FDA 483 - Wheeling Hospital IRB - April 12, 2022

This FDA Form 483 details significant deficiencies at Wheeling Hospital IRB related to its oversight of human subject research. Observations include failures to maintain proper quorum during convened meetings and inadequate detail in meeting minutes regarding attendance, actions, and voting. Furthermore, the IRB did not follow its own procedures for managing expired studies and lacked written procedures for promptly reporting serious noncompliance or suspension/termination of approvals to the FDA.