Full board review (also called convened review) requires a quorum of IRB members, including at least one non-scientist, to discuss and vote on a protocol at a scheduled meeting.
When required
- Research that exceeds minimal risk
- Studies involving vulnerable populations in many cases
- Studies that do not fit any expedited category
The IRB may approve, require modifications, defer, or disapprove the study, and must document its decision and the basis for risk/benefit determinations.