May 1, 2026

For the Record-May 1, 2026: Diversity In Clinical Trials Initiative Special Edition

In this Issue:

Diversity Plan for Clinical Trials Supplement

Significant Revisions and New Resource

HSD’s Diversity in Clinical Trials policy went into effect on January 1, 2026 and applies to new clinical trials submitted to HSD where UW employees or agents are responsible for or engaged in enrollment activities. With some exceptions, clinical trials submitted to HSD need to submit a Diversity Plan for Clinical Trials Supplement to describe how their study is addressing enrollment of underrepresented groups within the target study population.

Based on researcher feedback and HSD experience with the revised supplement, we have made revisions to the layout and instructional text of the questions. The Diversity in Clinical Trials policy requirements and information collected in the supplement are unchanged.

Significant changes include:

  • Integration of Enrollment Goals and Rationale sections. To improve the workflow of completing the supplement, questions in the Enrollment Goals and Rationale sections were combined and rearranged. Study teams will describe any needed rationale for planned enrollment goals for each underrepresented group immediately after describing the target population demographics and enrollment plans.
  • Clarification of non-English language preference section. The non-English language preference section was revised to clarify the expectations of the UW policy for enrolling participants who prefer a non-English language. Study teams now only need confirm that they will meet a set list of translation and interpretation requirements or explain what alternative steps they will take to comply with the UW policy.
  • New resource – annotated supplement. The annotated version includes explanations of the questions and additional guidance and examples of the information HSD needs to review the Diversity Plan.

Please email hsdinfo@uw.edu if you have questions about the revisions or the UW Diversity in Clinical Trials policy.

 

Diversity in Clinical Trials Town Hall

Wednesday, May 27, 2026 | 1:00–2:30pm PT

Registration is now open for the fourth webinar on the Diversity in Clinical Trials Initiative. This webinar will provide:

  • Important policy updates following the January 1, 2026 go-live date
  • Overview of currently available resources to support compliance with the policy including recruitment, community engagement, and eConsent resources

The Town Hall will conclude with a 30-minute Q&A session. Attendees are encouraged to submit questions in advance during registration. A recording will be available on the DCTI website.

UW Medicine Patient Demographics Dashboard

Updated

The UW Medicine Patient Demographics dashboard has been updated to include demographic information about UW Medicine patients from Epic within the past three calendar years (2023-2025).

This free 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.

The dashboard is accessible to UW employees while on campus or when actively connected to a UW VPN service such as Husky OnNet. Non-employee UW Affiliates (e.g., Fred Hutch) with an active UW NetID may request access to the dashboard by submitting an Access Request Form available from the dashboard’s “Overview” page on the UW BI Portal.

Questions? Contact hsdinfo@uw.edu.

 

Temporary Exclusion to E-Consent Requirement for FDA-regulated Studies

Expires November 1, 2026

WA State law and the UW’s Diversity in Clinical Trials (DCT) policy requires that clinical trials subject to the policy must make e-consent available as an option to participants, unless there is a legitimate reason for exclusion. In addition to the standard reasons for exclusion, HSD has been temporarily allowing FDA-regulated studies an exclusion from the e-consent requirement because the UW did not provide any enterprise supported e-consent tools that are compliant with FDA 21 CFR 11.

In our April 7, 2026 newsletter we announced the launch of UW REDCap Part 11 and UW Florence eConsent. Both tools are compliant with FDA 21 CFR 11 requirements for electronic signatures for clinical trials subject to FDA regulation. As such, we will be phasing out our temporary exclusion. Since use of these e-consent tools comes with costs, we are continuing our exclusion for another 6 months to allow study teams time to budget. New UW clinical trials subject to the DCT policy that are submitted to HSD for initial review/authorization on/after November 1, 2026, will be expected to offer e-consent unless they meet one of the other standard exclusions.

Existing DCT studies already approved with the temporary exclusion do not need to make any changes. Fred Hutch DCT studies relying on the UW IRB will also continue to be allowed to apply the temporary exclusion until the Fred Hutch instance of Florence eConsent is approved for use at UW.

Questions? Contact hsdinfo@uw.edu.

 

Diversity in Clinical Trials Initiative- Language Access Bridge Funding

Reminder

In alignment with the Diversity in Clinical Trials Initiative (effective January 1, 2026), the Office of Healthcare Equity (OHCE) launched the Language Access Bridge Funding Award.

UW Researchers conducting a clinical trial can apply for up to $5,000 to support language access needs—such as document translation, interpreter services, and Communication access real-time translation (CART) services—that will help researchers more effectively recruit and engage underserved populations in clinical trials.

Funding is intended for real-time language access needs (within 30 days)—not for future (e.g., grant planning, holding funds for the future, etc.) or unspecified use—as OHCE will be submitting payment for the desired support services for approved applications.

Researchers are required to submit an initial quote for support needs during the application process.

Awardees will be provided with a decision regarding their application within 2 weeks of their submission.

Translation & Interpreter Services – Resources for translation, interpretation, and other communication services or quotes for services are available on this Clinical Trials Resources page (UW Net ID required). Questions about these resources can be directed to uwlaca@uw.edu.

Learn more and apply here: Language Access Bridge Funding – Office of Healthcare Equity

Questions about this resource can be directed to ohce@uw.edu and Juliana Garcia (garcia00@uw.edu) with “Language Access Bridge Funding” in the subject line.