Achieving Ethically Appropriate & Effective Local Context Review by Single IRBs

A leading concern in transitioning from local Institutional Review Board (IRB) to single IRB review for multi-site studies, as now required by the revised Common Rule and the NIH for most federally funded studies, was whether and how sIRBs could consider local context in their review. NIH policies on sIRBs instruct participating sites to communicate “relevant information” to the sIRB regarding local context. However, there is no shared agreement as to the goals and content of local context review, raising concerns as to whether important protections are being missed, or, alternatively, whether some sites’ current processes introduce unnecessary barriers to the initiation of socially valuable research. The proposed research will engage key stakeholders to develop a conceptual model and related guidance for what local context review should entail.

Berman Institute Faculty

Stephanie Morain, PhD, MPH
PhD Program Director; Associate Professor
Jeremy Sugarman, MD, MPH, MA
Deputy Director for Medicine; Harvey M. Meyerhoff Professor of Bioethics and Medicine
Juli Bollinger, MS
Research Scientist