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).
Technology Used in Human Subjects Research
New: List all electronic technologies in the IRB application and complete a Technology intake form if needed.
As electronic tools play a growing role in research, Fred Hutch has launched a Technology Review pilot to better identify potential risks and provide improved guidance to protect research data and participant information.
As part of this effort, the IRB application now includes updated questions asking investigators to list all electronic systems and tools used in their study—whether or not participants interact with them. This includes tools used to collect, store, analyze, or share data, as well as those used to communicate with participants (e.g., REDCap, text messaging platforms).
What you can do:
- Complete the updated IRB application questions, ensuring all systems and tools are included.
- Determine whether your study involves collecting Restricted Use Data directly from participants using electronic systems.
- If yes, submit the Technology Review intake form early to avoid delays.
Restricted Use Data is the most sensitive category under the Fred Hutch Data Classification Guide and may require additional review by Compliance and IT. Technology Reviews (formerly ISO/GRC reviews) provide risk-based guidance, including required mitigations when applicable (see related article below for examples of Restricted Use Data).
To help streamline this process, IT maintains a Systems and Services Guide listing tools approved for use with sensitive data when configured as specified. Using these tools may reduce or eliminate the need for a separate Technology Review. Systems not listed, or used outside the published configurations, require a Tech Review, and any required mitigations must be addressed as a condition of IRB approval.
For now, the Technology Review applies only to studies reviewed by the Fred Hutch IRB. Studies relying on an external IRB will be included in a later phase of the pilot.
Questions? Contact Compliance at integrity@fredhutch.org (Technology Review), or Data Governance at datagovernance@fredhutch.org (data classifications).
Helpful resources:
Note: These links require Fred Hutch credentials. If you need access, contact integrity@fredhutch.org.
InfoSec Policies and Standards:
Systems and Services Guide:
https://centernet.fredhutch.org/u/it/infosec/governance-risk-and-compliance/sensitive-data.html
Data Classification Guide:
https://centernet.fredhutch.org/u/data-science-lab/data-governance/data-classification.html
Examples of Restricted Use Data
The IRB focuses on data classified as Restricted Use Data under the Fred Hutch Data Classification Guide. Review the guide for full details, and use the examples below to help determine whether your study data may fall into this category:
- Participant contact information (such as phone number, home address, email).
- Protected Health Information (PHI), including Limited Data Sets.
- Individually identifiable health information not regulated by HIPAA (for example, employee or student health data).
- Research data containing personally identifiable information (PII) or other sensitive data that could cause harm if disclosed.
- Identifiers combined with sensitive elements (such as Social Security number, full date of birth, medical history, or biometric data).
- Photographs, audio, or video recordings of participants.
- Sensitive health information (e.g., mental health, substance use, sexually transmitted infection data).
- Certain genomic data that could be used to identify an individual.
Questions? Contact datagovernance@fredhutch.org about data classifications at Fred Hutch.
Creating an External IRB Study: New Online Training Available
A new online training, Creating an External IRB Study, is now available for Cancer Consortium investigators and study team members working on studies to be reviewed by an external IRB.
When Fred Hutch is engaged in human subjects research but relies on an external IRB, an administrative file in the Hutch IRB system is still required. The new training explains how to create and submit that file, helping ensure institutional requirements are met while navigating external IRB processes.
This training provides step-by-step guidance on:
- Reliance agreements and when they apply
- Required information and documents
- Creating and submitting an External IRB study in the Hutch system
- Responding to system errors and clarification requests
- Understanding submission status, endorsement, and finalization
It also highlights common issues identified by IRO staff to help teams avoid delays.
Coming soon: A companion training on managing External IRB administrative files, including amendments, continuing review, and study closure.
Additional training resources, and information about our weekly Office Hours, are available on the Hutch IRB training page. If you have questions about the External IRB process, contact IRBreliance@fredhutch.org.
Common Enrollment Reporting Errors in Continuing Review Submissions
IRB reviewers and analysts frequently identify errors in enrollment totals reported during continuing review submissions. Most of these issues are avoidable and typically result from:
- Simple calculation errors in the Continuing Review Supplement, or
- Inconsistencies between the sub-totals and totals entered in the SmartForm and the Continuing Review Supplement enrollment tables, questions 3.1 and 3.2.
- Inconsistencies in written summary responses in the CR Supplement (in particular, questions 2.1 and 3.1.a.). Note, CR Supplement question 2.1 does not explicitly request enrollment data; however, any enrollment information included in the response must be consistent with the rest of the submission.
To prevent additional clarifications being requested on this topic prior to or after review, carefully review your enrollment data before submission and follow the color-coded guidance below.
Calculation Check
Cumulative Enrollment Totals (Reference Continuing Review Supplement question 3.1)
For the first three columns, the following relationship must always be true:
**“Not Eligible / Not Enrolled” includes any participant who consented but did not start the study or treatment, such as: Screen failures or participants who withdrew after consenting
The total enrollment reported in the SmartForm must match the Continuing Review Supplement, question 3.1:
Key Tips:
Before submitting your continuing review:
- Double‑check your math in the enrollment tables (Continuing Review Supplement questions 3.1 and 3.2).
- Confirm consistency between the data entered in the SmartForm and the Continuing Review Supplement questions.
- Ensure totals reflect enrollment for the current continuing review period.
- Ensure any text description responses are consistent with the enrollment data being reported.
Taking a little extra care to verify these details can help avoid clarifications and/or required modifications.
Preserving Fonts in PDFs in Hutch IRB
Some documents submitted to the IRB for review and approval get stamped in Hutch IRB. When the stamp is applied, the system converts those documents to PDF. During the PDF-conversion process, the fonts used in the Word document may change unexpectedly. This is because only certain fonts are recognized (“supported”) by the system during the PDF conversion process. Supported fonts will appear as expected in the final PDF. For unsupported fonts, the PDF conversion will attempt to replace them with a similar supported font. Because fonts have different character libraries, this conversion can result in characters in the PDF that do not match the original Word document.
This issue occurs most often with special characters, symbols, or non-English language characters.
Study teams may refer to this document for a list of supported fonts, and instructions for preserving unsupported fonts in documents that get converted to PDF in Hutch IRB.
Date Change for NWABR IACUC Conference
In our last newsletter, we announced the annual IACUC Conference offered by the Northwest Association of Biomedical Research (NWABR). The conference date has been changed to September 16, 2026. In-person and virtual attendance options are offered.
Join 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 the code MEMBER at registration.
Register and find additional details at the NWABR website:
Contact Us
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