Guidance for Onsite Clinical Research Activities

Updated March 5, 2021

Increasing Onsite Clinical Research Activities at UCSF 

 

General Principles

The purpose of this interim document is to provide guidance on the partial resumption of onsite clinical research at UCSF facilities located in the City and County of San Francisco. Whereas these policies apply to all UCSF-affiliated research, sites external to County of San Francisco may have additional or different requirements based on the local situation.

The top priority is public health: not just the h7ftealth of UCSF personnel, but the health of research participants, the city, and region. Premature repopulation of our buildings to an unsafe level could cause a rebound in infection rates that would threaten the lives of Bay Area residents and could compromise UCSF's workforce and capacity to provide medical care for COVID-19 patients.

This UCSF plan aligns with current state and local Public Health ‘shelter-in-place’ orders. UCSF leaders have considered these issues in establishing a tentative schedule for gradually increasing clinical research activities.

Overview of Research Policy to Date during Pandemic

After a brief pause in all research with the March stay at home directive, onsite clinical research activity was phased in gradually so that work practices and overall population density could be closely monitored to ensure health and safety. Onsite COVID-19-related clinical research and clinical research essential to the health of the participant (termed Category 2 research) have largely continued without density restriction throughout the pandemic.

In Phase 1 of research reopening, onsite clinical research that is not essential to the health of the participant (termed Category 3 research) was first allowed to resume operating at 12.5% density on May 18, 2020. In Phase 3 of research reopening (Phase 2 applied only to laboratory-based research policy), the allowable density increased to 25% on September 17, 2020. In Phase 4, density for onsite Category 3 clinical research was reduced from 25% to 12.5% on December 24, 2020 to prepare for an expected post-holiday surge of infections. Once the surge subsided, density was restored to 25% on February 1, 2021 as part of Phase 5.

Phase 6 Directives

In phase 6, density for onsite Category 3 clinical research will increase from 25% to 50%, effective March 8, 2021, as a result of the continued reduction in rates of COVID-19 infection and hospitalization at UCSF and in the Bay Area, vaccination of over 75% of our Phase 1A employee population, which includes our clinical research workforce, and outstanding safety practices of our researchers as explained in the Office of Research message. COVID-19 clinical research and clinical research determined to be essential to the health and/or well-being of the participant (Category 2 research) can continue without density restriction.

Every effort should be made to work remotely and limit onsite work to essential activities that cannot be accomplished from home.  In addition, the UCSF research community must still comply with the California Department of Public Health guidance recommending a 10-day quarantine for anyone traveling out of state or more than 120 miles from their place of residence.

The Office of Research has developed a document that summarizes density guidelines for UCSF research activities and guidance for quarantining and/or testing under the UCSF 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.


Current Guidelines for Clinical Research

Because clinical research encompasses a diverse range of modalities and considerations, investigators are asked to follow specific directives based on the category of their research, as detailed below and summarized in this document. We understand that these directives do not fit all circumstances –  we ask that faculty keep the health of their clinical research team members, research participants, and community as their top priority.

All clinical researchers at UCSF must comply with the directives below.

 COVID-19 focused clinical research

COVID-19-focused clinical research may proceed onsite (no change from current interim policy).

Every effort should be made to modify clinical research protocols to include telehealth-based conduct (e.g., electronic consent, virtual study visits, mail delivery of study drug or intervention, endpoint measurement using mobile health technology) wherever possible. HIPAA-compliant resources for telehealth-based research are available (see UCSF Telehealth).

At all UCSF sites, research involving COVID-19 infected patients must be conducted in COVID-19 approved locations. At the direction of the UCSF COVID-19 Coordination Task Force, research involving potentially infectious COVID-19 participants should be coordinated through the Office of Research; a detailed policy regarding this will be provided in early 2021. For the time being, COVID-19 clinical research protocols should be coordinated with the clinical units providing care for COVID-19 patients in order to protect the clinical and research workforce and prevent overburdening COVID-19 infected patients and clinical staff with research requests. UCSF Health Department of Hospital Epidemiology and Infection Prevention (HEIP) is available for consultation on appropriate safety practices for COVID-19 focused research performed in the clinical environment. 

Non-COVID-19 focused clinical research

Category 1: Clinical research that can be performed remotely (including computational/dry-lab research).

Non-COVID-19 clinical research that can be performed remotely (e.g., clinical research activities without direct human subjects contact, computational, dry lab research, office-based research performed entirely using telehealth or other virtual methods, among other types) must all continue remotely (no change from current interim policy).

Category 1 research team members should all continue to work from home. Every effort should be made to modify all clinical research protocols to include telehealth-based conduct (e.g., electronic consent, virtual study visits, mail delivery of study drug or intervention, endpoint measurement using mobile health technology) wherever possible. HIPAA-compliant resources for telehealth-based research are available (see UCSF Telehealth).

Category 2: Clinical research essential to the health of participants. 

Non-COVID-19 related clinical research that is essential to the health of participants may proceed onsite.

The determination of whether or not research is "essential to the health" of a participant is made by the principal investigator of the research study, the participant, and where possible the participant's care provider. This approach recognizes that the impact of clinical research on a participant's health is a medical decision that best rests with the research and health care team. Research is determined to be "essential to the health" of the participant if it is of potential direct benefit to a participant's health and/or well-being. In general, descriptive observational research would not be considered "essential to the health" of the participant.

Clinical research that is determined to be essential to the health of participants and conducted in the inpatient setting may proceed, and no longer requires submission of a declaration of essential visits to the Office of Research for approval (this was required in Phase 1).

Category 3: Clinical research not essential to the health of participants.

Non-COVID-19 clinical research that is not essential to the health of participants may be conducted at reduced density as detailed below.

In Phase 6 of research reopening, the allowable density for all Category 3 research will increase to 50% of the clinical research workforce onsite prior to the COVID-19 outbreak. Clinical research occurring off-site is not affected by Phase 3 and is governed by separate guidelines. Research teams should work with their colleagues, academic departments, and floor/building leadership as appropriate to develop an implementation plan.

Category 3 clinical research teams should develop and test workflows for the safe conduct of onsite clinical research visits at reduced population density, obtain the necessary personal protective equipment and signage for participants, and reconfigure clinical research space as necessary to allow for adequate physical distancing (i.e., a minimum of 6 feet between research team members), as summarized in the Clinical Research Return to Work Checklist. Only after research teams have completed the above safety modifications and tasks should research participants be allowed to start returning to campus.

Additional considerations for clinical research

Research teams should consider that certain populations of study participants may have increased risk for severe COVID-19 infection (see CDC guidance) and incorporate this in decisions about conducting onsite research visits.

Participants should be informed of UCSF's research policy governing clinical research during the COVID-19 outbreak and given the option to postpone the planned clinical research.

All in-person research visits should be conducted by research personnel wearing a face mask per institutional policy and eye protection (e.g., eye shields, face shields, or safety glasses) according to UCSF Health PPE policy.

Whenever possible, there should be a minimum of 6 feet between participants and research staff consistent with public health directives.

Further special considerations for all clinical research visits apply as follows:

Clinical research with increased risk of aerosolization

Clinical research that involves procedures that induce cough, sneezing or otherwise increase risk of aerosolization must be conducted with approved and proper infection control procedures, and these research participants must undergo COVID-19 RT-PCR testing prior to the research visit. This testing requirement is consistent with UCSF's policy for COVID-19 RT-PCR testing of ambulatory patients coming to UCSF for clinical care. Procedures that increase risk of aerosolization include but are not limited to:

  • Bronchoscopy
  • Laryngoscopy
  • Chest physiotherapy
  • Nebulized medication
  • Spirometry/Pulmonary function testing
  • Sputum induction
  • High-flow nasal cannula 
  • Intubation 
  • Non-invasive ventilation (BIPAP/CPAP)
  • Exercise testing (e.g., CPET)
  • Tracheostomy care
  • Selected oral and dental procedures
  • Open suction

In addition to the above, certain sponsors or other regulatory directives may require COVID-19 testing prior to research visits. Resources on COVID-19 testing and FAQs for patients are available here: https://coronavirus.ucsf.edu/patients; https://coronavirus.ucsf.edu/patients-faqs-covid-19-testing;  and https://www.sfcdcp.org/wp-content/uploads/2020/04/COVID19-CityTestSF-Flyer-FINAL-5.5.2020.

Clinical research performed in clinical care locations

Clinical research performed in clinical care locations (i.e., health system buildings) brings additional complexities due to concomitant clinical care reopening activities and the need to protect the health system workforce and health system capacity for future clinical care ramp-up. Because of this, clinical research performed in clinical care locations should only be restarted after the research activities have been discussed with the leadership of the clinical units on which the research will be conducted (e.g., ICU, hospital ward, ED, clinic) to ensure they will not interfere with essential clinical activities and/or workflows and will not complicate population density management by the health system.

“Research-only” visits (i.e., not conducted in conjunction with a clinical visit)

As required for clinical visits, all research participants undergoing "research only" visits should also be screened for COVID-19 symptoms by phone (or telehealth) prior to and at the time of arrival, as indicated in our Guidance for Screening of Research Participants

Additional Health and Safety Considerations

UCSF has established supplemental clinical research safety practices specifically to mitigate the risk of COVID-19 transmission. These and any group-specific safety practices should be discussed in research group meetings, and questions and feedback are encouraged. If questions or concerns cannot be resolved, please contact the Department Chair, Organized Research Unit (ORU) Director, or Division Chief. Graduate students can contact Associate Dean for Graduate Programs Elizabeth Silva, and postdoctoral fellows can contact Assistant Dean for Postdoctoral Scholars Gabriela Monsalve. The UCSF Office of Environment, Health and Safety (EH&S), the UCSF Health Safety Office, and the UCSF Health Department of Hospital Epidemiology and Infection Prevention (HEIP) are also available to evaluate any specific health or safety concerns, and to provide guidance.

Our strategies aspire to safeguard equity across diverse individuals.

The following details address specific circumstances across all clinical research categories:

  • Clinical researchers with laboratory-based components to their research must review and follow the phased directives for increasing laboratory-based research at UCSF.
  • In some cases, members of multiple research teams might, at different times, use the same equipment or room. These teams should avoid unnecessary interactions by coordinating or pre-scheduling activities.  
  • We understand that some clinical research activities require teamwork between at least two people. These interactions are allowed when necessary, but should be minimized whenever possible. Physical distancing of 6 feet must be employed whenever possible.

Buildings with large open floor plans (e.g., Mission Hall) where research is being conducted may pose higher inherent risk (e.g. the open work environment), and greater challenges coordinating across research units as multiple departments may be present on a single floor. In these cases, researchers should consider the designation of a floor captain to help coordinate activities. Additional recommendations for open workspaces include the use of enclosed offices whenever possible and attention to the micro-environment within the floor to ensure adequate physical distancing.

Scheduling and coordination of work hours

To allow multiple people to sequentially occupy the allotted space, research groups should develop calendar systems to schedule work shifts throughout the day and on weekends as is feasible for clinical research activities, bearing in mind that safety is a particular concern for people working late at night. The structure of these schedules and the length of shifts can be flexible. Another option is for specific people to reserve certain days of the week. Research team members should understand that their time onsite is limited and they have to be efficient. Furthermore:

  • Research team members should communicate openly and often (by text or other messaging systems) to coordinate and adjust schedules as necessary and to be sure that they avoid each other. Everyone should complete work within their shift and not work during others’ shifts.
  • Research team members should plan ahead to maximize the use of their limited onsite time, and they should do from home any research activities that can occur remotely.
  • Research team members should be encouraged to help their colleagues by doing minor tasks and work that will reduce the need for others to be onsite.
  • Where applicable, research team members' desk spaces should not be used by other research team members. The goal is to maintain these spaces free of contamination.  

Choice of research team members who return to work

When principal investigators are considering which research team members will be allowed to return to work initially, they must first determine which research activities are the most important to resume at this time (for example, research needed to meet a thesis, paper submission, or grant submission deadline). Then consider the research team member – or group – previously performing this work, as well as others who are able to do such work. Each team member in that set should be confidentially queried for their level of interest in returning onsite at this time. Those who express interest should be considered first, with final selections based on the following factors:

  • Trainees should be given high priority due to the need to complete their research projects in a timely fashion.
  • Consider occasional rotation of team members in the schedule to allow as many as possible to make progress in their research projects.
  • Consider equity, diversity, and inclusion, as well as the well-being of team members who are feeling isolated and may benefit greatly from the ability to come onsite.
  • If there are questions regarding which employee should be assigned to a particular project, consult the applicable collective bargaining agreement and Labor and Employee Relations.
  • Undergraduate volunteers will not be allowed onsite until further notice.

If an employee is requesting an accommodation due to a disability or medical condition, the employee should be directed to contact Disability Management Services (415-476-2621) to assess the situation and potentially start the interactive process to evaluate any reasonable accommodations that would allow performance of essential job functions. Should a medically-based leave be necessary, the established leave of absence processes should be followed.

Support staff, core facilities, and delivery of supplies

The reopening of clinical research may require additional support staff, access to core facilities, and increases in the flow of supplies into our buildings. As the resumption of work begins, we can expect delays in the reactivation of core facilities as they adjust to the new protocols, and there are likely to be delays in ramping up some supply lines. Furthermore, these added services will likely lead to increased population density and physical interactions. Therefore, the numbers of support staff should be kept to the minimum wherever possible.

Access to UCSF Facilities by Clinical Research Sponsors and Monitors

The onsite presence of clinical research sponsors and monitors is strongly discouraged at this time and requires pre-approval of the appropriate principal investigator or department head when absolutely necessary. All study teams and monitors must follow the Office of Research Guidelines for Clinical Research Monitoring for remote and onsite monitoring. 

Monitoring compliance

Based on good compliance with current research shutdown policies, we are confident that faculty, trainees, and staff understand the importance of these policies and will strive to operate accordingly. However, compliance checks by safety specialists, Infection Prevention personnel and others will be used to identify research locations where there is inappropriate density or lack of distancing or other protective measures. In these cases, faculty will be required to modify staff schedules or take other measures to minimize risk of transmission.

Principal investigators should make every effort to resolve compliance problems locally if possible. If safety deficiencies are not resolved locally in a timely fashion, the issue will be escalated to the appropriate department chair, dean, clinical unit leader, or research oversight committee for swift correction. Other options for initiating an evaluation of unresolved safety concerns are by emailing EH&S ([email protected]), through anonymous reporting on the EH&S website, or through an Improper Governmental Activity (“Whistleblower”) Report.

Health and Safety Protocols for Working Onsite

A significant increase in the population density in our buildings comes with health risks, and we will need to be more vigilant than ever in mitigating these risks.  All personnel must adhere to UCSF Protocols for Working Onsite, including but not limited to physical distancing, face covering, hand hygiene etc.

  • Beginning May 18, 2020, UCSF is using a Conversa Daily Health Screen tool which asks questions to determine if an employee or student is cleared to be onsite each day. The online tool can be accessed via mobile phone or home computer:
  1. Text "Screen" to 83973 (easiest) or 
  2. Access site via https://www.ucsfhealth.org/daily-health-screening and click “Take Screener” on a computer or web-enabled phone

Each person needs to receive clearance prior to entering a UCSF building, ideally, 2-4 hours before arrival. Health screens of research participants should be performed via telephone as described earlier in this planning document; the Conversa tool is designed only for UCSF employees and students.

Furthermore:

  • If a worker feels any signs of illness, no matter how mild, they must not come to work or perform work of any kind onsite, and should leave immediately for their residence or to a location directed by their healthcare provider. COVID-19 testing is available to all UCSF employees who have symptoms of illness; contact the COVID-19 hotline at (415) 514-7328.
  • All personnel working or learning at UCSF who test or have tested positive for COVID-19 at an outside facility must self-report the positive COVID-19 test result to either UCSF Occupational Health Services (OHS; for faculty, staff, trainees, and volunteers) or UCSF Student Health and Counseling Services (SHCS; for students).