Institutional Officials and HRPP Leadership Track
Breakout Session Series A
A09 - Not Less Work, But Different: Re-Engineering for Single IRB Review
Nichelle Cobb, PhD
Director, Health Sciences IRBs Office
University of Wisconsin-Madison- MK
Megan Kasimatis Singleton, JD, MBE, CIP
Assistant Dean, Human Research Protection; Director, HRPP
Johns Hopkins University School of Medicine 
Kimberly Summers, PharmD
Director, Research Protection Programs; Adjoint Assistant Professor,
University of Texas Health Center San Antonio
Speaker(s)
HRPPs and IRBs have often served as gatekeepers for research oversight and administrative functions beyond those required by the regulations. As institutions adapt to the brave new world of single IRB review, HRPPs and IRBs face new challenges. The shift to single IRB review offers the opportunity to rethink and reconfigure approaches to research oversight, and this session will tease apart institutional and IRB roles when using a single IRB, as well as highlight key administrative and operational efficiencies. Attendees are expected to have sufficient experience and understanding to actively contribute to the discussion of and solution to these difficult problems. This session will not review basic concepts. During this session, speakers and attendees will:
Learning Objectives:
- Delineate distinct roles for reviewing IRBs and relying institutions by identifying and separating appropriate (non-IRB) responsibilities of institutions from functions that are, by regulation, within the purview of the IRB
- Explore the challenges and potential benefits yielded through inter-institutional cooperation when using a single IRB