FDA EIR - Arnot Health IRB - January 13, 2012

An FDA inspection of Arnot Health in Elmira, NY, conducted from December 19, 2011, to January 13, 2012, revealed significant deficiencies in the company's Institutional Review Board (IRB) operations. The inspection was performed under FDA regulations pertaining to human subject protection and the oversight of clinical research involving human participants. The main violations cited on the FDA-483 form indicated widespread systemic issues: an IRB member participated in the review of studies where they had a conflict of interest; expedited review procedures were improperly applied to research deemed "Greater than Minimal Risk"; and continuing review was not conducted at intervals appropriate to the degree of risk. Crucially, the IRB lacked comprehensive written procedures for critical functions, including initial and continuing review of research, prompt reporting of changes, determining risk levels, and reporting unanticipated problems involving human subjects. Furthermore, the IRB's charter did not grant sufficient authority to approve, modify, suspend, or terminate research activities, and record-keeping was inadequate, with incomplete meeting minutes, unmaintained investigator correspondence, and insufficient IRB member rosters. The facility also failed to update its IRB registration information regarding changes in the contact person. Arnot Health was issued an FDA-483 form and instructed to provide a written response within 15 business days, detailing its proposed corrective actions. Following the inspection, the company voluntarily deactivated its IRB.