Capacity to Appoint a Proxy for Research Consent

指定研究同意代理人的能力

• 批准号: 7275290
• 负责人: Scott Y Kim
• 金额: $ 26.67万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7275290
• 关键词: Accounting; Adult; Affect; Alzheimer' s Disease; Anti-Inflammatory Agents; Anti-inflammatory; Area; Authorization documentation; Benefits and Risks; Clinic; Clinical; Clinical Research; Clinical Trials; Cognitive; Cognitive deficits; Competence; Consent; Data; Decision Making; Dementia; Disease; Dissent; Doctor of Philosophy; Elderly woman; Enrollment; Evaluation; Exhibits; Goals; Gray unit of radiation dose; Hand; Home environment; Human; Impaired cognition; Individual; Informed Consent; Intervention; Interview; Judgment; Learning; Life; Measures; Michigan; Neurodegenerative Disorders; Neuropsychology; Participant; Patients; Pennsylvania; Performance; Persons; Pharmaceutical Preparations; Policies; Principal Investigator; Protocols documentation; Proxy; Psyche structure; Randomized Clinical Trials; Range; Recruitment Activity; Research; Research Ethics; Research Personnel; Risk; Screening procedure; Severities; Structure; Testing; Thinking; Time; Universities; Voice; Work; base; cognitive function; design; experience; innovation; instrument; interest; neglect; neuropsychological; novel; programs; research study

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.

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。在这一领域的经验和概念性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优势。本项目旨在研究AD患者是否仍保留其他重要的伦理相关能力，这些患者无法提供独立的知情同意书以参加研究。具体而言，据推测，一个显着比例的人与AD谁是无法独立同意的研究可能仍然保留的能力，任命一个代理人的研究决策。该项目将使用一种经过充分验证的对研究知情同意能力的衡量标准和一种评估与任命研究代理人有关的能力的新工具，采访180名阿尔茨海默病患者，这些患者是从密歇根大学和宾夕法尼亚大学的诊所招募的。由于给予知情同意的能力是特定方案所特有的，因此将使用两种具有不同风险-收益特征的方案来评估知情同意的能力。因此，该项目将包括对研究风险-效益概况对能力确定的影响进行创新性评估。受试者的分类能力状态（知情同意和指定代理人）将由5名专家评审小组确定，他们将分别独立审查接受半结构化能力访谈的受试者的视频。该项目将回答AD研究中的受试者是否可以提供更多的同意或缺乏异议时，被要求参与研究，通过评估他们是否能够指定代理人的研究同意，即使他们已经发展了显着的认知缺陷，损害了他们的独立同意的能力。