Each Wednesday, UNMC Today features an informational article about changes affecting UNMC’s Institutional Review Board (IRB) and the research community. This week’s IRB message will discuss protocol violations.
What is a protocol violation?
Federal regulations state that changes in approved research cannot be initiated without IRB review and approval unless the change is necessary to eliminate apparent immediate harm to the subject or provide important information necessary for full informed consent. Protocol violations are deviations from protocol procedures which have not been reviewed and approved by the IRB.
When does the IRB need to be notified?
While investigators often either call or send the IRB a letter reporting protocol violations, the IRB prefers that the form “Retrospective Protocol Violation Report” be completed whenever a protocol violation has occurred which involved additional risk to subjects. This form was developed to provide responses to all the questions required for IRB review and consideration of the violation. This report must be filed within five (5) business days after discovery of the violation.
A study monitor found a protocol violation during a site visit and has required that it be reported to the IRB. The protocol violation does not meet the “additional risk to subjects” requirement. What should I do?
The IRB recognizes that sponsors often require IRB acknowledgement of the violation, and the IRB will appropriately respond with a letter for the sponsor and the study file.
Special Reminder
The Retrospective Protocol Violation Report asks the principal investigator to describe how this protocol violation will be avoided in the future. When answering this question keep in mind that the Principal Investigator assumes full responsibility for the conduct of a research protocol. The action plan must be presented in terms of actions undertaken by the Principal Investigator, not the study coordinator or other study personnel. However, the action plan may include specific duties to be carried out by the study coordinator or other study personnel.