DEMENTIA RESEARCH: INFORMED, PROXY, AND ADVANCE CONSENT

痴呆症研究：知情、代理和事先同意

• 批准号: 6335281
• 负责人: GREG A SACHS
• 金额: $ 5.3万
• 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 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6335281
• 关键词: Alzheimer's disease; audiotape; behavioral /social science research tag; caregivers; clinical research; cognition; decision making; dementia; ethics; family structure /dynamics; health related legal; health science research analysis /evaluation; human old age (65+); human subject; informed consent; interview; longitudinal human study; neuropsychology; paralinguistic behavior; videotape /videodisc

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.

在过去的50年里，知情同意的原则一直是 保护参与研究的人类受试者的基石。 然而，当一个人考虑对痴呆症的研究，如阿尔茨海默病， (AD)，人们立即面临着一种疾病的困境， 逐渐削弱潜在研究对象的能力， 知情同意。伦理学家建议的成功的方法 解决这一困境包括：1）直接从 痴呆症患者，如果他们保留决策， 能力，至少是同意，偏好和价值观， （2）获得事先同意， 使用预先指示进行模仿生前遗嘱的研究， 在临床决策中使用的医疗保健持久授权书 3）家庭作为决策单位的更丰富的概念 特别是考虑到家庭在生活中的作用， 老年痴呆症患者该项目的主要目的是 实证研究是否这些建议的方法，促进 对痴呆症患者进行伦理研究是可行和有效的。 通过结合几个学科的观点，并通过使用 研究插图和分析录像同意的遭遇，这 项目将回答有关的实际问题：痴呆症的能力 受试者参与研究决策，尽管他们 多学科方法的效用，以产生一个 更深入地了解痴呆症的知情同意和代理同意 研究;“以及事先同意程序的有效性， 痴呆症主体和代理人在一起

项目成果

Variable judgments of decisional capacity in cognitively impaired research subjects.

• DOI: 10.1111/j.1532-5415.2008.01922.x
• 发表时间: 2008-10
• 期刊: Journal of the American Geriatrics Society
• 影响因子: 6.3
• 作者: Stocking CB;Hougham GW;Danner DD;Patterson MB;Whitehouse PJ;Sachs GA
• 通讯作者: Sachs GA

Empirical research on informed consent with the cognitively impaired.

• DOI: 10.2307/3564119
• 发表时间: 2003-09-01
• 期刊: IRB
• 作者: Hougham, Gavin W;Sachs, Greg A;Wirshing, Donna
• 通讯作者: Wirshing, Donna

A longitudinal study of coping and burnout among Japanese family caregivers of frail elders.

• DOI: 10.1080/13607860802224318
• 发表时间: 2008-07
• 期刊: Aging & mental health
• 影响因子: 3.4
• 作者: Okabayashi H;Sugisawa H;Takanashi K;Nakatani Y;Sugihara Y;Hougham GW
• 通讯作者: Hougham GW