Ephraim McDowell Regional Medical Center IRB – FDA Warning Letter, Jan 6, 2010

The FDA issued a Warning Letter to Ephraim McDowell Regional Medical Center following an inspection of its Institutional Review Board (IRB) from December 21, 2009, to January 6, 2010. The inspection aimed to assess compliance with 21 CFR Parts 50 and 56 regarding human subject protection in clinical investigations.

The FDA concluded the IRB failed to adhere to statutory requirements and regulations. A response to the Form FDA 483 from the IRB Chairman, dated February 3, 2010, was not considered due to late submission.

Key violations include: 1. **Failure to prepare and maintain written IRB procedures (21 CFR 56.108(a) and (b), 56.115(a)(6))**: The IRB's Organizational Policy document lacked procedures for initial/continuing review, determining frequency of review, ensuring prompt reporting of changes, prohibiting unapproved changes, and reporting unanticipated problems, noncompliance, or suspension/termination of approval. 2. **Failure to maintain an adequate list of IRB members (21 CFR 56.115(a)(5))**: Membership rosters (2006-2009) lacked earned degrees, representative capacity, experience descriptions, and employment/relationship with the institution. This was a repeat finding from a January 2004 inspection. 3.