The VHA Handbook 1200.05(3) mirrors federal regulations and requires “prompt” reporting to the IRB, appropriate institutional officials, department or agency head, ORO and OHRP of i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB, and (ii) any suspension or termination of IRB approval. VA studies under the oversight of FDA must also be reported to FDA as specified in FDA regulations.

See Post-Approval Responsibilities for specific reporting timeframes.