Federal and State Regulations & Guidance Materials for Human Subjects Research
OHRP – Office for Human Research Protections
- 45 CFR 46 – Federal Regulations for the Protection of Human Subject – applies to ALL human subjects studies
NIH – National Institutes of Health
- Education Requirement – FAQs regarding the NIH Education Requirement
- Special Topics:
NSF – National Science Foundation
- Human Subjects – NSF Policy for human subjects research (HSR)
- Behavioral and Social Science Research – NSF interpretation of Common Rule and Behavioral and Social Science Research
FDA – Food and Drug Administration
Studies using investigational drugs, devices or biologics
- 21 CFR 50 – FDA Regulations for Protection of Human Subjects
- 21 CFR 56 – FDA Regulations for Institutional Review Boards
- Guidance for interpreting 21 CFR 50 and 56
- Comparison of FDA and HHS Human Subject Regulations
VHA – Veterans Health Administration
- ORO – Office of Research Oversight
HIPPA Regulations
DoD – Department of Defense
General
- The Belmont Report
- The Nuremberg Code
- Declaration of Helsinki (“The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.”)
- The Common Rule – Federal Policy for the Protection of Human Subjects