FDA 483 - Summa Health System IRB - October 07, 2020

An FDA inspection of Summa Health System IRB in Akron, OH, revealed a significant deficiency concerning its Institutional Review Board operations. The firm failed to establish written procedures for the implementation and management of a central IRB, despite utilizing one since 2018. This lack of documentation impacts critical aspects of research review, reporting, and compliance with regulations for human subject protection.