Continuing Review Request for Approved Research Projects

Click here to visit the Forms page and download the Continuing Review Form.

The IRB is required to review all non-exempt research projects at intervals appropriate to the degree of risk, but not less than once a year (45 CFR 46.109(e)). This is called "continuing review." The original Notification of Protocol Approval Notice indicates the expiration date of the approved protocol. If a project initially received expedited review and risks to subjects remain minimal, the continuing review may be expedited. If a project initially received full board review, the project generally requires full board continuing review.

It is the Principal Investigator's responsibility to submit an application for continuing review in sufficient time to permit the IRB chair or full board to review the application prior to its expiration date. As a service to investigators, OPRS sends the Principal Investigator a reminder notification 60-90 days prior the project's expiration date (i.e., the due date for continuing review).

NO HUMAN SUBJECTS ACTIVITY MAY TAKE PLACE AFTER THE EXPIRATION DATE OF THE PROTOCOL.

Continuing review information should be submitted on a Human Subjects Continuing Review Form. The Continuing Review Form is downloadable from the OPRS web site. If the investigator does not submit a Continuing Review application in due time, the investigator is notified by memo that IRB approval has lapsed. If the investigator fails does not respond it is understood by the OPRS that the study is going to close by the expiration date. A Human Subjects Expiration Notice will be sent to the investigator and the protocol file will be removed from the active file. Once the OPRS closes a project, the only way for the project to resume is for the investigator to submit a New Protocol Proposal Form for that project. All human subject interaction must cease until the new application has been approved.