The FDA and the Office for Human Research Protections (OHRP) finalized the August 2016 draft guidance for written procedures for institutional review boards (IRBs), and the final guidance includes a clear warning to them. The agencies said in the final that some IRBs have developed written procedures "that simply restate the regulations" in question, but that approach won't work anymore because a working set of procedures will have to provide at a minimum "a comprehensive and critical assessment" of that IRB's responsibilities, functions and organizational structure.