Human Research Protection Program (HRPP)
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
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