FDA WARNING_LETTER - Bay Regional Medical Center IRB - June 24, 2011

The FDA issued a Warning Letter to McLaren Health Care regarding its Institutional Review Board (IRB) at Bay Regional Medical Center (BRMC) following a June 2011 inspection. The inspection revealed the IRB failed to comply with 21 CFR parts 50 and 56, concerning the protection of human subjects.

Key violations include: 1. **Improper Expedited Review Procedures [21 CFR 56.110(b)]**: The IRB used expedited review for studies that were still open for subject accrual and had enrolled subjects, which should have undergone full board review. BRMC's proposed corrective actions (SOP modification, training) were deemed inadequate as they lacked administrative review or tools to ensure appropriate expedited review use. 2. **Failure to Conduct Annual Continuing Review and Follow Procedures [21 CFR 56.109(f), 56.108(a)]**: The IRB failed to conduct continuing review of research at least annually, as required by regulations and its own written procedures. This is a repeat violation from a September 2010 Warning Letter, indicating inadequate implementation of previous corrective actions. 3. **Inadequate Documentation of IRB Activities [21 CFR 56.115(a)(2)]**: The IRB maintained conflicting and inaccurate meeting minutes, with discrepancies in attendance, vote counts, and IRB member roles, making it difficult to verify quorum.