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Overview
This page contains information about submitting to the Fred Hutch IRB. Submissions are made via the Hutch IRB system.
Not sure whether Fred Hutch is the right IRB? See Selecting the Right IRB.
Planning to rely on an External IRB review? See How to Ask for an External IRB Review.
Submission Types
Navigate to the links below to see details about specific submission types.
Information about the process to apply for Institutional Review Board approval of studies, when Fred Hutch is the IRB of record.
Information about submitting a Modification for studies when the Fred Hutch IRB is the IRB of record. In general, any change to an IRB-approved research study must be submitted to the IRB for review and approval before the change is implemented.
Guidance for Continuing Review of studies for which the Fred Hutch IRB serves as the reviewing IRB.
Information about how to close research studies that are reviewed by the Fred Hutch IRB.
Information about the requirements for reporting new information to the IRB, including unanticipated problems, noncompliance, and third-party safety events (when applicable).
Guidance for submitting and managing multi-site studies when the Fred Hutch IRB serves as the reviewing IRB.
Not Human Research Determinations
Guidance for determining if a research activity is human research or not.
Submission Guidance
Guidance to provide researchers examples of different types of projects that may or may not constitute research under the federal Common Rule.
General turnaround times study teams can expect for submissions to the IRB.
Guidance on how to transition studies to different statuses when submitting a modification or continuing review.
General Submission Information
All IRB submissions are made through Hutch IRB. Complete study SmartForms and attach all requested documents.
Inquiries or questions can be sent to IRO@fredhutch.org.
Please take careful note of the following requirements. Failure to follow these requirements may result in delays in IRB review.
Submission Requirements
- All attachments should be in Word format, where possible.
- Separate, individual attachments are required for the following documents at a minimum (if applicable): IRB form under review (e.g., IRB Application, Continuing Review Supplement, etc.), protocol, each consent form, HIPAA authorization, and each IB.
- Name your attachments with readily understandable file names (such as "protocol", "patient consent", "donor consent", etc.) and include version and version dates for all documents.
- Consent forms should ideally include both a version and date.
- All study teams are responsible for maintaining Word versions of IRB-approved documents to be used for future revisions, and for ensuring careful version control of all study documents.
OnCore/CTMS Data Entry
All new research involving human subjects must be entered into the OnCore Clinical Trials Management System before submitting in Hutch IRB.
- Teams submit a REDCap Intake form to initiate the creation of a new protocol record in OnCore. This entry is required for all human subjects research protocols.
- For OnCore-related questions, please contact the CTMS Program Office at CTMS@fredhutch.org.
- OnCore entry is not required for Not Human Subject determination requests.
Scientific Review Committee (SRC)
If your new study or modification requires SRC review, proof of SRC approval must be included with the submission. The IRO cannot accept the submission until SRC approval is included. For questions about SRC, email PRMS@fredhutch.org or see the Cancer Consortium Study Reviews webpage.
University of Washington Zipline authorization
For investigators whose primary appointments are at UW or for research where UW as an institution is engaged, documentation of UW Zipline authorization to rely on the Fred Hutch IRB must be included. For more information, see the UW How to Ask for a Non-UW IRB webpage.
Seattle Children's authorization
For research where Seattle Children's (SCH) is engaged, an “Acknowledgement of Reliance on an External IRB” letter from SCH must be included as part of your submission to the Fred Hutch IRB. For instructions on how to obtain this letter, review Section A of the SCH-FH Guidance for Relying
Additional ancillary reviews
See HRP-309 - WORKSHEET - Ancillary Review Matrix to determine what other ancillary reviews may be required in relation to your submission.
IRB Approved Documents
After IRB Review, the IRB will provide you with a written decision via Hutch IRB indicating the IRB determination: Approval, Modifications Required to Secure Approval, Deferral, or Disapproval.
IRB approved study documents will be posted in Hutch IRB. The protocol, drug documentation, and participant-facing materials will be watermarked with an IRB stamp in the system.