Assent and Dissent for Dementia Research

描述（由申请人提供）：获得知情同意是进行伦理研究的基本要素。当一项研究需要缺乏提供知情同意能力的成年人（例如痴呆症患者）参与时，研究人员面临着获得潜在参与者的代理同意和同意的道德、法律和实践挑战。虽然尊重个人的原则要求给予那些决策能力下降的人在他们有能力的情况下选择是否参与研究的机会，但对评估研究同意和反对的标准缺乏共识，而且没有研究报告评估这些能力的标准的有效性或可靠性。本研究有两个具体目标：(1)确定评估缺乏知情同意能力的成年人对研究的同意和异议的标准，(2)基于这些标准，生成一组项目，这些项目将构成评估该人群中同意和异议的工具的基础。由于痴呆症的高患病率、对社会的影响以及针对该综合征各个阶段患者的密集研究，本研究将重点评估痴呆症患者的同意和反对意见。本研究将采用定性研究方法，包括与专家和其他关于痴呆症、痴呆症研究和研究伦理的关键信息提供者进行访谈和焦点小组讨论，以确定对研究的同意和反对意见，并确定评估该人群中同意和反对意见的标准。这些标准将成为衡量提供同意所需的决策能力以及如何在道德上尊重异议的标准。由于对成年人的同意和异议的实证研究很少，这些方法提供了理论发展和测试可以基于的数据。量表开发方法将用于生成一套评估工具的项目，即同意和异议评估工具（ADAT）。与会专家和其他关键举报人将对这些项目的内容和外观有效性进行审查和判断。这项工作为未来的研究奠定了基础，这些研究将对ADAT进行试点测试和最终确定，并确定其信度和标准相关的效度。准确评估痴呆研究的同意和反对意见的方法将提高保护潜在研究参与者利益的能力，并支持批判性研究的道德行为。

DESCRIPTION (provided by applicant): Obtaining informed consent is a fundamental element of conducting ethical research. When a study requires the participation of adults who lack capacity to provide informed consent, such as persons who have dementia, investigators are faced with the ethical, legal and practical challenges of obtaining proxy consent and assent from potential participants. While the principle of respect for persons requires that those with diminished decisional capacity be given the opportunity to choose, to the extent they are able, whether to participate in research, consensus on the standards for assessing assent and dissent for research is lacking and no studies report the validity or reliability of standards to assess these abilities. This study has two specific aims: (1) identify the standards by which assent and dissent for research should be assessed in adults who lack capacity to give informed consent, and (2) based on those standards, generate a set of items that will form the basis of an instrument to assess assent and dissent in this population. This study will focus on assessing assent and dissent in persons who have dementia because of its high prevalence, its impact on society and the intense research effort directed toward persons at all stages of the syndrome. This study will use qualitative research methods, including interviews and focus group discussions with experts and other key informants on dementia, dementia research and research ethics, to define assent and dissent for research and identify standards for assessing assent and dissent in this population. These standards will be the criteria for measuring the decision making abilities needed to provide assent and for how to ethically respect dissent. Since empirical research on assent and dissent in adults is scarce, these methods provide data on which theory development and testing can be based. Scale development methods will be used to generate a set of items for an assessment instrument, the Assent and Dissent Assessment Tool (ADAT). The participating experts and other key informants will review and judge these items for content and face validity. This work serves as the foundation for future studies that will pilot test and finalize the ADAT and determine its reliability and criterion-related validity. Methods for accurately assessing assent and dissent for dementia research will increase the ability to protect the interests of potential study participants and support the ethical conduct of critical research. Project Narrative This study will focus on identifying standards for assessing assent and dissent for research in those who have dementia because of its high prevalence, its impact on society and the intense research effort directed toward it. Based on the standards identified, it will generate a set of measurement items that will form the basis for an instrument to assess assent and dissent for research in this population. Methods for accurately assessing assent and dissent for dementia research will increase our ability to protect the interests of potential study participants and support the ethical conduct of critical research.