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Relevant IRB Policy/Procedure

It is the policy of Fred Hutch that Institutional Review Board continuing review of approved human research studies must occur based on the degree of risk of the study. Review will never be more than one year from the IRB review date unless the study is determined to be exempt from requiring IRB review.

Why is Continuing Review Required?

U.S. Department of Health and Human Services regulation 45 CFR 46.109(e) requires that the IRB review human subjects research at intervals appropriate to the degree of risk, but not less than once per year.

To ensure that all studies are reviewed and approved on an annual basis, the IRO sends reminder notices through interoffice mail several weeks before the Continuing Review Report, or CRR, is due.

How Are Approval Dates Calculated?

IRB maintains a "fixed anniversary date" whenever possible when continuing review of research after the initial review. This means the expiration date of a study will be on the same month and day each year. In rare situations, a study's anniversary date may be reset.

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 anniversary date will be reset.
 

General Submission Instructions

General submission guidelines include the following:

  • Use the CRR Form.
  • Submit original documents only (no copies).
  • All documents must be single-sided.
  • Do not use staples.
  • Keep a complete set of the documents submitted to the IRB for the study's records.
  • Spell all acronyms completely when first using them: for example, "Institutional Review Board," not "IRB."

When an application receives final approval, the Institutional Review Office, or IRO, will forward one copy of the approved documents to the study’s contact person.

Submissions for Full Review and Minimal Risk Expedited Review

Please submit the original CRR form.

In addition, submit all other documents as directed on the CRR form.

Submissions for Exempt Review

A New Application will need to be reviewed and approved every five years. Please submit the following original documents:

Submissions for Multi-Site Studies

Fred Hutch is the IRB of Record

Continuing review of the study occurs as normal (see above). In addition, each non-Cancer Consortium participating site submits their own continuing review form. Note: for studies whose participating sites were described on the Multi-Center Supplement, those sites do not need a separate CRR unless requested.

Fred Hutch Relies on an External IRB

When Fred Hutch is relying on an external institution's IRB for review, the approval period is determined by the external IRB.  At least annually, the following documents must be submitted to the Fred Hutch IRO:

  • External IRB Cover Sheet - Continuing Review or Other
  • Approved (signed, with current dates of approval) copy of the external IRB's continuing review/status report
  • Current approved version of the Protocol or Activity Plan (only if modified in the last approval period)
  • Current approved version of the consent form(s) (only if modified in the last approval period)
  • Current approved version of the participant materials (such as approach letters, questionnaires, advertisements, but only if modified in the last approval period)

Submissions for IRB Certification of Approvals

Multicenter studies are required to submit Certification of Approvals for performance sites they coordinate at the time of Continuing Research Review, or CRR. The CRR form will prompt for an updated Multi-Center Supplement when applicable.

  • Update the Multi-Center Supplement and include with CRR.
  • Submit the approval document from the performance site.

The approval document can be submitted in one of two ways:

1. An Assurance Identification/IRB Certification/Declaration of Exemption (formerly called Optional Form 310) can be completed by the performance site's IRB.

2. Submit the approval document from the performance site's IRB office, which includes the following:

  • Protocol number or institution's identification number (such as the IRB number)
  • Title of the protocol
  • Offsite principal investigator's name
  • Performance site's Federalwide Assurance, or FWA, and IRB numbers
  • Review date and approval dates
  • Type of review (for example, full or expedited)


Other Considerations

Fred Hutch/University of Washington Cancer Consortium: For questions regarding the Cancer Consortium IRB or the submission process, see www.cancerconsortium.org.

Clinical Research Division study: Clinical Research Support will email those conducting a Clinical Research Division or Fred Hutch/UW Cancer Consortium study all appropriate forms and current study documents. Submit these documents to the IRB.

Closing a study: A CRR that includes a final summary is required when reporting a closure. If a study was never activated (for example, if no subjects entered), indicate this on the CRR Form. Refer to closing a study.