Ethics of Surrogate Consent for Dementia Research

描述（由申请人提供）：基于代理许可（基于代理的研究，或SBR）的痴呆研究中招募具有决定性行为能力的成年人越来越多地实践，但尽管存在数十年的争议，但没有广泛接受的政策指导方针。当研究带来重大风险，但对研究对象几乎没有或根本没有直接好处的前景时，政策尤其模糊。由于在创新的早期阿尔茨海默病研究中越来越多地发生严重的不良事件，迫切需要制定更明确的政策。该项目将解决我们在SBR政策方面的一个重要知识空白：一个关键的非专业利益相关者群体（家庭代理人）和老年公众的观点，关于对具有重大风险且很少或没有潜在收益的研究进行代理同意的适当性。该提案结合了两个互补的项目，以最大限度地提高概括性和内部有效性。首先，对老年人对SBR的看法进行一项具有全国代表性的调查，将产生关于这一问题的第一个广泛概括的数据。它还可以审查个人在几个领域（种族和族裔背景、社会关系因素、志愿服务和公民意识等）对社会服务的态度的关键相关因素。第二，我们会与失智症人士的家属和年长市民举行一系列为期一天的协商民主谘询会议。DD项目通过提供平衡的教育和促进参与者之间的便利讨论，以及通过实验、控制设计来衡量其效果，从而优化了内部有效性。DD项目的定量结果将通过对DD会议进行彻底深入的定性分析来丰富，以进一步了解人们对SBR的态度。该提案汇集了痴呆症研究、研究伦理、协商民主理论与实践、调查研究、混合方法研究等领域的专家。一个多学科咨询小组将为发展发展会议的内容增加客观性和平衡性。本项目的结果将为研究伦理政策制定者、政策执行者（如irb）、招募无行为能力受试者的研究人员以及可能作为研究同意代理人的家庭成员的工作提供信息。

DESCRIPTION (provided by applicant): Enrolling adults with decisional incapacity in dementia research based on surrogate permission (surrogate-based research, or SBR) is increasingly practiced but without widely accepted policy guidelines, despite decades of controversy. Policy is especially vague when the research poses significant risks but holds little or no prosepect for direct benefit to the subjects. The need for clearer policy is acute, as serious adverse events increasingly occur in innovative, early phase Alzheimer's disease research studies. This project will address an important gap in our knowledge regarding SBR policy: the perspectives of a key lay stakeholder group (family surrogates) and of the older general public, regarding the appropriateness of surrogate consent for research with significant risks and little or no potential for benefit. This proposal combines two complementary projects to maximize generalizability and internal validity. First, a nationally representative survey of the older public's views regarding SBR will generate the first broadly generalizable data on this issue. It will also allow an examination of the key correlates of individuals' attitudes toward SBR in several domains (racial and ethnic background, social relational factors, volunteerism and civic mindedness, among others). Second, a series of day-long deliberative democratic (DD) consultation sessions with family members of persons with dementia and with members of the older general public will be conducted. The DD project optimizes internal validity by providing balanced education and promoting facilitated deliberations among participants and by an experimental, controlled design to measure its effect. The DD project's quantitative results will be enriched by a thorough in-depth qualitative analysis of DD sessions to provide further insights into people's attitudes towards SBR. This proposal brings together experts in dementia research, research ethics, deliberative democracy theory and practice, survey research, and mixed methods research. A multidisciplinary Advisory Panel will add objectivity and balance to the content of the DD sessions. The results of this project will inform the work of research ethics policymakers, policy-implementers (such as IRBs), researchers in their recruitment of incapacitated subjects, and family members who may act as surrogates for research consent.