Human Research Protections Office (HRPO)
Regulations
- Code of Federal Regulations: 45 CFR Part 46
- Belmont Report
- VA - Current ORD Policy Documents
- VA Regulations - Human Subjects Protections
FDA Regulations: 21 CFR
- Part 11 - Electronic Records; Electronic Signatures
- Part 50 - Protection of Human Subjects
- Part 54 - Financial Disclosure by Clinical Investigators
- Part 56 - Institutional Review Boards
- Part 312 - Investigational New Drug Application (IND)
- Part 314 - Applications for FDA Approval to Market a New Drug (NDA)
- Part 600 - Biological Products
- Part 812 - Investigational Device Exemptions
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