Continuing Review and Post-Approval Monitoring

Periodic Check-In of an Approved Protocol

Although the updated federal regulations no longer require IRBs to renew approved, nonexempt protocols every 12 months, the Campus IRB will continue to require a modified continuing review, now known as a "periodic check-in."

The Campus IRB has identified a number of reasons why researchers should continue to check in with the IRB on an annual basis about the status of approved protocols.

The continuing review process also includes a review of the approved version (i.e., “compiled” version) of the protocol. This review will allow the Campus IRB to complete post-approval monitoring of active protocols, as well as give researchers an opportunity to confirm that the approved protocol on file with the Campus IRB, including funding source,  matches the approved protocol in their records. This will also facilitate the transition to an e-IRB system.

All protocols, regardless of review type, are assigned an expiration date that is 364 days from the date of approval.

Researchers will continue to receive reminder messages instructing them to report to the IRB whether the research is ongoing.

Alternatively, researchers can notify the IRB that the research is complete and the protocol can be closed. All research activities must be suspended when a protocol is closed.

Exempt vs. Non-Exempt Protocols

A Periodic Check-in Form must be submitted for non-exempt protocols by the expiration date. Upon the processing of a Periodic Check-In form, the protocol will be assigned a new expiration date, 364 days from the previous expiration date.

Non-exempt protocols for which no Periodic Check-In Form is processed by the expiration date are automatically closed.

Protocols that were approved as exempt can be extended for an additional 364 days by simply informing the Campus IRB the research is ongoing. Periodic Check-In Forms are not required for exempt protocols.

Post-Approval Monitoring

Upon receipt of a Periodic Check-in Form, Campus IRB staff will provide researchers with a copy of the currently approved version of the protocol on record, also referred to as the “compiled” protocol.

Researchers will be instructed to review the compiled protocol and confirm it describes the research study as it is currently being conducted. The Periodic Check-In will be processed, and the protocol’s check-in date extended, only after Campus IRB staff receive confirmation from the researchers.

If researchers find that the compiled protocol is incorrect, please contact Campus IRB staff as soon as possible.

Changes Require a Separate Form

Most requests to amend the protocol cannot be incorporated during a Periodic Check-In. Changes should be submitted using the Request to Amend an Approved Protocol.

At present, updates related to funding and sponsors of an active protocol may be accepted at the time of a Periodic Check-In without a formal amendment. If changes include the addition of new funding by a federal sponsor, a copy of the award should be appended to the Check-In form.

Elements of Informed Consent

Consent forms submitted at the time of continuing review must reflect the required elements of informed consent.

Consent forms appended to the Periodic Check-in Forms will be returned if they are missing any of the required elements of informed consent.

Closing an Active Protocol

Protocols can be closed once all research activities, including analysis of identifiable data, have concluded. Protocols must be kept open if the data are to remain identifiable. Researchers can notify the Campus IRB at any time if they would like to close a protocol.

Reopening Closed Protocols

Researchers have up to 5 days after a non-exempt protocol is closed to reopen it. Exempt protocols can be re-opened up to one month after being closed. To re-open a closed protocol, researchers should submit the Protocol Re-Open Form.

Protocols that are reopened are assigned new expiration dates.

All research activities must be suspended until an expired or closed protocol is re-approved and a new expiration date has been assigned.