Assistant professor in the Department of Family Medicine at the University of Michigan.
Assistant professor in the Department of Emergency Medicine at the University of Michigan.
Ethics Hum Res. 2024 Jan-Feb;46(1):2-13. doi: 10.1002/eahr.500195.
The nature of the review of local context by institutional review boards (IRBs) is vague. Requirements for single IRB review of multicenter trials create a need to better understand interpretation and implementation of local-context review and how to best implement such reviews centrally. We sought a pragmatic understanding of IRB local-context review by exploring stakeholders' attitudes and perceptions. Semistructured interviews with 26 IRB members and staff members, institutional officials, and investigators were integrated with 80 surveys of similar stakeholders and analyzed with qualitative theme-based text analysis and descriptive statistical analysis. Stakeholders described what they considered to be local context, the value of local-context review, and key processes used to implement review of local context in general and for emergency research conducted with an exception from informed consent. Concerns and potential advantages of centralized review of local context were expressed. Variability in perspectives suggests that local-context review is not a discrete process, which presents opportunities for defining pathways for single IRB review.
审查机构审查当地情况的性质较为模糊。对于多中心试验的单一审查机构审查的要求，需要更好地理解对当地情况审查的解释和执行，以及如何最好地集中执行此类审查。我们通过探讨利益相关者的态度和看法，寻求对审查机构当地情况审查的务实理解。对 26 名审查机构成员和工作人员、机构官员和调查人员进行半结构化访谈，并对 80 名类似利益相关者进行调查，采用基于定性主题的文本分析和描述性统计分析进行分析。利益相关者描述了他们认为的当地情况、当地情况审查的价值，以及一般情况下和在知情同意豁免的情况下进行紧急研究时实施当地情况审查的关键流程。还表达了对集中审查当地情况的关注和潜在优势。观点的差异表明，当地情况审查不是一个离散的过程，这为定义单一审查机构审查的途径提供了机会。
