Proxy Decision Making for Alzheimer Disease Research

阿尔茨海默病研究的代理决策

• 批准号: 7209369
• 负责人: Laura B. Dunn
• 金额: $ 34.23万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-15 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7209369
• 关键词: Address; Adult; Affect; Age; Alzheimer' s Disease; Area; Attitude; Benefits and Risks; Caregiver Burden; Caregivers; Caring; Child; Clinical; Clinical Research; Complement; Consent; Data; Data Set; Decision Making; Disease; Education; Enrollment; Ethnic Origin; Feeling; Future; Gender; Gender Role; General Population; Generations; Impaired cognition; Individual; Informed Consent; Judgment; Laws; Legal; Literature; Measures; Mental Depression; Numbers; Participant; Patient Participation; Patients; Perception; Persons; Physician' s Role; Physicians; Policies; Process; Protocols documentation; Proxy; Public Health; Randomized; Relative (related person); Research; Research Ethics Committees; Research Personnel; Rest; Risk; Role; Severities; Severity of illness; Shapes; Staging; Standards of Weights and Measures; Stimulus; Work; base; cognitive function; decision research; design; experience; interest; member; neuropsychological; preference; programs; psychologic; response; willingness

DESCRIPTION (provided by applicant): Hopes for developing effective treatments for Alzheimer disease (AD) rest on clinical research, which will, by necessity, need to enroll AD patients, many of whom lack capacity to consent to research. AD researchers therefore must often rely on proxy consent alongside patient assent. The ethical integrity of AD research is thus highly dependent on proxy consent. Yet, very little is known about what factors influence proxies' decisions about enrolling their relatives, how proxies evaluate risks and benefits, and what factors influence their understanding of research protocols. This proposed work pertains to a focused, yet critical question: how do proxies make decisions about protocols of varying risk and benefit levels? Few empirical studies have used systematically varied, realistic protocols as stimuli to study proxy decision making. By carefully controlling the stimulus protocols and measuring a variety of potential influences on proxy decision making, we will provide important empirically grounded information regarding proxy consent. We will randomly assign 200 AD proxy decision makers to receive consent for one of four hypothetical AD pharmacologic research protocols, systematically varied by level of potential risk and potential for direct patient benefit. Aims include: (1) to determine influences on proxies' research decisions and perceptions of AD research, including perceived risks and benefits; and (2) to examine potential influences on the decision making abilities of the proxies themselves. In addition, we will evaluate several exploratory aims, including: examining an array of potential influences on proxies' willingness to enroll their relative and their perceptions of protocol risks and benefits, including the possible roles of caregiver burden and depression, patient illness severity, proxy/patient relationship, gender, and ethnicity; studying concordance between expert-defined levels of risk and benefit and proxies' perceptions; and exploring how proxies conceptualize the decision-making task as well as how proxies feel about serving as decision makers. Both scalar and open-ended questions will be used to generate a rich dataset focused on developing a nuanced contextual framework for understanding proxy decision making. This research has high public health and bioethical significance, as it will address issues that are fundamental to ethical enrollment of AD patients in vital clinical research, but for which little empirical data currently exist to guide research practice or policy.

描述（由申请人提供）：开发阿尔茨海默病（AD）有效治疗方法的希望取决于临床研究，这将需要招募AD患者，其中许多人缺乏同意研究的能力。因此，阿尔茨海默病研究人员必须经常依靠代理同意和患者同意。因此，AD研究的道德完整性高度依赖于代理同意。然而，对于哪些因素影响代理人关于招募其亲属的决定，代理人如何评估风险和收益，以及哪些因素影响他们对研究方案的理解，我们知之甚少。这项提议的工作涉及到一个重点突出而又关键的问题：代理如何对不同风险和收益水平的协议做出决策？很少有实证研究使用系统变化的、现实的协议作为刺激来研究代理决策。通过仔细控制刺激方案和测量代理决策的各种潜在影响，我们将提供关于代理同意的重要经验基础信息。我们将随机分配200名AD代理决策者接受四种假设的AD药理学研究方案之一的同意，这些方案根据潜在风险水平和直接患者获益的潜力进行系统地改变。目的包括：(1)确定代理人对AD研究决策和认知的影响，包括感知风险和获益；(2)考察对代理自身决策能力的潜在影响。此外，我们将评估几个探索性目标，包括：检查一系列对代理人登记其亲属意愿的潜在影响，以及他们对方案风险和益处的看法，包括照顾者负担和抑郁、患者疾病严重程度、代理人/患者关系、性别和种族的可能作用；研究专家定义的风险和收益水平与代理人感知之间的一致性；并探索代理如何概念化决策任务以及代理作为决策者的感受。标量问题和开放式问题都将用于生成一个丰富的数据集，重点是开发一个微妙的上下文框架，以理解代理决策。本研究具有很高的公共卫生和生物伦理学意义，因为它将解决在重要的临床研究中对AD患者的伦理招募至关重要的问题，但目前缺乏指导研究实践或政策的经验数据。