IRB Policy: #8 Closure of a Research Protocol

A protocol may be closed when the Protocol Principal Investigator (Protocol PI) (1) determines that the research protocol and all related publications, presentations, and websites derived from individually identifiable private information have been completed; and (2) submits a IRB Project Closure Form and other related documents to the Institutional Review Board (IRB). The closure of a study is a change in activity for a research protocol, which must be reported to the IRB under federal regulations. The key document related to the closure of a protocol is the IRB Project Closure Form. All Protocol PIs must submit a closure form when a protocol is completed or otherwise closed. This form not only formalizes and documents the closure of a study file, but also provides the IRB with information pertinent to its review and approval of similar or related studies. Failure to submit a closure form for all closed studies, including those that have expired or lapsed, may cause the IRB to postpone the review and approval of future research protocols.