FDA 483 - Western Reserve Health Education IRB - November 20, 2019

An FDA inspection of Western Reserve Health Education IRB in Youngstown, OH, revealed significant deficiencies in its oversight of clinical research. The firm failed to ensure informed consent documents adequately described risks and procedures, and its Institutional Review Board (IRB) operations exhibited multiple issues. These included improper meeting conduct, insufficient documentation of meeting minutes, and non-adherence to its own written procedures for research review and membership management.