April 7, 2026

For the Record- April 7, 2026: E-Consent Tools, CBRC Consultation Service, More

In this Issue:

New Electronic Consent Options Now Available for UW Researchers

Both Support Compliance with FDA 21 CFR 11 Requirements

UW researchers now have access to two new electronic consent (e-consent) solutions designed to support compliant, participant friendly consent processes – UW REDCap Part 11, which is now live, and UW Florence eConsent, launching April 15, 2026. Both tools support compliance with FDA 21 CFR 11 requirements for electronic records and signatures required for FDA-regulated research.

These tools also help advance the UW Diversity in Clinical Trials Initiative by offering more flexible, accessible consent options that can reduce participation barriers and better support diverse study populations.

Key Features & Requirements – REDCap Part 11

  • Enables both electronic consent and electronic data capture within the same validated REDCap environment—ideal for studies needing integrated data and consent workflows.
  • Signed consent forms are automatically retained within the REDCap system for required retention periods.
  • Requires REDCap Part 11 training, including user management and record locking procedures essential for compliance.
  • Project specific service fee applies.

More information, including instructions for requesting access, is available at UW Research IT’s website.

Key Features – UW Florence eConsent

  • Maintained and supported by the UW Clinical Trials Office and integrated with Florence eBinders.
  • Participants authenticate their identity via an email-based account, with study teams helping as needed.
  • Signed consent forms can be saved directly to the study’s regulatory binder or downloaded.
  • Requires Florence-provided training for all study team users.
  • Includes a one-time fee for industry sponsored and initiated studies.

More information will be available on the UW Clinical Trials Office website at launch or shortly thereafter. Study teams may contact the UW Clinical Trials Office at uwcto@uw.edu with “UW Florence eConsent” in the subject line.

Reminder – As with all electronic consent methods, using any e-consent tool requires UW IRB approval (for UW reviewed studies), or External IRB approval and HSD review (for externally reviewed studies). All applicable requirements for electronic consent documentation must be met. Please review HSD’s Consent Guidance for more information or contact hsdinfo@uw.edu with questions.

Consultation Service to Support Community Engaged Research

Now Available!

Community partners from 16 organizations, together with the UW Medicine Office of Healthcare Equity, are collaborating to deepen partnerships between researchers and marginalized communities—ensuring that research is shaped by community priorities and contributes to eliminating health disparities across Washington State.

The Community Based Research Collaboratory (CBRC) consultation service supports researchers by:

  • Building bidirectional communication between community and research teams
  • Offering education and guidance on best practices for community engagement
  • Supporting community leadership within research processes
  • Helping create equitable recruitment pathways for participation in clinical trials

This service supports compliance with the UW specific RCW 28B.20.540 requirement to enroll traditionally underserved populations in clinical trials as outlined in HSD’s Diversity in Clinical Trials Guidance. The guidance describes how these statutory and ethical requirements are incorporated into study design and recruitment planning, including expectations for community engagement.

Researchers interested in receiving CBRC consultation for an upcoming or existing study are encouraged to complete the CRBC intake form.

Capacity Note: As the Office of Health Care Equity begins integrating these consultations into existing meeting structures over the coming months, our availability is limited.

Expansion of UW Medicine Security Review Requirement for Research involving Artificial Intelligence

Effective Immediately!

To help ensure the appropriate protection of patient information in light of the increased privacy and reidentification risks introduced by AI technologies, UW Medicine has expanded its security review requirement. This requirement was previously limited to School of Medicine research. It now applies to all UW research using AI outside of a secure UW Medicine environment when the research:

  1. Uses UW Medicine Data, or
  2. Targets enrollment of UW Medicine patients

For studies reviewed by the UW IRB:

  • HSD’s IRB Protocol forms now include a question prompting researchers to obtain the required security review.
  • IRB approval will not be issued until documentation is provided that the UW Medicine security review has been completed.

For studies reviewed by a Non-UW IRB:

  • HSD has updated its external IRB request form to alert researchers to this requirement.
  • HSD will not hold its reliance authorization while the researcher completes this review, and researchers do not need to submit documentation of the security review outcome to HSD.

For questions and additional information:
For information about how to obtain a security review, refer to the UW Medicine Information Security Risk Management Program website. For questions about this process, contact uwmed-security@uw.edu.

New 1099 MISC Reporting Thresholds for Participant Payments

Updates

The Internal Revenue Service (IRS) has increased the threshold for reporting research participant payments as miscellaneous income on Form 1099 MISC from $600 to $2,000 and indicated the threshold is expected to adjust annually for inflation. In response, UW Finance has raised the University’s internal threshold for collecting tax reportable payee information (including SSNs) from $600 to $1,500.

HSD has updated our consent and subject payment guidance and revised our consent template language to reflect this change.

Consent forms utilizing the prior $600 threshold language do not require revision. However, researchers are welcome to submit a modification in Zipline to revise or remove the language if total payments are below the new UW internal reporting threshold of $1500 and SSN will no longer be collected.

For questions about the change in UW internal reporting requirements, contact UW Procurement Services at pcshelp@uw.edu. For questions about consent form template language or HSD guidance changes, email hsdinfo@uw.edu.

Revised Cooperative Agreement with Public Health Seattle & King County (PHSKC)

Enhanced Clarity and New Process

UW and Public Health – Seattle & King County (PHSKC) have completed negotiations and have reached agreement on a revised cooperative IRB agreement. This cooperative agreement establishes the policies and processes under which the UW will review research projects that involve both institutions. The longstanding cooperative agreement between UW and PHSKC was last updated in 2003. Since then, many changes have taken place in the regulatory landscape surrounding multi-institutional research including the NIH single IRB policy and the Common Rule single IRB requirement. Features of the new agreement:

  • Reiterates that UW provides IRB review and oversight for both institutions for research led by UW investigators in which Public Health Seattle King County (PHSKC) is engaged. UW does not provide review for PHSKC research in which UW is not engaged or for PHSKC led research in which UW does not have a leadership role. There is no change from the previous agreement, however shifting institutional practices have led to a lack of clarity in recent years about which studies UW provides review for.
  • Researchers may use the UW/Fred Hutch HIPAA Authorization Form to obtain authorization from study participants for research use of PHSKC held Protected Health Information (PHI), eliminating the need for different forms and allowing researchers access to an authorization form in 25+ different languages.
  • Researchers must obtain the sign-off from the PHSKC Research Administrative Review Committee (RARC) for each study in which PHSKC will rely on UW. This process will be similar to how HSD requires sign-off from most other institutions relying on the UW IRB.

For more information, read HSD’s new webpage on research involving PHSKC or contact hsdrely@uw.edu.

Upcoming JEDI Research Retreat

April 24, 2026

The UW Medicine Justice, Equity, Diversity & Inclusion Center for Transformational Research (UWM JEDICTR) will host a one day retreat on April 24th to bring together researchers from across the biomedical, translational, public health, clinical, and educational spectrum. The retreat will be held in-person at the Douglas Classroom at the Center for Urban Horticulture.

The retreat will feature reflections on JEDI principles in research and working sessions focused on values, mission, vision, and strategic priorities. Breakfast and lunch will be provided.

Space is limited to 45 participants.

Register here.
A waitlist will open if capacity is reached. Please feel free to share the invitation with colleagues.

Questions may be directed to Keenan Dowers at keenand@uw.edu.

Diversity in Clinical Trials Town Hall

Save the Date

Save the date for the upcoming virtual Diversity in Clinical Trials Town Hall on Wednesday, May 27, 2026 from 1:00-2:30pm PT.

This session will provide important policy updates following the January 1, 2026 go-live date and highlight resources available to support compliance across the UW research community.

A live Q&A will be included. Zoom registration information will be shared soon. Visit the DCTI website for updates.