March 28, 2025
HSD Announcement: Stop-work Orders, Suspension of Work, or Funding Terminations
Stop-work Orders, Suspension of Work, or Funding Terminations
Reminder
Sent via UW Human Subjects Division Newsletter recipients 3/28/2025
HSD expects that participant safety and welfare are prioritized, regardless of a study’s current funding situation. If a researcher receives a directive from a federal funding agency to stop, pause, suspend, or terminate activities on an award, and the change in funding will result in a premature suspension or termination of some or all of the research, they are reminded to take the following actions:
- If applicable, take any actions necessary to mitigate immediate risks to participants.
- If the UW is the IRB of record, submit a Report of New Information (RNI) in Zipline per HSD’s reporting guidelines.
- If the study is under review by an external IRB (e.g., Advarra, WCG, Fred Hutch), contact the external IRB for guidance.
If reporting to the UW IRB as a RNI, you should include a plan that addresses the following (where applicable):
- Description of any actions taken to mitigate immediate risks to participants
- Description of any procedures necessary to safely stop study-related activities/interventions for participants (e.g., tapering meds, removing devices, completion of any safety labs and imaging, follow up assessments, referrals)
- Provision of alternative treatment options for participants (e.g., arranging for therapeutic care outside of the research)
- Participant compensation obligations
- Communication plan for notifying study participants
- What will happen with study data and biospecimens (e.g., storage, disposition)
The above information may be provided either within the RNI Supplement or may be submitted as a separate document.
If you have questions or need guidance about a specific situation, please contact us at hsdinfo@uw.edu. If you have financial concerns about meeting any of these obligations, consult with your department administrator.