Helpful Links
- Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
- Handbook for Human Research Protection Programs
- Human Subject Regulations Decision charts (from Office of Human Research Protections)
- FDA Guidances, Information Sheets, and Notices (includes International Conference on Harmonisation Guidances)
- Institutional Review Boards (FDA): 21 CFR 56
- Investigational Device Exemptions (FDA): 21 CFR 812
- Investigational New Drug Application (FDA): 21 CFR 312
- Nuremberg Code
- Protecting Human Research Subjects: Institutional Review Board Guidebook (NIH/OPRR)
- Protection of Human Subjects (DHHS): 45 CFR 46
- Protection of Human Subjects (FDA): 21 CFR 50
- World Medical Association Declaration of Helsinki