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，这些研究往往需要本身患有痴呆症的受试者的参与。但是，道德规范限制了无法同意成为研究对象的痴呆症患者的参与。研究预先规划（RAP）可以提供一种方法来平衡竞争的需要，以促进知识和保护这些脆弱的科目。RAP是指一个人-在他们失去能力作出入组决定之前-表示他们愿意参加或不参加涉及无能力受试者的研究。但是，尽管RAP可能很有价值，但我们对它所保护的人是如何看待它的却知之甚少。我们专注于伦理上具有挑战性的研究：不为受试者提供直接医疗益处的前景的研究。使用定量和定性的技术，我们将研究老年人的意愿，以指定一个代理人的研究决策，提供一个提前同意，并愿意让他们的代理自由，或回旋余地，推翻他们的提前决定，换句话说，选择相反的他们的研究提前指令。为了确保我们的研究结果的普遍性，我们将研究具有广泛的社会，人口和态度特征的老年人。本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了受试者的意见，更好地定义什么是适当的内容和特殊性的研究代理的替代判断，并确定人口统计，态度和行为特征，解释有关RAP和代理决策的观点差异。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.