Useful Links:
US Department of Health & Human Services
Office of Human Research Protections (OHRP)
- Code of Federal Regulations: 45 CFR 46 (Common Rule)
- Decision Charts - Under What Category to Submit
- Exempt Review Categories
- Expedited Review Categories
- Federalwide Assurance
- International Compilation of Human Research Standards
- Policy and Guidance Documentation
- Tips on Informed Consent
Food and Drug Administration (FDA)
- List of Regulations (FDA 21 CFR 50 and 21 CFR 56)
- Running Clinical Trials - Good Clinical Practice Program
US Department of Education