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Federal Regulations on Human Research

Department of Health and Human Services (HHS)

Department of Health and Human Services (HHS)

45 CFR 46 ("The Common Rule" - Human Subject Protections)

Office for Human Research Protections (OHRP) Human Subject Regulations Decision Charts

National Institutes of Health (NIH) Guidance:

Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement (Delayed Onset Awards) (Notice Number: NOT-OD-12-130)

Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval (Notice Number: NOT-OD-12-129)

Food and Drug Administration (FDA)

Food and Drug Administration (FDA)

21 CFR 812 (Investigational Device Exemptions)

21 CFR 312 (Investigational New Drugs)

21 CFR 56 (Institutional Review Boards)

21 CFR 50 (Protection of Human Subjects)

Federal Regulation Tracker

Interactive Tool [D86.0000]

View the Regulation Tracker Interactive Tool

Comparison of FDA and HHS Human Subject Protection Regulations

View the Comparison of FDA & HHS Regulations

Code of Federal Regulations

National Archives, Office of the Federal Register (OFR)

View Code of Federal Regulations

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