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The Fred Hutch Institutional Review Office (IRO) maintains an administrative file for all research where Fred Hutch is 1) engaged and 2) is relying on an external IRB.
The IRO must authorize the use of any external IRB for each individual study, even under pre-established reliance agreements (e.g., cooperative agreements among our cancer consortium institutions). Permission to rely on an external IRB must be obtained prior to submitting a study to the external IRB.
This page describes scenarios where a reliance agreement already exists. To learn about requesting a new reliance agreement, see Requesting a Reliance Agreement.
Complete the External IRB Cover Sheet – New. Submit the form along with required attachments to IRBinbox@fredhutch.org. For more information on what is required with a New External IRB submission, see How to Complete the External IRB Cover Sheet - New.
An IRO staff member will be assigned to review your submission. We will contact you if additional information or clarification is required. You will receive an email about the outcome of the IRO’s review of your application.
Standard turnaround time from receipt of a complete submission:
Review may take longer if the submission is incomplete, or if the external IRB requires submission of a local context information (rare).
Following receipt of your submission, the IRO is responsible for the following:
After receipt of the signed endorsement, the researcher can submit to the external IRB, including a copy of the Fred Hutch endorsement letter.
After the external IRB has approved Fred Hutch as a site, send the approval documentation to IRBinbox@fredhutch.org (Exception: For WCG and Advarra, IRO staff will obtain approvals directly via their portals). The IRO will then be able to sign off on release of funding for the research.
If the IRO has not received approval documentation from the external IRB, the PI will receive a reminder every 30 days. The IRO will not be able to sign off on release of funding until the external IRB approval documentation is received.
IRO will contact you annually to submit a copy of the Continuing Review that was submitted to the external IRB. If the external IRB does not require Continuing Review, the IRO will send a Status Report check-in email.
For studies reviewed by an external IRB, Fred Hutch does not generally require modifications be submitted to the IRO. The exceptions that would require timely notice to the IRO are:
To submit these updates to the IRO, complete the External IRB Coversheet – Continuing Review or Other. Contact IRO@fredhutch.org with any questions.
Fred Hutch PIs are responsible for following the policies of the external IRB. This includes submitting to the reviewing IRB using their forms and processes (or assisting the lead site with that process), following their reporting requirements for noncompliance, unanticipated problems and new information about the study, and complying with the stipulations of the IRB’s approval.