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).
New Protocol Template for Observational Studies
Clinical Research Support (CRS) has released a new protocol template for non-interventional (observational) studies, now available on the Clinical Research Resources Website (CRRW) under Study Tools and Resources. Going forward, research teams should use this template when developing investigator-initiated observational studies. This template can be adjusted for minimal risk studies, sample collection studies, or biorepositories.
Observational studies look at health outcomes in participants without changing their usual medical care or daily routines. In other words, researchers observe rather than assign treatments or interventions.
CRS provides protocol templates for transplant, non-treatment interventional, and solid tumor research, also available on the CRRW.
UW’s Language Access Bridge Funding
The University of Washington (UW) has launched the new Language Access Bridge Funding Award to help cover clinical trial translation costs when research funds do not already include them. Investigators with a UW primary appointment can learn more and apply on the UW Office of Healthcare Equity website.
If your primary appointment is at Fred Hutch, please continue to use the Fred Hutch translation funding request process. This applies when research translation costs are not covered by the study sponsor.
If you’re unsure of a Cancer Consortium investigator’s primary appointment, search current members on the Consortium’s membership site. For other questions on research translations funding, contact IRO@fredhutch.org.
UW’s Diversity in Clinical Trials Guidance and Supplement
Starting January 1, 2026, the University of Washington will require a Diversity Plan for clinical trials. Information and guidance are available on UW’s Diversity in Clinical Trials page and through the Diversity Plan Supplement form.
For Cancer Consortium studies reviewed by the Fred Hutch IRB, investigators do not need to complete UW’s Diversity Plan Supplement. The Fred Hutch IRB forms already include questions and review steps to assess participant diversity and access.
Reminders about Modification Submissions
Any change to an IRB-approved study must be reviewed and approved by the IRB before it’s implemented (unless needed to eliminate immediate hazards). Here are a few tips to help your submission go smoothly.
1. Modification Summary
When completing a modification in Hutch IRB, include a clear and concise response to the SmartForm question “Summarize the modifications.”
Avoid copying from Protocol or IB summaries—reviewers already have those documents. Instead, focus your Hutch IRB summary on what’s changing across the submission and the rationale for those changes. A clear summary helps reviewers quickly understand the scope of your modification.
2. Document Updates
Check out this new brief training video on updating documents in Hutch IRB! If you’re updating an existing document:
- Always use the “UPDATE” button (to the left of the original file) to keep version history and allow system-generated tracked changes that are critical for reviewers.
- Only delete documents that no longer apply to the study. Deleting removes all past versions and tracked changes.
- Accidentally deleted something? You may need to discard and redo the modification. Save time—update, don’t delete!
3. Funding Changes
With each modification, review the Study Funding Sources section in the SmartForm to:
- Remove expired funding.
- Update start and end dates for any extensions.
- Attach any revised contract versions (once fully executed).
Accurate funding information helps prevent delays and ensures current and accurate IRB files.
4. Helpful Resources
IMPORTANT UPDATE - DoD-Funded Animal Protocols
Beginning January 1, 2026, the Department of Defense (DoD) Animal Care and Use Review Office (ACURO) will only accept IACUC protocols that are fully funded by the DoD.
In the past, investigators could indicate whether DoD “fully” or only “partially” funded their protocol. That “partially funded” option is now being phased out. Under the new DoD policy, every activity described in a protocol sent to ACURO must be covered entirely by DoD funds.
What this means for protocols that currently blend both DoD and non-DoD funding:
- Protocols that include both DoD and non-DoD funding will no longer be accepted by ACURO.
- This change applies only to new and triennial submissions sent to ACURO on or after January 1, 2026. Ongoing projects with current ACURO approval can continue as is—but this change must be addressed at the time of their next triennial review.
- Investigators should plan either to:
- Revise their existing protocol to include only the DoD-funded work, or
- Submit a new, DoD-only protocol to the IACUC for review before it’s sent to ACURO.
- A protocol supported by multiple DoD awards is fine, as long as all activities are DoD-funded.
Again, if you already have ACURO approval, this change won’t apply until your next triennial review. IRO will reach out to investigators with DoD-funded animal research activities to support addressing this change well ahead of the next triennial.
If you have questions or need guidance on how to update your protocol, please contact us at IACUC@fredhutch.org.
Animal Medical Use Screening (AUMS) Expirations
The IRO has recently seen an increase in amendment approvals being delayed due to expired EH&S Animal Medical Use Screening (AUMS) clearances. To avoid delays, review the Training tab in your protocol workspace before submitting an IACUC amendment. Confirm that all listed staff have current AUMS clearances (and any other required trainings) and ensure completion of any renewals as needed.
As a reminder, participation in the EH&S Animal Use Medical Screening Program is required for personnel who:
- Directly care for or use animals, their tissues, fluids, or housing materials.
- Work in areas where animals are present (e.g., shared lab spaces).
- Enter the vivarium as part of their role but do not handle animals (e.g., facilities, engineering staff).
Last year, EH&S changed the AUMS requirement from once every three years to annually. Individuals can check their status or access assigned questionnaires through the Enterprise Health Employee Portal via MyApps. For assistance, contact Occupational Health at ohn@fredhutch.org.
Fundable Scores and IACUC Submissions
If you’ve received notice that your grant has earned a potentially fundable score—meaning it’s under strong consideration for funding—it’s time to start your IACUC submission.
Starting the IACUC review process early helps ensure your project is ready to launch smoothly once funding is officially awarded. Beginning now can help prevent last-minute rushes or activation delays.
You can learn more about how IACUC review connects to the funding process on the Funding Verification and Activation website.
New Hutch IACUC Researcher’s Guide
We’re excited to share the new Hutch IACUC Researcher’s Guide, created to help research teams navigate the IACUC submission process.
The guide includes navigation tips as well as step-by-step instructions for creating or updating a protocol, requesting pre-submission assistance, and responding to Clarification Requests made by the IACUC.
Whether you’re new to animal research submissions or need a quick refresher, this guide can help you navigate Hutch IACUC submissions independently. The guide lives on the Hutch IACUC Training webpage and can also be found in the Help Center in Hutch IACUC.
Known Hutch IACUC Bugs
Thank you to everyone who’s helped us identify and report issues in Hutch IACUC since this spring’s upgrade. Users may still experience occasional “bugs,” or temporary glitches in system performance. You can view the current list of known system bugs, and their workaround steps, on the Hutch IACUC 2025 Upgrade support page.
If you notice unusual system behavior, please contact IACUC@fredhutch.org. Your reports help us make the system better for everyone.
Contact Us
206.667.5900
To unsubscribe or manage your subscription, please visit https://lists.fhcrc.org/postorius/lists/iro-news.lists.fhcrc.org/. Please be aware, we automatically subscribe principal investigators, PI proxies and study contacts to the IRO Newsletter using the email addresses provided for research files that the IRO receives.