IRBs and Ethical Issues in Psychiatric Research

产品说明：（由申请人提供）一些研究承诺关于心理健康和精神疾病的重要知识，也引起了困难的人类参与者的关注。拟议研究将（a）对500个具有联邦Asynchronous的IRB进行初始“筛选者”调查，并对其IRB主席的性别和种族以及其总审查量进行筛选，以及（B）向175名IRB主席的子样本提供病例情景并进行访谈，该子样本由有色人种和女性主席的过度样本组成。我们将研究IRB主席如何应对描述研究伦理中有争议问题的情景，例如停药研究和对决策能力有问题的人的研究。基于定性深入访谈和半结构化访谈，这项工作将（a）描述IRB主席认为在这些情况下重要的人类参与者问题，（B）描述IRB主席为解决这些人类参与者问题而提出的建议，（c）描述IRB主席如何向对IRB审查持怀疑态度的研究者传达其问题和方案修改，以及（d）根据我们的筛选者调查，生成IRB工作量和IRB主席人口统计数据的最新统计数据。该项目意义重大，因为IRB主席可以识别需要进一步讨论的人类参与者问题，建议其他IRB可能采用的最佳实践，提供文献中建议的策略反馈，并建议如何克服研究人员对IRB审查的怀疑态度。

DESCRIPTION: (provided by applicant) Some research that promises important knowledge about mental health and psychiatric illness also raises difficult human participants concerns. The proposed study will (a) conduct an initial "screener" survey of 500 IRBs with Federal Assurances, and screen these on gender and ethnicity of their IRB Chairs, and on their total review volume, and (b) present case scenarios to and interview a subsample of 175 IRB Chairs composed of an oversample of IRB Chairs of color and female chairs. We will study how IRB Chairs would respond to scenarios that depict controversial issues in research ethics, such as drug withdrawal studies and research on persons with questionable decision-making capacity. Based on qualitative in depth and semi structured interviews, this work will (a) characterize the human participant concerns that IRB Chairs consider significant in these scenarios, (b) characterize the suggestions IRB Chairs make to address these human participant concerns (c) characterize how IRB Chairs would communicate their concerns and protocol modifications to investigators who are skeptical of IRB review, and (d) produce updated statistics on IRB work volume and IRB Chair demographics based on our screener survey. This project is significant because IRB Chairs may identify human participants concerns that need further discussion, suggest best practices that other IRBs might adopt, provide feedback on strategies suggested in the literature, and suggest how to overcome the skepticism of researchers regarding IRB review.