UPDATE: On-site Clinical Research Activities at UCSF
Update 01/21/22 Update: Category 3 on-site clinical research visits can resume January 24: Early termination of the hold on Category 3 on-site clinical research visits is effective Monday, January 24. All Category 3 research activities can resume at that time, with careful attention to continued compliance with UCSF’s COVID policies. This decision is based on the following metrics: UCSF/ZSFG COVID hospitalizations; UCSF employee COVID cases; UCSF Health/ZSFG clinical workforce strength; and San Francisco (SF) County COVID cases. Available data and modeling demonstrate with confidence that UCSF is at or near the peak in COVID hospitalizations and employee cases, secure in our critical clinical workforce numbers, and past the peak in local SF County COVID cases.
Definition of Category 3 on-site clinical research
UCSF’s initial COVID-19 on-site clinical research policy defined different types of research by categories. Category 1 is research that can be performed remotely (i.e., off-site). Category 2 is research that requires on-site visits but is “essential to the health and well-being” of the participant. Category 3 is research that requires on-site visits but is not essential to the health and well-being of the participant. We have retained these categories for consistency across policies. There is no change to Category 1 and 2 research policy; both can continue without restriction.
Category 3 on-site clinical research: research that requires on-site visits but is not essential to the health and well-being of the participant. Determination of “essential” is to be made by the principal investigator of the relevant research protocol in coordination with the participant and, where appropriate, the participant’s clinical provider. As a guidance, essential visits should meaningfully impact the health and/or well-being of the participant to an extent that the benefits of conducting the visit outweigh the additional risks from COVID-19, and should lose their impact if delayed for a period of several weeks (i.e., while this policy change is anticipated to stay in effect).