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 91探花Researchers

Both Support Compliance with FDA 21 CFR 11 Requirements

91探花researchers now have access to two new electronic consent (e-consent) solutions designed to support compliant, participant friendly consent processes –聽, which is now live, and聽 91探花Florence eConsent, launching聽April 15, 2026. Both tools support compliance with聽聽for electronic records and signatures required for FDA-regulated research.

These tools also help advance the聽聽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聽and聽electronic data capture聽within the same validated REDCap environment鈥攊deal for studies needing integrated data and consent workflows.
  • Signed consent forms are聽automatically retained聽within the REDCap system for required retention periods.
  • 搁别辩耻颈谤别蝉听REDCap Part 11 training, including user management and record locking procedures essential for compliance.
  • Project specific service fee听补辫辫濒颈别蝉.

More information, including instructions for requesting access, is available at聽.

Key Features 鈥� 91探花Florence eConsent

  • Maintained and supported by the聽聽and integrated with Florence eBinders.
  • Participants authenticate their identity via an聽email-based account, with study teams helping as needed.
  • Signed consent forms can be聽saved directly to the study鈥檚 regulatory binder聽or downloaded.
  • 搁别辩耻颈谤别蝉听Florence-provided training聽for all study team users.
  • Includes a聽one-time fee聽for industry sponsored and initiated studies.

More information will be available on the 91探花Clinical Trials Office website at launch or shortly thereafter. Study teams may contact the 91探花Clinical Trials Office at聽uwcto@uw.edu聽with 鈥� 91探花Florence eConsent鈥� in the subject line.

Reminder聽– As with all electronic consent methods, using any e-consent tool requires 91探花IRB approval (for 91探花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聽HSD鈥檚 Consent Guidance聽for more information or contact聽hsdinfo@uw.edu聽with questions.

Consultation Service to Support Community Engaged Research

Now Available!

Community partners from 16 organizations, together with the聽, are collaborating to deepen partnerships between researchers and marginalized communities鈥攅nsuring that research is shaped by community priorities and contributes to eliminating health disparities across Washington State.

罢丑别听聽consultation service supports researchers by:

  • 叠耻颈濒诲颈苍驳听bidirectional communication聽between community and research teams
  • 翱蹿蹿别谤颈苍驳听education and guidance聽on best practices for community engagement
  • 厂耻辫辫辞谤迟颈苍驳听community leadership聽within research processes
  • Helping create聽equitable recruitment pathways聽for participation in clinical trials

This service supports compliance with the 91探花specific RCW 28B.20.540 requirement to enroll traditionally underserved populations in clinical trials as outlined in聽HSD鈥檚 Diversity in Clinical Trials Guidance.聽The guidance describes how these statutory and ethical requirements are incorporated into study design and recruitment planning, including聽expectations for community engagement.

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

Capacity Note:聽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 91探花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, 91探花Medicine has expanded its security review requirement. This requirement was previously limited to School of Medicine research.聽It now applies to all 91探花research using AI outside of a聽聽when the research:

  1. 鲍蝉别蝉听,听or
  2. Targets enrollment of聽 91探花Medicine patients

For studies reviewed by the 91探花IRB:

  • HSD鈥檚 IRB Protocol forms now include a question prompting researchers to obtain the required security review.
  • IRB approval聽will not聽be issued until documentation is provided that the 91探花Medicine security review has been completed.

For studies reviewed by a Non- 91探花IRB:

  • HSD has updated its external IRB request form to alert researchers to this requirement.
  • HSD will聽not聽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聽聽website. For questions about this process, contact聽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,听 91探花Finance has raised the University鈥檚 internal threshold for collecting tax reportable payee information (including SSNs) from $600 to $1,500.

HSD has updated our聽consent听补苍诲听subject payment聽guidance and revised our聽consent template language聽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 91探花internal reporting threshold of $1500 and SSN will no longer be collected.

For questions about the change in 91探花internal reporting requirements, contact 91探花Procurement Services at聽pcshelp@uw.edu. For questions about consent form template language or HSD guidance changes, email聽hsdinfo@uw.edu.

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

Enhanced Clarity and New Process

91探花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 91探花will review research projects that involve both institutions. The longstanding cooperative agreement between 91探花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 91探花provides IRB review and oversight for both institutions for research led by 91探花investigators in which Public Health Seattle King County (PHSKC) is engaged. 91探花does not provide review for PHSKC research in which 91探花is not engaged or for PHSKC led research in which 91探花does not have a leadership role.聽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 91探花provides review for.
  • Researchers may use the聽UW/Fred Hutch HIPAA Authorization Form聽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 91探花IRB.

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

Upcoming JEDI Research Retreat

April 24, 2026

罢丑别听 91探花Medicine Justice, Equity, Diversity & Inclusion Center for Transformational Research (UWM JEDICTR)聽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.

.
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聽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聽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 91探花research community.

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