Federal and State Regulations & Guidance Materials for Human Subjects Research and Institutional Review Board (IRB)
- The Belmont Report (external link)
- The Nuremberg Code (external link)
- Declaration of Helsinki (external link) (“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 (external link) – Federal Policy for the Protection of Human Subjects
Office for Human Research Protections (OHRP)
- Office for Human Research Protections (OHRP) (external link)
- 45 CFR 46 (external link) – Federal Regulations for the Protection of Human Subject – applies to ALL human subjects studies
National Institutes of Health (NIH)
- Education Requirement (external link) – Frequently asked questions (FAQs) regarding the NIH Education Requirement
- Special Topics:
National Science Foundation (NSF)
- Human Subjects (external link) – NSF Policy for human subjects research (HSR)
- Behavioral and Social Science Research (external link) – NSF interpretation of Common Rule and Behavioral and Social Science Research
Food and Drug Administration (FDA)
Studies using investigational drugs, devices or biologics
- 21 CFR 50 (external link) – FDA Regulations for Protection of Human Subjects
- 21 CFR 56 (external link) – FDA Regulations for Institutional Review Boards
- Guidance for interpreting 21 CFR 50 and 56 (external link)
- Comparison of Food and Drug Administration (FDA) and U.S. Department of Health & Human Services (HHS) Human Subject Regulations (external link)