Exception Process for Revised Common Rule Single IRB RequirementComparison of Common Rule_FDA_Revised FDA_May 2024Exception Process for Revised Common Rule Single IRB Requirement

The FDA Regulations cited in this table are primarily from 21 CFR 50 and 56 as these regulations refer to human subject protection and institutional review boards (IRBs). The proposed FDA changes cited in this table are from FDA proposed rules Protection of Human Subjects and Institutional Review Boards and Institutional Review Boards; Cooperative Research. The proposals, if finalized would harmonize certain sections of FDA’s regulations on human subject protection and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule), in accordance with the 21st Century Cures Act (Cures Act). This table does not attempt to comprehensively address all FDA requirements nor to capture every minor change or nuance in the proposed amendments to the regulations. Comparison of Common Rule_FDA_Revised FDA_May 2024