FDA And OHRP Issue Joint Draft Guidance On IRB Written
This month, the Food and Drug Administration and the Office for Human Research Protections issued a joint draft guidance titled Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs. If you are a research university with employees that also serve on an Institutional Review Board, this draft guidance may offer clarity to their roles and the responsibilities that should be provided to them. However, it is also important to keep in mind that the IRB, and possibly your institution, should also ask questions of the sponsor/researcher. You will need to understand how the IRB and/or your institution is being protected by the insurance terms and conditions that the sponsor has in place for clinical risk and site risks, especially if the research or trial is being done on your campus.