December 10, 2024
For the Record- December 10, 2024: Guidance on Engagement in Research
In this Issue:
Guidance on Engagement in Research
Update
HSD has moved and refreshed its guidance on engagement in research. Engagement is the term that institutions and IRBs use to describe the circumstances under which an institution’s employees or agents are conducting human subjects research and if yes, which IRB will provide review and oversight. This includes determining if a reliance agreement is required in circumstances where more than one institution is engaged in the research project. The guidance is now easier to find on HSD’s website, easier to read, and contains greater detail about how HSD defines and assesses engagement. There are no changes to HSD’s policies about engagement, however the guidance more clearly describes longstanding HSD policies such as:
- Who counts as an employee or agent for the purposes of assessing UW engagement (e.g. unpaid affiliate faculty, emeritus faculty and alumni are not agents of UW and cannot use the UW IRB or serve as PIs or faculty advisors)
- NOTE – PIs whose status as an employee or agent of the UW changes (e.g., move to emeritus or unpaid affiliate) must close out, transfer their active studies to a non-UW IRB, or transfer them to a PI who is an employee or agent of the UW.
- Who makes the determination (UW researchers are allowed to self-determine that they are not engaged, using the WORKSHEET Engagement or the WORKSHEET UW Engagement for Fred Hutch-led Research, or may submit to HSD for a formal determination). HSD is the final arbiter on whether an individual is an employee or agent of the UW conducting human subjects research activities.
- Which research the guidance applies to (all non-exempt research conducted by agents of UW regardless of which IRB will conduct the review).
Contact hsdinfo@uw.edu for questions.