Ethics of Surrogate Consent for Dementia Research

描述(由申请人提供)：招募有决策能力丧失能力的成年人参加基于代理许可的痴呆症研究(基于代理的研究，或SBR)的做法越来越多，但没有广泛接受的政策指导方针，尽管存在数十年的争议。当研究带来重大风险，但几乎不能或根本不能为受试者带来直接利益时，政策就特别模糊。迫切需要更明确的政策，因为在创新的早期阿尔茨海默病研究中，严重的不良事件越来越多地发生。这个项目将解决我们对SBR政策认识上的一个重要差距：一个关键的非专业利益相关者群体(家庭代孕)和老年公众的观点，即代孕同意对于具有重大风险和很少或没有潜在好处的研究是否合适。该提案结合了两个互补项目，以最大限度地提高概括性和内部有效性。首先，对老年公众对SBR的看法进行的具有全国代表性的调查将产生关于这一问题的第一个可广泛推广的数据。它还将允许在几个领域(种族和民族背景、社会关系因素、志愿精神和公民意识等)检查个人对SBR的态度的关键相关因素。第二，将与痴呆症患者的家人和年长的公众人士举行一连串为期一天的协商民主咨询会议。发展与发展项目通过提供均衡的教育，促进参与者之间的讨论，并通过试验性的受控设计来衡量其效果，优化了内部效度。发展与发展项目的量化结果将通过对发展与发展会议进行彻底深入的定性分析而得到丰富，以进一步深入了解人们对SBR的态度。这项建议汇集了痴呆症研究、研究伦理、协商民主理论和实践、调查研究和混合方法研究方面的专家。多学科咨询小组将为发展司会议的内容增加客观性和平衡性。该项目的结果将为研究伦理政策制定者、政策实施者(如IRBs)、招募无行为能力受试者的研究人员以及可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.