FDA WARNING_LETTER - Valley Baptist Medical Center IRB - April 18, 2008

This Warning Letter details objectionable conditions observed during an FDA inspection of Valley Baptist Medical Center IRB from April 17-18, 2008. The inspection aimed to ensure compliance with 21 CFR Part 56 (IRBs), Part 50 (Protection of Human Subjects), and Part 812 (Investigational Device Exemptions) for drug and device investigations.

The FDA identified serious violations, including: 1. **Failure to follow written procedures:** The IRB did not document review/approval of informed consent forms, ensure all committee members participated in approvals, or enforce annual report submissions from investigators. 2. **Lack of prompt reporting procedures:** The IRB had no procedures for reporting unanticipated problems, noncompliance, or suspension/termination of approval to the FDA. 3. **Failure to conduct continuing review:** Several significant risk studies were not reviewed annually as required. 4. **Failure to meet quorum requirements:** The IRB voted on FDA-regulated research without a majority of members present, including a nonscientific member. 5. **Inadequate informed consent:** Informed consent documents lacked required information (e.g., investigator/IRB contact) and there was no record of IRB review/approval for many. 6. **Inadequate documentation of IRB activities:** The IRB failed to maintain copies of research proposals, approved consent documents, and progress reports. 7. **Inaccurate/incomplete meeting minutes:** Minutes lacked vote details, attendance clarity