FDA WARNING_LETTER - Advocate Health Care IRB - November 30, 2011

The FDA issued a Warning Letter to Advocate Health Care IRB following an inspection from November 7-30, 2011, which aimed to assess compliance with 21 CFR Parts 50 and 56 regarding human subject protection in FDA-regulated clinical investigations. The inspection revealed that the IRB failed to ensure informed consent was sought from prospective subjects or their legally authorized representatives, as required by 21 CFR 56.111(a)(4) and 21 CFR Part 50.

Specifically, the IRB approved Study 4257, "The Effect of Etomidate on Patient Outcomes after Single Bolus Doses," without requiring informed consent under 21 CFR 50.24. Initially approved as a chart review with consent waiver in December 2006, the study's nature changed with a July 2007 amendment proposing randomization of subjects to receive midazolam or etomidate. The IRB approved this amendment in September 2007, maintaining the consent waiver, despite the study becoming a clinical investigation subject to FDA regulations requiring informed consent.

The FDA found the IRB's response regarding not connecting FDA regulations to Study 4257 until the inspection unacceptable. While acknowledging the IRB's corrective actions, including revising policies, educating members on informed consent, and holding workshops, the FDA deemed a May 8, 2012, response unacceptable. This