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听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 鈥渉uman subjects research鈥� (HSR). HSD鈥檚 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听IRB review will be required for some research involving AI that did not previously require IRB review.

How is the definition of 鈥渉uman subjects research鈥� changing?
Starting September 2, 2025, it will be a听new 91探花Policy听to require IRB review for research involving AI and the secondary use of听de-identified data听飞丑别苍听all听of the following criteria are met:

  • The research is led by a听School of Medicine PI;
  • The research involves use of听; and
  • Re-identification of the data would cause it to fall into risk levels 3 or 4听辞蹿听HSD鈥檚 Guidance on Data Security Requirements听(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:

  • Data has been determined by a听听to have low risk of re-identification;听or
  • Data remains within a听.

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鈥檚 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听hsdinfo@uw.edu.

 

 

Translated Pregnant Participants/Partners HIPAA Authorization Form

Published July 31, 2025

In our听June 3, 2025 newsletter, we announced the translation of the updated听HIPAA Authorization Form听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 91探花Office of Healthcare Equity, we have now translated the听HIPAA Authorization form for Pregnant Participants/Partners听into the same 24 languages. These translated documents may be found on the听HSD website.

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

 

 

Diversity in Clinical Trials Initiative- Support Services

Reminder

The January 1, 2026 effective date for compliance with the听听(supporting WA State听) is only months away.
To assist researchers with compliance, the University has established several supportive services including:

  • 听– Librarians are available to assist research teams with identifying underrepresented groups described in PubMed and the ClinicalTrails.gov registry for the study鈥檚 target population. For help submit a request via the听.
  • Institute of Translational Health Sciences (ITHS) Recruitment Support Service听– 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听听website.
  • Translation & Interpreter Services听– Resources for translation, interpretation, and other communication services are available on this听听( 91探花Net ID required). Questions about these resources can be directed to听uwlaca@uw.edu.

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

 

Advance Consultation about the 91探花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 91探花IRB resources. Therefore,听HSD must be consulted in advance of a funding application if a researcher wants to use the 91探花as the Single IRB for a study.听HSD policy听continues to be that it cannot guarantee 91探花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听hsdrely@uw.edu听if you would like to set up a consultation.

 

Zipline Tidbits

On the move?

Are you planning on moving to a new institution? Don鈥檛 forget your research project and IRB approval! Even if you will retain an unpaid affiliate appointment, that doesn鈥檛 always mean that the 91探花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听Transfers of IRB Oversight and PI Institutional Affiliation Changes, and consult with HSD’s听Reliance Team听well before you pack any boxes!