483
Rush University Medical Center IRBFDA 483 - Rush University Medical Center IRB - November 13, 2013
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · 78a2de75-cfd2-426f-a255-262c751d7656