Local context review by single institutional review boards: Results from a modified Delphi process.

Introduction: Local context is the most common concern regarding use of a single institutional review board (sIRB). Yet what "local context" constitutes remains underspecified. Developing a shared understanding of the goals of local context review, the categories of information that should be considered, as well as the types of studies for which sIRB review may be inappropriate, are critical for ensuring that sIRB review provides adequate protections for human subjects. Methods: We conducted a three-round modified Delphi process convening individuals with expertise in the conduct and oversight of multisite research. Delphi surveys explored: (1) the goals of local context review; (2) the types of information that should be considered; and (3) study types that should be exempted from sIRB requirements. Results: Twenty-one experts participated. Experts agreed that (1) local context review should aim to both protect local participants and ensure compliance and (2) that four types of information should be considered (population/participant-level characteristics; investigator and research team characteristics; institution-level characteristics; and state and local laws). There was less consensus about whether existing processes facilitated adequate consideration of this information. Experts agreed that exemptions from sIRB requirements should be permitted but disagreed about when and in what circumstances. Conclusion: There is overlapping consensus about both the goals of local context review and the types of information that should be assessed. Future work remains, however, to develop effective processes to best realize the goals of local context review - and do so with appropriate efficiency.