November 17, 2020
For the Record – COVID-19 Special Edition, November 2020
Impact of New State COVID-related Restrictions
HSD is receiving questions about whether UW human subjects research is affected by the new Washington State COVID-related restrictions announced over the weekend.
There are no changes to the criteria for allowed research. This is because the criteria already require all research to be conducted (1) with remote procedures except in-person procedures that are truly essential, and (2) with coverings, COVID symptom screening of study staff and participants, and physical distancing except when not possible and the research otherwise qualifies as “allowed”.
However, these two changes are being implemented, effective immediately.
- In-person visits from clinical study monitors should be accomplished via remote procedures, or delayed.
- When using the COVID Relative Risk Assessment Tool to decide whether their research is allowed, researchers should select “increasing” on Factor One (COVID pandemic trend in the local research location) for most research locations. This may mean that some ongoing research with a score near the cut-off threshold no longer qualifies to continue.
Ongoing studies whose COVID Risk Score was very close to the cut-off criterion
Research is allowed if the total score is 18 or less. Some ongoing studies may have been assessed as having a score of 16-18 when Risk Factor 1 about the local COVID situation was “Flat – 2 points”. The current Risk Score for these studies will now be 2 points higher, because of the COVID surge. These studies should be immediately modified to bring the current Risk Score down to the criterion level or 18 or less. There are many ways this can be accomplished; researchers should modify what makes the most sense for each specific study. Changes to any one of these is likely to be sufficient to adequately reduce the risk:
- Eliminate procedures with higher risk scores
- Exclude higher age groups
- Reduce the amount of time with “close” procedures
- Reduce the number of people interacting with participants
- Increase PPE protections beyond what is already required
What about UW research reviewed by an external (non-UW) IRB?
When the external IRB is a local non-commercial IRB (e.g., Fred Hutch, Seattle Children’s): Follow the requirements and policies of that IRB as to which research can resume and under what conditions.
For all other external IRBs: For domestic research locations (i.e., a U.S. location), only research allowed by HSD may resume or begin. For international research locations where a local IRB has provided review: The research may proceed if it is allowed by the local IRB.
UW, UW Medicine and SCCA policies on human subjects research will be updated if appropriate, as pandemic conditions change. This could include limits on clinical trials that occur in UW Medicine and SCCA clinical space, to avoid impact on clinics and clinical personnel.