How to Ask for an External IRB Review

Overview
Initiate the Process
What to Expect After Submission to the IRO
Turnaround Time
IRO Responsibilities
Applying to the External IRB
During the Research
PI Responsibilities When Using an External IRB

Overview

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.

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Initiate the Process

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.

How to avoid common, high-impact issues

• If you are unsure whether Fred Hutch is engaged in the research, review the Office for Human Research Protections (OHRP) guidance on engagement in human subject research. Contact the IRO at IRO@fredhutch.org for assistance.
• Initiate the request for a reliance agreement as soon as you are aware of the need.  With some institutions it can take weeks or months to negotiate.  If the IRO will be asked to complete a local context form, please include this form or any requests for local context information.
• Complete OnCore entry requirements before submitting to the IRO. You should include the study’s RG number on the External IRB Cover Sheet - New, and the study title should match the OnCore record (this should be consistent with the title on the protocol document and on any funding).
• Review Fred Hutch institutional requirements for consent at Fred Hutch Consent Requirements for External IRB Studies.  These requirements should be included in the informed consent and HIPAA authorization documents.
• Include all applicable attachments with your submission, as indicated on the External IRB Cover Sheet - New.

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What to Expect After Submission to the IRO

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.

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Turnaround Time

Standard turnaround time from receipt of a complete submission:

• If no Fred Hutch contract is involved:  2-3 days
• If a Fred Hutch contract if involved:  5-6 days

Review may take longer if the submission is incomplete, or if the external IRB requires submission of a local context information (rare). 

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IRO Responsibilities

Following receipt of your submission, the IRO is responsible for the following:

• Ensure that the proposed external IRB is appropriate and qualified, if it is a new IRB Fred Hutch has never relied on before.
• Confirm fully executed reliance agreement is in place.
• Confirm all Fred Hutch institutional requirements are satisfied.
• Provide local context information to the external IRB, if required. IRBs must consider any applicable state or local laws or institutional policies that apply to the Fred Hutch research. External IRBs request this information through questionnaires, worksheets, or webforms. Though the request may be received by the Fred Hutch researcher, the information should be provided in collaboration with the IRO to ensure its completeness and accuracy from an institutional perspective.
• Provide documentation authorizing the use of the external IRB. The IRO’s authorization will be documented in the IRO Endorsement of External IRB Application form which will be signed by the IRO Director or designee.

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Applying to the External IRB

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.

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During the Research

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:

• There is a change in Fred Hutch PI
• There is a change in the External IRB
• The study has been closed by the External IRB
• A new funding source has been added

To submit these updates to the IRO, complete the External IRB Coversheet – Continuing Review or Other. Contact IRO@fredhutch.org with any questions.

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PI Responsibilities When Using an External IRB

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.

Additional requirements:

• Ensuring that any relevant financial conflicts of interest are disclosed to the reviewing IRB and that conflict of interest management plans issued by Fred Hutch are given to the reviewing IRB.
• Obtaining any required ancillary review and approvals and providing the results of these reviews to the reviewing IRB if requested. 
• Making copies of IRB approvals available for inspection by monitors and auditors.

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