Informed Consent in Private Sector Mental Health 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，以及影响他们决定参加（或不参加）研究方案的因素。具体来说，这个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什么影响？嵌套在这个研究问题中，这个项目还将询问调查人员和研究人员的诱因如何影响这些研究实践？本研究采用定性和定量相结合的方法，收集和分析焦虑、抑郁、失眠研究方案的数据。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核心站点进行6个月。在12个月内收集的定量调查将通过增加参与分析的个人数量和受访者参与的研究方案数量，为研究提供更多的广度。这些调查将有助于对调查结果进行概括，以指导今后关于医学研究私有化对知情同意的影响和伦理问题的研究。此外，研究结果将开始为提出有效建议提供基础，以解决医学研究私有化带来的伦理挑战。

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.