The Food and Drug Administration (FDA) has the authority to regulate a wide variety of research activity, regardless of who sponsors the research. The FDA's core policies are published as title 21, part 50 and part 56 of the Code of Federal Regulations. Subject-specific FDA regulations apply to research that involves:
- New pharmaceuticals (21 CFR Part 312)
- Biological products (21 CFR Part 600)
- Medical devices (21 CFR Part 812)
Federal agencies may also impose requirements or provide guidance beyond the Common Rule. These agency-specific requirements apply only to research sponsored by the agency.
For example, DHHS policy includes additional protections for fetuses, pregnant women, and neonates (newborns) (Subpart B, 45 CFR 46), prisoners (Subpart C), and children (Subpart D).
The Office for Human Research Protections, in DHHS, also offers guidance documents as a source of information about DHHS's interpretation of the requirements. Although this guidance is not regulation, the UW-Stout IRB considers the guidance offered in these documents when establishing campus human subjects policy.
Federal HIPAA privacy rule creates additional requirements for medical research, but this tutorial does not address those issues. If you are doing research in the medical area, it may have HIPPA implications. Contact the IRB Administrator at UW-Stout (Research Services Office, 715-232-1126) for guidance.