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
- Important Margin Requirements for Uploaded Documents
- New Diversity in Clinical Trials Policy
- Recent IRB Policy & Form Updates
- Updates to Hutch IRB Local Research Locations
- Study Funding in Hutch IRB – What Teams Need to Know
IACUC
- Save the Date: Biomedical Research Awareness Day
- Local Continuing Education Opportunity
- Reminder: Renew Your Animal Use Medical Screening
IRO
Important Margin Requirements for Uploaded Documents
The IRB approval stamp is applied to the upper right corner of documents. Though somewhat transparent, the stamp can obscure underlying text. To ensure readability, we recommend documents submitted for IRB approval be prepared with a minimum 0.75-inch top margin.
Right-aligned header text can also be obscured, so we recommend any header text that is significant for the reader be given a right-hand indentation of 1.5 inches.
In the illustration below, note that the top margin is more important than the right margin for the stamp clearance in relation to a document’s body text, assuming the top margin is 0.75 inches or greater.
Things to keep in mind:
- The IRB stamp placement is automatic. IRO staff cannot adjust where the stamp is placed.
- The IRB stamp works best with standard 8.5” x 11” page size. While the stamp will still apply to non-standard page sizes, documents that contain a mix of different page sizes or layout orientations (portrait and landscape) may result in inconsistent stamp placement or visibility.
- Header text can be within the document’s top margin. A document’s header height can also affect the placement of body text on the page, regardless of what the top margin is set to. If there are questions about how the IRB stamp will interact with a document’s layout settings, study teams may contact IRO Support before submitting the documents for review.
- A top margin of 1 inch provides more standard spacing between the stamp and body text, but 0.75 inches is the minimum to avoid the stamp overlaying body text.
New Diversity in Clinical Trials Policy
Effective January 1, 2026, Fred Hutch has implemented a new Diversity in Clinical Trials policy to comply with Washington State RCW 69.78, which aims to improve participation in clinical trials among underrepresented communities. There are no new requirements for investigators submitting to the Fred Hutch IRB, as Fred Hutch was already meeting the standards outlined in the law. This policy formalizes and describes how the institution meets these standards.
Recent IRB Policy & Form Updates
Effective February 2, 2026, several policy and form updates have been issued to enhance protections for participants who may fall under special regulatory categories. Changes also respond to feedback from researchers, IRB members, and IRO staff.
If you have any questions about the updated documents, please contact IRO@fredhutch.org.
Policy Updates
- When using electronic informed consent (e-consent), study teams should have a paper copy available as a backup—both for use during electronic outages and for individuals who prefer paper consent.
Research Involving Special Populations
- Added language on the rare circumstance of enrolling a potential child participant who is a ward of the state.
- Added guidance for when re-consent of participants is required (e.g., procedure or risk change) but an individual participant’s decision-making capacity has changed since their original consent and therefore consent of a Legally Authorized Representative (LAR) is needed. If the study was not approved for enrollment of individuals with diminished decision-making capacity, investigators must submit a Modification before re-consenting with an LAR. This only needs to be assessed at the time a re-consent is needed for another reason (e.g., procedure or risk changes).
- Added a new section on recruitment and enrollment of employees:
- Employees should not be targeted solely for convenience.
- When actively recruiting employees, describe measures to prevent coercion or undue influence, and ensure the consent form clearly states that participation—or non-participation—will not affect employment.
- Investigators should consult unit leadership before actively recruiting employees; the IRB may request documentation of this consultation.
Use of Interpreter Services and Translated Documents
- Clarifies that the short form consent process may be used for pediatric enrollment.
- Explains appropriate consent process when using a fully translated consent form.
Form Updates
Please make sure to use the current versions of all IRB forms for new submissions. A 90-day grace period applies; after that, outdated forms will be returned for resubmission.
- Revised questions related to Certificates of Confidentiality for clarity and completeness.
- Updated HIPAA sections to reflect:
- Availability of a single Fred Hutch/UW Medicine HIPAA authorization form for non-transplant studies.
- Availability of translated versions of that single HIPAA form.
- Added a reminder to consider participants who may now require an LAR for re-consent.
- Aligned re-consent personnel options with those used for initial consent in the IRB Application.
- Updated prompts to ensure teams verify that Hutch IRB has the most current drug or device documentation.
Reportable New Information (RNI) Supplement
- Revised to encourage more thorough Corrective and Preventive Action (CAPA) descriptions, as incomplete information frequently causes screening delays and IRB queries.
Updates to Hutch IRB Local Research Locations
Hutch IRB has been updated to reflect several naming changes to the Local Research Locations selections. These changes support consistency across our systems and documentation as well as the newly renamed Sloan Clinic.
Below is a reference table summarizing the updates:
Previous Local Research Location Name | New Local Research Location Name |
Fred Hutch - Center for Community Health Promotion (Sunnyside, WA) | Fred Hutch - OCOE-Sunnyside |
*New* | Fred Hutch - OCOE-Spokane |
Fred Hutch - South Lake Union - Clinic | Fred Hutch - Sloan Clinic |
UW Medical Center - Northwest (formerly Northwest Hospital) | UW Medical Center - Northwest |
Study Funding in Hutch IRB – What Teams Need to Know
Understanding how study funding is captured in Hutch IRB is essential for ensuring accurate records, smooth IRB review, and compliance with federal and institutional requirements. Here’s a quick refresher to help your team stay on track.
Why Funding Information Matters
One of the responsibilities of the IRB under the Pre-2018 Requirements of the Common Rule is to review federal grant applications and the human subjects research activities they support. The IRB’s role is to ensure participants are not exposed to risk when there may be insufficient resources to meet the proposed study aims. At Fred Hutch, we also have an institutional responsibility to track funding on studies before signing off on the release of funding, which applies to studies under the revised 2018 Common Rule as well.
We apply this review standard to all external funding sources, including:
- Federal grants
- Nonfederal grants
- Industry contracts
- Foundation awards
- Restricted gifts
- Other monetary and non-monetary support (such as drugs, equipment, use of facilities, etc.)
Study Funding Sources must be identified in Hutch IRB at the time of initial submission to the IRB and kept up to date throughout the life of the study. Funding should be updated via a Modification whenever changes occur, such as execution of an amended contract or extension of a grant expiration date.
Hutch IRB Study Funding Sources Section Overview
Below is a snapshot of the fields you’ll see in the Study Funding Sources section in Hutch IRB:
Field-by-Field Guide
- Prime Sponsor/Institution: The organization issuing the award directly to the PI’s institution, for example if UW issues the award to FH, and a Fred Hutch-primary appointed individual is the PI of the study, UW is the prime sponsor.
- Flow Through Sponsor: The original source of the funding, even if the PI’s primary institution does not receive the award directly from that organization. Example for a FH PI: If UW received funds from the NIH and then issued a subaward to FH, NIH is the flow-through sponsor. (Think of this as where the funds are flowing from.)
- Sponsor’s Funding ID: The ID or federal grant number assigned by the funding organization.
- Project ID: The 6-digit budget ID (PeopleSoft).
- Funding Proposal/Award Number: The Hutch Grants funding proposal number and the PeopleSoft award number, as applicable. For example, for a new Cancer Center Support Grant (CCSG) pilot, enter both "FP5000AAAA/5000ZZZZ".
- Start Date: Provide the overall award project start date (not the budget start date). Start date may be left blank only if pending or unknown at the time of initial submission, but it should be updated once known.
- End Date: Provide the overall award project end date (not the budget end date). For contracts or when the study support is not limited by date, (i.e., support is through completion of the study) enter the final date as 01/01/2099.
- Funding Source Title: Enter the title of the funding source, if there is one. For example, you can enter the grant title in this field. If there is no funding source title, you should enter the study title.
- Attachments: A funding source document (FSD) must be attached for all support. The only exception is internal funding, for example discretionary or departmental funds, gifts or donations, endowment support, royalties, etc.
Hutch IRB Data Entry Requirements for Different Types of Funding
**Please reference the tagged fields in the screenshot above**
If the study is funded through a FEDERAL GRANT:
- Fields 1, 3–9
- Field 2 only if applicable
If the study is funded through a CONTRACT OR FOUNDATION:
- At initial submission, enter at least fields 1 and 6–8, using study title as funding title. The final funding source document (field 9) will be a contingency of initial IRB approval.
- Once the budget is finalized, submit a Modification to enter the Project ID (field 5) and any additional information newly available.
If the study is funded through a GIFT, DONATION or INTERNAL FUNDING:
Only the following fields are required to be completed:
- Field 1 (Prime Sponsor/Institution)
- Field 6 and 7 (Support Start/End Dates)
- No attachment required, but provide one if gift or donation documentation is available.
Save the Date: Biomedical Research Awareness Day
Fred Hutch’s third annual Biomedical Research Awareness Day (BRAD) will take place on Wednesday, April 15, 2026. BRAD celebrates the essential role of animal studies in advancing biomedical science and recognizes the dedicated professionals who provide exceptional care for research animals.
More details about the event will be shared as the date approaches—stay tuned!
Local Continuing Education Opportunity
The annual IACUC Conference put on by the Northwest Association of Biomedical Research (NWABR) is a fantastic training opportunity coming on April 27, 2026. Fred Hutch is a member organization, so we qualify for a 65% discounted attendance rate. Use the code MEMBER at registration. In-person and virtual attendance options are offered.
Attendees will gain access to the latest updates in regulatory requirements, best practices, and hands-on solutions that directly support their daily work. In addition, this event offers invaluable networking opportunities, fostering connections that enhance collaboration and knowledge-sharing across the field. Join us for a day of learning, engagement, and professional growth at the region’s leading conference on animal research ethics and oversight.
Register and find additional details at the NWABR website: https://www.nwabr.org/nwabrconference
Reminder: Renew Your Animal Use Medical Screening
Annual participation in the EH&S Animal Use Medical Screening (AUMS) Program is required for personnel who:
- Work directly with animals, their tissues, fluids, or housing materials
- Work in areas where animals are present (shared lab spaces)
- Enter the vivarium as part of their role (e.g., Facilities, Engineering)
The IACUC has recently seen delays in amendment approvals due to expired AUMS clearances. Before submitting an amendment, please check the Training tab in your protocol workspace to confirm all listed staff have current AUMS clearance (and any other required trainings).
Individuals can review their AUMS status or complete questionnaires through the Enterprise Health Employee Portal via MyApps. For assistance, contact Occupational Health at ohn@fredhutch.org.
Staff Updates
The IRO is now hiring for the following positions:
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.