Rush University Medical Center IRBSeptember 12, 2025

FDA 483 - Rush University Medical Center IRB - September 12, 2025

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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.

Company: Rush University Medical Center IRB
Inspection Date: September 12, 2025
Product Type: Other
Office: Chicago District Office
People: Chelsea W. Lamm (investigator)
Yuanyuan Li (issuing_officer)

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ID · 3db1a6ab-e2a6-4d87-8456-bef08d47f021