Proxy Decision Making for Alzheimer Disease Research

描述（由申请人提供）：开发有效治疗阿尔茨海默病（AD）的希望取决于临床研究，这将必然需要招募AD患者，其中许多人缺乏同意研究的能力。因此，AD研究人员必须经常依赖代理同意以及患者同意。因此，AD研究的道德完整性高度依赖于代理同意。然而，很少有人知道是什么因素影响代理人关于招募亲属的决定，代理人如何评估风险和收益，以及什么因素影响他们对研究方案的理解。这项拟议的工作涉及到一个重点，但关键的问题：代理如何作出决定的协议，不同的风险和利益水平？很少有实证研究系统地使用不同的，现实的协议作为刺激来研究代理决策。通过仔细控制刺激协议和测量各种潜在的影响，代理决策，我们将提供重要的经验为基础的信息，代理同意。我们将随机分配200名AD代理决策者，以获得四种假设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可能性而系统性变化。目标包括：（1）确定对代理人的研究决策和对AD研究的看法的影响，包括感知的风险和收益;（2）检查对代理人本身的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：检查一系列潜在的影响代理人的意愿，招募他们的亲属和他们的看法协议的风险和利益，包括可能的作用，照顾者的负担和抑郁症，病人的疾病严重程度，代理人/病人的关系，性别和种族;研究专家定义的风险和利益水平和代理人的看法之间的一致性;并探讨代理人如何概念化的决策任务，以及代理人如何感受作为决策者。标量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。这项研究具有很高的公共卫生和生物伦理学意义，因为它将解决的问题是至关重要的临床研究中的AD患者的伦理登记，但目前很少有经验数据来指导研究实践或政策。

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.