FDA WARNING_LETTER - Marquette General Health System IRB - October 21, 2010

The FDA issued a Warning Letter to Marquette General Health System following an inspection of its Institutional Review Board (IRB) from October 18-21, 2010. The inspection assessed compliance with 21 CFR Parts 56, 50, and 812, and Section 520(g) of the Federal Food, Drug, and Cosmetic Act, focusing on data validity, accuracy, and human subject protection in device investigations. The letter identified several violations, including the IRB's failure to ensure informed consent documents contained all information required by 21 CFR 50.25, such as identification of experimental procedures and the right to withdraw. The IRB also failed to follow its own written procedures for continuing review of research, specifically approving continuation without a required progress report, violating 21 CFR 56.108(a)(1). Furthermore, the IRB did not consistently include at least one nonscientific member at convened meetings when reviewing FDA-regulated research, as mandated by 21 CFR 56.108(c). Finally, the IRB failed to prepare and maintain adequate documentation of its activities, including meeting minutes that lacked sufficient detail on actions taken and discussions, violating 21 CFR 56.115(a)(2). The firm's written response was deemed inadequate, lacking sufficient detail on revised policies, procedures, and training. Marquette General Health System is required to provide written documentation of corrective actions within fifteen working days to prevent further regulatory action.