FDA WARNING_LETTER - Singing River Hospital System IRB - July 23, 2012

The FDA issued a Warning Letter to Singing River Health System's IRB following a July 2012 inspection, citing non-compliance with human subject protection regulations (21 CFR Parts 50 and 56).

Key violations include: 1. **Failure to prepare, maintain, and follow required written procedures (21 CFR 56.108(a), 56.108(b), 56.115(a)(6))**: The IRB's "Policy and Procedures Guidebook" lacked procedures for determining review frequency, verifying no material changes, and prompt reporting of noncompliance. Additionally, the IRB did not follow existing procedures, such as including all attachments in pre-meeting packets (e.g., missing protocols for approved studies) and notifying all members of expedited approvals. The IRB's corrective actions were deemed inadequate due to missing revised procedures and training plans. 2. **Failure to fulfill membership requirements (21 CFR 56.107)**: The IRB lacked the necessary professional competence, specifically a physician member, during numerous meetings where oncology research was reviewed and voted upon between February 2010 and May 2012. While a new physician member was added, the IRB's reliance on external scientific review (e.g., Regional Cancer Center medical staff, another IRB) was deemed insufficient without proper procedures for cooperative review. 3. **Failure