Submissions to the IRB

General Submission Information

All IRB submissions will be 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:

Document types:  All attachments should be in Word format.  In addition:

• 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 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 CRSSupportedCommittees@fredhutch.org or see https://www.cancerconsortium.org/en/support/study-management/study-start-up/committee-reviews/src.html.

University of Washington Zipline authorization:  For investigators whose primary appointments are at UW, documentation of UW Zipline authorization to rely on the Fred Hutch IRB must be included.  For more information, see: https://www.washington.edu/research/hsd/is-the-uw-irb-the-right-irb/how-to-ask-for-a-non-uw-irb/

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, please review Section A of the SCH-FH Guidance for Relying.

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 can be found in Hutch IRB.  They will be watermarked with an IRB stamp in the system.