U.S. Food & Drug Administration

The U.S. Food and Drug Administration (FDA) human subject protection regulations have similarities to the U.S Health and Human Services (HHS) regulations but do also have differences, such as the scope of oversight (clinical investigations), provisions for emergency use, and differing informed consent requirements such as inclusion of language regarding FDA access to records and registration on the clinicaltrials.gov website when appropriate. The FDA has not yet adopted the revised Common Rule (2018 requirements).

If a study requires compliance with the revised Common Rule (2018 requirements) as well as the pre-2018 requirements and/or the FDA requirements for the protection of human subjects (21 CFR 50) and IRBs (21 CFR 56), the stricter regulatory requirement must be followed. If a study is not conducted or supported by a Common Rule department or agency and is required to comply with the FDA requirements, the study must typically comply with the 2018 requirements unless otherwise determined by the IRB.

These regulations are codified at 21 CFR 50 and 21 CFR 56.