A04 - Local Context Review: Why It’s Essential and How to Do It Well

A recent article by Morain et al. (2025) on local context review in the sIRB model highlights significant challenges. The multisite research experts surveyed disagreed on the goals of local context review, what information should be gathered and considered, and whether current processes achieve their intended purpose. This variation in interpretation and practice can lead to inefficiencies and frustration in the IRB review process. This interactive session will use case examples to examine the respective roles of reviewing IRBs and relying institutions in fulfilling local context review requirements. Speakers and attendees will explore strategies for navigating differing expectations and key areas of variation, including the primary goals of local context review, the information requested and provided, and the appropriateness of current processes.