IRBs and Ethical Issues in Psychiatric Research

描述：（由申请人提供）一些承诺关于心理健康和精神疾病的重要知识的研究也引起了困难的人类参与者的关注。拟议的研究将(a)对获得联邦保证的500个IRB进行初步“筛选”调查，并根据其IRB主席的性别和种族及其总审查量对其进行筛选，以及(b)向175个IRB主席的子样本（由有色人种IRB主席和女性IRB主席组成的样本）提供案例场景并对其进行访谈。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，例如药物戒断研究和对决策能力有问题的人进行的研究。基于深度定性和半结构化访谈，本工作将(a)描述审查委员会主席认为在这些场景中重要的人类参与者关注的问题，(b)描述审查委员会主席为解决这些人类参与者关注的问题而提出的建议(c)描述审查委员会主席如何向对审查委员会审查持怀疑态度的研究人员传达他们的关注和协议修改。(d)根据我们对筛选者的调查，生成有关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主席可以确定需要进一步讨论的人类参与者关注的问题，建议其他IRB可能采用的最佳实践，对文献中建议的策略提供反馈，并建议如何克服研究人员对IRB审查的怀疑。

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.