- 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.
