Capacity to Appoint a Proxy for Research Consent

描述（由申请人提供）：阿尔茨海默病（AD）研究可能是最常见的研究类型，招募无行为能力的成年人。与这些参与者的研究仍然是研究伦理政策的一个未解决的领域。这一领域的经验和概念工作的一个缺点是忽视了进行性神经退行性疾病患者的实际力量。本项目探讨了不能提供独立知情同意参加研究的AD患者是否仍然保留其他重要的伦理相关能力。具体来说，假设很大比例的阿尔茨海默病患者无法独立同意研究，但他们可能仍然有能力指定研究决策的代理人。该项目将采用一种行之有效的研究知情同意能力衡量标准和一种评估指定研究代理相关能力的新工具，从密歇根大学和宾夕法尼亚大学的诊所招募180名阿尔茨海默病患者。由于给予知情同意的能力是特定于特定协议的，因此将使用两种不同风险-效益概况的协议来评估知情同意的能力。因此，该项目将包括对研究风险-收益概况对能力确定的影响的创新评估。受试者的分类能力状态（知情同意和指定代理人）将由5名专家评审团确定，他们将独立审查接受半结构化能力访谈的受试者的视频。该项目将通过评估受试者是否有能力指定研究同意的代理人，即使他们已经发展出严重的认知缺陷，损害了他们独立同意的能力，来回答AD研究中的受试者在被要求参与研究时是否能够提供更多的同意或缺乏异议。

DESCRIPTION (provided by applicant): Alzheimer's disease (AD) research is probably the most common type of research that enrolls incapacitated adults. Research with such participants continues to be an unsettled area of research ethics policy. One shortcoming of empirical and conceptual work in this area has been the neglect of the actual strengths of persons with progressive neurodegenerative disorders. This project examines whether persons with AD who are incapable of providing independent informed consent to enroll in research still retain other important ethically relevant abilities. Specifically, it is hypothesized that a significant proportion of persons with AD who are incapable of independent consent to research may still retain the capacity to appoint a proxy for research decision-making. Using a well-validated measure of capacity for informed consent to research and a novel instrument for assessing abilities relevant to appointing a research proxy, the project will interview 180 persons with Alzheimer's disease, recruited from clinics at the University of Michigan and the University of Pennsylvania. Since the capacity to give informed consent is specific to particular protocols, two protocols of varying risk-benefit profiles will be used to assess the capacity for informed consent. Thus, this project will include an innovative assessment of the effect of research risk-benefit profiles on capacity determinations. The subjects' categorical capacity status (for informed consent and for appointing a proxy) will be determined by a 5 expert judge panel who will each independently review videos of subjects undergoing semi-structured capacity interviews. This project will answer whether subjects in AD research can provide more than assent or lack of dissent when asked to participate in research by assessing whether they can capably appoint proxies for research consent, even after they have developed significant cognitive deficits that impair their capacity for independent consent.