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Diversity in Clinical Trials Initiative

ITHS › Diversity in Clinical Trials Initiative

Diversity in Clinical Trials Initiative

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

Page last updated: Jan 17, 2025

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, while taking guidance from the FDA regarding the equitable selection of clinical trial participants and development of a diversity plan.

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:

  • 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.
  • In addition, the Diversity Plan includes new requirements for enrolling participants with a Non-English Language Preference (NELP).

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..

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 the IRB on or after the effective date. This delayed effective date acknowledges that researchers will need time to obtain the funding and resources to support these new requirements.

Town Halls

There will be additional Town Halls coming in Spring 2025 about available resources and support for the DCTI. Please watch this space for dates and times.

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 Town Hall on DCTI Policy

9/20 Town Hall on Community Engagement

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?

For studies reviewed by the UW IRB, information will be collected at the time of continuing review about the level of success in meeting the enrollment target set by the researcher for enrolling underrepresented groups per their study-specific diversity plan. Researchers will be asked to provide a root cause analysis if their targets are not being met and propose new strategies for improvement. If needed, researchers may be referred to University resources. The focus will be on education and support versus penalizing any particular study or researcher that has otherwise followed their diversity plan. For studies reviewed by an external IRB, we intend to gather similar data through an annual survey. Data from both groups will be compiled and used to advise HSD and the University of common issues/challenges researchers face and inform future policy, guidance, education, and resource support.

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.
Implementation Team

The work towards implementation of the DCTI is underway and is being 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 that make up the Diversity in Clinical Trials Initiative Task Force. There are also five working groups supporting implementation of various aspects of the bill.

HSD is responsible for developing a set of institutional policies and supportive guidance for researchers to comply with the bill requirements. Other working groups are looking at such things as necessary pre- and post-award resources for researchers and how best to engage different community partners.

Latest News

What’s Happening Now?

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

Language Resources

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

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.

Will there be any funding assistance available to cover the cost of translation?

 Limited bridge funding will be available for unfunded and underfunded studies. The application for funding is estimated to open Fall 2025. Check back for more information as it becomes available in 2025.

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

The Office of Healthcare Equity (OHCE) is excited to announce several initiatives aimed at strengthening our community engagement efforts in research.

Building Partnerships: OHCE is actively formalizing relationships with existing and new community-based organizations (CBOs) to encourage their participation in UW Medicine research activities. Through the fall and winter, we will be meeting with Community Organizations to discuss Diversity in Clinical Trials and explore their interest in participating in a Community Based Research Collaboratory – to be formally launched in Summer of 2025. Through this process, we seek to create true collaboration, where decision making and governance is truly shared with our community (not just informed).

Expanding Reach and Optimizing Resources: OHCE has hired one position so far to focus on Community Engagement efforts, with another role in development. OHCE has also been working with the Andy Hill Cancer CARE fund to develop pathways for funding communities directly. We are seeking additional opportunities to fund the Community Based Research Collaboratory through more sustainable means.

Centering Community Voices: By strengthening our community partnerships and expanding our reach, OHCE aims to ensure that all voices are represented in UW Medicine research, ultimately leading to more equitable health outcomes. OHCE will be working to ensure community voices are engaged across multiple facets of this effort.

Institutional Policy

The role of the Human Subjects Division (HSD) is to develop a set of institutional policies and supportive guidance for researchers that meet the requirements of the DCT bill including:

  • 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.

The final policy and associated guidance were published on December 23, 2024 and announced in the HSD January 7, 2025 newsletter. The new policy has an effective date of January 1, 2026 and will apply to new clinical trials submitted to HSD on or after the effective date. Researchers submitting a new study subject to the DCT requirements will be required to complete a new Diversity Plan for Clinical Trials Supplement.

HSD will continue to work on additional policy and IRB review-related deliverables through 2025.

Data Collection & Reporting

The DCTI’s Data Collection & Reporting group has aggregated an initial de-identified dataset from Epic and from OnCore that provides demographic data from three years of UW Medicine patients and research participants.

These data provide an initial baseline for future comparisons and serves as the initial dataset that will be used during the design and development of reports starting in early 2025.