The key players in a clinical investigation are infamously made up of Sponsors, monitors, investigative sites, and patients.  A fundamental part of the team is also the Institutional Review Board (IRB), as they oversee the conduct of clinical research. Per the FDA’s IRB information sheet, “IRBs are responsible for continuing review of ongoing research to ensure that the rights and welfare of human subjects are protected.” That’s a tall order!

Institutional Review Boards (IRBs), sometimes called Ethic Committees, are responsible for reviewing and approving research studies involving human subjects. The rules that govern IRBs are clearly laid out in 21 CFR 56 which contains the general standards for the composition, operation, and responsibility of an IRB that reviews clinical investigations regulated by the FDA. The IRB has the authority to: