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).
Revised Informed Consent Templates
Updated Fred Hutch consent templates are now available and should be referenced for all new submissions.
Key updates include:
- IRS compensation language: Revised language for studies where participants may receive $1,500 or more in compensation (not reimbursement) in a calendar year. The consent template no longer includes a fixed dollar threshold, allowing flexibility as IRS requirements change.
- Injury language options: New options clarify how to describe injury coverage when Fred Hutch, UW, or both institutions are engaged. Study teams should select the option that best fits their study.
- Privacy and confidentiality section: Updated instructions and bracketed text to help ensure only relevant oversight entities are included in the final consent.
What you should know:
- Use the most current template when creating a new consent or updating sponsor-provided consents.
- Previously approved consents do not need to be revised to incorporate these updates.
- Always tailor template language to reflect the specifics of your study.
These updates are intended to provide clearer, more flexible language while supporting compliance with institutional and regulatory requirements.
For additional guidance, visit the IRB’s Informed Consent webpage for details on consent requirements and processes. Question? Contact IRO@fredhutch.org.
Florence e-Consent Now Available for Fred Hutch and UW Studies
Fred Hutch’s Florence e-consent tool is now available for use by both Fred Hutch and University of Washington investigators. Use for UW-led studies was previously pending a data-sharing agreement between the institutions, which is now in place.
Florence is currently the only Fred Hutch-approved e-consent platform for studies involving greater than minimal risk.
Please contact eRegSupport@fredhutch.org for assistance in setting up Florence.
Reminders: CTCAE v6.0 and Protocol Template
The National Cancer Institute released CTCAE v6.0, an updated version of the Common Terminology Criteria for Adverse Events grading system, in late 2025. The update reflects current clinical practice and improves alignment with MedDRA terminology. All new Cancer Consortium investigator-initiated studies must use CTCAE v6.0.
For the current CTCAE version, be sure to use the latest Cancer Consortium protocol templates when developing new protocols: https://fredhutch.sharepoint.com/sites/CRRWSPO/SitePages/Study-Tools.aspx
Do not update the CTCAE version for active studies; continue using the version specified in the IRB-approved protocol.
Questions? Contact regulatoryaffairs@fredhutch.org.
Guidance on Enrollment of Non-English Speaking Participants
As a reminder, the IRB’s Non‑English Speaking Participants page includes expanded information on consent and translation requirements. An extensive FAQ page was recently updated addressing common questions on this topic. Please review these pages when planning or conducting consent with non‑English speaking participants or when questions arise. Contact IRO@fredhutch.org if your question is not answered there.
2026 NWABR IRB Online Conference Series
The Northwest Association for Biomedical Research (NWABR) is offering a 2026 IRB Online Conference Series, featuring expert-led sessions on current topics in human research protections. The series is designed for IRB members, HRPP professionals, investigators, and research staff, and offers practical guidance on regulatory and ethical issues. Several upcoming sessions are still available for registration.
Continuing education credits are available. As an NWABR member institution, Fred Hutch faculty and staff receive a 50% discount on registration. Use code MEMBER2026 to access the discount.
Learn more and register on the NWABR conference website.
CMUA Requirements Expanded to Additional Chemical Categories
Environmental Health & Safety (EH&S) has expanded oversight of chemical use at Fred Hutch. EH&S review—and a Chemical Memorandum of Understanding and Agreement (CMUA)—is now required for the following:
- Carcinogens
- Hazardous drugs
- Reproductive toxicants
- Highly or otherwise particularly toxic chemicals
- Reactive, peroxide-forming, or explosive chemicals
The CMUA renewal cycle has also changed from every five years to every three years, and the application is now available as an online fillable PDF.
Updates to the Hutch IACUC system to reflect this expanded scope will be implemented in a future release. In the meantime, these requirements are already in effect and should be followed.
What you can do:
- Review your current and planned chemical use to determine whether a CMUA is now required.
- Ensure CMUAs are submitted and renewed on the updated three-year cycle.
Additional information and forms are available here. Questions? Contact EH&S at ehs@fredhutch.org.
Aligning IACUC Protocols with New Funding
If your study receives a fundable score or you anticipate funding, please submit your IACUC protocol or amendment as soon as possible. To avoid delays, do not wait until an award is finalized.
When adding new funding to an IACUC protocol, ensure that all relevant procedures supported by that funding are already approved in the protocol. If not, include these changes on the amendment so the funding can be approved on the protocol, and the work can begin once funding is received.
Order of IACUC Amendments: Personnel First
When you need to add both new lab members and experimental changes to your IACUC protocol, submit a personnel‑only amendment first. These have a quick turn-around time as they do not require IACUC review. Once the personnel amendment is approved, submit a separate amendment for your experimental changes. This allows new lab members to start work without being delayed by protocol review.
Pre-Submission Assistance in Hutch IACUC
Pre-submission assistance, introduced with the 2025 Hutch IACUC system upgrade, lets study teams request feedback from IRO staff or CM veterinarians on draft protocols before formal submission. This feature is intended to help identify issues early and support smoother IACUC review.
Please be aware that responses to pre-submission requests are emailed to all protocol team members. If you didn’t request the assistance, you can ignore the system notification (it has the subject line “Pre-Submission Assistance Ready for Your Review”).
NWABR IACUC Conference
Join us on September 16, 2026, for a day of learning, engagement, and professional growth at the region’s leading conference on animal research ethics and oversight. Fred Hutch is a member organization, so we qualify for a 65% discounted attendance rate. Use code MEMBER at registration.
Register and find additional details at the NWABR website.
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