Fred Hutch Cancer Center
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Fred Hutch Cancer Center
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Last Modified: 09-10-24

Continuing Review

Relevant IRB Policy/Procedure

This page provides guidance for Continuing Review of studies for which the Fred Hutch IRB serves as the reviewing IRB (also known as the IRB of record).

For studies being reviewed by another IRB, instead see the During the Research section of the How to Ask for an External IRB Review page.

To close an existing study, refer to Closing a Study.

When is Continuing Review Required?

Most studies must be re-reviewed by the IRB on at least an annual basis, per federal regulations. This is called continuing review, and it occurs based on the degree of risk of the study. 

The following research must undergo IRB continuing review:

  • All greater than minimal risk research.
  • All non-exempt human research initially approved prior to January 21, 2019, provided they have not undergone a de novo review since that date.
  • Some minimal risk non-exempt research approved on or after January 21, 2019 (under the revised Common Rule) if stipulated by the IRB.

Continuing review is generally not required for the following studies:

  • Not Human Research (NHR).
  • Exempt research.
  • Most minimal risk studies approved under the revised Common Rule (initially approved on or after January 21, 2019, or having undergone a de novo since then), although the IRB retains the right to require continuing review on such studies.

Even though formal continuing review is not required for some research, the investigator is still prompted annually to review the record in Hutch IRB, to confirm that there are no changes to the research to be made and to verify funding information remains current in Hutch IRB. On an ongoing basis, all investigators must also consider whether any events may meet the definition of an unanticipated problems or noncompliance that requires prompt reporting to the IRB. 

    What is the Continuing Review (CR) Notification Process?

    To ensure that all studies requiring continuing review are reviewed and approved on an annual basis, Hutch IRB sends automatic notifications at 90, 60 and 30 days prior to the study expiration date. IRO staff will also follow-up with the study team directly if no Continuing Review (CR) has been received within 30 days before study expiration. Note, it is the responsibility of the Principal Investigator to ensure that IRB approval is maintained by submitting a CR in a timely manner, 45 days prior to the expiration date. 

      How Are Approval and Expiration Dates Calculated?

      The Approval date of a study is the date of review when all IRB approval criteria were satisfied. The expiration date of a study is generally one year, minus one day, from the date of initial approval or continuing review approval.

      The IRB will generally approve studies for one year. However, there are instances where the IRB may approve a study for a shorter period. If the IRB approves a study for less than one year, the expiration date will be calculated according to the IRB-directed review period. 

        CR Submission Instructions for the Study/Lead File

        Each study/lead file must complete the following steps:

        • Complete the Continuing Review Supplement.
        • Create and submit a “Continuing Review” submission in Hutch IRB.
        • If your study includes non-Cancer Consortium participating sites (pSites), see additional steps for pSites below

        TIPS for your Study/Lead file CR submission:

        • DSMC or DSMB reports:  With the submitted CR, the PI should include any DSMC or DSMB reports that were released within the review period. If such reports require changes to the study or raise safety concerns, these should instead be submitted via a separate modification within 30-45 days of receipt of the information - see following note for additional context.
        • Hutch IRB will allow you to submit a combination Modification and Continuing Review (MODCR). However, please consider the complexity of the Modification, as it may be best to submit it separately from the CR. If the IRB is unable to approve the Modification, the study could risk a lapse in approval if the submissions are combined. 

          CR Submission Instructions for Participating Sites

          A continuing review submission is created for the study/lead file as described above. In addition, for each non-Cancer Consortium participating site, the study team here must complete the following steps:

          • Complete the Continuing Review Supplement - Participating Site
            • Note: The participating site can complete this form and send a copy to the study/lead file. The signature of the site PI or the site PI’s designee is required on this form.
          • Complete the “Report Continuing Review Data” Activity for each pSite in Hutch IRB
            • You can access this activity in two ways:
              1. At the site workspace in Hutch IRB
              2. On the main study continuing review workspace created above, under the "sites" tab
            • Note: Only the PI or PI Proxy from the lead file will have access to complete this activity on behalf of the pSite.

          TIPS for your multi-site CR submission: