FDA 483 - Indiana University IRB - February 14, 2020

The Food and Drug Administration (FDA) issued a Form 483 inspectional observation report to Indiana University IRB following an inspection conducted from February 6 to February 14, 2020. The primary observation highlighted the Institutional Review Board's failure to adhere to its own written procedures regarding expedited review processes. Specifically, the IRB did not consistently report research proposals approved under expedited review procedures back to the full board, as mandated by section 3.4 of its "IRB Review Process" document. This practice deviates from established internal protocols designed to keep all board members informed of approved research, including amendments to studies involving investigational new drugs (IND) and investigational device exemptions (IDE). The report cited examples, such as an expedited amendment approval on December 13, 2018, and another on July 24, 2019, for which no records indicated subsequent reporting to the full board. These findings suggest a lapse in internal compliance with the IRB's operational guidelines, which are crucial for maintaining oversight and ensuring participant protection in human research studies. While the FDA 483 report, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, does not dictate specific corrective actions, it serves as notification of observed deficiencies that the Indiana University IRB is expected to address promptly and comprehensively to ensure full compliance with regulatory requirements and its own internal procedures.