F16 - [IN-PERSON/RECORDED] Mission Overlap Between IRBs and IBCs and the Institutional Implications

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.

Review of research, especially research with novel technologies like gene therapy and immunotherapy, increasingly involve the use of viral vectors. These trigger protections from both IRBs, who are charged with protecting research participants, and IBCs, who are charged with protecting research personnel, the community, and the environment. While their jurisdictions are distinct, the content of their reviews can often overlap. For instance, while IBCs are responsible for third party safety from viral vectors, only IRBs have jurisdiction over the consent form which can detail safety measures required of the participants to protect those third parties. This means that communication between these committees is paramount. This session will discuss the challenges in the "gray zone" between IRBs and IBCs and how these are either addressed or exacerbated with different structural relationships. Specifically, with the increase in central IRBs and external IBCs, when these boards exist across different institutional divides, what are the implications for communication and co-review?