Institutional Review Board
External Resources
Department of Health and Human Services
- The Belmont Report
- Research That May Be Reviewed Through an Expedited Procedure
- Statutory Basis for 45 CFR 46
- Title 45 Code of Federal Regulations Part 46 Protection of Human Subject
Food and Drug Administration (FDA)
- 21 CFR 50 – Protection of Human Subjects (PDF)
- 21 CFR 54 – Financial Disclosure by Clinical Investigators (PDF)
- 21 CFR 56 – Institutional Review Boards (PDF)
- 21 CFR 312 – Investigational New Drug (IND) Applications (PDF)
- 21 CFR 812 – Investigational Device Exemptions (IDEs) (PDF)
- FDA Center for Devices and Radiological Health
- FDA Forms – Devices
- FDA Forms – Drugs
- FDA ICH E6: Good Clinical Practice: Consolidated Guidance
- FDA Information Sheets
National Institutes of Health (NIH)
Office for Human Subject Research Protection (OHRP)
Clinical Trials
- ClinicalTrials.gov
- FAQ about ClinicalTrials.gov
- Clinicaltrials.gov registration requirements fact sheet (PDF)
Other Sites of Interest
- American Society of Bioethics and Humanities
- Applied Research Ethics National Association (ARENA)
- AAMC Clinical Research Compliance & Human Subjects Protection
- Medical College of Wisconsin IRB Discussion Forum
- National Bioethics Advisory Commission (NBAC)
- Public Responsibility in Medicine and Research