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Federal Policy for the Protection of Human Subjects
(Often referred to as the "Common Rule")
The Common Rule (Federal Policy for the Protection of Human Subjects) is codified at
(*) The HHS regulations incorporate the Common Rule as Subpart A of 45 CFR 46 (56 FR 28003). Statutory authority for the HHS Human Subject Protection Regulations (45 CFR 46) derives from 5 U.S.C. 301; 42 U.S.C. 300v-1(b); and 42 U.S.C. 289.