Federal Regulations
Federal Regulations
- Office for Human Research Protections (OHRP)
- 45 CFR 46 - Protection of Human Subjects
- U.S. Food and Drug Administration (FDA)
- 21 CFR 50 - Protection of Human Subjects
- 21 CFR 56 - Institutional Review Boards
- 32 CFR 219-Protection of Human Subjects
Guidance
- FDA Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
- FDA Guidance for Institutional Review Boards and Clinical Investigators 1998 Update
- FDA Investigational New Drug (IND) Guidances
- OHRP Frequently Asked Questions
- OHRP Guidance on Research Involving Coded Private Information or Biological Specimens
- OHRP Human Subjects Research Guidance Charts
- OHRP International Compilation of Human Subject Research Protections
- OHRP Policy Guidance
- OHRP Spanish website
- NIH Certificates of Confidentiality Kiosk
- NIH Guidelines on Women and Minorities
- NIH Inclusion of Children Policy Implementation
- NIH Guidelines on Human Stem Cell Research
- NIH OER FAQs