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Diversity in Clinical Trials Initiative

Diversity in Clinical Trials Initiative

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

Welcome to the official website dedicated to UW’s Diversity in Clinical Trials Initiative (DCTI). This initiative is inclusive of Washington Legislature House Bill 1745 as well as the  guidance from the FDA regarding the equitable selection of clinical trial participants and development of a diversity plan. The Diversity in Clinical Trials Initiative 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 University of Washington is taking this opportunity to review and revise our clinical trial policies with deeper and more comprehensive diversity criteria to usher in a new era of inclusive medical research.

This website 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 Town Halls

Please save the date and join us at one of our upcoming town hall events to learn more about the DCTI. Registration details coming soon.

  • Tuesday, September 4, 2024, 9:00–10:30am Pacific Time
  • Friday, September 20, 2024, 2:00–3:30pm Pacific Time

Have questions? Please contact us via this form.

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 will conduct town halls in summer 2024 (dates TBD) to engage with the UW Community and external research partners to answer questions and hear community feedback.

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 to begin one year after its announcement.

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.

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.

Resource Support

UW Medicine Language Access & Cultural Advocacy is responsible for:

  • Providing information about and access to interpretation, translation, and ancillary communication services to clinical researchers
  • Support researchers wishing to complete bilingual staff assessments
  • Serve as a resource for questions about language access inside and outside of UW
  • Provide information about language access regulations and best practices
  • Create a process for invoicing/payment for interpreter services (spoken/sign language)

Website (requires UW NetID) for Clinical Trials Language Access Resources

Includes:

  • Language Access term definitions
  • Grant writing considerations
    • Costs for interpretation and translation
    • Sample Document Translation Cost Breakdown
    • Links to contact information for vendors contracted with UW Medicine
  • Checklist of considerations when planning community consultation and language access
  • FAQs
  • Establish a process for invoicing/payment for interpreter (spoken/sign language)
  • Collaborate with OHCE for community consultation resources and best practices
  • Educate interpreters and communities in our region about HB1745
  • Collaborate with HSD on interpretation for short form consents
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 seeking to formalize relationships with existing and new community-based organizations (CBOs) to encourage their participation in UW Medicine research activities. This summer, we will be attending and supporting events to connect with these CBOs and community members.

Expanding Reach and Optimizing Resources: We recognize the importance of including underrepresented populations in research endeavors. OHCE is committed to building connections with these communities and will be actively seeking their participation. To further support these efforts, we will be hiring staff positions to support this work.

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.

HSD is currently gathering feedback and finalizing the general policy/approach toward implementing the DCT bill requirements. Drafting content for the specific deliverables including the diversity plan format, and new guidance on equitable selection of subjects and recruitment/enrollment of Limited English Proficient participants.

Data Collection & Reporting

Details to come.

Communication & Training

Details to come.