June 18, 2024
Diversity in Clinical Trials Initiative: Special Edition Newsletter from HSD- June 18, 2024
In this Issue:
WA State Diversity in Clinical Trials Bill
Update
In our April 2, 2024 newsletter, we introduced the new WA State Diversity in Clinical Trials (DCT) bill (2SHB 1745) and its requirements. In our May 7, 2024 newsletter, we outlined the scope and applicability of these requirements for the UW and the University’s approach toward implementation.
With extensive feedback from interested parties, including University and department leadership, and support from the Diversity in Clinical Trials Initiative (DCTI) Strategic Leadership Committee, HSD has put together a policy proposal. This policy was informed by the nature of our UW clinical trials, where they are conducted, and which IRB has oversight.
Clinical Trials at UW in CY23
- FDA Regulated
- 65% of clinical trials
- Trial Location
- 76% UW/Fred Hutch/Seattle Children’s
- 92% Puget Sound region
- IRB of Record
- 45% WCG/Advarra
- 28% UW IRB
- 15% Fred Hutch/Seattle Children’s IRB
- 12% Other IRB
Since the IRB will have primary responsibility for ensuring DCT compliance, our UW policy is organized around the IRB of record, which creates four different strategies for implementing the DCT bill.
UW IRB
For studies reviewed by the UW IRB, we are proposing the development of a supplemental Diversity Plan modeled on FDA guidance, that researchers would complete and submit as part of their initial IRB application.
The rationale for using this model is that the DCT bill directs us to use FDA methods and when FDA finalizes this guidance and implements this approach for sponsor submissions, the UW approach would mirror it, reducing duplication of effort on the part of researchers and sponsors. Since nearly 2/3 of our clinical trials are FDA-regulated, the FDA requirement for a diversity plan would apply to the majority of UW clinical trials.
Cooperative Partner IRBs
Cooperative partners include those institutions within WA State with which the UW has a cooperative IRB review agreement (e.g., Fred Hutch, Seattle Children’s). All these institutions are also subject to the DCT bill requirements and therefore must develop policies and procedures for implementation.
UW research relying on a cooperative IRB will follow the policies and procedures of that institution instead of the UW requirements. HSD is working closely with our cooperative partners to align our practices as much as possible.
Commercial IRBs
Commercial IRBs are not subject to the requirements of the DCT bill. However, Advarra and WCG have agreed in principle to review the UW Diversity Plan. UW researchers would submit a copy of their plan to HSD as part of the authorization process so that we may verify that a diversity plan has been created. Researchers would then include the diversity plan with their WCG or Advarra IRB application and the plan would be evaluated as part of their initial IRB review.
Other External IRBs
These are primarily other academic institutions outside WA State. They too are not subject to the DCT bill requirements and are unlikely to agree to review the standalone UW Diversity Plan. For these studies, UW researchers will submit a copy of their plan to HSD for evaluation during the authorization process. HSD will conduct a review of the plan to ensure it is complete and direct the researcher to include the applicable elements of their plan into the IRB application of the reviewing external IRB.
HSD is working on developing the UW Diversity Plan template along with new supportive guidance to assist researchers in creating diversity plans for their studies. Both the diversity plan and supportive guidance will be made available for public comment. There will also be a series of town halls starting in early September, exact dates TBD, where researchers and other interested parties will have an opportunity to ask questions and provide feedback. More information on these town halls will be published in a future newsletter.
Translation and Interpreter Services
Resources
One of the requirements of WA State’s Diversity in Clinical Trials bill is that researchers provide information to trial participants in languages other than English and provide translation services or bilingual staff. To help researchers meet this requirement, UW Medicine Language Access & Cultural Advocacy (UW LACA) has assumed responsibility for:
- Providing information about and access to interpretation, translation, and ancillary communication services to clinical researchers
- Conducting bilingual staff assessments to qualify those staff to conduct interpretation for research visits
- Serving as a resource for questions about language access inside and outside of UW
- Providing information about language access regulations and best practices
- Creating a process for invoicing/payment for interpreter services (spoken/sign language)
UW LACA has created a website (requires UW NetID) that includes language access resources for clinical trials. Some of the resources already in place include:
- Language Access term definitions
- Budgeting considerations
- Rates for interpretation and translation including a sample document translation cost breakdown
- Links to translation and interpreter vendors contracted with UW Medicine
- Checklist of considerations when planning community consultation and language access
- FAQs
UW LACA is continuing to work on:
- Establishing a process for invoicing/payment for research only interpreter services. Research visits conducted in association with UW Medicine clinical care will continue to receive interpreter services at no additional cost.
- Collaboration with UW Medicine Office of Health Care Equity to provide community consultation resources and best practices
- Education of interpreters and non-English speaking communities in our region about the Diversity in Clinical Trials bill and its requirements
Questions? Please contact UW LACA at uwlaca@uw.edu.
Diversity in Clinical Trials Initiative Website
New
The Institute of Translational Health Sciences (ITHS) has created a new website dedicated to the UW’s Diversity in Clinical Trials Initiative (DCTI). This website will serve as a comprehensive resource hub, providing information, updates, and resources related to the DCTI and its implementation efforts. Check it out for the latest information.