FDA Regulations for the Protection of Human Research Subjects

The FDA human subject protection regulations have similarities to the DHHS 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.

In instances when both HHS and FDA regulations apply and conflict, the stricter regulatory requirement must be followed. For example, HHS regulations permit an alteration to the required elements of informed consent when certain criteria are met while the FDA regulations do not.

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