E11 - [IN-PERSON ONLY] Maintaining a Robust HRPP in a Single IRB World

This session is being held in-person only at PRIMR23. It will not be recorded for on-demand access or for the PRIMR23/SBER23 Virtual Meeting.

Since the implementation of the NIH policy and revised Common Rule requirements, institutions have been grappling with adapting to single IRB review for multi-site research. With the expectation that the FDA also will adopt a single IRB requirement, more institutions will need to comply with single IRB requirements for the first time or face a significant expansion of research that will require the use of a single IRB. In many cases, using external IRBs requires institutions to adopt new approaches to ensure appropriate oversight of research under their purview because their finely tuned HRPPs have been disrupted by the removal of a traditional compliance gatekeeper, the local IRB. Further, institutions must help researchers navigate a new world that involves working with many IRBs that differ in processes and policies from each other as well as those of a study team's local institution.