UW Research

August 5, 2025

For the Record- August 5, 2025: SOM AI Review, Translated HIPAA Forms for Pregnancy, More

In this Issue:

Changes to When School of Medicine AI Research Requires IRB Review

Effective September 2, 2025

In our July 1 newsletter, HSD announced upcoming plans to implement an augmented IRB review process for School of Medicine research involving artificial intelligence (AI) systems in September.

The focus of this announcement is on just one component of this process and that is the expansion of how HSD defines “human subjects research” (HSR). HSD’s current interpretation of the regulatory definition of a human subject does not capture some research that should be reviewed by the IRB to mitigate the risks to data subjects that may result from re-identification of their data. We are therefore revising our interpretation to include use of data that is at high risk of re-identification and could lead to significant harm if re-identified. This means that IRB review will be required for some research involving AI that did not previously require IRB review.

How is the definition of “human subjects research” changing?
Starting September 2, 2025, it will be a new UW Policy to require IRB review for research involving AI and the secondary use of de-identified data when all of the following criteria are met:

  • The research is led by a School of Medicine PI;
  • The research involves use of UW Medicine Data; and
  • Re-identification of the data would cause it to fall into risk levels 3 or 4 of HSD’s Guidance on Data Security Requirements (e.g., personal health information, financial account information, HR records, information about illegal behavior).

This policy does not apply to secondary use of de-identified data if either of the following criteria are met:

How do you determine if your research requires IRB review?

  • HSD does not require the submission of an IRB application for a formal determination that a study is not human research requiring IRB review. Researchers may make their own determination using the information above. This information will be incorporated into HSD’s Human Research Determination worksheet on September 2nd.
  • If you have questions about the expanded definition of human research and whether your study requires IRB review, please reach out to us at hsdinfo@uw.edu.

 

 

Translated Pregnant Participants/Partners HIPAA Authorization Form

Published July 31, 2025

In our June 3, 2025 newsletter, we announced the translation of the updated HIPAA Authorization Form for research into 24 languages to facilitate and support the inclusion of study participants with a non-English language preference. At the request of researchers, and in partnership with Fred Hutch and the UW Office of Healthcare Equity, we have now translated the HIPAA Authorization form for Pregnant Participants/Partners into the same 24 languages. These translated documents may be found on the HSD website.

If the language you need is not posted, contact hsdinfo@uw.edu.

 

 

Diversity in Clinical Trials Initiative- Support Services

Reminder

The January 1, 2026 effective date for compliance with the University of Washington’s Diversity in Clinical Trials Initiative (DCTI) (supporting WA State RCW 69.78) is only months away.
To assist researchers with compliance, the University has established several supportive services including:

  • UW Health Sciences Library – Librarians are available to assist research teams with identifying underrepresented groups described in PubMed and the ClinicalTrails.gov registry for the study’s target population. For help submit a request via the DCTI Library Intake form.
  • Institute of Translational Health Sciences (ITHS) Recruitment Support Service – A free service that includes assistance with study design, budget development, input on recruitment materials, and connections to other resources. For more information, visit the Recruitment Support Service website.
  • Translation & Interpreter Services – Resources for translation, interpretation, and other communication services are available on this Clinical Trials Resources page (UW Net ID required). Questions about these resources can be directed to uwlaca@uw.edu.

If you have questions about other resource needs or applicability of the DCTI requirements for your research, contact hsdinfo@uw.edu.

 

Advance Consultation about the UW as a Single IRB

Reminder

Serving as the Single IRB for a multi-site trial or multi-institutional collaborative research requires a significant commitment of limited HSD and UW IRB resources. Therefore, HSD must be consulted in advance of a funding application if a researcher wants to use the UW as the Single IRB for a study. HSD policy continues to be that it cannot guarantee UW IRB review of any multi-institutional research for which it has not been consulted in advance of any commitment to funding agencies or other institutions. Contact us at hsdrely@uw.edu if you would like to set up a consultation.

 

Zipline Tidbits

On the move?

Are you planning on moving to a new institution? Don’t forget your research project and IRB approval! Even if you will retain an unpaid affiliate appointment, that doesn’t always mean that the UW IRB will remain the appropriate IRB.

It is important to ensure that your human participant research has continuing and appropriate IRB oversight.

Visit our website on Transfers of IRB Oversight and PI Institutional Affiliation Changes, and consult with HSD’s Reliance Team well before you pack any boxes!