FDA 483 - Philadelphia FIGHT IRB - February 02, 2017

An FDA inspection was conducted at Philadelphia FIGHT IRB, an institutional review board, from January 27 to February 2, 2017. The inspection resulted in an FDA Form 483 observation, indicating a deficiency in the organization's adherence to regulatory requirements for human subject protection. The primary issue identified was that the IRB failed to ensure that informed consent documents provided to research participants contained all necessary elements. Specifically, it was observed that thirteen FDA-regulated protocols, which commenced on or after March 7, 2012, utilized IRB-approved informed consent forms that omitted a statement mandated by U.S. law. This critical statement describes the availability of clinical trial information on ClinicalTrials.gov, reassuring participants that their identifying information would not be included. The absence of this required disclosure in numerous protocols highlights a gap in the IRB's oversight process for ensuring transparent and fully compliant informed consent. Philadelphia FIGHT IRB is now expected to provide a comprehensive response detailing corrective and preventive actions to rectify this observation and ensure full compliance with federal regulations governing informed consent for all future and ongoing clinical research.