Whether you're working on a biomedical clinical trial or a social-behavioral survey, this resource ensures you're aligned with the laws and principles that govern human research.
Division of Research
Understanding Human Research Regulations & Federal Guidance
Core Federal Regulations
45 CFR 46 – The Common Rule
The Federal Policy for the Protection of Human Subjects, applicable to all U.S. Department of Health and Human Services (HHS)-funded research.
- Defines IRB roles, informed consent, and risk/benefit requirements
- Includes subparts for:
- Subpart A – Basic protections
- Subpart B – Pregnant women, fetuses, and neonates
- Subpart C – Prisoners
- Subpart D – Children
21 CFR 50 & 56 – FDA Regulations
Applies to FDA-regulated research (e.g., drugs, devices, biologics).
HIPAA Privacy Rule (45 CFR Parts 160 and 164)
Protects personally identifiable health information (PHI) used in research.
- Regulates access, use, and disclosure of PHI
- Requires authorization or IRB/Privacy Board waiver for use in research
FERPA – Family Educational Rights and Privacy Act
Applies to research involving student educational records at institutions receiving U.S. Department of Education funds.
Foundational Ethical Guidance
The Belmont Report
Framework for ethical conduct of human research, emphasizing:
- Respect for Persons
- Beneficence
- Justice
Additional Federal Guidance Documents
| Document | Issuing Body | Purpose |
|---|---|---|
| ICH-GCP E6(R2) | FDA / ICH | Good Clinical Practice standards for drug/device trials |
| OHRP FAQs and Guidance | HHS/OHRP | Clarifies Common Rule interpretation |
| FDA Guidance Documents | FDA | Protocol deviations, eConsent, IND/IDE waivers |
| NIH Single IRB Policy | NIH | Requirements for multi-site studies |
| Certificates of Confidentiality Guidance | NIH | Protects identifiable research data from forced disclosure |
| Human Gene Transfer Guidelines | NIH (OBA) | For studies involving genetic material |