FDA EIR - Advocate Health Care IRB - November 08, 2013

The FDA conducted a for-cause inspection of Advocate Health Care IRB (Downers Grove, IL) from October 15 to November 8, 2013. This inspection served as a follow-up to a June 1, 2012 Warning Letter, which resulted from a 2011 inspection that found the IRB had inappropriately waived informed consent for an FDA-regulated clinical investigation, violating federal regulations such as 21 CFR 50 and 56. The 2013 inspection, carried out under compliance program 7348.809, verified that the previously identified non-compliance had been successfully corrected, and no new issues of non-compliance were observed. Consequently, no Form FDA-483 was issued.

While the main issues were resolved, the inspection highlighted areas for process enhancement. These included improving the clarity of meeting minutes by consistently documenting quorum maintenance, assigning explicit responsibility for follow-up actions, and ensuring accurate notation of pediatric risk categories (e.g., distinguishing between 21 CFR 50.51 and 50.52). The IRB proactively reported serious non-compliance from two clinical investigators to the FDA, addressing concerns like failure to obtain informed consent, protocol deviations, inadequate staff training, and poor record-keeping. Advocate Health Care IRB's Chair committed to continuous regulatory vigilance.