On July 25, 2017, FDA issued a guidance document implementing a policy which allows IRBs to waive general informed consent requirements for minimal risk studies, similar to the waivers allowed under the Common Rule.
Last week, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS) issued joint draft guidance on responsibilities for preparing and maintaining written policies and procedures for Institutional Review Boards (IRBs). The agencies, both responsible for issuing and enforcing federal regulations designed to protect human subjects in research, have been working together to harmonize federal regulatory requirements and guidance in this area. The draft guidance entitled “Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs” (the Draft Guidance) is designed to assist IRBs and institutions responsible for the review and oversight of human research protections under both FDA (21 CFR Parts 50 and 56) and HHS regulations (45 CFR Part 46).
HHS’ Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) have simultaneously released notices seeking comments on draft guidance documents regarding the transfer of previously approved research projects to another Institutional Review Board (IRB) or research institution. These guidances were released as part of a joint effort between the FDA and