Guidance for Onsite Clinical Research Activities

The purpose of this interim document is to provide guidance on the complete resumption of onsite clinical research at UCSF facilities located in the City and County of San Francisco. These policies apply to all UCSF-affiliated research. Affiliates sites and sites external to County of San Francisco (e.g., BCH Oakland, SFVA, ZSFG) may have additional or different requirements based on the local situation, and researchers should contact administrators at their local site in case of discrepancy or if they have any other questions.

The top priority is public health: not just the health of UCSF personnel, but the health of research participants, the city, and region. This UCSF plan aligns with current state and local Public Health orders.

Overview of Research Policy to Date during Pandemic

The Office of Research monitors the pandemic situation closely and continuously reassesses research policies based on the review of metrics, discussions with various stakeholders across the UCSF and broader UC research community, and consideration of current public health guidance.

After a brief pause in all research with the March 2020, 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, and further increased to 50% on March 8, 2021. For Phase 7, that began on April 28, 2021, specific density restrictions on clinical research activities were removed and UCSF research guidelines were linked directly to compliance with the Cal/OSHA COVID-19 policy in place at that time, which still required 6-foot distancing in the workplace, regardless of vaccination status.

Current Guidelines for Clinical Research

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

Clinical research categories

Because clinical research encompasses a diverse range of modalities and considerations, investigators were previously asked to follow specific directives based on the category of their research (e.g., COVID-19-related clinical research; clinical research essential/not essential to the health of the participant). The clinical research categories have now been phased out and the same directives apply to all onsite clinical research.

Research density and physical distancing

Beginning April 28, 2021, specific density restrictions on clinical research activities were removed and UCSF research guidelines were linked directly to compliance with the Cal/OSHA COVID-19 policy.

Effective June 17, 2021, changes in state regulations have removed the COVID-19 public health requirement for maintaining 6-foot physical distancing in the workplace in most non-clinical environments. Maintaining physical distancing is still required for everyone in all indoor patient care or clinical settings regardless of vaccination status. Physical distancing will no longer be necessary for employees and learners working in UCSF research laboratories and other on-site non-clinical research facilities, allowing laboratory and clinical research activities taking place in non-clinical settings to return to pre-pandemic levels.

Revised Masking/Face Covering Policy

Effective July 1, UCSF adopted a new policy for wearing masks and face coverings that depends on whether individuals are fully vaccinated or not, and on the particular UCSF setting and building. This policy was revised on July 15 to account for an increase in COVID-19 infections related to the Delta variant.

In short, employees and learners at UCSF will be required to wear face coverings in indoor places, regardless of vaccination status. Masking is not required in most outdoors settings for fully vaccinated individuals except when within thirty feet of the entrance to a health care building or while standing in line at shuttle stops, and is recommended for unvaccinated individuals.

Please review the revised Masking/Face Covering on Campus and Health Facilities guidelines, and follow the guidelines applying to your particular clinical research study.

Daily Health Screener

All personnel are required to adhere to UCSF Health Screening policy and use the COVID-19 health-screening tool, which asks questions to determine if an employee or student is cleared to be onsite each day. Research personnel should complete the health screener two hours before coming to campus.

Starting July 8, 2021, all UCSF employees and learners will use a new COVID-19 daily health-screening tool that replaces Conversa, which will no longer be available. The new digital health-screening tool takes only five minutes to complete and is accessible in multiple languages via the UCSF Mobile App or online at the Daily Health Screening website.

For more details on the daily health screener, please visit the UCSF Daily Health Screening website and see answers to frequently asked questions here.

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).

Remote vs. onsite work for clinical research study personnel

In agreement with the current guidance for telework at UCSF that extended the work-from-home guidance through October 1, 2021, clinical research activities that can be performed remotely should all continue remotely (no change from current interim policy). This includes clinical research activities without direct human subjects contact, computational, dry lab research, office-based research performed entirely using telehealth or other virtual methods, etc. For additional guidelines and resources on telework that apply to all UCSF employees, please refer to the UCSF Telework Toolkit, which combines resources developed by departments across UCSF in a usable, easy-to-navigate format.

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.

Considerations for Research Participants

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 current research policy governing clinical research during the COVID-19 pandemic and given the option to postpone the planned clinical research.

Masking and distancing

All in-person research visits should be conducted by research personnel and participants wearing a face mask per institutional policy, and other appropriate PPE according to the UCSF Health PPE policy applying to research visits in your specific study. Whenever possible, there should be a minimum of 6 feet distancing between participants and research staff consistent with public health directives. Please refer to UCSF Health Guidance for Masking and Physical Distancing and Frequently-Asked Questions for additional details.

COVID-19 screening

As required for clinical visits, all participants coming for research visits conducted in-person, regardless of visit location, should be screened for COVID-19 symptoms by phone (or telehealth) prior to and at the time of arrival for the visit, using the self-screening tool (pdf of questions) used by UCSF Health for patients. Please refer to the Updated Guidance for Screening of Research Participants for details.

In summary:

Participants whose research visit includes a clinical encounter should be screened by the research study team only if they have not yet been screened by UCSF Health clinic staff at the time of their research visit.

Participants undergoing "research only" visits (no concurrent clinic visit) should be screened by the research study team.

If the answer to any of the screening questions is YES (other than indicated as “ENTRY OK” in the form), the research visit should be postponed and the participant referred to their medical provider.

Please note that research participants need to consent to COVID-19 screening and/or testing that are unrelated to the study protocol and are done for the sole purpose of adhering to UCSF Guidance for Onsite Clinical Research Activities. Please refer to COVID-19 Screening and Testing Forms developed by the IRB for additional guidance on when and how to use these forms.

Additional considerations for specific types of clinical research

Further special considerations apply to specific types of clinical research visits as follows:

COVID-19 focused clinical research

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

In response to a UCSF COVID-19 Research Coordination Task Force recommendation, the Office of Research established a process to review and coordinate COVID-19 research involving human participants. COVID-19 clinical research protocols should be coordinated as indicated below in order to protect the clinical and research workforce and prevent overburdening COVID-19 patients and clinical staff with research requests.

COVID-19 clinical trials requiring use of UCSF outpatient space (e.g., Respiratory Screening Clinics (RSCs)) and/or intending to recruit COVID-19 positive outpatients should contact the COVID-19 Ambulatory Research Committee for review by emailing [email protected].

Interventional COVID protocols conducted using UCSF inpatient clinical space should be reviewed by the COVID Interventional Clinical Trials Committee (contact [email protected] & [email protected]). In addition, this committee will review all interventional COVID-19 studies conducted at UCSF, ZSFG & VAMC (outpatient and inpatient). Researchers interested in conducting COVID-19 studies can also submit questions in the Contact Us box on the Office of Research COVID-Related Research website.

Clinical research with increased risk of aerosolization (AGPs)

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. Research participants must undergo COVID-19 RT-PCR testing prior to research visits involving Aerosol Generating Procedures (AGPs), regardless of their vaccination status. Please refer to UCSF Health’s revised FAQs for COVID-19 screening of adult or pediatric patients for current guidance on testing research participants before AGPs (e.g., type of tests, timing of testing, etc.)

For a list of AGP procedures and current PPE and other safety requirements, please refer to UCSF Health’s guidance for use of PPE for Aerosol Generating Procedures, and visit the HEIP website for a complete list of resources on Aerosol Generating Procedures (AGPs).

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://sf.gov/get-vaccinated-against-covid-19

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. While approval by clinical units is no longer a requirement for research activities performed in clinical care locations, we advise study teams to discuss with the leadership of the clinical units on which the research will be conducted (e.g., ICU, hospital ward, ED, clinic) before they re-start or ramp-up research activities. This will ensure that research activities will not interfere with essential clinical activities and/or workflows and will not complicate population density management by the health system.

Support staff, core facilities, and delivery of supplies

The full 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.

Access to UCSF Facilities by Clinical Research Sponsors and Monitors

All non-essential monitoring visits should be done remotely. 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. Study teams and monitors must follow the Office of Research Guidelines for Clinical Research Monitoring for both remote and onsite monitoring. Monitors are also required to follow UCSF Vendor policies for the travel, testing, and screening that apply to their current vaccination status.

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