FDA, HHS Guide on IRB Written Procedures

FDA and HHS’ Office for Human Research Protections have issued a joint guidance on “Institutional Review Board (IRB) Written Procedures; Guidance for Institutions and IRBs.” The document is intended to clarify requirements, reaffirm important human subject protections, and provide consistent recommendations for institutions and IRBs reviewing and overseeing research involving human subjects. It provides recommendation to institutions and IRBs for preparing and maintaining written procedures. It also clarifies which written procedures are specifically required, and which are recommended. For example, the guidance includes a Written Procedures Checklist that identifies the FDA and HHS regulatory requirements for written procedures for the IRB and provides recommendations on the type of information to include to support each of these requirements. “The Checklist is designed to prompt a thorough and more efficient evaluation of written procedures that are needed to help ensure the protection of human research subjects,” the agencies say.