Ethics of Surrogate Consent for Dementia Research

描述（由申请人提供）：尽管存在数十年的争议，但越来越多地采用基于代理人许可的痴呆症研究（基于代理人的研究，或SBR）招募决策能力丧失的成年人，但没有广泛接受的政策指导方针。当研究构成重大风险，但对受试者的直接利益几乎没有或没有前景时，政策尤其模糊。对更明确的政策的需求是迫切的，因为严重的不良事件越来越多地发生在创新的早期阿尔茨海默病研究中。该项目将解决我们关于SBR政策的知识中的一个重要空白：一个关键的利益相关者群体（家庭代理人）和老年公众的观点，关于代理同意对具有重大风险和很少或没有潜在利益的研究的适当性。这一建议结合了两个互补的项目，以最大限度地提高普遍性和内部有效性。首先，一个全国性的代表性调查的老年公众对SBR的意见将产生第一个广泛的概括性数据在这个问题上。它还将允许在几个领域（种族和民族背景，社会关系因素，志愿服务和公民意识等）的个人对SBR的态度的关键相关因素的检查。第二，将与痴呆症患者的家人和老年公众举行一系列为期一天的协商民主（DD）协商会议。DD项目通过提供均衡的教育和促进参与者之间的讨论，并通过实验性的控制设计来衡量其效果，从而优化了内部效度。通过对发展与合作会议进行全面深入的定性分析，将丰富发展与合作项目的定量结果，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，协商民主理论和实践，调查研究和混合方法研究的专家。一个多学科咨询小组将使荒漠化与发展会议的内容更加客观和平衡。该项目的结果将为研究伦理政策制定者、政策实施者（例如IRB）、招募无行为能力受试者的研究人员以及可能充当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.