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*New* Changes to UW Human Subject Rules

Posted: 5/25/2020 (Demography News)

The UW Office of Research has announced changes to Human Subjects to expand currently allowable research. The Human Subjects Division is still taking a conservative approach to clinical research and there is a new Checklist that is required, so please read the rules carefully to ensure your project meets all the criteria before getting started. If you have any question about your project being eligible, please reach out to Karen Moe, Director, Human Subjects Division (kemoe@uw.edu).

Effective May 22, some temporarily-halted human subjects research is now allowed to begin or resume. See this Human Subjects Division (HSD) webpagefor a description of the allowed research. 

A summary of the changes:

  • The description of already-allowed research has been re-worded to fit into new categories that improve usability and make it easier to incorporate future changes
  • Expansion of allowed clinical trials.
  • Expansion of studies whose only in-person procedures are brief and for the purpose of obtaining a specimen, measurement, or specific physical exam.

 

Rationale. This first step in resuming halted human subjects research is somewhat conservative. This is because of (1) the present uncertainty about the impact of the recent state-wide relaxation of earlier restrictions and (2) the rapidly-evolving understanding about the factors that affect the transmission of the SARS-CoV-2 virus. Additional research will be allowed in the future as appropriate for changing conditions and information.

Required CHECKLIST. There are some new and important requirements for all new or ongoing human subjects research. These are described in the CHECKLIST Human Subjects Research During the COVID-19 Pandemic, available here and through the HSD COVID-19 webpage. This applies to current on-going research as well as research that will now begin or resume. The Checklist includes the very recent new requirements for all research and for allowing staff to return to UW locations, such as the requirement for a COVID Supervisor for staff who come to campus locations to conduct research.