FDA 483 - Mercy Health System IRB - August 03, 2017

An FDA inspection of Mercy Health System IRB, conducted from July 25 to August 3, 2017, identified multiple operational deficiencies related to regulatory compliance for Institutional Review Boards. Key issues included a clinical investigator's failure to report the emergency use of a test article within five days, along with a lack of documented justification, informed consent, and independent physician evaluation. The IRB did not consistently follow its written procedures for promptly reporting serious or continuing noncompliance with regulations or IRB determinations. This encompassed not investigating non-conformance allegations, significant delays in reviewing such issues, and failing to classify or report serious non-conformance to the FDA. Additionally, the IRB failed to adequately communicate findings and actions, such as suspensions, to investigators. Other observations involved the failure to report research termination to the FDA, inadequate adherence to procedures for initial and continuing review of research, and a lack of maintained correspondence with investigators. The IRB also lacked a properly documented list of members' earned degrees and evidence of training for all members. Mercy Health System IRB must address these observations to ensure compliance with federal regulations governing human subject protection in clinical research.