Finalized Diversity in Clinical Trials Guidance and Revised Short Form Consent Policy Implemented

Finalized Diversity in Clinical Trials Guidance and Plan

Effective January 1, 2026, the University of Washington (UW) will implement new requirements to improve the enrollment of underrepresented groups in clinical trials. This initiative follows the 2023 WA State legislature's passage of the Diversity in Clinical Trials (DCT) bill, aiming to ensure that clinical trial data reflects the diversity of the population for better health outcomes.

Key Information:

• UW Policy mandates a Diversity Plan for all clinical trials where UW employees or agents are involved in recruitment or consent activities.
• The policy applies regardless of where the interventions occur, to UW sites reviewed by an external IRB, and as a condition for UW IRB to review on behalf of non-UW institutions.
• New requirements include enrolling participants with a Non-English Language Preference (NELP).

For Studies Reviewed by UW IRB:

• Applicable studies must submit a Diversity Plan as part of the Zipline application.
• For multi-site trials, all sites must comply with the policy as a condition for UW to serve as the reviewing IRB.

For Studies Reviewed by External IRBs:

• Requirements vary depending on the external IRB. UW researchers must include the Diversity Plan in their Zipline application for reviews conducted by WCG IRB or Advarra.
• A one-year transition period is provided for compliance, with the effective date set for January 1, 2026.

Revised Short Form Consent Policy Implemented

Changes to the short form consent policy took effect on January 1, 2025, requiring prospective IRB approval for greater than minimal risk and FDA-regulated studies.

Key Changes:

• Prospective IRB approval is now required for using the short form consent method in certain studies.
• Researchers must notify the IRB after using the short form consent process and provide a translated consent form within 30 days.
• Participants must receive an IRB-approved translated consent form within two weeks of IRB approval.

For Ongoing Research:

• Studies that are greater than minimal risk or FDA-regulated must obtain prospective IRB approval before using the short form consent process.
• Minimal risk studies not FDA-regulated do not need IRB approval for the short form consent process but are encouraged to provide a translated consent form.

For Research Reviewed by External IRBs:

• UW researchers must follow the external IRB's policies regarding short forms, which may not require prospective approval.
• A translated consent form must be submitted to the reviewing IRB within 30 days of using the short form consent process.

Resources and Questions

UW is developing resources to support researchers in meeting these new requirements. For questions, contact hsdinfo@uw.edu.