Diversity in Clinical Trials Guidance and Background and Summary of Comments
The University of Washington must comply with a new Washington State law (RCW 69.78) which aims to improve participation in clinical trials from underrepresented communities. Implementation of the bill’s requirements is overseen by the UW Medicine Office of Healthcare Equity and led by a Strategic Leadership Committee comprised of interested parties and subject matter experts. There are also five working groups supporting various aspects of the Diversity in Clinical Trials Initiative (DCTI). HSD is responsible for developing a set of institutional policies and supportive guidance for researchers to comply with the bill requirements.
HSD drafted a diversity plan form to be submitted as a supplement to the IRB application and related guidance outlining the UW policies and procedures for complying with the State law.
In developing these materials, HSD sought input from the UW community including consultation with subject matter experts and research leadership, publishing drafts for a 30-day public comment period (August 16-September 16, 2024), and hosting virtual town halls to answer questions and hear feedback.
In the attached document, HSD provides background information about the development of the guidance and a summary of the key comments we received, much of which shaped the final guidance and supplement which were published January 2025.
Change Notes
Background and summary of comments published – 12.23.2024