June 2, 2026

For the Record- June 2, 2026: Reliance Web Resources, Expiration Dates for Expedited Studies, More

In this Issue:

Streamlined IRB Reliance Navigation and Resources for UW Researchers

Available 5/29/2026

External and single IRB processes are often complex, and UW researchers have asked for clearer, easier to find guidance and resources to navigate the process. HSD has updated its website to improve navigation and expand support for completing reliance submissions.

What鈥檚 new for researchers?

Improved navigation for IRB reliance guidance

Information about IRB reliance processes is now centralized in a new 鈥�IRB Reliances鈥� page linked from the HSD homepage. This page brings together guidance for both:

  • Studies that rely on an external (non-UW) IRB, and
  • Studies where the UW IRB serves as the reviewing IRB for another institution (e.g., Seattle Children鈥檚 or Johns Hopkins).

This reorganization provides a clearer, more streamlined starting point for researchers.

Expanded Zipline guidance

Revised and expanded instructions are now available on the HSD website to support researchers submitting applications in Zipline. These include:

These updates provide clearer direction and practical support for navigating complex reliance processes.

Thank you to the researchers who provided feedback on early designs and helped shape these improvements. If you have questions or suggestions for future enhancements, please contact hsdinfo@uw.edu.

Expiration Dates for Expedited Research

Beginning June 2026

In anticipation of future changes that will impact HSD鈥檚 IRB review system (Zipline), HSD is discontinuing the practice of approving expedited applications without an expiration date. All new expedited applications reviewed by the UW IRB on or after June 1, 2026, will be assigned an expiration date with a three year approval period, unless a shorter approval period is otherwise required by regulations or the IRB. This change will help ensure regular review of ongoing research and support accurate tracking of active studies.

Existing Studies with No Expiration – Status Inquiry Process
For studies previously approved by expedited procedures without expiration dates before June 1st, researchers will receive automated notifications from Zipline requesting submission of a Continuing Review application to confirm the study is still active and avoid study closure. These email notifications will be sent through Zipline at 60 days and 30 days prior to potential closure of the study.

As part of the continuing review process, studies will be reassessed and may require minor updates, such as alignment with current data security standards.

If no response is received by the deadline in the notice, HSD will presume that the study is inactive and administratively close the study.

Due to the large number of studies in Zipline without expiration dates, notifications will be staggered over approximately 12-18 months to help manage the volume of continuing review applications.

Questions? Contact us at hsdinfo@uw.edu.

Zipline Downtime

June 10, 2026

Zipline will be unavailable while we make some updates to the e-IRB system the evening of June 10, 2026, 6 pm to approximately 8 pm Pacific Time. Please remember to save your work and log off before this time.

Included in this patch:

  • New notifications for studies with no expiration date (review the eNews article for more details)
  • Updated notification to Ancillary Reviewers outlining the responsibilities of a Faculty Advisor (review the eNews article for more details)

All other updates are internal facing and should not impact researchers.

If you have any questions, please contact hsdinfo@uw.edu.

Faculty Advisor Role & Responsibilities

Update

Faculty advisor review has long been required for student and resident led research. This review must be completed and documented in Zipline before the study can be approved. What鈥檚 new is that HSD guidance and policy have been updated to be more explicit about the role and responsibilities of Faculty Advisors for student and resident-led research.

HSD has clarified that Faculty Advisors are responsible for ensuring that:

  • The study design is scientifically sound and accurately described in the IRB application
  • The study is conducted as approved
  • Any safety and compliance events are properly reported
  • Appropriate steps (e.g., closeout, transfer) are taken when a student leaves the UW and the project is finished

For all the requirements for student and resident researchers, visit HSD鈥檚 Getting Started webpage.

Diversity Plan for Clinical Trials Supplement 鈥� Example Language

New Resource

In last month鈥檚 special edition Diversity in Clinical Trials Initiative Newsletter, HSD introduced the annotated Diversity Plan for Clinical Trials Supplement, a tool designed to provide expanded guidance for completing the form.

Building on that foundation, HSD has now incorporated approvable example language for select questions into the annotated Supplement. These examples are intended to give researchers subject to the Diversity in Clinical Trials policy clearer direction and practical support in preparing their responses.

By combining the guidance and examples in a single resource, HSD hopes that this enhanced tool will help researchers to more effectively meet the requirements of the Diversity in Clinical Trials policy and reduce review turnaround time.

NIH Updates Definition of 鈥淚ntervention鈥� for Clinical Trial Determinations

No Material Change Anticipated

On March 27, 2026, NIH to align with the . The revised definition describes an intervention as 鈥渂oth physical procedures used to collect information or biospecimens (such as venipuncture) and manipulations of a participant or the participant鈥檚 environment performed for research purposes.鈥�

We do not anticipate that the revised definition will materially change which studies are considered Clinical Trials. NIH鈥檚 broader clinical trial definition and review process have not changed, and most studies are expected to receive the same determination as they would have under the previous definition.

Adding e-Consent to Externally Reviewed Studies

New Addendum

To support study teams who wish to add a new use of eConsent to already authorized studies, HSD has developed a new REQUEST External IRB Review 鈥� E-Consent Addendum. This short addendum replaces the need to revise and resubmit the external request form. Once complete, study teams should follow the Zipline instructions to create and submit a Study Update. Once HSD鈥檚 authorization to use eConsent has been granted, follow your external IRB鈥檚 requirements to obtain IRB approval. For questions contact hsdrely@uw.edu.

HSD Administrative Fee Change for Industry Clinical Trials

Update

Effective July 1, 2026, HSD鈥檚 administrative fee will be changing from $2117.78 to $2,103.36. This one-time fee only applies to industry-sponsored-and-initiated clinical trials reviewed by a non-UW IRB where the contract was negotiated by UW鈥檚 Office of Sponsored Programs (OSP) or Clinical Trials Office (CTO). This fee is charged because this type of research has an indirect cost rate that does not cover HSD鈥檚 costs for performing necessary administrative and regulatory oversight activities. The rate change reflects updated costs for HSD to perform these activities. It is common for universities and research institutes to charge these fees for industry research.

Applicable external authorization requests submitted in Zipline on or after the effective date will have the new rate applied.

Contact hsdrely@uw.edu if you have any questions.