West Jefferson Medical Center IRB – FDA Warning Letter, Jul 26, 2007

The FDA inspected West Jefferson Medical Center's IRB from July 23-26, 2007, to assess compliance with 21 CFR Parts 50 and 56 regarding human subject protection in clinical studies. The inspection revealed significant deficiencies.

Violations included: 1. **Conflict of Interest:** An IRB member participated in the initial review and vote of their own study without being excused (21 CFR 56.107(e)). 2. **Inadequate Written Procedures:** The IRB lacked written procedures for determining significant risk (SR) or non-significant risk (NSR) for device studies, as required by 21 CFR 56.115(a)(6), 56.108(a)(1), and 812.66. 3. **Failure to Follow Continuing Review Procedures:** * Written procedures did not reflect actual practice, leading to studies expiring before continuing review (21 CFR 56.108(a)(1)). * The IRB failed to follow up with investigators who did not submit required progress reports by deadlines. 4. **Improper Meeting Quorum/Composition:** Several meetings lacked a majority of members and/or a nonscientific member, as required for non-expedited reviews (21 CFR 56.108(c)). 5. **Failure