Research Density Update, Framework for Decision-Making, and Other New Resources

December 29, 2020

Dear Research Community:

The Bay Area continues to experience high rates of COVID-19 infections and decreased capacity in intensive care units. These problems are expected to worsen due to holiday travel, and city and state restrictions will likely be extended. As a result, the Chancellor’s Executive Team (CET) has approved an extension of the current decreased research density levels until 12:01 a.m. on January 19, at which point it will be reassessed and may be extended. We will continue to monitor the situation closely (see below for more details) and communicate updates to the research community.

As announced on December 18, the current densities (effective December 24, 2020, and now extended until January 19, 2021) are:

  1. Laboratory research density at 25%. LARC operations will continue unabated, and there is no need to reduce animal census.
  2. Clinical research that is not essential to the health of the participant (termed Category 3 research) at 12.5%. It is strongly recommended that research-only onsite visits (i.e., conducted without a concomitant clinical visit) be postponed. COVID-19 clinical research and clinical research determined to be essential to the health and/or well-being of the participant can continue without density restriction.

As a reminder, the UCSF research community must comply with the public health emergency order imposing a mandatory 10-day quarantine for anyone traveling, moving, or returning to San Francisco from anywhere outside the nine-county Bay Area, except for essential categories of personnel. Every effort should be made to work remotely and limit onsite work to essential activities that cannot be accomplished from home.

The Office of Research has developed a document that summarizes density guidelines for UCSF research activities and requirements for quarantining and/or testing under the UCSF quarantine order and travel policy. It is designed to provide quick guidance for different categories of research and personnel, and does not replace the full guidelines and policies implemented by UCSF and the Office of Research.

Guiding Principles for Decisions about On-site Research During COVID-19

To support decisions regarding research reopening and density, the Office of Research has developed a framework that relies on indicators and metrics to assess the status of the COVID-19 pandemic and UCSF's resources and risks.

The framework guides Office of Research leadership in developing recommendations for policy changes that increase or decrease the amount of research and was presented in the July 29 Office of Research Town Hall.

The indicators/metrics data being used by the Office of Research are now available here. This resource will be updated regularly with current metrics.

Resources for Clinical Research Monitoring

I also write to make you aware of two new guidance documents developed to answer questions and support efforts for clinical research monitoring.

  1. UCSF Office of Research Guidelines for Clinical Research Monitoring – guidelines developed to clarify clinical research monitoring given the current public health emergency order.
  2. MD Link and Remote Monitoring Visits: CRC and Monitor Workflow – a resource that provides an overview for how study teams can use MD Link for the remote monitoring of studies by study monitors.

If you have questions about the Guidelines for Clinical Research Monitoring, please contact the Office of Research at [email protected]. For questions about the MD Link resource, please contact [email protected].

I greatly appreciate your commitment to safely conducting our research activities during this pandemic, so that we can ensure UCSF’s ability to care for patients in our hospitals and protect the health and well-being of our faculty, staff, students, visitors and the general public.

Sincerely,

Lindsey A. Criswell, MD, MPH, DSc
Vice Chancellor of Research
Professor of Medicine and Orofacial Sciences