Continuing Review

Depending on the study’s risk, either the fully convened IRB or an expedited designated reviewer will do this review. The IRB looks at your study’s progress over the past year to decide if your project should continue. They make sure you are still protecting participants and that the risks are reasonable compared to the possible benefits and the knowledge your research may provide.

If your research is regulated by the FDA, you must complete a continuing review every year, no matter which version of the Common Rule your study follows (pre-2018 or 2018).

If you follow the pre-2018 Common Rule, you must do a continuing review for all non-exempt research—even if your study is only in long-term follow-up or data analysis. If your protocol has an expiration date, you need to complete a continuing review. You can find your protocol’s expiration date in the outcome letter from your initial IRB approval letter or most recent CR approval letter.

If your study was initially approved by expedited review under the revised Common Rule (rCR) starting January 2019, you do not need to complete a continuing review.

At continuing review, the IRB looks for any new information that could change the risks or benefits of your research. This information might come from you or from other sources. The IRB uses this information to decide if your research should still be approved.

The IRB reviews the following:

• Reports from safety monitoring groups, such as a Data Safety Monitoring Board (DSMB), Data Monitoring Committee (DMC), or Independent Medical Monitor (IMM)
• Any unanticipated problems that have happened since the last review
• The most recent consent form that your participants have signed, to make sure you are using the current version
• Any participant complaints that have not been resolved
• Current enrollment numbers, to see if you are enrolling participants as planned
• Reasons why participants have withdrawn from your study, to check for possible problems with how you are running the research

The IRB decides when your next continuing review (CR) is due during the IRB or designated reviewer’s review of your study. Most studies need a CR every 12 months. However, if your study has higher risks—like a phase I first-in-human study—the IRB may require more frequent reviews. If this happens, you will see a shorter expiration date in your IRB outcome letter.

The time between two CRs cannot be more than 364 days. The IRB will set your study’s expiration date based on either the Full Board meeting date or the date the designated reviewer approves your submission. You will find this date in your IRB Approval letter. The eIRB system will send you a reminder when your CR is due. To avoid any issues, you should submit your Continuing Review Form in PROTECT at least six weeks before the due date. This helps make sure your protocol does not expire.

You cannot extend your study’s expiration date, and there is no grace period.

If you do not submit your continuing review on time, your IRB approval may lapse.

• If the CR is not approved by midnight the day the protocol expires, all research activities and enrollment must stop until approval by the IRB.
• If is in the best interests of participants enrolled on study to continue in the research during the period of lapse in IRB approval, the PI may request permission to continue participation of already enrolled subjects during this period.
  • The PI may email the IRB Chair, Nicole Grant, to request permission to continue some or all of the research
• If a study has lapsed due to the PI's failure to obtain timely CR, the IRB may elect not to review other active or new studies submitted by the PI until the CR is resolved.
• If the study lapses more than 45 days, the PI must submit a new initial review for the research to continue.
• If the study does lapse, this lapse is not considered noncompliance requiring expedited submission of an event report in PROTECT.

FDA Guidance: IRB Continuing Review After Clinical Investigation Approval

OHRP Guidance: Continuing Review Guidance (2010)