Consent Methods and Participation in Geriatric Clinical Research

描述（由申请人提供）：痴呆症是未来几十年最严重的公共卫生挑战之一。为了应对这些挑战，需要进行研究，而这些研究往往需要那些本身就患有痴呆症的受试者的参与。但是道德规范限制了那些不能同意成为研究对象的痴呆患者的参与。研究提前规划（RAP）可以提供一种平衡竞争需求的方法，以促进知识和保护这些脆弱的受试者。RAP指的是一个人——在失去做出入学决定的能力之前——表达他们愿意参加或不愿意参加涉及非称职受试者的研究。但是，尽管RAP可能很有价值，我们却很少知道它被设计用来保护的人是如何看待它的。这个项目的目的是了解老年人对RAP的态度。我们关注的是具有伦理挑战性的研究：不能给受试者带来直接医疗效益的研究。使用定量和定性技术，我们将检查老年人是否愿意指定代理人进行研究决策，提供事先同意，以及他们是否愿意允许代理人自由或余地推翻他们的事先决定-换句话说，选择与他们的研究事先指示相反的决定。为了确保我们的结果具有普遍性，我们将研究具有广泛社会、人口和态度特征的老年人。这项研究的结果将有助于国家、州和机构审查委员会的政策更好地反映受试者的观点；更好地界定研究代理人替代判断的适当内容和特异性；并确定解释RAP和代理决策观点差异的人口统计学、态度和行为特征。这些结果将有助于研究人员和代理人进行以受试者为中心的知情同意讨论。

DESCRIPTION (provided by applicant): Dementia is one of the most serious public health challenges of the coming decades. To respond to these challenges, research is needed that often requires the participation of subjects who are themselves demented. But ethical norms limit the participation of demented persons who are not able to consent to become a research subject. Research advance planning (RAP) may provide a way to balance the competing needs to advance knowledge and protect these vulnerable subjects. RAP means that a person -- prior to the loss of their capacity to make an enrollment decision - expresses their willingness to participate or not to participate in research that involves noncompetent subjects. But as valuable as RAP may be, we know very little about how the people for whom it is designed to protect view it. The goal of this project is to understand elderly persons' attitudes about RAP. We are focusing on ethically challenging research: research that does not offer the prospect of direct medical benefit to the subject. Using both quantitative and qualitative techniques, we will examine the willingness of elderly persons to designate a proxy for research decision making, to provide an advance consent, and their willingness to allow their proxy freedom, or leeway, to overturn their advance decision-in other words, to choose the opposite of their research advance directive. To assure the generalizability of our results, we will study elderly persons with a broad range of social, demographic and attitudinal characteristics. The results of this research will help national, state and institutional review board policies better reflect the views of the subjects; better define what is the appropriate content and specificity of a research proxy's substituted judgment; and identify demographic, attitudinal, and behavioral characteristics that explain differences in views about RAP and proxy decision making. These results will assist researchers and proxies in conducting subject-centered informed consent discussions.