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Informed Consent in Private Sector Mental Health Research

私营部门心理健康研究中的知情同意

基本信息

批准号：
6803563
负责人：
JILL A FISHER
金额：
$ 4.12万
依托单位：
RENSSELAER POLYTECHNIC INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2003
资助国家：
美国
起止时间：
2003-09-17 至 2005-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6803563
关键词：
anxiety behavioral /social science research tag clinical research decision making depression ethics health science research human subject informed consent interview medical outreach /case finding persuasion predoctoral investigator questionnaires sleep disorders volunteer

项目摘要

DESCRIPTION: (provided by applicant) The project investigates medical research in the private sector to document how human subject volunteers obtain and understand information before enrolling in medical research and what factors influence their decisions to participate (or not participate) in research protocols. Specifically, this project will answer the following question: What are the effects of private sector recruitment, inducement, and consent practices on human subject volunteers' understanding of and decision-making about participation in medical research? Nested within this research question, this project will also query how do inducements for investigators' and research staff influence these research practices? The research mobilizes both qualitative and quantitative methods to collect and analyze data on research protocol for anxiety, depression, and insomnia. Observational studies and semi-structured interviewing will be carried out over 6 months in a core site in a national full-service contract research organization. The quantitative surveys, collected over 12 months, will provide additional breadth to the study by increasing the number of individuals in the analysis and the number of research protocols in which respondents are involved. The surveys will enable a generalization of the findings to guide future research on the effects of and ethics of the privatization of medical research on informed consent. Additionally, the results will begin to provide a basis for valid recommendations to address the ethical challenges raised by the privatization of medical research.

产品说明：（由申请人提供）该项目调查私营部门的医学研究，以记录人类受试者志愿者在参加医学研究之前如何获得和理解信息，以及哪些因素影响他们参与（或不参与）研究方案的决定。具体而言，本项目将回答以下问题：私营部门的招募，诱导和同意的做法对人类受试者志愿者的理解和参与医学研究的决策有什么影响？嵌套在这个研究问题，这个项目也将询问如何诱因的研究人员和研究人员影响这些研究实践？本研究采用定性与定量相结合的方法，收集并分析了焦虑、抑郁和失眠的研究方案数据。观察性研究和半结构化访谈将在一个国家全方位服务合同研究组织的一个核心地点进行6个月以上。在12个月内收集的定量调查将增加分析中的个人数量和答卷人参与的研究方案数量，从而扩大研究的广度。这些调查将有助于归纳调查结果，以指导今后关于知情同意医学研究私有化的影响和道德问题的研究。此外，研究结果将开始为有效的建议提供基础，以解决医学研究私有化带来的伦理挑战。