March 3, 2026

For the Record- March 3, 2026: Diversity Plan Supplement, UW Medicine Honest Broker Program

In this Issue:

Diversity Plan for Clinical Trials Supplement

Significant Revisions

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 recruitment or consent 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 HSD’s experience and feedback from researchers, we made revisions to the Diversity Plan for Clinical Trials Supplement. These revisions clarify and provide additional guidance for the information that HSD needs in order to assess the Diversity Plan. A couple of minor revisions were made at the same time to the Diversity in Clinical Trials guidance to harmonize with the Diversity Plan document.

Significant changes include:

  • Tables in the Enrollment Goals section. Columns have been added to capture the demographics of the patient population at the UW site(s) to make comparisons with proposed enrollment goals easier. Biological sex has been pulled out of the race and ethnicity tables and made into a separate table.
  • Guidance in the Rationale section. The Rationale for Enrollment Goals section was expanded to provide researchers with more guidance on specific information that HSD needs to assess the Diversity Plan. Individual text boxes were added after guidance prompts to allow researchers to organize relevant information to facilitate HSD’s review.
  • Community Engagement section. Guidance and clarifications were added to two of the Stage 2 Community Engagement requirements to better explain what activities HSD is considering for each requirement during assessment.

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

UW Medicine Honest Broker Program

Review and Updates

In our July 2025 newsletter, we announced important changes to how UW Medicine clinical data may be used for research. Since July 1, 2025, all research-related data sets containing UW Medicine Identified or De-Identified Clinical Data must undergo review by a certified Honest Broker to ensure alignment with the approved IRB application and proper de-identification methods.

This month’s update provides a brief refresher and highlights several new clarifications and tools now available to support researchers.

Honest Broker Options

  • Research IT: Can pull data sets and/or review data already extracted to ensure compliance with the approved IRB (fee-based service).
  • Affiliated Developers/Analysts: Individuals who have completed annual Honest Broker training may pull data sets for research.
  • Researchers Pulling Their Own Data: Investigators may extract data themselves, but the data set must be reviewed by a certified Honest Broker before release.

For full governing rules, researchers should review the UW Medicine compliance policies COMP.307 (Honest Broker Policy) and COMP.306 (Release of Clinical Data for Research Purposes).

New & Expanded Tools for Researchers

Research IT continues to develop resources to streamline research data requests and support compliant workflows. Existing resources include templates for Data Use Agreements (DUAs) and procedural style guides, along with how-to’s and checklists.

Newly available or expanded tools include:

Additional self-service tools will be added in the coming months to include:

  • A specialized, Epic-integrated instance of REDCap to support secure research data workflows
  • Registry lists (that include data owners and stewards)
  • Standard new proposal (boilerplate) language

Details about the Honest Broker Program, including FAQs, are available on the UW Medicine Honest Broker Program page. Questions can be directed to Research Data Services at ritdatahelp@uw.edu. For more information about Research IT, visit the Research IT webpage.