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* Workflow - Fred Hutch Relies on a sIRB

View the above workflow for details about setting up a reliance agreement and submitting your study to an external institution's IRB.

Illustration of Fred Hutch IRB as a participating site relying on a sIRB.
Illustration of reliance arrangement

At a high level, the Fred Hutch investigator will need to do the following.

Pre-Award Steps:

1. Contact the participating site investigator and the site's IRB to obtain written confirmation that the institution will serve as the sIRB. Provide the written confirmation to the IRO; the letter of support can also be used as part of documenting the sIRB plan in the NIH funding application.

2. Contact the IRO Director to provide details of the planned study and request for Fred Hutch to rely on another institution's IRB.

3. Facilitate communication with the participating site as needed during reliance agreement negotiations.

4. When the reliance agreement is executed, retain a copy of the signed agreement in your study files. 

Post-Award Steps:

5. When you are ready to submit the study for IRB review, you must first submit the external IRB's application to the IRO. (Submit through CRS if appropriate.)

6. Once the IRO endorses the submission, send the IRB application to the external IRB for review. 

7. After receiving IRB approval from the external IRB, send approval documents to the IRO.