Informed Consent in Private Sector Mental Health Research

私营部门心理健康研究中的知情同意

• 批准号: 6742231
• 负责人: JILL A FISHER
• 金额: $ 4.13万
• 依托单位: RENSSELAER POLYTECHNIC INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-17 至 2006-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6742231
• 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

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.

描述：（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取和理解信息，以及哪些因素影响他们参与（或不参与）研究方案的决定。具体来说，该项目将回答以下问题：私营部门的招募、诱导和同意做法对人类受试者志愿者对参与医学研究的理解和决策有何影响？嵌套在这个研究问题中，该项目还将询问研究者和研究人员的诱因如何影响这些研究实践？该研究采用定性和定量方法来收集和分析焦虑、抑郁和失眠研究方案的数据。观察性研究和半结构化访谈将在国家全方位服务合同研究组织的核心站点进行 6 个月以上。这些定量调查在 12 个月内收集，将通过增加分析中的个体数量以及受访者参与的研究方案数量来扩大研究的广度。这些调查将使研究结果得到概括，以指导未来关于医学研究私有化对知情同意的影响和伦理的研究。此外，研究结果将开始为有效建议提供基础，以解决医学研究私有化带来的伦理挑战。