FDA WARNING_LETTER - Memorial Hospital Of South Bend, IRB - April 23, 2012

The FDA issued a Warning Letter to Memorial Hospital of South Bend's IRB following an inspection from April 11-23, 2012, which found non-compliance with 21 CFR Parts 50 and 56 concerning human subject protection in FDA-regulated clinical investigations.

Key violations include: 1. **Failure to determine and document compliance with 21 CFR Part 50, Subpart D (Additional Safeguards for Children in Clinical Investigations)** for pediatric studies, specifically three listed studies. The IRB's proposed corrective actions were deemed inadequate for lacking specific determinations, copies of revised procedures, and timelines. 2. **Failure to prepare, maintain, and follow required written procedures** for reporting unanticipated problems, serious or continuing noncompliance, and suspension/termination of IRB approval. The response was inadequate due to missing revised procedures. 3. **Failure to prepare and maintain adequate documentation of IRB activities**, including meeting minutes, leading to discrepancies in informed consent document approvals and unclear initial vs. continuing review status for a protocol. The response was inadequate due to missing revised procedures. 4. **Failure to review proposed research at convened meetings with a majority of members present, including at least one nonscientific member.** A February 4, 2009, meeting lacked a nonscientific member. The response was inadequate due to missing revised procedures. 5. **Failure to ensure no member participated in review with a