Fred Hutch Relies on an Independent IRB

Generally, Fred Hutch allows the use of an independent IRB to cover Fred Hutch engagement for industry-sponsored, multi-site trials. Fred Hutch has a master services agreement with Advarra and WCG, where the independent IRB can serve as the IRB of record.

Use of other independent IRBs will require a protocol-specific reliance agreement.

Requesting Authorization

Before you submit for review to either Advarra or WCG, follow the instructions under How to Ask for an External IRB Review to obtain authorization. Although Fred Hutch has established reliance agreements with Advarra and WCG, the IRO must authorize the use of an external IRB for each individual study. Advarra and WCG must receive documentation of IRO’s authorization before they can review an application covering Fred Hutch engagement.

Advarra IRB

New to submitting applications to Advarra? Work with Advarra’s representatives to Fred Hutch to understand the application and approval process.

Advarra Contact Information:
Celeste Duran or Andrew Saunders
institutions@advarra.com

Creating an Advarra Submission

Once you are ready to submit to Advarra IRB, please follow these steps: 

1. Go to www.cirbi.net.
2. If you do not already have an account, please click here to create one. 
   • Anyone else who needs to be added to your submission will also need to be registered. You can register anyone on their behalf by clicking “Do you need to register? Sign up” on the CIRBI login page.
   • When registering for an account in CIRBI, Advarra’s online system, make sure to list your institutional affiliation as “Fred Hutchinson Cancer Center.”
3. Once you are logged in to CIRBI, click the “Investigator Application” button in the left vertical menu.
4. Complete your application and click “Submit.”
   • If it is the PI’s first time submitting to Advarra, submit a copy of his/her CV signed and dated within the past 2 years.
   • Insert your required language (as applicable) into the Advarra-approved sponsor ICF using tracked changes and upload with your submission.
5. Once submitted, your application will be assigned to an Advarra coordinator, who will be your operations point of contact for the duration of your study. For any questions related to the submission or approval process, please follow these steps to contact your coordinator: 
   • In the “My Studies” tab of your CIRBI dashboard, click the appropriate study hyperlink.
   • From the left vertical menu, click “Contact IRB” and compose your message. Click “OK” for your message to be sent directly to the coordinator.
   • All communications will be archived in the “History” tab for the study.
6. Once your submission has been approved, you will receive an email notification from CIRBI.
   • To access all approval documents, click the appropriate study hyperlink in the “My Studies” tab, then click “IRB Issued Documents.” 

For any contractual questions, please contact Institutions@advarra.com. For study-specific questions, contact your coordinator following the instructions in step 5 above.

Funding Review

Advarra does not review site funding for congruency. If you anticipate having to request release of study funds through a Funding Verification and Activation form (FVAF), ensure the funding is listed on the Funding Smart Form page in Hutch IRB.

Requesting Partial HIPAA Waiver from Advarra

The site must indicate on their Advarra submission that they are requesting a partial HIPAA waiver, even if the sponsor has indicated that they are requesting a partial HIPAA waiver for the study.  This will ensure that it is listed on their approval letter.

Protocol-Wide Approvals with Advarra

Waivers of consent, waiver of documentation of consent, and HIPAA waivers approved at the protocol level don’t always get listed on initial site-approval documentation. Study teams should work with the sponsor to request a copy of the Notice of Approval documentation necessary to document protocol-level waivers.

Research Location

Ensure that any Cancer Consortium sites that are engaged in the research are listed as a research location on the Advarra application.