UW Research

January 6, 2026

For the Record- January 6, 2026: DCT Policy Live, Longer Turnaround Times for External IRB Clinical Trials

In this Issue:

Diversity in Clinical Trials Policy- Now Live

Effective January 1, 2026

It has now been more than a year since HSD’s Diversity in Clinical Trials Guidance was published to comply with WA State RCW 69.78, which aims to improve participation in clinical trials from underrepresented communities. This advanced publication was done to provide ample time for researchers to familiarize themselves with the policy requirements and ensure that they have the necessary resources in place to support implementation. The policy is now live effective January 1, 2026, and applies to new clinical trials submitted to HSD 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.
  • The 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.
  • Study registration and enrollment reporting in OnCore are also required. Review our November 4th eNews for details.

Available Resources:

The UW has several resources available to support researchers. These include:

  • 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).
  • Language Access Bridge Funding – Up to $5,000 to support language access and cultural advocacy needs for unfunded or underfunded studies. More information is available on the UW Medicine Office of Healthcare Equity website.
  • Institute of Translational Health Sciences (ITHS) Recruitment Support Service – A free service that includes assistance with study design, budget development, input on recruitment materials, and connections to other resources. For more information, visit the Recruitment Support Service website.
  • UW Medicine Patient Demographics dashboard (UW Net ID required) – Free, online tool designed to help researchers align their enrollment goals with the requirements of the Diversity Plan. It provides a data-driven foundation for setting realistic and inclusive recruitment targets based on the populations served by UW Medicine.
  • UW Health Sciences Library – Librarians are available to assist research teams with identifying underrepresented groups described in PubMed and the ClinicalTrails.gov registry for the study’s target population. For help submit a request via the DCTI Library Intake form.
  • E-consent tools – UW has two enterprise supported electronic consent platforms, ITHS REDCap and Docusign. Further information can be found at HSD’s UW Electronic Signature Tools page. Additional Part-11 compliant e-consent tools are expected in early 2026.

If you have questions about other resource needs or applicability of the Diversity in Clinical Trials policy requirements for your research, contact hsdinfo@uw.edu.

 

 

Longer Turnaround Times for External Authorizations for Clinical Trials

Reminder

As announced in our December 2nd newsletter, beginning January 1, 2026, HSD anticipates longer turnaround times for authorization requests to rely on a non-UW IRB for clinical trials subject to the new Diversity in Clinical Trials policy. This is due to the additional time required to review the study’s diversity plan. As this process is new for both researchers and HSD, it is difficult to know exactly how much time this will add to the review. It will depend on the quality and completeness of the plan submitted and study team responsiveness to clarification requests. We anticipate that assessment of a diversity plan could extend HSD’s review time by several days to a week or more.

Please review our December eNews for more information about how you can ensure a shorter review time.

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