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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. [ABSTRACT FROM AUTHOR]

The National Institutes of Health (NIH) requires use of a single institutional review board (sIRB) for multisite, nonexempt, NIH‐funded research with human participants. The Clinical Trials Transformation Initiative (CTTI) conducted in‐depth interviews with 34 stakeholders at two universities and in research administration leadership positions at multiple institutions about their experiences implementing the sIRB model, focusing on the NIH policy's goals soon after the policy was enacted. While some stakeholders suggested that using an sIRB has streamlined and reduced inefficiencies associated with the local IRB model, more stakeholders indicated that the sIRB model has not simplified the ethics review process and instead created new inefficiencies due to unclear roles and responsibilities for staff and institutions; a lack of systems and processes for implementing the sIRB model, including communication systems; and increased workloads. CTTI used these findings to propose a new framework for evaluating the NIH sIRB policy. [ABSTRACT FROM AUTHOR]

Implementing the National Institutes of Health's (NIH's) new single institutional review board (IRB) policy has caused a paradigm shift in IRB review across the country. IRBs and human research protection programs are looking more closely at their processes for ceding review and developing procedures to handle local review when relying on a single IRB. This article describes an NIH‐funded network that proactively instituted a central IRB (CIRB) in 2012, anticipating the NIH future mandate. Lessons learned are described. There was a steep learning curve for IRBs and participating sites. IRB submission workload burden shifted from study teams to the data coordinating center, which created new workflow challenges, especially preparing hundreds of consent documents centrally. Despite difficulties encountered with CIRB review, this network is now fully functioning under a CIRB model. Further review and experience are needed to determine whether this shift in IRB review has eliminated duplicative review or regulatory burden from study teams. [ABSTRACT FROM AUTHOR]