Human Research Protections Program Office
Uniformed Services University of the Health Sciences
4301 Jones Bridge Road
Bethesda, MD 20814
Phone: (301) 295-9534
Guidance, References and Useful Links
- 10 USC 980, "Limitations on use of humans as experimental subjects"
- 21 CFR 50, "Protection of Human Subjects"
- 21 CFR 56, "Institutional Review Boards"
- 32 CFR Part 219, "Protection of Human Subjects"
- 45 CFR Part 46, "Protection of Human Subjects, Department of Health and Human Services"
- DoD and OUSD(P&R) Specific and Unique Requirements
- DOD HIPAA
- DoD Instruction 3216.02, "Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research"
- Exempt Categories
- Expedited Review Categories
- FDA guidance
- FDA regulations governing the conduct of clinical trials
- Human Subjects Regulations Human Research Decision Charts
- IND Exemption
- OHRP guidance
- Significant Risk & Non-SR Device
- USU Instruction 3200
- USU Instruction 3201