General Information

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Continuing Reviews – Purpose

The purpose of this process is to review the entire study and evaluate whether the anticipated risks and benefits are reflected in the actual experience of subjects and that the safeguards in place at the time of original approval are, in fact, adequate to ensure the safety of subjects.

Continuing Reviews – Procedures

Continuing review will be conducted on all research protocols at intervals designated by the NJMRC IRB at least once per year. EXEMPT protocols do not require continuing review to be conducted.

Continuing review may be conducted by expedited review only if the initial review was expedited or the study has changed such that the only activities remaining are eligible for expedited review. An expedited review procedure may be used for the continuing review of research previously approved by the convened IRB as follows:

1. Where the research is permanently closed to the enrollment of new subjects; and all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up of subjects; OR
2. Where no subjects have been enrolled and no additional risks have been identified; OR
3. Where the remaining research activities are limited to data analysis.

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For a multi-center protocol, an expedited review procedure may be used by the IRB at a particular site whenever the conditions of category (8)(a), (b), or (c) are satisfied for that site. However, with respect to category 8(b), while the criterion that "no subjects have been enrolled" is interpreted to mean that no subjects have ever been enrolled at a particular site, the criterion that "no additional risks have been identified" is interpreted to mean that neither the investigator nor the IRB at a particular site has identified any additional risks from any site or other relevant source. (45 CFR 46.110)

Projects involving high risk may require more frequent review. The IRB may require frequent review or reports on a specific number of cases. The terms of the review are delineated at the time the original approval is granted.

Continuing Review Submissions

The PI and the Study Contact will receive a single notice from the IRB office approximately 75 days prior to the expiration date of the protocol. No additional notices will be sent.

It is the responsibility of the PI to ensure that a complete continuing review packet is submitted at least 6 weeks prior to the expiration date.

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Missing the Continuing Review Deadline

Once the protocol continuing review date has passed, the protocol is considered expired (21 CFR 56.109f and 113). If the continuing review is in progress, then the study must cease enrollment of subjects until the continuing reviewed is approved by the IRB. Permission must be obtained from the NJMRC IRB in order to continue treatment of currently enrolled subjects. If continuing review documents have not been submitted by the expiration date the protocol will be closed by the IRB.

Response Required from a Continuing Review

After a review has occurred, the IRB may require a response to stipulations before a renewal certificate is issued.

The PI must provide a single “original” of the written response to each of the NJRMC IRB's stipulations along with the original signature of the PI on the cover letter.

• Submit changes marked in highlighter/track-changes and numbered as shown on the IRB's stipulations memo.
• If changes to the informed consent are requested, please use the latest IRB approved version of the informed consent to make the required changes. Use track-changes when updating the informed consent and remember to update the version date of the informed consent after making the changes. Include one clean copy of the consent for stamping and one copy with track changes.

Final approval for renewal is pending until the changes are submitted, approved, and the IRB issues a certificate of renewal.

According to federal regulations, if final approval is not granted by the study's expiration date, the IRB must suspend or terminate the study, and all study- related activities must stop.