Expiring Protocols

The Utah State University Institutional Review Board reviews and approves four different kinds of protocols. Each expire at various intervals, and requires specific actions to keep active. Below, you can learn more information on how to keep your protocol active based on its review type.

Exempt Protocols

Protocols that are approved as “Exempt” are valid for up to five years. The expiration date for exempt protocols is five years, or whatever date the study team lists as the study end date, whichever is sooner.

To keep an exempt protocol active, simply amend the end date in the Study Procedures section before the protocol expires. The USU IRB strongly recommends that you do not make other changes to the protocol when extending the end date. If the other changes require revisions that take time to complete, the protocol might expire in the interim. There is no way for USU IRB staff to reactivate an expired protocol in Kuali. The USU IRB requires at least three business days’ lead time on extending the expiration date of a protocol.

Protocols that have been completed should be closed by going into the Kuali Protocol and selecting “Request Close.” No new protocols will be accepted by a PI with an outstanding expired protocol.

Expedited Protocols

Protocols that are approved under the Expedited categories of review can be renewed indefinitely. Continuation Review (called “Renewal” in Kuali) will occur at least every five years, or at the previous date by which the study team has identified as the end date, whichever is sooner. Amending the end date for an Expedited protocol is certainly permissible, but it will still require a Continuation Review at the time the study team originally stated the study would be completed. The USU IRB recommends that study teams give themselves a comfortable amount of time to complete the study when they set an end date during the initial review of the protocol.

To renew an Expedited protocol, go to your protocol in Kuali and click “Renew.” Follow the instructions listed there. Before requesting renewal, your protocol must be up-to-date. If your renewal paperwork indicates that your protocol is not up-to-date, the USU IRB cannot complete the renewal of your protocol. This could result in a lapse in approval, requiring a new review of your project. Be sure to file and gain approval for any necessary amendments before requesting renewal of your protocol.

Renewal requests must be submitted five business days prior to the expiration date for your protocol. The USU IRB will make every attempt to renew a protocol with less time, but cannot guarantee the completion of the renewal. Once a protocol expires, it cannot be reactivated in Kuali.

If a protocol coming up on a continuation review or expiration date is complete, be sure to close that protocol. No new protocols will be accepted by a PI with an outstanding expiredprotocol, and allowing an Expedited protocol’s approval to lapse may result in a finding of noncompliance requiring corrective action.

Full Board Protocols

Full Board protocols expire every year on the anniversary date of the approval, and require continuation review at the meeting date prior to the continuation review date set in the protocol. This often requires the Principal Investigator to submit renewal requests at least two weeks ahead of the expiration/continuation date for the protocol. It is the Principal Investigator’s responsibility to ensure that renewal requests are submitted no later than five business days prior to the IRB meeting that most closely precedes the expiration/continuation review date for the protocol. IRB meeting dates are published at the beginning of every semester. The USU IRB does not meet regularly during the summer.

To renew a Full Board protocol, go to your protocol in Kuali and click “Renew.” Follow the instructions listed there. Before requesting renewal, your protocol must be up-to-date. If your renewal paperwork indicates that your protocol is not up-to-date, the USU IRB cannot complete the renewal of your protocol. This could result in a lapse in approval, requiring a new review of your project. File and gain approval of any necessary amendments before requesting renewal of your protocol.

If a protocol coming up on a continuation review or expiration date is complete, be sure to close that protocol. No new protocols will be accepted by a PI with an outstanding expired protocol, and allowing a Full Board protocol’s approval to lapse may result in a finding of noncompliance requiring corrective action.

External Reliance Protocols

External Reliance protocols expire on the date the Reviewing IRB sets for expiration or continuation, or after five years, whichever is sooner. To extend the approval period for an External Reliance protocol, amend your External Reliance protocol in Kuali to provide the renewal paperwork from the Reviewing IRB.

If a protocol with a Reliance Agreement is completed, be sure to close that protocol by selecting “Request Close” in Kuali and following the instructions listed there. No new protocols will be accepted by a PI with an outstanding expired protocol, and failure to close or renew an External Reliance protocol will result in notification to the Reviewing IRB of the lapse in approval on the Utah State University side of the project.