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 a record in Hutch IRB to administratively document our institution's involvement in research when Fred Hutch is 1) engaged in human subjects research and 2) 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.

Initiate the Process

Create a New Study submission in Hutch IRB. In the study SmartForm, answer "yes" to the question, "Are you requesting authorization for an external IRB to review the study instead of the Fred Hutch IRB?"

Complete the study SmartForm questions and attach the following required materialst to the record in Hutch IRB:

• External IRB Supplement (and any attachments prompted by this form)
• Draft copy of the IRB application form required by the external IRB
• Protocol
• Consent(s)

Note: Only the PI of designated PI Proxies can "Submit" the study in Hutch IRB.

For more information on how to create and submit a New External IRB submission in Hutch IRB, see the training course "Creating and Managing an External IRB File".

How to avoid common, high-impact issues

• Engagement: 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.
• Reliance Agreement: 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 with your External IRB submission in Hutch IRB.
• General Submission Requirements: Review these requirements related to document format and naming.
• OnCore Entry: Complete OnCore entry requirements before submitting to the IRO. You should include the study’s RG number on the External IRB Supplement, and the study title should match the OnCore record (this should be consistent with the title on the protocol document). For OnCore-related questions, please contact the CTMS Program Office at CPRMS@fredhutch.org.
• Site-specific Content: When Fred Hutch is involved in consenting, a site-specific consent form should be developed to include the site investigator information and any required institutional language for Cancer Consortium sites. Review the 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.
• HIPAA Authorization: Fred Hutch recommends using the Fred Hutch template HIPAA authorization form but will also allow HIPAA authorization language to be embedded in the consent form. When HIPAA language is embedded in a consent form, the Office of General Counsel is asked to review the consent to ensure compliance with HIPAA and state law.
• Electronic Consent (e-consent): Considerations when Fred Hutch investigators will be consenting participants. 
  • Greater than minimal risk studies - Fred Hutch allows the Florence e-consent tool, the use of which has been evaluated institutionally and confirmed to be a legally valid signature method that is FDA Part 11 compliant. Sponsor-provided, part 11-compliant platforms may also be acceptable.
  • Minimal risk studies - If proposing the use of an e-consent tool other than Florence (including DocuSign or REDCap), Fred Hutch institutional policy only allows these alternative e-consent tools in conjunction with a waiver of documentation of consent (a waiver of the signature requirement) approved by the IRB of record.
• Attachments: Include all applicable attachments with your submission, as indicated on the External IRB Supplement.

What to Expect After Submission to the IRO

An IRO staff member will be assigned to review your submission. We will contact you through Hutch IRB if additional information or clarification is required. The PI, Primary Contact, and designated PI Proxies will receive an email about the outcome of the IRO’s review of your application.

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 is 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.

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.

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, submit the approval documentation in Hutch IRB using the "Add Comment" activity. (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, Primary Contact, and PI Proxies will receive a reminder email after 30 days and weekly thereafter. The IRO will not be able to sign off on release of funding until the external IRB approval documentation is received.

During the Research

You will receive an annual reminder prompting you to submit a copy of the Continuing Review information that was submitted and approved by the external IRB. To report Continuing Review information to the IRO, complete the following in Hutch IRB:

1. Run the Report Continuing Review Data activity and fill out the form. Attach the external IRB's approval letter and any related attachments to the activity.
2. Review the current SmartForm for accuracy.
3. If any updates need to be made, select Update Study Details to update the study record, and/or Create Site Modification to update the site record (multi-site studies only).    

Attach any of the following if updated in the last approval period:

• The current protocol to the Basic Study Information page
• The study consent form to the Consent Form Templates section of the Study-Related Documents page
• The Fred Hutch site consent form to the Consent Forms section of the Local Site Documents page

If the external IRB does not require Continuing Review, you will still receive an email reminder prompting you to confirm the accuracy of the SmartForm and to submit any updates that occurred within the prior year (steps 2 and 3 above).

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 the local PI
• There is a change in the External IRB
• A new funding source has been added that requires sign off by the IRO through the Funding Verification and Activation (FVAF) process

To submit these updates, select Update Study Details to update the study record and/or create a Site Modification to update the site record in Hutch IRB. Contact IRO@fredhutch.org with any questions.

Closing an External IRB Study

Once the external IRB closes the study or Fred Hutch as a site, you can close the External IRB file in Hutch IRB. Click Add Comment to attach closing documentation from the external IRB and notify the assigned IRB Coordinator.