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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: Nov 12, 2024

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.

The University of Washington is currently reviewing and revising its clinical trial policies with deeper and more comprehensive diversity criteria to usher in a new era of inclusive medical research.

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

Implementation of these policies will be gradual and phased in throughout the next year and will apply to new studies only. Existing clinical trials will not be subject to the new requirements. The effective date for compliance will be one year from publication of the new policies. Please see the timeline below for more details.

DCTI Policy and Associated Guidance

Thank you to everyone who provided feedback on the proposed new SUPPLEMENT Diversity Plan for Clinical Trials and associated policy/guidance. The public comment period is now closed. HSD is busy evaluating all the comments and questions received.

The HSD intends to publish the final SUPPLEMENT and guidance this January 2025. Compliance with the new requirements would be one year from the publication date (i.e., January 2026) though preparatory work at the pre-award/study design stage will need to occur before then. The new requirements would only apply to new studies submitted to the IRB on or after the 2026 effective date.

Timeline

Phase 1: The scope of the University’s policies regarding the DCTI will be developed and the project phases will be formulated into an implementation plan. Input from our research community, institutional and community partners, and other interested parties will be actively solicited. The DCTI Task Force has conducted two town halls thus far and plans to produce more in the future. Please see the recordings for the town halls below, and don’t hesitate to reach out to our contact form if you have a topic you’d like to see covered in a future town hall. This phase is predicted to end January 2025.

Phase 2: Once the policies are developed, the Task Force will identify resources, continue to build out the implementation plan and begin to train research teams. The implementation plan will include a phased rollout of the policy which is predicted to begin in January 2025 and end January 2026.

Phase 3: Implementation of the Diversity in Clinical Trials Initiative will begin. New studies submitted to the IRB on or after this date will need to follow the Diversity in Clinical Trials policies. Phase 3 is to begin one year after Phase 2 begins (anticipated January 2026).

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.

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 with Limited English Proficiency (LEP) study participants.
  • Provision of interpretive services for LEP participants.
  • Provision of electronic consent.

There are several deliverables HSD will be creating or revising (e.g., guidance, updated IRB applications forms) which will eventually live on the HSD website.

The HSD developed a new SUPPLEMENT Diversity Plan for Clinical Trials and associated guidance to assist researchers in complying with the requirements of RCW 69.78 (WA State’s new Diversity in Clinical Trials law). This was published for a public comment period from August 16 – September 16, 2024. A Town Hall presentation on the proposed new guidance and supplement was given on September 4, 2024 (recorded) and responses to questions during the event are published here.

The HSD intends to publish the final SUPPLEMENT and guidance this January 2025. Compliance with the new requirements would be one year from the publication date (i.e., January 2026) though preparatory work at the pre-award/study design stage will need to occur before then. The new requirements would only apply to new studies submitted to the IRB on or after the 2026 effective date.

Data Collection & Reporting

A group that includes membership from UW Medicine Research IT, the UW Medicine Clinical Trials Office, the CTMS Program Office, the School of Medicine’s Office of Research and Graduate Education, and the ITHS has been working to develop the UW’s aggregated and de-identified dataset of UW Medicine patients and research participants pulled from both Epic and OnCore. This anonymous dataset will provide counts across several demographic characteristics including age, race, ethnicity, sex, and ZIP code to assist researchers in identifying their target study population. The initial generation of this dataset is scheduled to be completed by December 2024, with planned periodic refreshes to keep the data current. The successful generation of this dataset in 2024 will lead to the group’s next steps of designing and developing reports in 2025 that reference the dataset to address the reporting requirements for the Diversity in Clinical Trials Initiative.