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the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS) issued joint draft guidance on responsibilities for preparing and maintaining written policies and procedures for Institutional Review Boards (IRBs).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 The draft guidance entitled “Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs” (the Draft Guidance) is designed to assist IRBs and institutions responsible for the review and oversight of human research protections under both FDA (21 CFR Parts 50 and 56) and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).
Hogan Lovells has issued a Sponsored Research Alert outlining a Notice of Proposed Rulemaking (NPRM) issued by the U.S. Department of Health and Human Services (HHS) that seeks to amend the U.S. Government’s policy on protection of human research subjects. As the Alert describes: The NPRM would substantially change, in several respects, the regulatory framework with which universities and research