DEMENTIA RESEARCH: INFORMED, PROXY, AND ADVANCE CONSENT

痴呆症研究：知情、代理和事先同意

• 批准号: 2545183
• 负责人: GREG A SACHS
• 金额: $ 27.95万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-30 至 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2545183
• 关键词: audiotape; behavioral /social science research tag; caregivers; clinical research; cognition; decision making; dementia; ethics; family structure /dynamics; health care professional practice; health related legal; health science research analysis /evaluation; human old age (65+); human subject; informed consent; interview; longitudinal human study; paralinguistic behavior; videotape /videodisc

DESCRIPTION (Adapted from the Investigator's Abstract): For the past 50 years, the doctrine of informed consent has been the cornerstone of the protection of human subjects involved in research. Yet, when one considers research on dementia, such as Alzheimer disease (AD), one is immediately confronted by the dilemma of an illness that gradually impairs the capacity of potential research subjects to give informed consent. The methods suggested by ethicists for successfully addressing this dilemma include: 1) obtaining information directly from people with dementia, informed consent if they retain decisional capacity, and at least assent and preferences and values in the absence of the capacity to give informed consent; 2) obtaining advance consent, using advance directives for research modeled after the living will and durable power of attorney for health care employed in clinical decision making; and 3) a richer notion of the family as the unit of decision making, especially considering the role that families play in the lives of people with dementia. The central aim of this project is to empirically study whether these proposed methods for facilitating ethical research on subjects with dementia are feasible and effective. By combining the perspectives of several disciplines, and by using research vignettes and analysis of videotaped consent encounters, this project will answer practical questions about: the ability of dementia subjects to participate in research decision making despite their impairments; the utility of a multidisciplinary approach to yield a deeper understanding of informed consent and proxy consent for dementia research; and the effectiveness of an advance consent process involving dementia subject and proxy together.

描述(改编自《调查者摘要》)：过去50年 多年来，知情同意原则一直是 保护参与研究的人类受试者。然而，当人们考虑到 对阿尔茨海默病(AD)等痴呆症的研究，一是立竿见影 面对逐渐削弱能力的疾病的两难境地 对潜在的研究对象给予知情同意。这些方法 伦理学家提出的成功解决这一困境的建议包括：1) 直接从痴呆症患者那里获取信息，知情同意 如果他们保持决策能力，至少同意和偏爱和 在没有能力给予知情同意的情况下的价值；2)获得 事先同意，使用仿照 生前遗嘱和医疗保健的持久授权书 临床决策；3)以家庭为单位的更丰富的观念 决策，尤其是考虑到家庭在 痴呆症患者的生活。这个项目的中心目标是 经验性地研究这些提出的促进道德的方法 对痴呆症患者的研究是可行和有效的。通过组合 几个学科的观点，并通过使用研究小插曲和 分析录像中的同意相遇，这个项目将回答 关于痴呆症受试者参与能力的实际问题 在研究决策中，尽管他们有损伤；一个 多学科方法，加深对知情人士的理解 痴呆症研究的同意和代理同意；以及 痴呆症受试者和代理人共同参与的高级同意程序。