The Institutional Review Office (IRO) sits within Compliance at Fred Hutch Cancer Center. IRO supports the ethical and compliant review of research involving human participants or live, vertebrate animals by coordinating the Institutional Review Boards (IRBs) and the Institutional Animal Care and Use Committee (IACUC).
HIPAA Authorization Form Translations are Available
The new protocol-specific HIPAA authorization form for research (effective on 5/6/2025) has been translated into the top 20 languages seen in the clinic. The translations can be found on the IRO HIPAA Authorization for the Use of Patient Information for Research webpage.
If the HIPAA form is available in a participant’s preferred language, you should provide them with a translated version to sign. For participants with languages not covered by an existing translation, you can continue to follow the existing process (most Fred Hutch studies are approved with an alteration of HIPAA, which is a waiver of the HIPAA signature so they don’t have to sign the English-language HIPAA).
For more information about the new protocol-specific HIPAA authorization form for research, please see the New HIPAA Authorization Form Available article in IRO News Volume 63.
Which IRB Reviews?
It can be challenging for Cancer Consortium researchers to identify which IRB should review any given research study. Here are some basic tips to help you identify the correct IRB to review your research. More information can also be found on the Fred Hutch IRB webpage: Selecting the Right IRB.
PI Primary Appointment
The PI’s primary appointment is a key factor in determining which IRB within the Cancer Consortium should review the research. For researchers with dual appointments, it’s important to know which institution is considered the primary appointment. Generally, the PI’s primary appointment is determined by the institution that pays their salary.
General rule of thumb for selecting the right IRB (when single IRB requirements are not in play):
Information for UW Investigators Conducting Oncology Research:
For UW oncology research, the situation is more nuanced.
If the research is oncology related and more than minimal risk, the Fred Hutch IRB may conduct the review, even if Fred Hutch is not otherwise involved in the research. (NOTE: If the request will involve serving as the IRB of record for sites outside the Cancer Consortium, you must consult with IRO first.)
Research that is considered minimal risk (eligible for Expedited Review) should generally be submitted to the UW IRB. On rare occasions, the UW IRB may determine they do not have the expertise to review a minimal risk oncology study. In these cases, the Fred Hutch IRB may review the research. Please work with UW HSD if you have questions.
We would strongly recommend UW investigators reference UW HSD’s webpage, Cancer‑Related Research. This page includes a thorough listing of criteria UW researchers need to consider when deciding which IRB should review the research. If you are still unsure which IRB to select, email to hsdrely@uw.edu to discuss.
Note about Exempt or Not Human Research (NHR) Determinations:
Exempt and Not Human Research (NHR) determinations are generally considered institutional determinations. Fred Hutch reviews these projects only for Fred Hutch PIs. Investigators with a primary appointment other than Fred Hutch should work with the IRB office at their primary institution.
Additional Notes:
This does not preclude researchers from sending studies to an external IRB (e.g., commercial IRB or institutional IRB outside the Cancer Consortium).
Single IRB mandates also affect the selection of an IRB. See How to Determine When a Single IRB (sIRB) is Required for more information.
When multiple Cancer Consortium institutions are engaged in the research, the non-reviewing IRB office(s) still require an administrative External IRB submission in their respective electronic systems, to track their own institution’s engagement.
Hutch IACUC Training and Office Hours
IRO offers the following resources to support your use of the Hutch IACUC protocol system.
- Training resources are available here.
- Virtual office hours through Microsoft Teams are also available to support study teams with Hutch IACUC: Wednesdays 10:00am-11:00am. Team meeting link available here.
- Individual support is offered over Teams or in person. Contact IACUC@fredhutch.org to schedule.
As a reminder, upon the first submission in the recently upgraded system (whether an Amendment or a Triennial), there will be additional steps necessary to complete new questions and verify migrated data. Please plan ahead for some additional time.
Have You Read Your IACUC Protocol?
The #1 cause of protocol noncompliance is unfamiliarity with the IACUC-approved protocol and procedures.
You can help prevent protocol noncompliance by carefully reading your IACUC protocol. Within the protocol, click on each procedure, and you'll find step-by-step instructions, dosages, analgesia requirements, potential complications, and more.
Protocol noncompliance refers to the conduct of animal-related activities without appropriate IACUC review and approval and/or failure to adhere to IACUC-approved protocols. This could include performing a procedure that is not listed on the IACUC protocol or performing a procedure in a way that deviates from how it is described in the IACUC protocol.
We are here to help! If you are experiencing difficulty with accessing the protocol or discerning details about any of the procedures, or have any questions, please contact IACUC@fredhutch.org. You may also contact Regulatory Veterinarian Ashlee Langford directly at atyler@fredhutch.org or 206-667-6771.
NABR Responds to FDA’s Plan on Reducing Animal Testing
The National Association for Biomedical Research (NABR) responded to the FDA this April regarding the FDA’s plans to phase out animal testing in the development of monoclonal antibody therapies and other drugs, emphasizing why animal research remains necessary and important:
“We all want better and faster ways to bring lifesaving treatments to patients,” NABR President Matthew R. Bailey said. “But no AI model or simulation has yet demonstrated the ability to fully replicate all the unknowns about many full biological systems. That’s why humane animal research remains indispensable.”
NABR’s full response can be read at: https://www.nabr.org/about-nabr/news/nabr-statement-fda-animal-testing
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