FDA 483 - Rush University Medical Center IRB - November 13, 2013

An FDA inspection of Rush University Medical Center IRB in Chicago identified a significant issue regarding IRB meeting quorum. The IRB failed to consistently ensure that convened meetings for non-expedited research reviews included a non-scientist member, leading to numerous instances where quorum was not met between 2002 and 2013. This indicates a serious lapse in adherence to regulatory requirements for human subjects protection.