Mercy Hospital Medical Center IRB – FDA Warning Letter, Jun 13, 2013

The FDA issued a Warning Letter to Mercy Hospital & Medical Center Institutional Review Board (IRB) following an inspection from May 6 to June 13, 2013, which revealed significant violations of federal regulations governing IRBs, specifically 21 CFR Part 56, Part 50, and Part 812.

Key violations include: 1. **Failure to follow written procedures (21 CFR 56.108(a)(1))**: The IRB approved protocols for significant risk investigational devices without requiring the mandated IDE information (IDE number, FDA approval letter) as per its own SOPs. 2. **Failure to review research at convened meetings with a majority present (21 CFR 56.108(c))**: FDA-regulated research was reviewed when less than a majority of IRB members were present, compromising adequate review. 3. **Failure to prepare and maintain required written procedures (21 CFR 56.115(a)(6) and 56.108(a)(1)-(2))**: The IRB lacked written procedures for verifying no material changes in projects from sources other than the investigator, and for reporting findings/actions to the institution. 4. **Failure to retain IRB records for at least 3 years (21 CFR 56.115(b))**: Essential records like IRB rosters, meeting minutes, research proposals, and