D03 - [IN-PERSON/RECORDED] A Tale of Two Institutions: Examining the Impact of the FDA Single (sIRB) Mandate

This session will be offered in-person and recorded for on-demand access by in-person PRIMR23 attendees registered for this day, and PRIMR23/SBER23 Virtual Meeting registrants.

In Fall 2022, the FDA released a Notice of Proposed Rule-Making (NPRM) that detailed a requirement for a large proportion of multi-site studies regulated by the FDA to be reviewed and approved by a sIRB. As many of these studies will be funded by industry Sponsors, there is a consensus amongst IRB professionals that commercial IRBs will fulfill this requirement and this transition from local IRB review to reliance reviews has the potential to have a tremendous impact on IRB offices around the country. In this session, attendees will hear from institutions that will be impacted very differently: one institution will have to adapt to studies transitioning "out" and another institution which already utilizes commercial IRB services for industry-funded studies. The institutions will address enforcing HRPP (local context) requirements when serving as neither the IRB of record or Sponsor (holding the investigational new drug or investigational device exemption). Additionally, this session will include the view from an independent IRB about the potential FDA sIRB mandate will affect the IRB-review landscape.