FDA 483 - Nova Southeastern University IRB #1 - August 17, 2023

An FDA inspection of Nova Southeastern University IRB #1 in Davie, FL, revealed three observations concerning its Institutional Review Board (IRB) operations. The firm failed to adhere to its written procedures for initial research review and omitted critical information from informed consent documents, specifically regarding alternate treatment options and the potential for FDA record inspection. These findings highlight deficiencies in the IRB's compliance with established protocols and informed consent requirements.