Policy & Guidance Refresher
Protocol Deviations and Violations
All deviations from and violations of Columbia IRB policies or IRB determinations, including departures from the requirement for adherence to the approved protocol, must be reported to the IRB.
• A protocol deviation is defined as a variation from the approved protocol for one subject or to address a temporary situation that is identified by the research team and approved by the IRB before implementation.
• A protocol violation is defined as a variation from the approved protocol that was implemented without prospective approval by the IRB (and was not implemented to avoid or minimize imminent harm*). Protocol violations may be considered as noncompliance with the federal regulations and institutional policies for the protection of human subjects. If the violation is noncompliance, the provisions of the IRB Noncompliance Policy will apply.