Surrogate consent for dementia research: a national survey of older Americans.
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ABSTRACT: Background
Research in novel therapies for Alzheimer disease (AD) relies on persons with AD as research subjects. Because AD impairs decisional capacity, informed consent often must come from surrogates, usually close family members. But policies for surrogate consent for research remain unsettled after decades of debate.Methods
We designed a survey module for a random subsample (n = 1,515) of the 2006 wave of the Health and Retirement Study, a biennial survey of a nationally representative sample of Americans aged 51 and older. The participants answered questions regarding one of four randomly assigned surrogate-based research (SBR) scenarios: lumbar puncture study, drug randomized control study, vaccine study, and gene transfer study. Each participant answered three questions: whether our society should allow family surrogate consent, whether one would want to participate in the research, and whether one would allow one's surrogate some or complete leeway to override stated personal preferences.Results
Most respondents stated that our society should allow family surrogate consent for SBR (67.5% to 82.5%, depending on the scenario) and would themselves want to participate in SBR (57.4% to 79.7%). Most would also grant some or complete leeway to their surrogates (54.8% to 66.8%), but this was true mainly of those willing to participate. There was a trend toward lower willingness to participate in SBR among those from ethnic or racial minority groups.Conclusions
Family surrogate consent-based dementia research is broadly supported by older Americans. Willingness to allow leeway to future surrogates needs to be studied further for its ethical significance for surrogate-based research policy.
SUBMITTER: Kim SY
PROVIDER: S-EPMC2663398 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:OBJECTIVES:To describe how members of the older general public deliberate with one another in finding solutions to the dilemma of involving persons with decisional incapacity in dementia research. DESIGN, SETTING, AND PARTICIPANTS:One hundred sixty persons age 50 years and older who participated in an all-day deliberative democracy session on the ethics of surrogate consent for dementia research. The deliberative democracy day consisted of both extensive, interactive education with experts in clinical research and ethics, as well as small group deliberations. MEASUREMENTS:Audiotaped small group deliberations were transcribed and analyzed and the main thematic elements were coded. RESULTS:During deliberation, participants acknowledged the limitations of advanced research directives and discussed ways to improve their use. Although there was consensus about the necessity of surrogate consent, the participants recognized potential pitfalls and looked for ways to safeguard the process. Participants supporting surrogate consent for research emphasized societal and individual benefits, the importance of assent, and trust in surrogates and the oversight system. Other participants felt that the high risk of some research scenarios was not sufficiently offset by benefits to patients or society. CONCLUSIONS:Members of the older general public are able to make use of in-depth education and peer deliberation to provide reasoned and informed opinions on the ethical use of surrogate consent for dementia research. The public's approach to surrogate consent is one of cautious pragmatism: an overall trust in science and future surrogates with awareness of the potential pitfalls, suggesting that their trust cannot be taken for granted.
| S-EPMC3357450 | biostudies-literature
Project description:ObjectiveTo assess the informed, deliberative views of the older general public toward a policy of allowing surrogate consent for Alzheimer disease (AD) research.MethodsA total of 503 persons aged 50+ recruited by random digit dialing were randomly assigned to 1 of 3 groups: deliberation, education, or control. The deliberation group attended an all-day education/peer deliberation session; the education group received written information only. Participants were surveyed at baseline, after deliberation session (or equivalent time), and 1 month after the session, regarding their attitudes toward a policy of allowing surrogate consent for research studies of varying risks and potential benefits (a lumbar puncture study, a drug randomized controlled trial, a vaccine randomized controlled trial, and an early phase gene transfer trial).ResultsAt baseline, a policy of surrogate consent for AD research was supported by 55%-91%, depending on the scenario. The education group had a transient increase in support for one research scenario after receiving the information materials. In the deliberation group, support for surrogate consent was higher after deliberation for all scenarios (67% to 97%), with much of the increase sustained 1 month after the deliberation session. No changes occurred in the control group. The study's limitations include self-selection of participants due to the demanding nature of attendance at the deliberation sessions.ConclusionsThis sample of the older general public generally supported a policy of surrogate consent for AD research at baseline. Their support increased with democratic deliberation involving informed, in-depth exploration of the relevant scientific and ethical issues.
| S-EPMC3235352 | biostudies-literature
Project description:Most critically ill adults have impaired decision-making capacity and are unable to consent to research. Yet, little is known about how Institutional Review Boards interpret the Common Rule's call for safeguards in research involving incapacitated adults. We aimed to examine Institutional Review Board practices on surrogate consent and other safeguards to protect incapacitated adults in research.A cross-sectional survey of 104 Institutional Review Boards from a random sample of U.S. institutions engaged in adult human subject research (response rate, 68%) in 2007 and 2008.None.Institutional Review Board acceptance of surrogate consent, research risks, and other safeguards in research involving incapacitated adults.Institutional Review Boards reported that, in the previous year, they sometimes (49%), frequently (33%), or very frequently (2%) reviewed studies involving patients in the intensive care unit. Six Institutional Review Boards (6%) do not accept surrogate consent for research from any persons, and 22% of Institutional Review Boards accept only an authorized proxy, spouse, or parent as surrogates, excluding adult children and other family. Institutional Review Boards vary in their limits on research risks in studies involving incapacitated adults: 15% disallow any research regardless of risk in studies without direct benefit, whereas 39% allow only minimal risks. When there was potential benefit, fewer Institutional Review Boards limit the risk at minimal (11%; p < .001). Even in populations at high risk for impaired decision making, many Institutional Review Boards rarely or never required procedures to determine capacity (13%-21%). Institutional Review Boards also varied in their use of independent monitors, research proxies, and advanced research directives.Much variability exists in Institutional Review Board surrogate consent practices and limits on risks in studies involving incapacitated adults. This variability may have adverse consequences for needed research involving incapacitated adults. Clarification of current regulations is needed to provide guidance.
| S-EPMC3939835 | biostudies-literature
Project description:To evaluate current trainers' attitudes and practices for informing patients about the trainee participation in cataract surgery within the United Kingdom.An anonymous online survey was distributed to current cataract surgery trainers via all Royal College of Ophthalmologists' tutors within the United Kingdom. Trainers were asked specific questions about their current consent practice regarding trainee participation in the cataract surgery. Questions also targeted experiences of patient complaints about training.One hundred and twenty-three trainers completed the survey. Ninety-three percent (n=114) of responders were consultants and 7% (n=8) were non-consultant career-grade doctors or other grades. A total of 34% (n=42) of responders stated that consent was usually taken by themselves or the trainee assigned to the list, whereas 26% (n=32) always took consent themselves. Sixty percent of responders (n=74) stated that consent is taken on the day of surgery; 59% (n=73) indicated consent is taken where listing takes place. Thirty-three percent (n=41) of trainers indicated that they had experienced patient dissatisfaction or complaints. Surgical complications, length of surgery, and discussions during surgery were the leading causes of complaints. Thirty-nine percent (n=48) would operate themselves if patients requested no trainee participation.There is a wide variety in the current practice of disclosure and level of information given regarding trainee participation in surgery. This will influence patients' expectations, experiences, and satisfaction.
| S-EPMC3351061 | biostudies-other
Project description:BACKGROUND:Significant debate surrounds the issue of whether written consent is necessary for pragmatic randomized, controlled trials (RCTs) with low risk. OBJECTIVE:To assess the U.S. public's views on alternatives to written consent for low-risk pragmatic RCTs. DESIGN:National experimental survey (2 × 2 factorial design) examining support for written consent versus general notification or verbal consent in 2 research scenarios. SETTING:Web-based survey conducted in December 2014. PARTICIPANTS:2130 U.S. adults sampled from a nationally representative, probability-based online panel (response rate, 64.0%). MEASUREMENTS:Respondent's recommendation to an ethics review board and personal preference as a potential participant on how to obtain consent or notification in the 2 research scenarios. RESULTS:Most respondents in each of the 4 groups (range, 60.3% to 71.5%) recommended written informed consent, and personal preferences were generally in accord with that advice. Most (78.9%) believed that the pragmatic RCTs did not pose additional risks, but 62.5% of these respondents would still recommend written consent. In contrast, a substantial minority in all groups (28.5% to 39.7%) recommended the alternative option (general notification or verbal consent) over written consent. LIMITATION:Framing effects could have affected respondents' attitudes, and nonrespondents may have differed in levels of trust toward research or health care institutions. CONCLUSION:Most of the public favored written informed consent over the most widely advocated alternatives for low-risk pragmatic RCTs; however, a substantial minority favored general notification or verbal consent. PRIMARY FUNDING SOURCE:Time-sharing Experiments for the Social Sciences and Intramural Research Program of the National Institutes of Health Clinical Center.
| S-EPMC5573142 | biostudies-literature
Project description:Background Informed consent for acute myocardial infarction and stroke research is challenging. Time for enrollment decisions is limited, patients and family are usually stressed, and being asked to participate in research is often unexpected. Despite these barriers, patients and surrogates have reported a preference for prospective involvement in research decisions and generally positive views of the consent process. It is unknown what drives positive or negative consent experiences. These data are crucial to making consent processes more context appropriate. Methods and Results We conducted a qualitative interview study with 27 patients and surrogates enrolled in acute myocardial infarction and stroke trials in the past 5 years. Purposive sampling from the P-CARE (Patient-Centered Approaches to Research Enrollment) study was based on participant characteristics and responses to initial patient-centered interviews. In-depth interviews used open-ended questions to explore factors influencing consent experiences. Qualitative descriptive analysis was performed utilizing a multilevel coding strategy. Participants identified specific researcher behaviors as important, including expressions of respect, professionalism, and nonpressuring communication. Participants preferred consent conversations focused on risks/benefits and the trial protocol. They had varying views of consent forms and communicated several reasons the form was valuable unrelated to informational content. Participants also valued postenrollment interactions as opportunities to ask questions and learn about the study. Conclusions Barriers to consent in acute myocardial infarction and stroke trials are unavoidable, but participants identified productive ways to demonstrate respect for patients during enrollment conversations. These include key researcher behaviors, concentrating consent discussions on what participants find most important, and structured postenrollment follow-up.
| S-EPMC6915273 | biostudies-literature
Project description:BackgroundBy 2035, it is expected that older adults (aged 65 years and older) will outnumber children and will represent 78 million people in the US population. As the aging population continues to grow, it is critical to reduce disparities in their representation in medical research.ObjectiveThis study aimed to describe sociodemographic characteristics and health and information behaviors as factors that influence US adults' interest in engaging in medical research, beyond participation as study subjects.MethodsNationally representative cross-sectional data from the 2014 Health Information National Trends Survey (N=3677) were analyzed. Descriptive statistics and weighted multivariable logistic regression analyses were performed to assess predictors of one's interest in patient engagement in medical research. The independent variables included age, general health, income, race and ethnicity, education level, insurance status, marital status, and health information behaviors.ResultsWe examined the association between the independent variables and patient interest in engaging in medical research (PTEngage_Interested). Patient interest in engaging in medical research has a statistically significant association with age (adjusted P<.01). Younger adults (aged 18-34 years), lower middle-aged adults (aged 35-49 years), and higher middle-aged adults (aged 50-64 years) indicated interest at relatively the same frequency (29.08%, 29.56%, and 25.12%, respectively), but older adults (aged ≥65 years) expressed less interest (17.10%) than the other age groups. After the multivariate model was run, older adults (odds ratio 0.738, 95% CI 0.500-1.088) were found to be significantly less likely to be interested in engaging in medical research than adults aged 50 to 64 years. Regardless of age, the strongest correlation was found between interest in engaging in medical research and actively looking for health information (P<.001). Respondents who did not seek health information were significantly less likely than those who did seek health information to be interested in engaging in medical research.ConclusionsPatients' interest in engaging in medical research vary by age and information-seeking behaviors. As the aging population continues to grow, it is critical to reduce disparities in their representation in medical research. Interest in participatory research methods may reflect an opportunity for consumer health informatics technologies to improve the representation of older adults in future medical research.
| S-EPMC6914241 | biostudies-literature
Project description:BackgroundAs Vietnam and other low- and middle-income countries (LMIC) experience a rapid increase in the number of people living with dementia, an acute need exists to strengthen research capacity to inform policy, improve care and support, and develop national dementia plans. We describe the development and early outcomes of an National Institutes of Health (NIH)/National Institute on Aging (NIA)-funded national dementia research capacity building program in Vietnam.MethodsThe research capacity building program commenced in 2019 and has three components: (1) Vietnam Alzheimer's and other dementias research Network (VAN), (2) a mentored pilot grant program, and (3) research training, networking, and dissemination activities. The pilot grant program funds Vietnamese researchers for one to two years to conduct research focusing on Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD). Grants are reviewed and scored using NIH criteria, and priority is given to pilot grants with policy relevance and potential for future funding. An international pool of high-income country (e.g., United States, Australia, and United Kingdom) mentors has been engaged and mentors paired with each funded project. Training and networking activities include workshops on AD/ADRD research topics and regular meetings in conjunction with Vietnam's annual national dementia/geriatric conferences. Dissemination is facilitated through targeted outreach and the creation of a national network of institutions.ResultsOver four years (2019-2023), we received 62 applications, reviewed 58 applications, and funded 21 projects (4-5 per year). Funded investigators were from diverse disciplines and institutions across Vietnam with projects on a range of topics, including biomarkers, prevention, diagnosis, neuropsychological assessment, family caregiver support, dementia education, and clinical trials. A network of 12 leading academic and research institutions nationwide has been created to facilitate dissemination. Six research training workshops have been organized and included presentations from international speakers. Grantees have published or presented their studies at both national and international levels. The mentoring program has helped grantees to build their research skills and expand their research network.ConclusionThis research capacity building program is the first of its kind in Vietnam and may serve as a useful model for other LMIC.
| S-EPMC10832103 | biostudies-literature
Project description:Caring for a family member with Alzheimer's disease (AD) or a related dementia is stressful, and this may especially be the case for racial/ethnic minority caregivers. This study examined the feasibility and acceptability of a pilot intervention for Vietnamese American dementia caregivers. A secondary, exploratory aim was to examine post-intervention effects on AD knowledge and psychosocial outcomes. Of the 87 individuals contacted, 32 met inclusion criteria. Of this number, 14 enrolled in the study with 11 caregivers completing the intervention, and 10 of the 11 completing 3-month follow-up data. Caregivers provided positive feedback on the intervention and had higher scores on AD knowledge and self-efficacy in seeking support services post-intervention, with the effect on self-efficacy maintained at 3-month follow-up. Recruitment for the intervention was difficult; however, once caregivers came to the first session, they were engaged and found the classes informative. Recommendations for a future intervention are discussed.
| S-EPMC7584753 | biostudies-literature
Project description:BackgroundClinical trials remain key to the development of evidence-based medical practice. However, they are becoming increasingly complex, mainly in a multinational setting. To address these challenges, the European Union (EU) adopted the Clinical Trial Regulation EU No. 536/2014 (CTR). Once in force, the CTR will lead to more consistent rules and simplification of procedures for conducting clinical trials throughout the EU. Existing harmonization initiatives and "research infrastructures" for clinical trials may facilitate this process. This publication offers a snapshot of the current level of harmonization activities in academic clinical research in Europe.MethodsA survey was performed among the member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardized questionnaire. Three rounds of data collection were performed to maximize completeness and comparability of the received answers. The survey aimed to describe the harmonization of academic clinical research processes at national level, to facilitate the exchange of expertise and experience among countries, and to identify new fields of action.ResultsMost scientific partners already have in place various working groups and harmonization activities at national level. Furthermore, they are involved in and open to sharing their know-how and documents. Since harmonization was mainly a bottom-up approach up until now, the extent and topics dealt with are diverse and there is only little cross-networking and cross-country exchange so far.ConclusionsCurrently, the ECRIN member countries offer a very solid base and collaborative spirit for further aligning processes and exchanging best practices for clinical research in Europe. They can support a smooth implementation of the EU CTR and may act as single contact with consolidated expertise in a country.
| S-EPMC8051345 | biostudies-literature