The Institutional Review Office (IRO) sits within Research Administration 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).
Upcoming AAHRPP Reaccreditation Site Visit – October 28 - 30
The Fred Hutch IRB will undergo its next reaccreditation site visit by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) from October 28–30, 2025. The visit will be conducted remotely.
During the visit, AAHRPP site visitors will:
- Interview leadership, staff, and representatives from various divisions
- Meet with key collaborators from our Consortium partners
- Review IRB records and documentation
The IRO is actively working with teams across Fred Hutch to prepare and gather the required materials. All individuals likely to be selected for interviews have already been notified, and Outlook invitations will be sent once the agenda has been set.
Fred Hutch IRB was first accredited by AAHRPP in 2008. Reaccreditation occurs three years after initial accreditation and then every five years. The most recent site visit took place in November 2020.
Change to IRB Document Stamping
Starting September 19, 2025, IRB-approved documents will be stamped with the effective date rather than the approval date.
This change is intended to provide greater clarity in cases where there is a delay between when the IRB approval criteria are met and when all conditions of approval have been satisfied. IRB approval criteria refer to the ethical and regulatory requirements like minimized risks, equitable subject selection, and ensuring informed consent or appropriate waivers. The conditions of approval are the requested modifications such as completion of ancillary reviews, minor changes to the consent form, or submission of the final contract.
Using the effective date ensures that the stamped date accurately reflects when all conditions of approval have been met, and the study can officially begin or the modified documents can be used.
Presumptive Not Human Research List Update
The IRO maintains a list of “IRB Pre-Reviewed Sources of De-Identified Human Specimens and/or Data.” Research projects that use information, biospecimens, or cell lines obtained exclusively from sources on this list are presumed to be Not Human Research (NHR) and do not require submission to the IRO for an NHR determination.
This list is reviewed periodically to ensure that all sources remain appropriate for inclusion. As of September 12, 2025, the following sources have been removed from the list because the companies now offer custom procurement services, which may involve human subjects research:
- Cooperative Human Tissue Network (CHTN)
- Lonza, Inc.
- Stemcell Technologies
New projects using materials from these sources may still qualify as NHR. However, IRO submission is now required so we can confirm that only off-the-shelf materials are being used.
If you would like to propose a new source for inclusion on the list, please contact IRO@fredhutch.org. To be eligible, the source must not offer custom collection services.
New Emergency Preparedness Policy Now in Effect
Fred Hutch has implemented a new Emergency Preparedness Policy (HRP-065) to ensure continuity of IRB operations during emergencies. The policy outlines procedures for maintaining IRB review and oversight when standard operations are disrupted. Researchers are encouraged to familiarize themselves with the policy to understand how emergency scenarios may impact IRB processes.
For details, see HRP-065 – POLICY – HRPP Emergency Preparedness and Response Plan on the IRB policy webpage.
Reminder: Track Your Animal Usage
All researchers are required to track animal usage throughout the life of the protocol. While you may choose your preferred method of tracking, this data must be reported in the required Hutch IACUC format during your triennial review. Please note that Cayuse alone is not sufficient, as it does not account for breeding or rodent pups prior to weaning. Refer to IACUC Policy 27.0 Animal Use and Tracking Animal Usage on the IACUC policy webpage for guidance.
Known Bug in Hutch IACUC
Please be aware there is a known bug in the Hutch IACUC electronic protocol system. When creating an Amendment or Triennial Review, clicking Continue from the Summary page will take the submission creator to a read-only view of the protocol SmartForm pages.
Workaround: Exit the submission, then click the Edit Amendment or Edit Triennial Review button from the submission workspace to access the editable SmartForm pages.
We are working with the vendor to address this issue and will communicate when it is fixed. Contact IACUC@fredhutch.org with any questions.
Kudos for Streamlining Triennial Reviews
Thank you to everyone who has completed their triennial reviews in the upgraded Hutch IACUC system! We appreciate the effort to simplify protocols, including removing unused procedures, strains, and entire experiments no longer being conducted. These updates not only improve accuracy but also make future amendments easier to manage.
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