To minimize risks to participants and our community in the conduct of human subject research the UW, its Office of Research, and the Human Subjects Division are announcing a mandatory temporary halt on some research activities that involve in-person interactions with participants.
Effective March 23, 2020 through May 1, 2020, subject to re-evaluation and any needed changes, this restriction aligns with several peer institution's recent actions as well as current guidance from the NIH and the FDA. Many research teams have already implemented some or all of the appropriate actions – i.e., halting new enrollment and/or modifying in-person procedures to remotely-conducted procedures.
Which studies or study procedures must be paused?
This applies to all ongoing and new studies or study procedures that involve in-person interactions with participants except those that involve:
- A significant likelihood of direct and meaningful benefit for individual participants, or
- A necessary safety monitoring procedure that cannot be done in an alternative manner, or
- Clinical trials where all in-person interactions can occur in the context of a needed clinical care visit, or
- Diagnosis, treatment, interventions, or other research activities directly focused on COVID-19 or SARS-CoV-2, or
- Studies involving in-person interactions that can be modified to appropriate remote interactions (e.g., phone calls, emails) that don’t compromise participant safety or the scientific integrity of the research.
The Human Subjects Division COVID-19 webpage has more detailed information including the requirements for continuing studies and interpretation of “direct and meaningful benefit”. HSD staff are also available to answer questions hsdinfo@uw.edu.