Abstract：
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.
摘要：
机构审查委员会（IRB）对当地情况进行审查的性质含糊不清。对多中心试验进行单一IRB审查的要求需要更好地理解当地背景审查的解释和实施，以及如何最好地集中实施此类审查。我们通过探索利益相关者的态度和看法，寻求对IRB本地背景审查的务实理解。与26名IRB成员和工作人员进行了半结构化访谈，机构官员，研究人员与80项类似利益相关者的调查进行了整合，并通过基于主题的定性文本分析和描述性统计分析进行了分析。利益相关者描述了他们认为是当地的情况，地方背景审查的价值，以及用于实施对一般当地情况的审查以及除知情同意外进行的紧急情况研究的关键过程。与会者表达了集中审查当地情况的关切和潜在优势。视角的变化表明，本地背景审查不是一个离散的过程，这为定义单一IRB审查的途径提供了机会。
