Managing Participating Sites Relying on the Fred Hutch IRB

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Confirm Fred Hutch will Serve as IRB of Record

• Review Selecting the Right IRB to confirm that Fred Hutch is an appropriate reviewing IRB for this study and any participating sites.

• If Fred Hutch will be the reviewing IRB, be aware of the set-up and ongoing management work required for pSites outside the Cancer Consortium.
  • It is critical to know that the Fred Hutch study team must serve as the timely communicator with all relying participating sites for the life of the study.  
  • Responsibilities include:
    • Planning IRB and other regulatory timelines and addressing problems as they arise.
    • Working with pSites and their IRB/compliance offices to establish reliance agreements.
    • Collecting local context information (for example, state age of majority) for each site.
    • Serving as an intermediary between the IRB and the participating sites for initial and ongoing site IRB submissions.
    • Coordinating continuing IRB review by gathering information from all sites and submitting it to the reviewing IRB.
    • Helping pSites respond to IRB requests (pSite staff outside the Cancer Consortium cannot access Hutch IRB).
    • Coordinating the payment of IRB fees by the lead site.

• To confirm Fred Hutch can serve as IRB of record for a site, contact IRBreliance@fredhutch.org.  Fred Hutch cannot serve in all contexts (for example, VA sites).

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Submit Study in Hutch IRB

• Submit the protocol for IRB review in Hutch IRB
  • Complete the appropriate IRB Application (Contact or No Contact) to cover all protocol activities (regardless of whether Fred Hutch is conducting Contact activities).
  • Complete the Multi-Center Supplement and any other forms prompted in the IRB Application form.
  • Prepare and submit the study in Hutch IRB. This submission covers the protocol, Fred Hutch’s involvement, and any other Cancer Consortium sites under the authority of the Fred Hutch PI.
  • The study must be approved before a Participating Site can be reviewed by the IRB. 

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Start Reliance Agreement

You may start the reliance process while the study is under IRB review.

For each pSite outside the Cancer Consortium (or Consortium sites not under the authority of the lead Fred Hutch PI):

• Complete the Reliance Request Intake Form.
• Email the form to IRBreliance@fredhutch.org to initiate the reliance agreement.
• Work with IRO and the pSite until the reliance agreement is executed.  Additional details about this process are available on the Reliance Agreements page.

Research may not begin at a pSite under the Fred Hutch IRB’s purview until it has a site-specific approval letter from Fred Hutch; the reliance agreement alone is not sufficient.

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Submit Participating Site for IRB Review

• After reliance is executed for a pSite, work with the site to prepare a Participating Site Supplement and required attachments.
• Submit the pSite in Hutch IRB on behalf of the site.  
• Fred Hutch IRB will evaluate the qualifications of the site and the site investigator using the application and local context review information (typically required for sites outside Washington and from non-Cancer Consortium sites in Washington).
• Wait for IRB approval for the pSite before starting research at that site.

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Ongoing Management of Participating Site

• For the life of each pSite, the Fred Hutch study team manages all IRB submissions on the site’s behalf.
  • Submit Participating Site Modifications for changes to site-specific documents or plans.
  • Submit Reportable New Information if events at the site meet reporting criteria.
    
  • If Continuing Review is required, submit a single Continuing Review for the overall study that includes all pSites:  
    • Collect a Continuing Review Supplement - Participating Site from each pSite.
    • Upload each site’s Supplement in Hutch IRB using the “Report Continuing Review Data” Activity.
    • Plan ahead; allow time to collect information and forms from all pSites before the study’s expiration date.
• Once a pSite has completed all research activities, submit a Closure - Participating Site form to change it to inactive. All pSites are formally closed in Hutch IRB once the overall study is closed. 

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