FDA WARNING_LETTER - Florida Atlantic University IRB - August 14, 2009

This Warning Letter addresses objectionable conditions observed during an FDA inspection of Florida Atlantic University's Institutional Review Board (IRB) from August 3-14, 2009. The inspection aimed to ensure compliance with 21 CFR Parts 56, 50, 312, and 812, focusing on human subject protection and scientific data validity. The review revealed serious violations of 21 CFR Part 50 (Protection of Human Subjects) and Part 56 (Institutional Review Boards). Two primary violations were identified: 1) Failure to ensure informed consent information was in accordance with 21 CFR 50.25, specifically regarding descriptions of procedures, experimental nature, foreseeable risks, and alternative treatments in several clinical trials. The IRB's suspension and termination of the problematic studies were deemed adequate, but further details on planned training and assessment tools are required. 2) Failure to have written procedures governing IRB functions and operations as mandated by 21 CFR 56.108. The existing procedures only addressed 45 CFR Part 46, not FDA requirements. The university is modifying procedures and plans to outsource FDA-regulated clinical trials. A copy of modified procedures or a timeline, and status of study transfers, are requested. The IRB must provide written documentation of corrective actions within fifteen working days to prevent recurrence. Failure to comply could result in further regulatory action.