UW Research

November 4, 2025

For the Record-November 4, 2025: Dissolution of Committee B, DCTI Updates

In this Issue:

Dissolution of Committee B & Department Re-Assignments

Effective December 9, 2025

Due to changing workload patterns HSD will be disbanding IRB Committee B effective December 9th, 2025. Committee B was one of four long standing IRB review committees supporting HSD.

HSD’s review system is based on pairing each academic department with a specific IRB committee and supporting team. This dissolution will require some shifting of new and existing IRB protocols.

New Submissions
All departments currently assigned to B will be reassigned to one of the remaining three review teams (i.e., A, D, and J). New submissions received on or after December 9th will be assigned to their new team in the Zipline system.

Existing Studies
Existing studies will be automatically re-assigned to their new IRB committee and associated team in Zipline by HSD.

Who is my new team and how do I contact them?
All information about new team assignments and contact details will be available on our website on December 9th.

We are deeply appreciative of the time, careful thought, and integrity that Committee B members have brought to this very important process for protecting participants in UW research.

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

 

 

Updated Diversity in Clinical Trials Guidance and Supplement

Effective January 1, 2026

At the beginning of this year, HSD announced the publication of a Diversity Plan for Clinical Trials Supplement and Diversity in Clinical Trials Guidance to comply with the bill passed by WA State legislature (RCW 69.78) aimed at improving participation in clinical trials from underrepresented communities. These documents have now been updated and will go into effect on January 1, 2026. The requirements will apply to new clinical trials submitted to the IRB on or after this effective date.

Key Information:

  • UW Policy requires a Diversity Plan to improve the enrollment of underrepresented groups within the target study population for all research that meets the definition of a clinical trial and where UW employees or agents are responsible for or engaged in recruitment or consent activities.
  • This policy applies:
    • Regardless of where the interventions occur;
    • To UW site(s) being reviewed by an external (non-UW) IRB; and
    • To all sites as a condition of the UW IRB agreeing to review on behalf of non-UW institutions and individuals.
  • Exceptions: The guidance describes some limited exceptions to the policy.

What’s New?

  • Clarification of policy for community engagement. The updated guidance introduces a Spectrum of Community Engagement in Clinical Trials Research outlining different stages of engagement and associated requirements. All clinical trials that require submission of a Diversity Plan for Clinical Trials must at minimum meet Stage 2 requirements of this spectrum which include, but are not limited to, the following:
    • Ensuring that trial design and set-up is informed by individuals who are knowledgeable about the community or a literature review.
    • Informing the community about the research.
    • Sharing the aggregate results of the research with participants.
  • Clarification of policy requiring use of e-consent. All clinical trials that require submission of a Diversity Plan for Clinical Trials Supplement must make e-consent available as an option, unless there is a justified reason for not including e-consent. The guidance has been revised to clarify that the justification must demonstrate that exclusion is based on legitimate study needs, not preference. Examples include:
    • Timing of Study Visits. If all recruitment and consent occur during in-person clinical visits (e.g., pre-op appointments, emergency room encounters).
    • Population Characteristics. When the target population inherently requires in-person interaction (e.g., physical impairment, severe visual impairment).
    • Operational Feasibility. If implementing e-consent would impose disproportionate cost or complexity without improving access (e.g., Part 11 compliance for studies that never use remote consent).
  • Incorporation of new policy for reporting enrollment requirements. As explained in HSD’s October 17 Newsletter, all clinical trials that require submission of a Diversity Plan for Clinical Trials Supplement must provide annual updates on their enrollment for underrepresented groups using the OnCore Clinical Trials Management System (CTMS). The guidance has been revised to incorporate these new requirements.
  • Additional information about resources: The guidance has also been revised to include information about the Language Access Bridge Fund which was announced in the HSD October 17 Newsletter and the UW Medicine Patient Demographics Dashboard described in this newsletter.

Questions. Contact hsdinfo@uw.edu with any questions.

 

 

 

Diversity in Clinical Trials Town Hall

November 19, 2025

Registration is now open for the final Diversity in Clinical Trials Town Hall before the University’s policy goes into effect on January 1, 2026. The Town Hall will be held on Wednesday, November 19th from 3-4:30pm Pacific Time.

This webinar will review:

  • Policy requirements and applicability
  • Currently available tools and resources to support compliance
  • Future resources in development (e.g., 21 CFR 11 compliant e-consent tools)

There will be a question & answer session. Attendees are encouraged to submit their questions in advance when registering.

 

 

 

UW Medicine Patient Demographics Dashboard

New Tool

A UW Medicine Patient Demographics dashboard is now available in the UW’s BI Portal to support researchers in developing their Diversity Plans for Clinical Trials. This resource is especially helpful for studies recruiting from the UW Medicine patient population, providing access to aggregated demographic data to inform enrollment goals.

Key Features:

  • Free and accessible to anyone with a UW NetID
  • Built from a dataset aggregated from Epic and OnCore
  • Allows filtering by:
    • Demographics (age, race, sex, sexual orientation, ethnicity)
    • ICD-10 code blocks
    • Language interpretation needs
  • Shows percentages of UW Medicine patients across:
    • Demographics (age, race, sex, sexual orientation, ethnicity)
    • Language interpretation needs
    • Area Deprivation Index (ADI)
    • Social Vulnerability Index (SVI) Themes

This tool is designed to help researchers align their enrollment goals with the requirements of the UW Diversity in Clinical Trials policy and complete the Diversity Plan for Clinical Trials Supplement. It provides a data-driven foundation for setting realistic and inclusive recruitment targets based on the populations served by UW Medicine.

Questions? Contact hsdinfo@uw.edu.

 

 

 

UW Diversity in Clinical Trials (DCT) Policy Reporting Requirements

Clarification

Recently HSD published information in our October 17, 2025, newsletter regarding new reporting requirements for clinical trials subject to the UW Diversity in Clinical Trials (DCT) policy.

To clarify, clinical trials that already must report into OnCore (e.g., oncology-related, have UW Medicine billable activities, and/or require Epic activation for orders for participant tracking purposes) do not need to make any additional reporting nor do study staff need to take any additional training. These studies will continue to follow existing requirements.

Beginning January 1, 2026, NEW clinical trials that are not already required to report in OnCore AND are subject to the UW DCT policy will follow the new OnCore reporting requirements outlined on the UW Reporting Requirements for Clinical Trials page.

Regardless which primary pathway you are reporting into OnCore, starting January 1, 2026, HSD will require proof of study registration in OnCore for all NEW clinical trials that are subject to the UW DCT policy that submit an:

  • Initial application submission for UW IRB review, or
  • Initial request seeking authorization to use an external IRB.

This proof can be satisfied by uploading a copy of the OnCore CTMS email confirmation to your submission in Zipline.

Contact us at hsdinfo@uw.edu with questions.