Diversity in Clinical Trials Initiative

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A partnership of our community, the Office of Healthcare Equity, the Human Subjects Division, UW Medicine, and UW School of Medicine. 

The University of Washington’s Diversity in Clinical Trials Initiative (DCTI) aims to enhance representation of historically underrepresented communities among participants in clinical studies, ensuring that medical treatments and interventions are effectively studied across diverse populations, leading to more equitable healthcare outcomes for all individuals and better medicine. 

The DCTI honors Washington Legislature House Bill 1745, (RCW 69.78)  while taking guidance from the FDA regarding the equitable selection of clinical trial participants and development of a diversity plan as well as recommendations from the Multi-Regional Clinical Trials (MRCT) Center 

This page will serve as a comprehensive resource hub, providing information, updates, and resources related to the DCTI and its implementation efforts.

To comply with the requirements of the bill, HSD has developed a Diversity Plan for Clinical Trials. This form is intended to be used with the new Diversity in Clinical Trials Guidance and includes links to relevant information.

For more details about the development of the guidance, refer to this background information and summary of key comments that shaped the guidance.

DCTI Policy and Associated Guidance – Highlights

Key Information:

Beginning January 1, 2026, The UW Diversity in Clinical Trials Policy goes into effect. 

This policy consists of several key components and applies to 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.

There are a limited number of exceptions to this policy.

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

Diversity Plan: Each clinical trial that is subject to the Diversity in Clinical Trials Policy will need to submit a Diversity Plan describing the enrollment of underrepresented groups within the target study population to the Human Subjects Division when requesting IRB approval or requesting external IRB review. HSD has developed a Diversity Plan for Clinical Trials supplement to capture this information. This form is intended to be used with the new Diversity in Clinical Trials Guidance and includes links to relevant information.

Non-English Language Preference: Clinical trials that are subject to the policy must have resources in place to include prospective participants with non-English language preference (NELP) unless there is a compelling reason for their exclusion. See the Diversity of Clinical Trials guidance for specific requirements.

Community Engagement: Clinical trials that are subject to the policy will be required to meet minimal community engagement requirements at all stages of the research lifecycle. Minimal requirements are described in the Diversity of Clinical Trials guidance.

Electronic consent: Clinical trials that are subject to the policy must make e-consent available as an option, unless there is a justified reason for not including e-consent. See the Diversity of Clinical Trials guidance for specific requirements.

Enrollment Data Collection and Reporting: With limited exceptions, most clinical trials that require the submission of a Diversity Plan must provide annual updates on their enrollment targets for underrepresented groups using the OnCore CTMS. See the Diversity in Clinical Trials guidance for specific requirements.

The UW DCTI has been working to develop pre- and post-award resources for researchers and the infrastructure to support the engagement of community partners. The Diversity in Clinical Trials guidance includes a section on Planning, Budgeting, and Resources which points to a number of these resources, some of which are still in development. Additional information and updates will be provided on this website as resources become available.

Contact Us!

Resources and Information

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 – 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 Net ID required). This dashboard allows for filtering based on demographic data, diagnostic codes, and interpreter needs from three years of UW Medicine patients and research participants.

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. The librarians can assist with non-clinical trial research via the Ask Us feature.

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.

Timeline

The effective date for compliance with the new Diversity in Clinical Trials requirements is January 1, 2026. The requirements will apply to new studies submitted to HSD on or after the effective date.

Town Halls

Previous Town Halls
If you were unable to make any of our town halls, please find the recordings and Q&A answers here.

9/4/24 Town Hall on DCTI Policy

9/20/24 Town Hall on Community Engagement

11/19/25 Town Hall

Human Subjects Communications

FAQ

How is “underrepresented community” defined?

The DCTI uses the HB 1745 definition which defines an “underrepresented community” or “underrepresented demographic group” as a community or demographic group that is more likely to be historically marginalized and less likely to be included in research and clinical trials represented by race, sex, sexual orientation, socioeconomic status, age, and geographic location. The DCTI acknowledges there are other underrepresented groups in research (e.g., pregnant women, people with disabilities) and researchers are encouraged to consider inclusion of these groups where appropriate.

Will the new DCTI requirements apply to existing clinical trials?

No. Compliance with the DCTI will take time and resources. As such, the new requirements would apply only to new studies that intend to submit for IRB review one year from when the final policy and guidance are published. Existing active studies are exempt from the requirements. 

What if I don’t meet my target recruitment goals?

Not meeting target recruitment goals does not automatically mean noncompliance with the UW Diversity in Clinical Trials Policy. Investigators are expected to make good‑faith efforts to implement their approved Diversity Plan, monitor enrollment, and address barriers to participation.
If enrollment falls short, researchers should document recruitment challenges, adjust strategies when feasible, and communicate with the reviewing IRB or HSD as needed. The policy emphasizes planning, effort, and responsiveness, not meeting targets at all costs.

What does this mean for studies reviewed by the UW IRB?

Applicable studies must submit the Diversity Plan as part of the Zipline application. When UW is the reviewing IRB for a multi-site trial, the requirement for all sites to comply with the policy will be a condition of the agreement for UW to serve as the reviewing IRB.

What does this mean for studies Reviewed by an External (non-UW) IRB?

The requirements differ depending on which external IRB is conducting the review.

  • Local (WA State) Partners with Established Cooperative Agreements.
    • When the review is conducted by Fred Hutchinson Cancer Center, Seattle Children’s, and Washington State IRBs, UW researchers do notneed to complete the Diversity Plan as part of the Zipline request to use any of these external IRBs for review. The UW will defer to the policies developed by these cooperative partners to comply with the DCT bill.
  • Commercial IRBs and Other External IRBs.
    • When the review is conducted by WCG IRB or Advarra, UW researchers must include the Diversity Plan as part of the UW external review Zipline application and provide the supplement to WCG IRB or Advarra as part of their submission.
    • When the review is conducted by an external IRB that is not WCG IRB, Advarra, or a cooperative partner listed above, UW researchers mustinclude the Diversity Plan as part of the Zipline request to use an external (non-UW) IRB for review. The UW Reliance Team will assess the Diversity Plan for compliance with UW policy. Researchers then incorporate the Plan information into the external IRB’s application materials.
    • For multi-site trials reviewed by commercial IRBs or other external IRBs, the diversity plan and policy requirements technically only apply to the UW site. However, in most cases it will make sense to discuss the target study population and enrollment goals in the context of the larger study and across sites.

Key Contributing Partners

Find out what each team working on the Diversity in Clinical Trials is currently doing.

Implementation Team

The Diversity in Clinical Trials Initiative is overseen by members of the UW Medicine Office of Healthcare Equity and led by a Strategic Leadership Committee comprised of interested parties and subject matter experts. Following the guidance of this committee, there are five implementation working groups and an initiative-wide evaluation committee.

DCTI Implementation Team Org Chart

HSD was responsible for developing a set of institutional policies and supportive guidance for researchers to comply with the bill requirements. Working groups consist of members from the UW Medicine’s Office of Healthcare Equity Language Access & Cultural Advocacy and, the UW’s Human Subjects Division, Clinical Trials Office and Research IT, along with the UW’s School of Medicine Research Graduate and Education.

Language Services

UW Medicine Language Access & Cultural Advocacy is responsible for:

  • Providing information about and access to interpretation, translation, and ancillary communication services to clinical researchers
  • Supporting researchers wishing to complete bilingual staff assessments
  • Serving as a resource for questions about language access inside and outside of UW related to all aspects of research participant communication
  • Providing information about language access regulations and best practices
  • Creating a process for invoicing/payment for interpreter services (spoken/sign language)
  • Collaborating with Office of Healthcare Equity for community consultation resources and best practices
  • Educating interpreters and interpreter vendors about HB1745

Website (requires UW NetID) for Clinical Trials Language Access Resources
This central resource provides guidance regarding:

  • Accessing Interpreter, Translation, and other Communication Services
  • Considerations for inclusion of community consultation and language access
  • Grant writing: Budgeting for language access and community consultation
    • Costs for interpretation and translation
    • Sample Document Translation Cost Breakdown
    • Links to contact information for vendors contracted with UW Medicine
  • Managing Short Form Consents when working with interpreters
  • Language Access term definitions
  • FAQs

What kinds of Language Access resources will researchers need to consider?

  • Document Translation
  • Interpretation (spoken language and sign language)
  • Braille Transcription
  • Auxiliary Devices

Will there be any funding assistance available to cover the cost of translation?
The Office of Healthcare Equity is excited to launch the Language Access Bridge Funding Award in support of WA State RCW 69.78, which aims to improve participation in clinical trials from underrepresented communities.
Clinical trial researchers, with an appointment at UW, can apply for up to $5,000 to support language access and cultural advocacy 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.
For eligibility and more information please see the UW Medicine Office of Healthcare Equity Language Access Bridge Funding website

Can I use AI or machine translation/interpretation resources?

Guidance from the FDA’s language access plan states that machine translation or other AI applications should not be utilized without a qualified human translator to review the text before it reaches the intended audience.
The Americans with Disability Act’s website has extensive guidance around what constitutes effective communication. Elsewhere on ada.gov, concerns regarding discrimination as a result of use of AI are noted.
UW Medicine’s Interim Guidance regarding Generative in Healthcare (and research) indicate that AI can be utilized with several limitations, including the need for careful review of materials generated by AI.
UW’s Language Access & Cultural Advocacy aligns with the above; any machine-generated translation/interpretation must be reviewed by a qualified human before providing to participants, surrogate decision makers, or communities.

Translation Policy
Per federal language access regulations:

  • When 5% or more of the target population speaks a primary language other than English:
    • The study must have translations of any written materials to be read by participants (eg consent forms, recruitment materials, surveys) available at the outset of the research
    • There must be resources in place to support their inclusion for the duration of the study
  • When less than 5% of the target population speaks a primary language other than English:
    • There must be a plan in place to support their enrollment and participation in the research when they are encountered
    • The UW provides services and resources for translation and interpretation

Community Engagement

WA RCW 69.78 includes several provisions to improve engagement with communities who are underrepresented in clinical trials. These include:

  • Identification and recruitment of underrepresented demographic groups
  • Collaboration with community-based organizations (CBO).
  • Use of methods recognized by FDA to identify and recruit members of underrepresented groups.
  • Use of culturally specific recruitment materials.
  • Use of translated materials for individuals with a Non-English Language Preference (NELP) study participants.
  • Provision of interpretive services for NELP participants.
  • Provision of electronic consent.

HSD has developed a Diversity Plan for Clinical Trials and new Diversity in Clinical Trials Guidance and provides supportive resources to meet these criteria and a pathway for documenting planned activities.

Beginning January 1, 2026, clinical trials that are subject to theUW Diversity in Clinical Trials Policy will be required to meet minimum (stage 2) community engagement requirements across the lifespan of the clinical trial. For specifics, see the UW Diversity in Clinical Trials Guidance section “Policy – Community Engagement, Local Context, and Cultural Humility and Competency”

Institutional Policy

Beginning January 1, 2026, The UW Diversity in Clinical Trials Policy goes into effect.

The UW Human Subjects Division (HSD) developed a set of institutional policies and supportive guidance for researchers that meet the requirements of Washington Legislature House Bill 1745, (RCW 69.78). The policy applies to 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.

There are a limited number of exceptions to this policy.

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

Data Collection & Reporting

All clinical trials that require the submission of a Diversity Plan must provide annual updates on their enrollment targets for underrepresented groups using the OnCore CTMS. See the Diversity in Clinical Trials guidance for specific requirements. These data will be deidentified and aggregated to provide an initial baseline for future comparisons of progress toward improving representation at an institutional level.