Federal Regulations

Please click on the links below to view various Federal Regulations documents and other related information

Department of Health and Human Services (DHHS) 

  • 45 CFR 46 - DHHS regulations on the protection of human subjects. Subpart A of the HHS regulations incorporates the Federal Policy for the Protection of Human Subjects.

Food and Drug Administration (FDA) 

  • 21 CFR 50 - FDA regulations on the protection of human subjects.
  • 21 CFR 56 - FDA regulations on institutional review boards.
  • 21 CFR 312 – FDA regulations on investigational new drug application.
  • 21 CFR 812 – FDA regulations on investigational device exemptions.
  • 21 CFR 814 (subpart h) - FDA regulations on premarket approval of medical devices

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Other Federal Departments/Agencies that have codified the Federal Policy for Protection of Human Subjects 

  • 7 CFR 1c: Department of Agriculture (Subpart A)
  • 10 CFR 745: Department of Energy (Subpart A)
  • 14 CFR 1230: National Aeronautics and Space Administration (Subpart A)
  • 15 CFR 27: Department of Commerce (Subpart A)
  • 16 CFR 1028: Consumer Product Safety Commission (Subpart A)
  • 22 CFR 225: International Development Cooperation Agency, Agency for International Development (Subpart A)
  • 24 CFR 60: Department of Housing and Urban Development (Subpart A)
  • 28 CFR 46: Department of Justice (Subpart A)
  • 32 CFR 219: Department of Defense (Subpart A)
  • 34 CFR 97: Department of Education (Subpart A, D)
  • 38 CFR 16: Department of Veterans Affairs (Subpart A)
  • 40 CFR 26: Environmental Protection Agency (Subpart A – Q)
  • 45 CFR 690: National Science Foundation (Subpart A)
  • 49 CFR 11: Department of Transportation (Subpart A)

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Health Insurance Portability and Accountability Act (HIPAA) 

Federal Register proposed, interim or final regulations not yet published in the Code of Federal Regulations 

  • 71 FR 32827 – Interim Final Rule. FDA Medical Devices; Exception from General Requirements for Informed Consent (21 CFR 50.23(e)). Published June 7, 2006.
  • 71 FR 6137 – Final Rule. Environmental Protection Agency Protections for Subjects in Human Research (40 CFR 9, 26). Published February 6, 2006.