FDA 483 - Wheeling Hospital IRB - April 12, 2022

The U.S. Food and Drug Administration (FDA) issued a Form 483 to Wheeling Hospital IRB following an inspection conducted from March 28 to April 12, 2022. The observations identified critical non-compliance issues related to the IRB's oversight of human subject research.

Specifically, the inspection revealed that the IRB did not consistently ensure the presence of a proper quorum at convened meetings when reviewing proposed research, with instances of insufficient voting members or quorum loss due to conflicts of interest. Meeting minutes were also found to be deficient, lacking sufficient detail regarding attendance, actions taken, and voting records, and inaccurately reflecting member status or vote counts. The IRB further failed to adhere to its own written procedures for initial and continuing review of research, exemplified by the absence of documented notifications to investigators for expired studies and discrepancies in approval dates.

Significantly, Wheeling Hospital IRB lacked established written procedures for promptly reporting instances of serious or continuing noncompliance with FDA regulations or IRB determinations to the agency. Similarly, the IRB had no documented process for promptly reporting the suspension or termination of IRB approvals to the FDA. These observations highlight a critical need for Wheeling Hospital IRB to develop and implement robust corrective actions to ensure full adherence to human subject protection regulations and established operational protocols.