Abstract：
A leading concern about single IRB (sIRB) review for multisite studies, as is now required by federal policies, is whether and how sIRBs consider local context in their review. While several types of local context considerations have been proposed, there is no shared agreement among those charged with the ethics oversight of human subjects research as to the goals and content of local context review, nor the types of research studies for which sIRB review might be inappropriate. Through a scoping review of published scholarship, public comments, and federal guidance documents, we identified five assumed goals for local context review: protecting the rights and welfare of local participants; ensuring compliance with applicable laws and policies; assessing feasibility; promoting the quality of research; and promoting procedural justice. While a variety of content was proposed to be relevant, it was largely grouped into four domains: population/participant-level characteristics; investigator and research team characteristics; institution-level characteristics; and state and local laws. Proposed characteristics for exclusion from sIRB requirements reflected both protection- and efficiency-based concerns. These findings can inform ongoing efforts to assess the implications of policies mandating sIRB review, and when exceptions to those policies might be appropriate.
摘要：
对多中心研究的单一IRB(sIRB)审查的主要关注，正如现在联邦政策所要求的那样，sIRB在审查中是否以及如何考虑当地情况。虽然已经提出了几种类型的本地背景考虑因素，对于地方背景审查的目标和内容，负责对人类受试者研究进行伦理监督的人之间没有共同的协议，sIRB审查可能不合适的研究类型。通过对已发表奖学金的范围审查，公众意见,和联邦指导文件，我们为本地背景审查确定了五个假设目标:保护本地参与者的权利和福利;确保遵守适用法律和政策;评估可行性;提高研究质量;促进程序正义。虽然各种内容被提议是相关的，它主要分为四个领域:人口/参与者级别的特征;研究者和研究团队的特征;机构级别的特征;以及州和地方法律.排除在sIRB要求之外的拟议特征反映了基于保护和效率的关切。这些发现可以为正在进行的努力提供信息，以评估强制sIRB审查的政策的影响，以及这些政策的例外情况何时可能是适当的。
