Regulatory Resources
US Department of Health & Human Services
- Office for Human Research Protections (OHRP)
- 45 CFR 46 – Protect Human Subjects
- FWA (Federal Wide Assurance) Application
- Individual Authorization Agreement (must contact the human subjects administrator in the UF IRB Office)
FDA Regulations
- 21 CFR 50 – Protect Human Subjects
- 21 CFR 54 – Financial Disclosure
- 21 CFR 56 – IRBs
- 21 CFR 312 – Investigational Drugs
- 21 CFR 812 – Investigational Devices
- FDA Device Advice (Investigationl Device Exceptions)
- FDA Warning Letters Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
Office of Civil Rights (OCF) – for HIPAA