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).
In this issue:
IRB
- CARDS Authorization and IRB Submission Guidance
- Avoid Training-Related Noncompliance
- Report Participating-Site Continuing Review (CR) Data Before Submitting the Lead CR
- Think Twice Before Closing Your IRB File
- Hutch IRB System Help is Available
- Protect Translated Text: Submit Documents as PDFs
IACUC
CARDS Authorization and IRB Submission Guidance
CARDS is a new resource that provides investigators access to healthcare data and tools to support translational research. Accessing data through CARDS is preferred over direct access to Epic because its authorization process helps ensure that data access is appropriate and aligned with the approved use of the data for the project.
Before identifying CARDS as a data source in an IRB application or other research project documentation, investigators should obtain study-specific data use authorization through the CARDS and CAIA Data Use Authorization Request Form. Data Governance reviews each request and issues a CARDS Authorization Letter (also known as a gatekeeper letter). Authorization is protocol specific and does not extend to other studies.
After obtaining IRB approval or an IRB determination, investigators may request access to CARDS through the CARDS Access Request page (requires VPN or campus access). Access requests require completion of applicable training and role-based access validation.
Below are instructions for how to address CARDS use in common research scenarios:
New studies
Identify CARDS as a data source in the IRB application, describe its use in the protocol, and include the protocol-specific CARDS Authorization Letter with the submission.
Existing studies switching from HIDRA
HIDRA was an earlier mechanism for research access to medical record data. If the only change is replacing HIDRA with CARDS to access data already approved by the IRB, the update may be reported with the next continuing review rather than submitted as a standalone modification. Use a combined modification/continuing review (MODCR) submission to report continuing review data, make any necessary updates to the study record and documents, and include the CARDS Authorization Letter.
Update any references to HIDRA or other outdated systems in the protocol and IRB application. If these documents refer generally to "medical records," no wording changes are required; however, include the CARDS Authorization Letter in the MODCR submission to complete the study record.
Questions? Contact IRO@fredhutch.org about IRB submissions, or datagovernance@fredhutch.org about CARDS authorization.
Avoid Training-Related Noncompliance
IRO has recently seen an increase in noncompliance related to expired Human Subjects Protection (HSP) and Good Clinical Practice (GCP) training. Under the Fred Hutch IRB Training Policy, required training must remain current throughout a team member's involvement in research activities, with applicable HSP and GCP training renewed every three years.
Please check your training status in Hutch Learning and complete any required courses or refreshers before your training expires. If you receive notifications from Hutch Learning that training is nearing expiration or has expired, take prompt action to maintain compliance.
Principal Investigators are responsible for ensuring that all study team members complete and maintain the training required for their roles, as attested to in the initial IRB application and at continuing review. Study teams should regularly monitor training status and plan for renewals before expiration. If IRO must contact a study team regarding expired or incomplete required training, the study may already be out of compliance with IRB requirements.
Remember that training requirements also apply to personnel who prepare or submit IRB materials on behalf of a study, even if they are not otherwise engaged in the conduct of the research.
Not sure which training you need? Visit the IRB Training webpage and HRP-062 - POLICY - Training. Questions? Contact IRO@fredhutch.org.
Report Participating-Site Continuing Review (CR) Data Before Submitting the Lead CR
For multi-site studies reviewed by the Hutch IRB, complete the “Report Continuing Review Data” activity for all participating sites (P-Sites) before submitting the lead study's continuing review (CR) or combined modification/continuing review (MOD/CR). Once the lead submission enters review, participating-site records become non-editable and site continuing review data can no longer be entered or updated (unless the lead submission is returned to the study team for changes).
To avoid delays in continuing review approval, coordinate site reporting early and confirm that all participating-site data have been reported before submitting the lead CR. If participating-site data must be entered or corrected while the lead submission is under review, contact the assigned IRB Coordinator for assistance.
Think Twice Before Closing Your IRB File
Closing a study in Hutch IRB is permanent and cannot be undone. If a closed study later needs to re-open to facilitate additional research activities, data analysis, or other IRB-regulated work, a new IRB application must be submitted.
Before requesting closure, confirm that all study closure criteria have been met, including:
- All study procedures have been completed.
- Collection of private identifiable information is complete.
- Analysis of private identifiable information is complete.
- All research biospecimens have been used, destroyed, or transferred.
- For sponsored studies, the sponsor has agreed that the site may be closed and no further site activities are anticipated.
If additional research activities may be needed, keep the study open. Consider waiting until manuscripts are published, as additional analyses are sometimes required during the publication process. For sponsored studies, confirm that sponsor monitoring, data queries, audits, and other closeout activities have been completed before requesting study closure.
Before submitting a closure request, review the study closure criteria and instructions on the IRB’s Closing or Reopening a Study webpage.
Hutch IRB System Help is Available
Need help navigating Hutch IRB or preparing an IRB submission? The IRO offers virtual Office Hours every Wednesday from 10:00-11:00 a.m., except during holiday weeks. Drop in to ask questions, troubleshoot system issues, or get guidance on preparing your submission.
If you need assistance outside of Office Hours, contact IRO@fredhutch.org.
Protect Translated Text: Submit Documents as PDFs
As an update to the “preserving fonts” topic in the IRO’s May 2026 newsletter, IRO now recommends submitting translated consent forms and other translated study documents in PDF format whenever possible.
When Hutch IRB converts Word documents to PDF, unsupported fonts may be substituted, causing characters to appear incorrectly or become unreadable. This issue is particularly common with non-English text, special characters, and symbols.
To help preserve translated content, convert documents to PDF before uploading them into Hutch IRB and verify that all text and characters display correctly in the PDF. If you need to submit a Word document, use supported fonts or embed fonts before uploading (for instructions, see Preserving Fonts Used in Documents Converted to PDF in Hutch IRB on the Hutch IRB Training webpage).
Protect Translated Text: Submit Documents as PDFs
As an update to the “preserving fonts” topic in the IRO’s May 2026 newsletter, IRO now recommends submitting translated consent forms and other translated study documents in PDF format whenever possible.
When Hutch IRB converts Word documents to PDF, unsupported fonts may be substituted, causing characters to appear incorrectly or become unreadable. This issue is particularly common with non-English text, special characters, and symbols.
To help preserve translated content, convert documents to PDF before uploading them into Hutch IRB and verify that all text and characters display correctly in the PDF. If you need to submit a Word document, use supported fonts or embed fonts before uploading (for instructions, see Preserving Fonts Used in Documents Converted to PDF in Hutch IRB on the Hutch IRB Training webpage).
New Veterinary Verification and Consultation (VVC) Process
The IACUC has approved a new policy that allows for specific (limited) types of significant changes to IACUC protocols to be handled administratively in consultation with a veterinarian authorized by the IACUC. Under this process, known as Veterinary Verification and Consultation (VVC), the veterinarian serves as a subject matter expert to verify that the proposed significant change is compliant with the policy and is appropriate for the animal activity proposed. VVC authorization is at the discretion of the veterinarian, and the veterinarian may choose to refer any VVC request to the IACUC for review for any reason.
Researchers should continue to follow the usual process for submitting protocol amendments and may request VVC consideration in the comment field when submitting.
See the IACUC-approved Comparative Medicine Veterinary Verification and Consultation Policy for more information and examples of when the VVC process may and may not be used.
NCI Grant Applications: New Abstract Guidance for Animal Studies
Beginning with the October 5, 2026 deadline, NCI grant applications proposing animal studies should include two brief statements in the Abstract:
- Why animal models are necessary and alternatives would be inadequate.
- How findings from animal experiments will be validated in a human model.
A sentence or two for each is generally sufficient. For details, review NCI Director Dr. Anthony Letai’s Guidance on Applications for Studies with Animal Models.
Tracking Animal Usage
All researchers are required to track animal usage throughout the life of their protocol. While you may choose your preferred method of tracking, this data must be reported in the required Hutch IACUC format at your triennial review. Most labs use spreadsheets (Excel or shared Google sheets), SoftMouse, or a combination.
Cayuse alone is not sufficient for tracking animal usage because it does not account for breeding or rodent pups prior to weaning. It can, however, help you identify the number of mice ordered or received and your current census. For guidance, refer to IACUC Policy 27.0 Animal Use and Tracking Animal Usage.
Hutch IACUC also does not track animal usage. On the main protocol page’s Animal Counts tab, the far right “Used” column displays 0. This value can be disregarded; it does not reflect your actual animal usage.
Research Team vs. Protocol Team in Hutch IACUC
The Research Team and Protocol Team serve different purposes in Hutch IACUC.
- The Research Team is the broader group associated with the PI’s workspace. You are encouraged to review this at least annually to add any new staff members and remove those who have left.
- The Protocol Team reflects personnel involved with a specific animal research protocol. This is the most critical piece because it gives approval to conduct animal research activities. You must maintain the Protocol Team accuracy and update it as soon as changes are needed to reflect who is conducting research.
For more information, see the Hutch IACUC Guidance on Managing Research and Protocol Teams. Questions about where to add someone? Contact IACUC@fredhutch.org.
Hutch IACUC System Help is Available
Need help navigating Hutch IACUC or creating a protocol submission? The IRO offers virtual Office Hours every Wednesday from 10:00-11:00 a.m., except during holiday weeks. Drop in to ask questions, troubleshoot system issues, or get guidance on preparing your submission.
If you need assistance outside of Office Hours, contact iacuc@fredhutch.org.
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