Institutional Review Board for Health Sciences Research (IRB-HSR)

Managing Protocol After Initial Approval

Suspension or Termination of IRB Approval

The IRB has the authority to suspend or terminate approval of human subject's research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected, related and serious harm to subjects. Any suspension or termination of approval includes a statement of the reasons for the IRB's action and is reported promptly to the investigator, the investigator's department chair, and to Office of Sponsored Programs/ Office of Grants and Contracts. The IRB may require remedial action or education as deemed necessary for the investigator or any other key personnel. Federal regulatory agencies are notified as required by federal regulation. Suspension is the temporary closing of a human research project or discontinuing an investigator's privilege to conduct human subject research. The suspension may be partial in that certain activities may continue while others may stop or it may be complete in that no activity related to the research may proceed. The IRB will make this determination.

Termination is the ending of all activities related to a human research project or an investigator's privilege of conducting human subject research at the University of Virginia except for the continuation of follow-up activities necessary to protect subject safety.