FDA 483 - Covenant Medical Center Inc. - April 20, 2011

An FDA inspection of Covenant Healthcare's Institutional Review Board (IRB) in Saginaw, MI, revealed significant deficiencies in its oversight of clinical research. The IRB improperly used expedited review for high-risk studies involving vulnerable populations, failed to manage conflicts of interest among its members, and maintained inadequate documentation for meeting minutes and informed consent processes. These issues indicate a systemic failure to protect human subjects and adhere to regulatory requirements for clinical investigations.