Guidance for Researchers

For questions about UCSF research that aren't addressed in the policies and guidance below, please contact [email protected].

Office of Research Messages

The evolving COVID-19 situation is prompting quick response from within our local research community and labs. In order to keep UCSF researchers informed of changes to our research activities as well as current research related to COVID-19, the Office of Research co-sponsored two town halls:

Research Operations during the COVID-19 Outbreak
Wednesday, March 25
Watch the town hall recording »

COVID-19 Campus-wide Research at UCSF: Making an Impact
Thursday, March 26
Watch the town hall recording »

 

March 26, 2020
Revised Directive Regarding Use of Personal Protective Equipment (PPE)
Read the full message

March 19, 2020
Laboratory Research: Ongoing Research Update
Read the full message

March 16, 2020
IMPORTANT: Updated Directive to UCSF Laboratory Researchers
Read the full message

IMPORTANT: Updated Directive to UCSF Clinical and Non-laboratory Researchers
Read the full message

March 15, 2020
IMPORTANT: Directive to UCSF Researchers to Cease Research Activities
Read the full message

For more archived communications, visit the Office of Research website.

 


Interim Research Policies

 

Laboratory Research

It is imperative that we take action to reduce the spread of COVID-19 in our population, to "flatten the curve" and thereby prevent the many unnecessary deaths that will result if our health care system is overwhelmed. To this end, UCSF is directing all faculty with research laboratories to take measures immediately to reduce viral spread. Read the message from the Office of Research.

Ongoing Maintenance

A ‘skeleton crew’ of key personnel is allowed to enter laboratory buildings to monitor equipment and carry out essential maintenance, including, for example, the filling of liquid nitrogen containers and checks on freezers and complex machinery. This minimal maintenance will require only occasional visits at odd hours, greatly reducing the likelihood of social interactions. The majority of our research laboratories are now being maintained by occasional visits from one or two key personnel, and all experiments in these labs have stopped. Staff and trainees from these research groups are working from home. 

Much of the research at UCSF depends on animal models, and this research is not so easily shut down. It is critical for our research programs, and for animal welfare, that our animal care facilities remain staffed to care for the thousands of unique animal strains used in our research laboratories. Many of our laboratories work with large numbers of complex transgenic animals, some of which require special care by laboratory members. Laboratories with these needs are allowed to delegate additional key personnel to care for their animal lines.  

For the time being, a minimal amount of laboratory research will be allowed to continue. A committee of nine senior basic science faculty scanned requests to continue research, and approved experiments fall into two categories, listed below. In all cases, laboratory heads are required to make every effort to reduce social interactions.

Faculty have been strictly cautioned to excuse anyone who does not feel comfortable coming into the laboratory. Students should be assured that if they feel any pressure to carry out experiments, they are welcome to voice their concerns with graduate program directors, thesis committees, or the supportive staff of the Graduate Division.  

1. COVID-19 research: Many labs at UCSF have rapidly mobilized efforts to understand and fight the COVID-19 disease. Almost overnight, dozens of our talented faculty have initiated a broad array of studies, including the structural biology of viral proteins, development of novel anti-viral drugs, studies of the infection process in cultured lung cells, and clinical studies of patients with the disease. Our policy is to approve any research that has clear potential to reduce the impact of COVID-19 on human health. 

2. Completion of ongoing long-term projects: Many scientists at UCSF study long-term processes in health and disease, and their experiments can sometimes continue over many months and even years. Many of these experiments cannot be stopped in mid-flight without destroying the entire experiment, resulting in major losses of data and effort. We are allowing these sorts of experiments to continue, on the condition that they are maintained by the fewest possible personnel with minimal interactions.

Some of our senior PhD and MD PhD students have concrete plans to graduate in the next quarter and have positions or medical school lined up after graduation. Some of these students are within weeks of completing all experiments, and in these cases we allow students to do the minimum work required to finish up. The number of other people in the lab is kept to a minimum, and work hours are being used to reduce interactions with others. 

Some common types of approved research include the following:

  • studies of tumor growth or other pathologies in mouse models injected with a potential treatment over a period of many months.
  • studies of the effects of aging on behavior or physiology, in animals that have been aged for one or two years prior to the experiment.
  • long-term studies of the effects of specific diets in mouse models that must be analyzed at specific time points over the course of many months.
  • studies in a differentiated primary cell line that has required many months to generate from a unique patient or other source, and cannot be frozen down without loss of viability.
  • final experiments by a postdoctoral fellow whose position ends in one month, after which she is starting a new position at a biotechnology company.
  • final experiments by a student who is scheduled to graduate at the end of May, and has just 2-3 weeks of experiments to complete the work for his thesis.

Research that is not allowed includes the following:

  • 2-3 weeks of biochemical experiments by a 3rd-year student to finish results for a possible paper submission. These experiments should be paused.
  • several weeks of experiments to complete revisions of a paper to allow resubmission to a journal before some deadline. Journal deadlines are unlikely to be enforced in the current crisis.
  • experiments to generate preliminary data for a grant submission in 2 months. Faculty should expect to submit grant applications with the results that are currently in hand. 
  • breeding of new mouse lines to begin new experiments.
  • any new experiments whatsoever.

Use of Personal Protective Equipment (PPE)

Laboratory researchers can reduce their lab’s rate of PPE use by:

  • Pausing all research unless it has been deemed essential as described in interim policy for laboratory research released March 15th, 2020.
  • Deferring purchases of new PPE if the existing PPE is still in acceptable condition.
  • Ensuring that engineering controls such as fume hoods and biosafety cabinets are working properly and are used by the research group members.

Of course, safety remains a vital priority at UCSF. Any continuing essential research activities should be conducted while wearing the appropriate PPE.  If you have questions about the appropriate use of PPE, please contact your EH&S Department Safety Advisor (DSA).

 

Interim UCSF Policy on Human Subjects-Related Research Visits at San Francisco Campuses

Updated March 26, 2020

In the context of the rapidly evolving COVID-19 outbreak, the UCSF Office of Research has revised UCSF's policy on human subjects-related research visits at its San Francisco campuses. This policy is being implemented to conform to the San Francisco City and County Department of Public Health Order of the Health Officer and other public health measures undertaken by UCSF Leadership and the City and County of San Francisco. Its goal is to protect patients, research participants, staff, and the UCSF community from risk of infection with COVID-19, to protect UCSF's critical healthcare capacity and resources, and to preserve access to important life-saving clinical research studies.

The policy on human subjects-related research visits at UCSF's San Francisco campuses will continue to be revised when appropriate based on new information circulated to the UCSF research community.

Human Subjects-Related Research Visits Performed in Inpatient Settings

All human subjects-related research visits performed in inpatient settings at UCSF Health, Zuckerberg San Francisco General, or the San Francisco Veterans Administration are to be postponed unless directly related to COVID-19 or approved as "essential". An essential research visit conducted in the inpatient setting is defined as a visit providing life-saving patient care that cannot be postponed.

"Essential" Visit Approval Process

Principal investigators should submit a declaration of essential study visit to [email protected]. Declarations should include a brief study synopsis, inpatient location of visit, IRB approval number, and a statement of how the research visit is providing life-saving patient care. Declarations also require assurance of compliance with institution-specific health and safety training for research staff in infection control and proper handling of biospecimens (if relevant) in the acute care setting. For selected situations, declarations may address multiple in-person visits that are part of research protocols delivering important lifesaving patient care that cannot be postponed.

All declarations will be reviewed and approved within 24-48 hours.

See additional guidance regarding determination of "essential to the health and/or well-being" for human subject research visits conducted in the ambulatory setting.

Human Subjects-Related Research Visits Performed in Ambulatory Settings

Research teams should follow the following steps in determining whether to conduct human subjects-related research visits in ambulatory settings:

Step 1: Research visits planned for ambulatory settings should be performed remotely whenever possible. Options for remote visits include phone and Zoom (or other web-conferencing services). See for guidance on Zoom.

Step 2: Research visits planned for the ambulatory setting that cannot be performed remotely and are not essential to a participant's health and/or well-being should be postponed. A research visit in the ambulatory setting should only be determined to be "essential" if it is urgent and medically necessary to a participant's health and/or well-being. This determination is made by the principal investigator of the research study, the participant, when possible the participant's care provider and should be informed by current public health considerations and directives regarding the COVID-19 outbreak.

Step 3: Research visits planned for the ambulatory setting that cannot be performed remotely and are urgent and medically necessary to a participant's health and/or well-being (i.e., "essential") may be performed in person, with the following additional requirements.

a)  All participants should be provided with information regarding the current COVID-19 epidemic and how best to reduce their risk of infection. This information may be provided in multiple forms suited to the type of contact, including a website link, a telephone script and an in-person handout. If possible, this information should be shared before the research visit. See the CDC COVID-19 link for reference and materials.

b)  All research participants should be screened for fever, cough and flu-like symptoms by research staff prior to the research visit if possible, with repeat screening by research staff at the time of an in-person visit. Those who screen positive will require triage site-specific protocol.

Human Subjects-Related Research Visits: Additional Requirements

All research study personnel (faculty and staff) must comply with guidance regarding research participant screening for COVID-19 and research participant triage should a research participant be deemed at risk for COVID-19 infection during an in-person research visit screening.

Principal investigators or their designee should contact study sponsors to notify them of this policy and make appropriate arrangements. UCSF is not contacting sponsors centrally at this time. See our open letter to research sponsors and collaborating institutions.

All sponsor visits for human subject-related research should be performed remotely or postponed. Any in-person monitor visits deemed essential to the health and/or well-being of the participants will require pre-approval. Please contact [email protected] for approval requests.

Use of Personal Protective Equipment (PPE)

All UCSF human-subjects-based research faculty and staff are asked to postpone clinical research visits requiring PPE unless the research visit can be combined with clinical care and be conducted by team members required for clinical care (i.e., not research-only staff). We recognize the impact this directive will have on essential research. Research teams are asked to consider this directive and work with clinical staff as appropriate in the planning of research visits essential to the health and well-being of participants in the inpatient and ambulatory settings as per interim policy and guidance.

 

Research Personnel

All study personnel (faculty and staff) should receive appropriate training regarding proper research participant screening (e.g., masking protocols) and participant triage should a research participant be deemed at risk for COVID-19 infection during an in-person research visit screening. Please contact your local Environmental Health and Safety office/website for guidance.

Guidance from the IRB will be forthcoming on a master amendment to studies addressing missed visits, remote visits, study visits out of window, etc., as well as reporting of study deviations for the same.

 

Study Sponsors

Principal investigators or their designees are asked to contact study sponsors to notify them of this policy and make appropriate arrangements. All sponsor visits for clinical trials or other human subject-related research, whether for site qualification, site initiation, or monitoring visits, should be postponed whenever feasible. Consideration for remote monitoring should be based on study need and resource availability.