UW Research

July 11, 2023

For the Record-July 11, 2023: New UW Medicine Requirement, Consent Templates, HSD Fee Changes

In this Issue:

New UW Medicine Security Review Requirement for Research using Machine Learning

Effective Immediately!

The rapid evolution of artificial intelligence (AI), and specifically machine learning, introduces new questions and considerations concerning the privacy and confidentiality of research participants. To help safeguard patient health information, UW Medicine is requiring a security review of research involving the use of UW Medicine patient data (whether identified or de-identified) for machine learning outside of UW IT systems.

For research reviewed by the UW IRB. A question has been added to HSD’s IRB application forms to prompt researchers to obtain the security review. Research that is subject to this requirement will not receive IRB approval without documentation that the security review has been completed.

For research reviewed by a Non-UW IRB. Information about this requirement has been added to the form requesting review by an external IRB. Researchers are responsible for identifying the need for this review and obtaining that review prior to beginning the research. HSD will not hold its authorization to obtain review from a non-UW IRB in relation to this new requirement. Documentation of the outcome does not need to be provided to HSD.

Questions about this new requirement? Contact Sally Beahan, Senior Director, UW Medicine Enterprise Records & Health Information at sbeahan@uw.edu

New Consent Templates and Guidance

Reminder

On June 1st, HSD published new consent materials to support a participant-focused consent process and form. These new tools will assist researchers with designing a consent process that is compliant with the regulatory consent changes implemented in 2018. Full details can be found in the June edition of For the Record. Key points include:

  • Designing Consent web guidance that provides information about what must be included in the consent process/form. It may be used to supplement the instructions embedded in the templates or can be used to create a consent process/form without starting from a UW template. It includes a section specific to designing consent for multi-institutional research.
  • Consent Templates that will assist researchers with designing a participant-focused consent process and form which emphasizes the key information most likely to influence a subject’s enrollment decision. The templates are flexible so researchers can modify them to suit the needs of their study population.
  • Example Consent forms that demonstrate some of the many ways consent may be designed while also satisfying regulatory and UW IRB policy requirements.

Transition period. HSD recognizes that this new approach to consent represents an important but significant change. To ease the transition, HSD will accept consent forms submitted on the old, Standard template until October 1, 2023. However, researchers are encouraged to begin using the new templates and approach as soon as possible.

Questions. Contact hsdinfo@uw.edu with any questions about the new materials.

Changes to HSD Fee for Industry Clinical Trials

Reminder

Initially announced in our April 4, 2023 newsletter, and updated in our June 6, 2023 newsletter, this is a reminder that effective July 1, 2023, HSD made the following changes to our industry clinical trials fee:

  1. Fee Increase: All new authorization requests to use a non-UW IRB submitted on or after this date will be charged $1933.70. HSD anticipates that this fee will modestly increase on an annual basis commensurate with HSD’s costs.
  2. Change in Billing Process: GCA is no longer involved in billing the fee. Instead, HSD will work with the Office of Research to charge the fee using a researcher-provided worktag, which is the new equivalent of a budget number in Workday. You will be solicited for this information in a new section of the REQUEST External IRB Review. HSD will begin its review without a worktag, however final authorization will not be provided until a worktag is received.

For questions about these changes, contact hsdrely@uw.edu.