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:
  • 金额:
    $ 17.68万
  • 依托单位:
  • 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

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参与时,如痴呆症患者,调查人员面临着从潜在参与者那里获得代理同意和同意的伦理、法律和实践挑战。虽然尊重人的原则要求给予决策能力减弱的人机会,在他们可能的范围内选择是否参与研究,但就评估对研究的同意和异议的标准缺乏共识,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的:(1)确定在缺乏知情同意能力的成年人中评估同意和反对研究的标准,以及(2)根据这些标准,产生一套项目,作为评估这一人群中同意和反对的工具的基础。这项研究将重点评估痴呆症患者的同意和反对意见,因为痴呆症的高患病率,它对社会的影响,以及针对综合症所有阶段的人的密集研究努力。这项研究将使用定性研究方法,包括与痴呆症、痴呆症研究和研究伦理的专家和其他关键信息者的访谈和焦点小组讨论,以确定研究的同意和不同意,并确定在这一人群中评估同意和不同意的标准。这些标准将成为衡量获得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不同意的实证研究很少,这些方法提供了理论发展和检验的数据。将使用量表开发方法来为评估工具--同意和异议评估工具(ADAT)生成一套项目。与会专家和其他关键信息提供者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,并确定其可靠性和标准相关效度。准确评估对痴呆症研究的赞成和反对的方法将提高保护潜在研究参与者的利益和支持关键研究的伦理行为的能力。 项目叙事 这项研究将集中于确定评估对痴呆症患者进行研究的同意和反对的标准,因为痴呆症的高患病率、对社会的影响以及针对它的密集研究努力。根据确定的标准,它将产生一套测量项目,这些项目将成为评估对这一人群进行研究的赞成和反对意见的工具的基础。准确评估对痴呆症研究的赞成和反对的方法将提高我们保护潜在研究参与者的利益和支持关键研究的伦理行为的能力。

项目成果

期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

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Betty E Black其他文献

Betty E Black的其他文献

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{{ truncateString('Betty E Black', 18)}}的其他基金

Ethical issues in Dementia Research involving Surrogates and Study Partners
涉及代孕者和研究合作伙伴的痴呆症研究中的伦理问题
  • 批准号:
    8721297
  • 财政年份:
    2011
  • 资助金额:
    $ 17.68万
  • 项目类别:
Ethical issues in Dementia Research involving Surrogates and Study Partners
涉及代孕者和研究合作伙伴的痴呆症研究中的伦理问题
  • 批准号:
    8184211
  • 财政年份:
    2011
  • 资助金额:
    $ 17.68万
  • 项目类别:
Ethical issues in Dementia Research involving Surrogates and Study Partners
涉及代孕者和研究合作伙伴的痴呆症研究中的伦理问题
  • 批准号:
    8520143
  • 财政年份:
    2011
  • 资助金额:
    $ 17.68万
  • 项目类别:
Ethical issues in Dementia Research involving Surrogates and Study Partners
涉及代孕者和研究合作伙伴的痴呆症研究中的伦理问题
  • 批准号:
    8331463
  • 财政年份:
    2011
  • 资助金额:
    $ 17.68万
  • 项目类别:
Assent and Dissent for Dementia Research
对痴呆症研究的同意和反对
  • 批准号:
    7384772
  • 财政年份:
    2007
  • 资助金额:
    $ 17.68万
  • 项目类别:
Ethical Aspects of Dementia Research
痴呆症研究的伦理问题
  • 批准号:
    6435591
  • 财政年份:
    2002
  • 资助金额:
    $ 17.68万
  • 项目类别:
Ethical Aspects of Dementia Research
痴呆症研究的伦理问题
  • 批准号:
    6874369
  • 财政年份:
    2002
  • 资助金额:
    $ 17.68万
  • 项目类别:
Ethical Aspects of Dementia Research
痴呆症研究的伦理问题
  • 批准号:
    6735642
  • 财政年份:
    2002
  • 资助金额:
    $ 17.68万
  • 项目类别:
Ethical Aspects of Dementia Research
痴呆症研究的伦理问题
  • 批准号:
    6621661
  • 财政年份:
    2002
  • 资助金额:
    $ 17.68万
  • 项目类别:

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