Guidance for Clinical Research Conducted “Offsite”, Outside of UCSF-Affiliated Facilities

Updated July 30, 2021

General principles

The purpose of this interim document from the UCSF Office of Research is to provide guidance on the resumption of UCSF clinical research conducted “offsite,” which includes research (clinical research, clinical trials, social and behavioral research, community research, among other research types) conducted in homes, offices, parks, prisons, congregate living facilities, community centers, non-UCSF-affiliated health care facilities, and other non-UCSF community settings.

Previous guidance allowed research protocols traditionally conducted onsite to be moved off-site as an approach to reducing risk of COVID-19 exposures for both staff and research participants. Specific density restrictions on research activities and clinical research categories have now been phased out, and clinical research activities typically conducted onsite can now resume without density restrictions.  Separate guidance has been developed for safely conducting clinical research onsite at UCSF-affiliated facilities.

Whereas these guidelines apply to all UCSF researchers conducting offsite research, locations external to UCSF or outside the jurisdiction of the City and County of San Francisco’s Department of Public Health (DPH) may have additional or differing requirements based on the local directives. Public health orders and/or local guidance with the highest level of rigor (i.e. the “safest” policies) should be adopted in cases where multiple jurisdictions are involved.

Adapting Study Visits to Utilize Virtual Technology and Reduce In-Person Interaction

Guidance for remote vs. in-person activities

Every effort should be made to modify research protocols to include telehealth-based methods (i.e., electronic consent, virtual study visits, mail delivery of study drug or intervention, electronic/remote data collection instruments, remote gift card and other incentives, endpoint measurement using mobile health technology).

Research teams should refer to guidance on video-conferencing and remote visit tools permitted for research visits, and should have standardized protocols in place to train study participants on using telehealth and other virtual options (i.e., how to use Zoom, Microsoft teams, etc.). HIPAA-compliant resources for telehealth-based research are available (see UCSF Telehealth).

When research activities necessitate in-person contact offsite:

  1. Conduct as much of the required work as possible remotely or on the phone prior to and/or after in-person interactions in the field (e.g., conduct consents and interviews virtually prior to collecting specimens in person), and seek to limit in-person contact time.
  2. Maintain >6 feet (2 meters) of distance to the fullest extent possible during the visit.
  3. When feasible and appropriate, consider conducting in-person research activities outdoors or in well-ventilated areas.
  4. Follow all other current requirements described below to ensure the safety of participants and study staff (PPE, health screenings, etc.)
Risk evaluation and participants options

The risk of in-person interactions for research visits conducted in the community should be considered for both participants and study staff. In deciding whether in-person study visits are necessary and possible, and whether it would be safer to conduct visits offsite or onsite, research teams should consider that certain populations of study participants may have lower vaccination rates and/or increased risk for severe COVID-19 infection. Risks to others connected to the research participants should also be considered (e.g., a member of the household with immune-compromised comorbidity or otherwise high-risk individuals). All researcher activities should adhere to SFDPH orders (also see the FAQs page for the current version of the health order) and directives.

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/or a mailed or in-person handout. If possible, this information should be shared before the research visit. Materials and resources are available at the UCSF COVID-19 Resources website and at the CDC’s Coronavirus website.

Research teams planning on conducting in-person interactions with participants offsite should discuss operational and safety issues involved and develop protocols to mitigate risk, including but not limited to plans for infection control (see below for guidance and Appendix A for an Operational Checklist). Participants should be informed of UCSF's current research policies governing onsite and offsite clinical research during the COVID-19 pandemic, and given the option to postpone the planned clinical research visit.

Community engagement

In consideration of the higher than normal levels of public health concern and social anxiety around participation in research during the ongoing COVID-19 pandemic, and the disproportionate toll of the pandemic on people of color and lower income communities, research teams are encouraged to adhere to the following good practices in relation to conducting research in the community:

  1. Seek advice from community members before heading into the field. Community voices can help provide a “reality check” about perceptions of the risk of COVID exposure and related concerns related to study participation, and insights into strategies to address these concerns. Ideally, studies should establish a formal community advisory council for ongoing community guidance. At a minimum, research teams should reach out to a few key community or study participant informants for their input in thinking through the challenges in conducting offsite research during the pandemic.   
  2. Include study personnel who have cultural and linguistic skills and life experiences that will promote trust among the targeted study population and can serve as effective community navigators.
  3. Study teams are strongly encouraged to seek consultation on community engagement strategies from the CTSI Community Engagement and Health Policy Program.

Prior to In-Person Study Visits

Transportation plan

As part of preparation for launching offsite research, the development of a transportation plan is advised. Transportation of study staff, supplies, PPE, data and biological samples requires deliberate planning by the study team. Further guidance on using transportation during the COVID-19 pandemic is available from UCSF Campus Life Services.  Travel to offsite locations outside the Bay Area should follow UCSF’s travel guidelines.

Participant screening for COVID-19

When any in-person contact is deemed necessary for the research, all participants need to complete a health screen conducted by research staff by telephone (or telehealth) prior to the visit using the self-screening tool (pdf of questions) used by UCSF Health for patients.  All participants should also be re-screened at the beginning of their research visit. Refer to Guidance for Screening of Research Participants for complete screening protocols and additional resources.   

If a participant answers YES to any of the screening questions, the research visit should be postponed, and the participant referred to their medical provider.

Staff screening and training

Research staff personnel working offsite must adhere to the same UCSF safety practices required for onsite work, including daily health screens.  All UCSF Health and campus employees and learners, including those at UCSF Benioff Children’s Hospital Oakland, 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 or offsite, 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).

Refer to the Office of Research’s Clinical Research Guidelines webpage for COVID-19-related training, resources and support developed for research staff.

Infection control logistics planning

Prior to initiating any studies, researchers must determine what personal protective equipment, disinfection supplies, or other materials may be required to safely conduct research activities. The COVID-19 pandemic has resulted in global disruptions to manufacturing and distribution, and many supplies are still facing long lead times. UCSF is making efforts to procure many standard PPE items and disinfectant supplies centrally, which are being made available through the “SCM COVID STORE” in BearBuy (accessible through MyAccess).

During In-Person Study Visits

Personal Protective Equipment (PPE)

For in-person research visits, research personnel should follow the PPE policies applying to healthcare personnel providing direct patient care. Refer to UCSF Health’s Hospital Epidemiology and Infection Prevention (HEIP) website for the most current PPE recommendations and additional guidance and resources. All in-person research visits should be conducted by research personnel wearing a face mask, and eye protection (e.g., eye shields, face shields, or safety glasses) is strongly recommended for direct patient contact according to UCSF Health PPE policy. When interacting with individuals in the field, additional infection prevention and control practices may be needed and research personnel should apply the current CDC guidance applying to the particular setting and participant population in each study.  

Study participants should wear face coverings during the study visit, and researchers must provide masks to participants if needed.  Gloves should also be provided to study participants as needed based on the study visit activities.

Cleaning and Disinfection

If research participants are provided data collection or other reusable equipment (i.e., laptops, wearable devices) for use in the field, that equipment must be thoroughly cleaned and sanitized by the research team using EPA approved disinfecting wipes/cleaners, 70% ethanol, or 1:10 dilute bleach prior to release and following return from each participant’s use (see Reducing Viral Transmission below). Refer to updated cleaning and disinfection protocols for UCSF Health and UCSF Campus for current resources.

Cleaning supplies and language-appropriate directions for using those supplies with the reusable equipment must be provided to participants for their own use if appropriate for the particular visit setting.

To reduce viral transmission, all research groups should:

  • Use EPA approved disinfecting wipes/cleaners, 70% ethanol, or 1:10 dilute bleach to disinfect bench surfaces, tables, doorknobs, other high-touch surfaces, and shared equipment surfaces, frequently throughout the day and at the beginning and end of each shift. In situations where the research space is not controlled by the study team (“research space” includes any offsite space where research is being conducted), team members should seek permission to clean surfaces before and after research activities.
  • Wash hands with soap and water regularly throughout the day, especially after removing gloves, and at the end of the research visit. Remove gloves before leaving the research environment. Gloves used for research should not be worn in hallways, elevators, or offices.
  • Note and comply with any capacity signs and markings in elevators, restrooms, and other offsite facilities.
  • When physical distancing is not possible (e.g., research or office spaces with corridors less than 6 feet wide), seek an alternate route whenever possible.
Collection of biospecimens

Procedures for the collection of biological specimens must adhere to federal, state/local, and community organization guidelines and appropriate COVID-19 precautions. Refer to the Office of Research COVID-19 Biospecimen Guidelines for additional details and links to most current CDC guidelines.

In addition to standard surgical mask and face shield recommendations for all study staff interacting with research participants, those collecting biological specimen may need a higher level of protection, depending on the activity, which may include an N95 mask, gloves, gown and/or “bunny suit” (see PPE section above).  Investigators must consider any additional risk associated with the procedure (e.g., phlebotomy requires researchers to be physically closer to participants than interviews) and have in place appropriate safety precautions necessary to adequately protect participants and research staff.

Researchers must weigh the risk of collecting a specific specimen against its importance to the research, patient, and community in determining whether it is truly necessary. The balance of potential benefits and harms will vary by study objectives, target patient population, and may change as the COVID-19 outbreak evolves.

Research with increased risk of aerosolization and COVID-19 testing

Research visits involving procedures that induce cough, sneezing or otherwise increase risk of aerosolization must be conducted with approved 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 procedures cited 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:

Special considerations for COVID-19 focused clinical research 

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. In addition, research involving persons undergoing workup and/or who have a confirmed diagnosis for COVID-19, and research involving household contacts of persons with COVID-19, requires adherence to special infection control practices.

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]. This includes studies conducted in a community or any off-campus setting.

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.  

In case of exposure

In the event of a confirmed COVID-19 infection in the research team and/or concerns about possible exposures to or from study participants in association with in-person study visits, the study team should immediately contact UCSF Occupational Health Services to notify them of the infection and to determine next steps and the need for contact tracing. Please refer to UCSF Occupational Health Services guidelines for additional details.

Additional Resources

The following websites provide detailed guidance on a number of topics relevant to clinical care that are also relevant for clinical researchers, including various applications of personal protective equipment.


APPENDIX A: Operational Checklist for Offsite Conduct of Clinical Research