Assent and Dissent for Dementia Research

对痴呆症研究的同意和反对

• 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
• 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

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参与时，如痴呆症患者，研究者面临着获得潜在参与者的代理同意和同意的伦理、法律的和实际挑战。虽然尊重人的原则要求给予决策能力受损者机会，让他们尽可能选择是否参加研究，但在评估同意和不同意研究的标准上缺乏共识，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同意和不同意研究的标准，以及（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同意和不同意的工具的基础。这项研究将侧重于评估同意和异议的人谁有痴呆症，因为它的高患病率，其对社会的影响和密集的研究工作针对人在综合征的各个阶段。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，以定义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依据的数据。量表开发方法将用于为评估工具（同意和不同意评估工具（ADAT））生成一组项目。参与的专家和其他关键信息提供者将审查和判断这些项目的内容和表面有效性。这项工作作为未来研究的基础，将试点测试和最终确定的ADAT，并确定其可靠性和标准相关的有效性。准确评估痴呆症研究的同意和异议的方法将提高保护潜在研究参与者利益的能力，并支持关键研究的道德行为。 项目叙述 由于痴呆症的高患病率、对社会的影响以及针对痴呆症的密集研究工作，本研究将重点确定用于评估痴呆症患者同意和反对研究的标准，并根据确定的标准生成一组测量项目，这些项目将构成评估痴呆症患者同意和反对研究的工具的基础。准确评估痴呆症研究的同意和异议的方法将提高我们保护潜在研究参与者利益的能力，并支持关键研究的道德行为。