Effective January 3, 2022

Clarification 01/12/2022: Temporary Hold on On-site Clinical Research Activities at UCSF

The temporary hold through January 28, 2022, applies only to participants coming onto UCSF’s campuses solely for research purposes and who's research visit does not involve care of any kind deemed essential to the health and well-being of the participant. Thus, research conducted on participants already at UCSF for clinical purposes (e.g., ambulatory visit, procedure, inpatient stay) is still allowed.

UPDATE 01/11/2022: On-site Clinical Research Activities at UCSF

The COVID-19 omicron variant is causing an unprecedented increase in cases around the world. As our own UCSF data demonstrate, and as reflected by the San Francisco DPH and surrounding county epidemiology, the Bay Area is in the midst of a major surge. This surge is expected to be shorter than the ones caused by the delta variant and previous strains, but there will be a very high risk for infection to our faculty, staff, trainees, patients, and research participants over the next few weeks. 

The purpose of this document is to provide UCSF faculty, staff, and trainees with specific guidance regarding the temporary policy change (effective January 3, 2022) for on-site clinical research at UCSF due to the omicron variant. All clinical researchers at UCSF must comply with this updated policy.

On-site Clinical Research Policy Change

After careful consideration, UCSF will continue its temporarily hold on Category 3 on-site clinical research effective January 3, 2022. See below for definition of Category 3. We anticipate this change lasting through January 28, 2022; the actual duration will depend on the course of the pandemic. This decision was made to achieve two fundamental goals: protecting the health of our patients, research participants, faculty, staff, and trainees; and preserving our clinical workforce to care for the anticipated surge in COVID-19 hospitalizations.

As has been the case throughout the pandemic, research teams conducting on-site clinical research must use established workflows for the safe conduct of on-site clinical research visits including personal protective equipment and signage for participants and configuration of the clinical research space as necessary to allow for adequate physical distancing (i.e., a minimum of 6 feet between research team members). Clinical researchers should follow the latest guidance from UCSF Health’s Hospital Epidemiology and Infection Prevention.

Whereas these policies apply to all UCSF-affiliated research, locations external to UCSF may have additional or different requirements based on the local situation. Policies with the highest level of protection (i.e., the “strictest” policies) should be adopted in cases where multiple institutions are involved.

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).