FDA 483 - Memorial Hospital Of South Bend, IRB - April 23, 2012

An FDA inspection of Memorial Hospital Of South Bend's Institutional Review Board (IRB) revealed multiple deficiencies, primarily concerning the oversight of pediatric research. The IRB failed to ensure compliance with specific regulations for studies involving children, maintain proper documentation for expedited reviews and serious adverse events, and adhere to quorum requirements. Furthermore, the IRB lacked adequate procedures for member identification, conflict of interest management, non-scientific representation, and reporting of noncompliance or unanticipated problems.