FDA 483 - LifeBridge Health, Inc. IRB - March 13, 2019

During an inspection conducted from March 11-13, 2019, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to LifeBridge Health, Inc. IRB, located in Baltimore, MD. The inspection identified a significant observation related to the Institutional Review Board's (IRB) oversight of clinical investigations involving children. The primary issue noted was the IRB's failure to determine at the time of initial review that specific studies were in compliance with 21 CFR Part 50 Subpart D, which outlines "Additional Safeguards For Children in Clinical Investigations." Specifically, the FDA found no documentation that the IRB made the necessary determinations for four active, IRB-approved studies, identified as IRB #1017132, #1017176, #1017298, and #1017139, which had been approved between 2012 and 2016. This observation indicates a gap in the IRB's adherence to federal regulations designed to protect pediatric participants in clinical research. LifeBridge Health, Inc. IRB is expected to evaluate this observation, investigate the root cause, and implement appropriate corrective and preventive actions to ensure full compliance with regulatory requirements for the protection of human subjects, particularly children, in future and ongoing studies.