483
Rush University Medical Center IRBFDA 483 - Rush University Medical Center IRB - September 12, 2025
Record Details
Rush University System for Health IRB in Chicago, IL, was inspected by the FDA, revealing a significant deficiency in their informed consent process. The IRB failed to ensure that informed consent documents for multiple studies included a statement notifying participants of the possibility of FDA record inspection. This indicates a compliance issue related to human subject protection regulations.
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ID · 3db1a6ab-e2a6-4d87-8456-bef08d47f021