Human gene therapy trials may require clinical research teams to coordinate two distinct but connected oversight processes: institutional review board (IRB) review and institutional biosafety committee (IBC) review. When teams are unclear on how these reviews differ, where they intersect, or when coordination should occur, study start-up can stall.

This session will clarify the IBC’s role in assessing biosafety risks, containment considerations, and institutional responsibilities while showing how coordinated IBC–IRB review can support participant safety, ethical oversight, and efficient study start-up.

Attendees will examine practical collaboration points across submission planning, review sequencing, communication, amendments, and ongoing safety oversight. Using real-world operational scenarios, the session will help site, regulatory, and study management professionals recognize avoidable delays, close oversight gaps, and build more connected review workflows for human gene therapy and engineered genetic material research.

CEU: 1.0 ACRP

Speaker:

James Riddle, MCSE, CIP, CPIA, CRQM, SVP Global Review Operations, Advarra