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New IRB Procedure for Study Closure

April 27, 2017

The Human Subjects Office (HSO) has released new procedures for study closure. As of April 27, 2017, the previously-used Study Closure Report form will no longer be accepted, and study closure must be reported via KC IRB.

To view specific instructions for reporting a study closure to the IRB, including step-by-step KC IRB instructions, see Human Subjects Study Closure.

Please note, it is very important the instructions be followed carefully to ensure proper submission to the IRB. Specifically, any attachments submitted with the closeout submission must be attached LAST, just prior to completing the “submit” action.

Closure of studies involving greater than minimal risk research (i.e. full board) and FDA-regulated research MUST be reported to the IRB. These studies cannot be allowed to expire, and failure to report study closure prior to expiration will be considered noncompliance.

Study closure of minimal risk research may also be reported via KC IRB; however, failure to submit closure information for these studies is not required and will not be considered noncompliance. Researchers may allow minimal risk, non-FDA regulated studies to expire, and the expiration will be treated as a study closure.