consent: A Nursing Research Perspective.

    Science.gov (United States)

    Cassidy, Virginia R.; Oddi, Lorys F.

    1986-01-01

    Issues related to the doctrine of informed consent for research on human subjects are discussed as they concern the conduct of nursing research. They include the subject's capacity to consent, disclosure of information, and freedom to decide. (MSE)

  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. 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

  8. Dentists' knowledge and attitude towards informed consent taking in a Nigerian teaching hospital.

    Science.gov (United States)

    Adeyemi, A T; Kosoko, J O; Ifesanya, J U

    2011-09-01

    There has been an increase in medical and dental knowledge in the world today. More and more people are getting to know their rights and cases of medical and dental liability is on the increase. Hence a proper approach towards obtaining informed consent in dental practice has become necessary. This study assessed dentists' perception on informed consent taking for dental procedures. Self administered questionnaires were given to all dentists working in one of the teaching hospitals in the south west region of Nigeria. The questionnaires assessed the doctors' ability to properly define informed consent, knowledge of aspects relevant to informed consent taking and procedures for which they felt informed consent should be taking routinely. The result revealed 10 out of 56 dentists (17.5%) were able to rightly and fully define informed consent. Almost all the dentists (98.4%) claimed to have taken informed consent at one time or the other, out of which 31 dentists (59.6%) claim that they always take verbal informed consent on routine dental treatment. However 21 (42%) of the dentists believed that informed consent scares patients, while 31 (54.5%) believed informed consent prepares patients better for the procedure. Generally the dentists agreed that the more invasive the dental treatment procedure was the more they felt informed consent should be taken. Dentists knowledge about informed consent seems to be inadequate as only few of them were able to define informed consent. However their attitude towards informed consent seems to be more positive as almost all claimed to have taken informed consent from patients at one time or the other. Therefore regular update about knowledge and significance of informed consent should be encouraged.

  9. Consent to treatment by minors attending accident and emergency departments: guidelines.

    OpenAIRE

    Williams, L; Harris, A; Thompson, M; Brayshaw, A

    1997-01-01

    The absolute right to refuse medical treatment, even if the reasons are irrational, is confined to competent adults. Children under 16 years can give legal consent to treatment in the absence of consent from those with parental responsibility. Children under 18 years do not, however, have an absolute right to consent, or refuse to consent, to treatment. The views of children assume increasing importance with age and maturity. Accident and emergency medical and nursing staff may face difficult...

  10. 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…

  11. 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...

  12. 21 CFR 50.24 - Exception from informed consent requirements for emergency research.

    Science.gov (United States)

    2010-04-01

    ... Exception from informed consent requirements for emergency research. (a) The IRB responsible for the review... investigation without requiring that informed consent of all research subjects be obtained if the IRB (with the... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Exception from informed consent requirements for...

  13. 76 FR 55390 - Guidance on Exculpatory Language in Informed Consent, Draft

    Science.gov (United States)

    2011-09-07

    ... Language in Informed Consent document to the Division of Policy and Assurances, Office for Human Research... HUMAN SERVICES Guidance on Exculpatory Language in Informed Consent, Draft AGENCY: Office for Human... the availability of a draft guidance entitled, ``Guidance on Exculpatory Language in Informed Consent...

  14. 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

  15. Informed consent: attitudes, knowledge and information concerning prenatal examination

    DEFF Research Database (Denmark)

    Dahl, Katja; Kesmodel, Ulrik; hvidman, lone

    2006-01-01

    of the possibility of a false negative result. The risk of miscarriage in relation to amniocentesis (AC) is unknown to 11-53%. Uptake rates are associated with attitudes towards prenatal examinations, but not knowledge of the test offered. A total of 88 % concidered their health care provider an important source...... of information, and 57 % stated that this information has influenced their decision.  Conclusions: Pregnant women favor prenatal examinations, but the choice of participation does not seem to be based on insight to enable full informed consent. Health care providers are perceived as an essential source......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...

  16. Ethical issues in videorecording patients lacking capacity to consent

    Directory of Open Access Journals (Sweden)

    Carlo Petrini

    2011-01-01

    Full Text Available Videorecording of patients requires the utmost respect for the privacy and confidentiality of the patients. Consent should be requested from patients for all videorecording. When a mental disability or mental or physical illness prevents patients from giving their permission, agreement to recording from a legal representative or from a close relative or carer are necessary. Three documents on this subject issued in the United Kingdom, the United State of America and Italy are briefly summarized and discussed. The problem of consent for videorecording is addressed particularly in reference to persons incapable of making decisions on their own, such as persons in vegetative state. The general ethical framework is outlined and a few practical proposals are given.

  17. Informed consent in experimentation involving mentally impaired persons: ethical issues

    Directory of Open Access Journals (Sweden)

    Carlo Petrini

    2010-12-01

    Full Text Available The problem of experimentation involving subjects whose mental condition prevents them from understanding information and providing proper informed consent has been addressed in various codes, declarations, conventions, treaties and regulations adopted by national, international and supranational institutions and authorities. This article summarizes the basic ethical criteria these documents provide and stresses the historical development from the nearly total exclusion of incapacitated subjects, established in the mid-twentieth century, to their contemporary inclusion in clinical trials on certain ethical conditions. The problem of proxy consent by legal representatives for participation in clinical trials is addressed particularly in reference to current Italian regulations. Exceptions to human experimentation requirements in emergency situations are also briefly discussed.

  18. Patient autonomy and informed consent in critically lll

    Directory of Open Access Journals (Sweden)

    Todorović Zoran M.

    2017-01-01

    Full Text Available Patient autonomy has been a cornerstone of contemporary clinical ethics since the Nuremberg trial, especially in American school of bioethics. Topic: Patient autonomy has been defined in the Nuremberg Code, and re-defined in the Declaration of Helsinki, Belmont Report and Barcelona Declaration. Founders and followers of the rights-oriented bioethics (for example, Hellegers, Beauchamp and Childers have established and promoted the patient autonomy as the main principle of bio(medical ethics since 1970s. However, there is a lot of controversy surrounding such a principle, especially in vulnerable patients. We aimed at evaluating the real meaning and value of patient autonomy in critical care settings regarding the communication between health workers and their patients and families. Conclusion: Protection of patients autonomy in critically ill is a complex issue. Careful benefit-risk assessment is needed in order to find the most appropriate way of obtaining the informed consent, proxy consent or to omit or delay it.

  19. Informed consent in psychiatric research - concepts and challenges.

    Science.gov (United States)

    Bagarić, Dario; Zivković, Maja; Curković, Marko; Radić, Krešimir; Brečić, Petrana

    2014-09-01

    Research involving vulnerable population of mentally impaired persons is raising considerable controversies from its very beginnings. These controversies are created around everlasting tensions between two positive duties: the duty to protect vulnerable subjects, and the duty not to deny them potential benefits. Most of the contemporary ethical guidelines and regulations, including most recent revision of the Declaration of Helsinki, permit these researches under certain ethical conditions. The notion of informed consent as a cornerstone of bioethics emerges as essential requisite of moral research. We are presenting some key concepts and safeguards regarding informed consent that researcher needs to be aware off when conducting a research involving mentally impaired persons. Theoretical and practical challenges that are arising from these safeguards are discussed with an overview of most recent scientific data. Lastly, we briefly address the most important legal standings that will be introduced in 2015, by new Croatian Law on the Protection of Persons with Mental Disorders.

  20. Language use in the informed consent discussion for emergency procedures.

    Science.gov (United States)

    McCarthy, Danielle M; Leone, Katrina A; Salzman, David H; Vozenilek, John A; Cameron, Kenzie A

    2012-01-01

    The field of health literacy has closely examined the readability of written health materials to optimize patient comprehension. Few studies have examined spoken communication in a way that is comparable to analyses of written communication. The study objective was to characterize the structural elements of residents' spoken words while obtaining informed consent. Twenty-six resident physicians participated in a simulated informed consent discussion with a standardized patient. Audio recordings of the discussions were transcribed and analyzed to assess grammar statistics for evaluating language complexity (e.g., reading grade level). Transcripts and time values were used to assess structural characteristics of the dialogue (e.g., interactivity). Discussions were characterized by physician verbal dominance. The discussions were interactive but showed significant differences between the physician and patient speech patterns for all language complexity metrics. In this study, physicians spoke significantly more and used more complex language than the patients.

  1. Modular forms

    NARCIS (Netherlands)

    Edixhoven, B.; van der Geer, G.; Moonen, B.; Edixhoven, B.; van der Geer, G.; Moonen, B.

    2008-01-01

    Modular forms are functions with an enormous amount of symmetry that play a central role in number theory, connecting it with analysis and geometry. They have played a prominent role in mathematics since the 19th century and their study continues to flourish today. Modular forms formed the

  2. Patient privacy, consent, and identity management in health information exchange

    CERN Document Server

    Hosek, Susan D

    2013-01-01

    As a step toward improving its health information technology (IT) interoperability, the Military Health System is seeking to develop a research roadmap to better coordinate health IT research efforts, address IT capability gaps, and reduce programmatic risk for its enterprise projects. This report identifies gaps in research, policy, and practice involving patient privacy, consent, and identity management that need to be addressed to improve the quality and efficiency of care through health information exchange.

  3. Patient and parent understanding of informed consent in orthodontics.

    Science.gov (United States)

    Mortensen, Micah G; Kiyak, H Asuman; Omnell, Lena

    2003-11-01

    In both medical and dental settings, researchers have found that patients do not adequately comprehend the information given during informed consent discussions, especially the less educated, low-income patients. Because of the importance of patient compliance with orthodontic treatment regimens, this study examined patient and parent understanding of the child's Phase I orthodontic treatment in a public dental clinic with ethnically diverse, low-income patients. Interviews were conducted with 29 children (ages 6-12) and their parents or guardians at the orthodontic case presentation appointment. The orthodontist explained the reasons for treatment, the orthodontic procedures to be used, the risks, the alternatives, and patient and parent responsibilities during treatment; the session was audiotaped. Interviews were conducted immediately after this discussion and the results compared with the orthodontists' presentations. In general, both children and parents recalled significantly fewer reasons for treatment (1.10, 1.66, and 2.34 items, respectively), procedures (1.55, 1.59, and 2.45, respectively), risks associated with treatment (0.66, 1.48, and 4.66, respectively), and responsibilities of the child during treatment (2.21, 2.07, and 3.38, respectively) than what the orthodontist had told them. They were also less likely to recall the reasons, procedures, and risks that were most frequently cited by the orthodontist. These findings raise concerns about the effectiveness of current informed consent techniques with public health populations, especially the low recall rates within 30 minutes of the case presentations. Low recall of risks by children and their parents, particularly for critical risks such as relapse, caries, and periodontal problems, raises concerns about treatment compliance, success, and more importantly, the effectiveness of the informed consent process itself. Future research should focus on methods to improve the informed consent process among

  4. Informed consent in human subject research: a comparison of current international and Nigerian guidelines.

    Science.gov (United States)

    Fadare, Joseph O; Porteri, Corinna

    2010-03-01

    Informed consent is a basic requirement for the conduct of ethical research involving human subjects. Currently, the Helsinki Declaration of the World Medical Association and the International Ethical Guidelines for Biomedical Research of the Council for International Organizations of Medical Sciences (CIOMS) are widely accepted as international codes regulating human subject research and the informed consent sections of these documents are quite important. Debates on the applicability of these guidelines in different socio-cultural settings are ongoing and many workers have advocated the need for national or regional guidelines. Nigeria, a developing country, has recently adopted its national guideline regulating human subject research: the National Health Research Ethics Committee (NHREC) code. A content analysis of the three guidelines was done to see if the Nigerian guidelines confer any additional protection for research subjects. The concept of a Community Advisory Committee in the Nigerian guideline is a novel one that emphasizes research as a community burden and should promote a form of "research friendship" to foster the welfare of research participants. There is also the need for a regular update of the NHREC code so as to address some issues that were not considered in its current version.

  5. Emergency surgery on mentally impaired patients: standard in consenting

    Directory of Open Access Journals (Sweden)

    Mihai Paduraru

    2018-04-01

    Full Text Available Emergency surgery is often performed on the elderly and susceptible patients with significant comorbidities; as a consequence, the risk of death or severe complications are high. Consent for surgery is a fundamental part of medical practice, in line with legal obligations and ethical principles. Obtaining consent for emergency services (for surgical patients with chronic or acute mental incapacity, due to surgical pathology is particularly challenging, and meeting the standards requires an up-to-date understanding of legislation, professional body guidelines, and ethical or cultural aspects. The guidance related to consent requires physicians and other medical staff to work with patients according to the process of ‘supported decision-making’. Despite principles and guidelines that have been exhaustively established, the system is sometimes vulnerable in actual clinical practice. The combination of an ‘emergency’ setting and a patient without mental ‘capacity’ is a challenge between patient-centered and ‘paternalistic’ approaches, involving legislation and guidelines on ‘best interests’ of the patient.

  6. Informed consent in human experimentation before the Nuremberg code.

    Science.gov (United States)

    Vollmann, J; Winau, R

    1996-12-07

    The issue of ethics with respect to medical experimentation in Germany during the 1930s and 1940s was crucial at the Nuremberg trials and related trials of doctors and public health officials. Those involved in horrible crimes attempted to excuse themselves by arguing that there were no explicit rules governing medical research on human beings in Germany during the period and that research practices in Germany were not different from those in allied countries. In this context the Nuremberg code of 1947 is generally regarded as the first document to set out ethical regulations in human experimentation based on informed consent. New research, however, indicates that ethical issues of informed consent in guidelines for human experimentation were recognised as early as the nineteenth century. These guidelines shed light on the still contentious issue of when the concepts of autonomy, informed consent, and therapeutic and non-therapeutic research first emerged. This issue assumes renewed importance in the context of current attempts to assess liability and responsibility for the abuse of people in various experiments conducted since the second world war in the United States, Canada, Russia, and other nations.

  7. Is Informed Consent Necessary for Research on Stored Human Samples?

    Directory of Open Access Journals (Sweden)

    Lawrence Fred Sembajwe

    2016-06-01

    Full Text Available Informed consent is always required before patients can be treated in health centers as well as participating in any kind of research. This requirement often poses a serious challenge to researchers in situations where existing guidelines are not clear about the ownership of donated or discarded human biological samples in hospital archives. The current regulations demand that when doing research, the major bioethical principles of autonomy, beneficence, non-maleficence and justice should always be respected and adhered to. There is increased value of stored biomaterials due to advancement in biotechnology which has also contributed to increased debate on whether researchers should seek informed consent from the individual donors before such materials can be used for research. In enforcing these bioethical principles, most guidelines focus on research involving direct contact with human beings, and no much attention is given to stored or discarded body parts and biomaterials that end up being used for research in later years. There are some hypotheses that can be tested by doing research on the stored biological samples, especially by students or scientists attached to various University hospitals, research-centers and laboratories. We attempt to provide some scenarios and reviewed guidelines that can help provide a consensus as to whether it is strictly necessary to have informed consent for research on stored or discarded human body parts and who should claim ownership of collected human biomaterials for research or potential commercial purposes. [Archives Medical Review Journal 2016; 25(2.000: 119-128

  8. The Consequences of Vagueness in Consent to Organ Donation.

    Science.gov (United States)

    Shaw, David M

    2017-07-01

    In this article I argue that vagueness concerning consent to post-mortem organ donation causes considerable harm in several ways. First, the information provided to most people registering as organ donors is very vague in terms of what is actually involved in donation. Second, the vagueness regarding consent to donation increases the distress of families of patients who are potential organ donors, both during and following the discussion about donation. Third, vagueness also increases the chances that the patient's intention to donate will not be fulfilled due to the family's distress. Fourth, the consequent reduction in the number of donated organs leads to avoidable deaths and increased suffering among potential recipients, and distresses them and their families. There are three strategies which could be used to reduce the harmful effects of this vagueness. First, recategorizing the reasons (commonly referred to as 'overrules' under the current system) given by families who refuse donation from registered donors would bring greater clarity to donation discussions. Second, people who wish to donate their organs should be encouraged to discuss their wishes in detail with their families, and to consider recording their wishes in other ways. Finally, the consent system for organ donation could be made more detailed, ensuring both that more information is provided to potential donors and that they have more flexibility in how their intentions are indicated; this last strategy, however, could have the disadvantage of discouraging some potential donors from registering. © 2016 John Wiley & Sons Ltd.

  9. Gaining environmental resource consents: a New Zealand experience

    International Nuclear Information System (INIS)

    Hopkins, K.N.; Pritchard, N.E.

    1995-01-01

    In 1991 the Electricity Corporation of New Zealand was faced with the renewal of existing permits and rights under the requirements of the newly-passed Resource Management Act. Specifically for Huntly Power Station a strategy was required to ensure new Consents were gained to replace Water Rights and a Clean Air Act Licence due to expire in 1994. Key aspects of the Act are environmental protection, a requirement to consider Maori cultural concerns, and the need for a public participation stage in the Consents process. This paper documents aspects of the work completed to ensure Huntly gained its new Air and Water Resource Consents and indicates follow-up work in progress. Most attention in the water area focused on the discharge of condenser cooling water into the Waikato River with studies on fish health, migration and breeding habits being carried out. A novel solution involving the installation of 'Iowa Vanes' in the river has been decided on to optimize effective mixing of the cooling water with the river channel in front of the Station and thus minimize the effect of warm water entering the river. (author). 3 figs., 3 refs

  10. Presumed consent for organ donation: is Romania prepared for it?

    Science.gov (United States)

    Grigoras, I; Condac, C; Cartes, C; Blaj, M; Florin, G

    2010-01-01

    In November 2007, a legislative initiative regarding the presumed consent for organ donation was proposed for parliamentary debate in Romania and was followed by public debate. The study aimed to asses public opinions expressed in the Romanian media. An Internet search was made. The pro and con reasons, the affiliation of parts involved in the debate and suggested future direction of action were identified. The Internet search had 8572 results. The parts involved in the pro and con debate consisted of governmental structures, physicians, ethicists, politicians, media, religious authorities, nongovernmental associations, and lay persons. The main pros were the low rate of organ donation and the long waiting lists, enhancement of organ procurement, avoidance of wasting valuable organs, avoiding responsibility, and the stress imposed to the family in giving the donation consent, humanitarian purposes (saving lives), going along with the scientific progress, and less bureaucracy. The main cons were an unethical issue, violation of human rights, denial of brain death, unethical advantage of public ignorance, unethical use of underprivileged people, little results in terms of organ procurement, but huge negative effects on public opinion, public mistrust in transplant programs and impossibility of refusal identification due to particularities of the Romanian medical system. The con opinions prevailed. For the moment, Romania seems to be unprepared to accept presumed consent. A future change in public perception regarding organ transplantation may modify the terms of a public debate.

  11. [Informed consent right of the appraised individuals in forensic clinical examination].

    Science.gov (United States)

    Li, Ju-Ping; Han, Wei; Gu, Shan-Zhi; Chen, Teng

    2015-02-01

    Informed consent right is not just for basic ethical consideration, but is important for protecting patient's right by law, which is expressed through informed consent contract. The appraised individuals of forensic clinical examination have the similar legal status as the patients in medical system. However, the law does not require informed consent right for the appraised individuals. I recommend giving certain informed consent right to the appraised individuals in the forensic clinical examination. Under the contracted relationship with the institution, the appraised individuals could participate in the examination process, know the necessary information, and make a selected consent on the examination results, which can assure the justice and fairness of judicial examination procedure.

  12. Holy consent--a dilemma for medical staff when maternal consent is withheld for emergency caesarean section.

    Science.gov (United States)

    Weiniger, C F; Elchalal, U; Sprung, C L; Weissman, C; Matot, I

    2006-04-01

    A parturient (grand multipara) developed arrested labour complicated by severe fetal heart rate decelerations. Senior physicians explained the need for a caesarean section, but she chose to deliver vaginally since rabbinical blessing could not be obtained. Forcing the mother to have a cesarean section without consent is considered "civil battery." The dilemma faced by medical staff and the implications of her refusal for the treating medical staff are described.

  13. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 7: Informed consent and xenotransplantation clinical trials.

    Science.gov (United States)

    Vanderpool, Harold Y

    2009-01-01

    This essay explores the meaning and implications of informed consent in xenotransplantation clinical trials from both ethically justifiable and international perspectives. In international and national codes and guidelines involving human subject research and in the laws of many nations, the informed consent of research subjects is obligatory. Its moral foundations include and also extend beyond respect for individual persons as autonomous agents in Western nations. Axioms regarding the value of human life and duties to protect innocent and vulnerable persons from harm, duress, and deceit underlie Western individualism and are broadly shared in many non-Western cultures. Accents on family and/or community consent in China and other nations are compatible with individual consent as long as family and community consent supplement, rather than replace, individual consent. Reflecting its moral foundations, informed consent in medical research is rightly characterized as "voluntary" or "freely given" informed consent because it encompasses researchers' disclosure and subjects' comprehension of all the relevant information about the protocol that reasonable persons would want to know in order to freely and affirmatively enroll in the research. The interplay between these conceptual foundations of informed consent and the realities of xenotransplantation research defines what the nature and functions of consent should be in xenotransplantation clinical trials. Because these trials involve a complex body of medical information, numerous procedures, numerous risks (associated with failure rates, immunosuppression, xenogeneic infections, and so on) and the subject's obligation to abide by extensive national and international precautionary guidelines, informed consent should be enacted as an organized, sequential, thoughtfully paced, jargon-free process of communication. The features and functions of consent forms or consent documents should accord with this process. Rather

  14. Informed consent to healthcare interventions in people with learning disabilities--an integrative review.

    Science.gov (United States)

    Goldsmith, Lesley; Skirton, Heather; Webb, Christine

    2008-12-01

    This paper is a report of an integrative review of informed consent to healthcare interventions in people with learning disabilities. Consent to treatment lies at the heart of the relationship between patient and healthcare professional. In order for people with learning disabilities to have equity of access to health care, they need to be able to give informed consent to health interventions--or be assessed as incompetent to give consent. The British Nursing Index (BNI), CINAHL, MEDLINE, Social Care Online, ERIC and ASSIA and PsycINFO databases were searched using the search terms: Consent or informed choice or capacity or consent to treat* or consent to examin* AND Learning disab* or intellectual* disab* or mental* retard* or learning difficult* or mental* handicap*. The search was limited to papers published in English from January 1990 to March 2007. An integrative review was conducted and the data analysed thematically. Twenty-two studies were reviewed. The main themes identified were: life experience, interaction between healthcare professionals and participants, ability to consent, and psychometric variables. A consensus seemed to emerge that capacity to consent is greater in people with higher cognitive ability and verbal skills, but that the attitudes and behaviour of healthcare professionals was also a crucial factor. The findings support use of the functional approach to assessing mental capacity for the purpose of obtaining informed consent. Future research into informed consent in people with learning disabilities is needed using real life situations rather than hypothetical vignettes.

  15. Informed consent under the European Convention on Biomedicine and the UNESCO Declaration on Bioethics.

    Science.gov (United States)

    Salako, Solomon E

    2011-03-01

    The desirability of obtaining freely given consent is universally accepted. The point, however, is that there is no unanimity on the definition of informed consent or its application in bioethics. Whether informed consent is based on principalism or casuistry or the virtue theory, the problem is how to handle the ethically complex situation created in the interface between informed consent and social justice under international biomedical instruments. This article will proceed by offering detailed historical and critical analyses of informed consent under the European Convention on Human Rights and Biomedicine 1997 and The UNESCO Universal Declaration on Bioethics and Human Rights 2005. Three conceptions of justice will be utilised to show that the doctrine of informed consent has driven the ethos of research on human beings and shaped the physician-patient relationship; and that casuistry and virtue theory are consistent with and not rivals of a principle-based account of informed consent.

  16. Parental Perceptions About Informed Consent/Assent in Pediatric Research in Jordan.

    Science.gov (United States)

    Khabour, Omar F; Alomari, Mahmoud A; Al-Sheyab, Nihaya A

    2017-10-01

    The informed consent/assent process during enrollment in pediatric research is integral to protecting children from possible harm. Here we explored parents' perceptions about the informed consent/assent process in Jordan. Therefore, focus group interviews were conducted that focused on the importance of consent/assent, the quality of the information provided during consent process, and the parents' perceptions toward written/verbal informed consent. Content thematic analysis approach was adopted in the transcription and translation processes of the interviews. The majority of parents have an ethically acceptable understanding of many of the aspects related to consent/assent; however, some views were not consistent with the proper conduct of research. For example, some parents believed that informed consent is not required for questionnaire studies. Discrepancies were also noted regarding the appropriate age of a child's assent. Some parents would force their child to participate. Thus, the development of Jordanian, culturally sensitive pediatric research guidelines is required.

  17. Analysis of Informed Consent Document Utilization in a Minimal-Risk Genetic Study

    Science.gov (United States)

    Desch, Karl; Li, Jun; Kim, Scott; Laventhal, Naomi; Metzger, Kristen; Siemieniak, David; Ginsburg, David

    2012-01-01

    Background The signed informed consent document certifies that the process of informed consent has taken place and provides research participants with comprehensive information about their role in the study. Despite efforts to optimize the informed consent document, only limited data are available about the actual use of consent documents by participants in biomedical research. Objective To examine the use of online consent documents in a minimal-risk genetic study. Design Prospective sibling cohort enrolled as part of a genetic study of hematologic and common human traits. Setting University of Michigan Campus, Ann Arbor, Michigan. Participants Volunteer sample of healthy persons with 1 or more eligible siblings aged 14 to 35 years. Enrollment was through targeted e-mail to student lists. A total of 1209 persons completed the study. Measurements Time taken by participants to review a 2833-word online consent document before indicating consent and identification of a masked hyperlink near the end of the document. Results The minimum predicted reading time was 566 seconds. The median time to consent was 53 seconds. A total of 23% of participants consented within 10 seconds, and 93% of participants consented in less than the minimum predicted reading time. A total of 2.5% of participants identified the masked hyperlink. Limitation The online consent process was not observed directly by study investigators, and some participants may have viewed the consent document more than once. Conclusion Few research participants thoroughly read the consent document before agreeing to participate in this genetic study. These data suggest that current informed consent documents, particularly for low-risk studies, may no longer serve the intended purpose of protecting human participants, and the role of these documents should be reassessed. Primary Funding Source National Institutes of Health. PMID:21893624

  18. Analysis of informed consent document utilization in a minimal-risk genetic study.

    Science.gov (United States)

    Desch, Karl; Li, Jun; Kim, Scott; Laventhal, Naomi; Metzger, Kristen; Siemieniak, David; Ginsburg, David

    2011-09-06

    The signed informed consent document certifies that the process of informed consent has taken place and provides research participants with comprehensive information about their role in the study. Despite efforts to optimize the informed consent document, only limited data are available about the actual use of consent documents by participants in biomedical research. To examine the use of online consent documents in a minimal-risk genetic study. Prospective sibling cohort enrolled as part of a genetic study of hematologic and common human traits. University of Michigan Campus, Ann Arbor, Michigan. Volunteer sample of healthy persons with 1 or more eligible siblings aged 14 to 35 years. Enrollment was through targeted e-mail to student lists. A total of 1209 persons completed the study. Time taken by participants to review a 2833-word online consent document before indicating consent and identification of a masked hyperlink near the end of the document. The minimum predicted reading time was 566 seconds. The median time to consent was 53 seconds. A total of 23% of participants consented within 10 seconds, and 93% of participants consented in less than the minimum predicted reading time. A total of 2.5% of participants identified the masked hyperlink. The online consent process was not observed directly by study investigators, and some participants may have viewed the consent document more than once. Few research participants thoroughly read the consent document before agreeing to participate in this genetic study. These data suggest that current informed consent documents, particularly for low-risk studies, may no longer serve the intended purpose of protecting human participants, and the role of these documents should be reassessed. National Institutes of Health.

  19. A comparison of the gender-specificity of age of consent legislation in Europe and China : Towards a gender-neutral age of consent in China

    NARCIS (Netherlands)

    Zhu, Guangxing; van der Aa, Suzanne

    2017-01-01

    Age of consent—the age at which young people are considered legally competent to consent to sexual activities—is an important weapon invented by law makers to protect young children from being sexually abused and exploited by predatory adults. In this study, a comparison of the age of consent

  20. Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.

    Science.gov (United States)

    Vickers, Andrew J; Young-Afat, Danny A; Ehdaie, Behfar; Kim, Scott Yh

    2018-02-01

    Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.