August 16, 2024
Diversity in Clinical Trials Initiative: Special Edition Newsletter from HSD- August 16, 2024
In this Issue:
Draft Diversity Plan & Associated Guidance
For Public Comment
As promised in our June 18, 2024 newsletter, the HSD has 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).
The draft supplement and associated guidance are posted on our website for public comment now through September 16, 2024. Feedback may be embedded as comments and/or tracked changes within the Word document or in whatever method you prefer. Please send all feedback to hsdinfo@uw.edu.
The HSD intends to publish the final supplement and guidance this winter 2025. The new requirements will go into effect one year from the publication date (i.e., winter 2026) to give researchers time for the preparatory work at the pre-award/study design stage that 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.
Upcoming DCTI Town Hall
Reminder
Registration for the September 4, 2024 (9:00-10:30am Pacific Time), virtual town hall meeting regarding the UW’s Diversity in Clinical Trials Initiative remains open. This event is intended to provide researchers and other interested parties with the opportunity to ask questions and provide feedback on the now published draft SUPPLEMENT Diversity Plan for Clinical Trials and associated guidance.
The event will begin with a 30-minute overview presentation, followed by a 60-minute Q&A. Attendees are encouraged to submit in advance any questions they would like addressed using the Contact Us form on the UW DCTI website. For those unable to attend, a post-session recording will be available.
Revised Short Form Consent Policy
Update
HSD is making changes to its policy for using short form consent when enrolling participants with limited English proficiency (LEP). These changes are motivated by updated FDA guidance as well as the development of our new UW draft guidance on Diversity in Clinical Trials.
Some of the more significant changes include:
- Prospective IRB approval to use the short form method is now required for all greater than minimal risk and FDA-regulated studies
- Study participants must be provided an IRB-approved translated consent form at the participant’s next study visit or within 60 days, whichever occurs first
- Researchers must notify the IRB of use of the short form consent process and provide a translated consent form as a modification in Zipline within 2 weeks
- In most instances, the required impartial witness must be proficient in the language of the oral consent presentation
With the above additional requirements, HSD will no longer limit use of short form consent to only studies that provide the prospect of direct benefit that is not available outside the research. Instead, the IRB will evaluate the appropriateness of using the short form consent process for an individual study at the time of initial review.
A draft of the revised short form consent policy is available on our website. A final version will be published when the SUPPLEMENT Diversity Plan for Clinical Trials and associated guidance are finalized (i.e., winter 2025).
Please contact hsdinfo@uw.edu if you have questions.