FDA EIR - Bay Regional Medical Center IRB - June 24, 2011

An FDA inspection of Bay Regional Medical Center IRB in Bay City, MI, conducted from June 22-24, 2011, identified significant compliance issues related to the oversight of clinical research. The inspection, a follow-up to a previous Warning Letter, found the IRB improperly used expedited review for high-risk cardiac drug studies (Alecardio and Trilogy) that were actively enrolling subjects, contrary to FDA regulations (21 CFR 56.110(b)). Further violations included the IRB's failure to adhere to its own written procedures (21 CFR 56.108(a)(1)). Specifically, primary and alternate board members voted on studies simultaneously, meeting minutes were often inaccurate regarding quorum and voting members, and annual conflict of interest disclosure statements were largely missing. Record-keeping was found to be incomplete, with instances of missing IRB approval stamps on informed consent forms and inconsistent meeting documentation (21 CFR 56.115(a)(2)). Management, including Hospital President Alice Gerard, agreed to immediately suspend enrollment in the Alecardio study and convene a full IRB meeting. Bay Regional Medical Center is also in the process of consolidating its IRB operations with McLaren Healthcare IRB by early 2012. The facility was directed to submit a written response to the observations within 15 business days, outlining corrective actions and their consolidation plans, and to update its FDA registration upon completion of the transfer. These actions are crucial to ensure proper ethical and regulatory oversight of human subject research.