Assent and Dissent for Dementia Research

对痴呆症研究的同意和反对

基本信息

批准号：
7502165
负责人：
Betty E Black
金额：
$ 17.68万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-30 至 2010-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7502165
关键词：
Address Adult Aggressive behavior Agitation Agreement Antipsychotic Agents Authorization documentation Benefits and Risks Binding Caring Condition Consensus Consent Data Decision Making Dementia Development Dissent Double-Blind Method Effectiveness Elements Empirical Research Enrollment Eye Face Focus Groups Foundations Future Guidelines High Prevalence Husband Individual Informed Consent Interview Judgment Legal Measurement Measures Methods Nursing Homes Participant Persons Pharmaceutical Preparations Phenotype Population Protocols documentation Proxy Psychotic Disorders Purpose Qualitative Methods Qualitative Research Randomized Controlled Trials Recreation Reporting Research Research Ethics Research Methodology Research Personnel Research Project Grants Risk Social Welfare Societies Staging Standards of Weights and Measures Syndrome Testing Withdrawal Work base design end of life care experience instrument interest method development neuropsychiatry preference response theories tool ward

项目摘要

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.

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（例如患有痴呆症的人）参与时，研究人员在获得潜在参与者的代理同意和同意方面面临着伦理、法律和实际挑战。虽然尊重人的原则要求决策能力受损的人有机会在力所能及的范围内选择是否参与研究，但对于评估同意和反对研究的标准缺乏共识，也没有研究报告评估这些能力的标准的有效性或可靠性。这项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反对的标准，以及（2）根据这些标准，生成一组项目，这些项目将形成评估该人群同意和反对意见的工具的基础。这项研究将重点评估痴呆症患者的同意和反对意见，因为痴呆症的患病率很高、对社会的影响以及针对处于该综合症各个阶段的人的大量研究工作。本研究将采用定性研究方法，包括与痴呆症、痴呆症研究和研究伦理方面的专家和其他关键知情人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。由于对成年人同意和反对的实证研究很少，这些方法提供了理论发展和测试所依据的数据。量表开发方法将用于生成评估工具的一组项目，即同意和反对评估工具 (ADAT)。与会专家和其他关键知情人将对这些项目的内容和表面有效性进行审查和判断。这项工作是未来研究的基础，这些研究将试点测试和最终确定 ADAT，并确定其可靠性和标准相关的有效性。准确评估对痴呆症研究的同意和反对的方法将提高保护潜在研究参与者的利益并支持关键研究的道德行为的能力。项目叙述这项研究将重点确定评估对痴呆症患者研究同意和反对的标准，因为痴呆症患病率高、对社会的影响以及针对痴呆症的大量研究工作。根据确定的标准，它将生成一组测量项目，这些项目将构成评估对该人群研究的同意和反对的工具的基础。准确评估对痴呆症研究的同意和反对的方法将提高我们保护潜在研究参与者的利益并支持关键研究的道德行为的能力。