Guidance for Category 2 and 3 Research Conducted “Offsite”, Outside of UCSF-Affiliated Facilities

Version August 17, 2020

UCSF research activities conducted “offsite”, outside of UCSF-affiliated facilities

The purpose of this interim document is to provide guidance on the partial resumption of UCSF Category 2 and 3 research (i.e., non-COVID-19 related 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, and other non-health care facility community settings. Some research protocols affected by this guidance are designed specifically to be conducted in the community, while other research protocols traditionally conducted onsite are also being moved off-site as an approach to reducing risk of COVID-19 exposures for both staff and research participants.  Separate guidance has been developed for safely conducting clinical research onsite at UCSF-affiliated health facilities (https://research.ucsf.edu/guidance-onsite-clinical-research-activities).

Whereas these guidelines apply to all UCSF researchers conducting research (clinical research, clinical trials, social and behavioral research, community research, among other research types) offsite, 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

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.)

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, research teams should also consider that certain populations of study participants may have increased risk for severe COVID-19 infection. Risk 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 (https://www.sfdph.org/dph/alerts/coronavirus-healthorders.asp) and directives (https://www.sfdph.org/dph/alerts/coronavirus-health-directives.asp).

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 Novel 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).

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.

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

Per guidance from the Office of Research for the resumption of research activities, the research team supervisor or study PI should confidentially query the research team about interest and capacity to return to work, and assign duties accordingly.

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 (https://coronavirus.ucsf.edu/travel).

PARTICIPANT SCREEN 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.  All participants should also be re-screened at the beginning of their research visit. Refer to Guidance for Screening of Research Participants by Clinical Research Staff for complete screening protocols and additional resources. An example of current questionnaire for COVID-19 symptoms check is also provided in Appendix B.   

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 research staff must complete the Conversa-based UCSF Daily Health Screen at least 2 hours before interacting with individuals in the field. See Daily Health Screenings for more info.

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).

All UCSF faculty, staff, and student employees are required to complete training in infection control and COVID-19, regardless of where the research activities take place. Refer to the Office of Research’s Clinical Research: Return to Work and Checklist for COVID-19-related training, resources and support developed for research staff.

During the In-Person Study Visits

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) according to UCSF Health PPE policy expanding eye protection requirements. When interacting with individuals in the field, additional infection prevention and control practices may be needed as per UCSF EH&S guidance.  Study participants should also wear face coverings during the study visit, and researchers must provide masks to participants.  As needed based on the study visit activities, gloves should be provided to study participants. Refer to UCSF Health’s Hospital Epidemiology and Infection Prevention (HEIP) website for additional guidance and resources.

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). Cleaning supplies and language-appropriate directions for using those supplies with the reusable equipment must also be provided to participants for their own use.

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. The Office of Research is currently developing guidelines to help principal investigators, participants, and participant care providers make this determination.

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 centrally procure many standard PPE items and disinfectant supplies, which are being made available through the “SCM COVID STORE” in BearBuy (accessible through MyAccess).

Reducing 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 and restrooms.
  • 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.

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.

Research with increased risk of aerosolization:

Research visits involving procedures that induce cough, sneezing or otherwise increase risk of aerosolization, including so called “aerosol generating procedures” (AGP’s), must be conducted with approved infection control procedures. Research participants must undergo COVID-19 RT-PCR testing prior to the research visit. This testing requirement is consistent with UCSF's policies on 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:

Chest physiotherapy

Nebulized medication

Spirometry testing

Sputum collection

High-flow nasal cannula

Non-invasive ventilation (BIPAP/CPAP)

Tracheostomy care

Open suction

 

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 research related to or with populations undergoing COVID-19 studies

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. Additional guidance is under development and will be posted on the Office of Research website when completed.

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 Plan Checklist for Offsite Conduct of Clinical Research

 

Plan Element

Plan Specifics

Physical Distance Plan

  • Provide details on the provision of ample physical distance that is consistent with the current recommendations.
  • Establish maximum occupancy for space.
  • Establish workspace markings (distances) where appropriate.
  • Provide separate sections/discussion for specialized/shared equipment that need their own personnel distance guidelines and markings.
  • Provide guidance on spacing for work areas

Space

Logistics Plan

  • The PI is responsible for creating a system whereby it is known in near real- time who is in the space and when they are in the space.
  • A list of all personnel who are allowed in the lab/space. If cohorts are utilized, the cohort groups may be provided.
  • Work (open) hours for the lab/space should be stated (staggered schedules recommended).
  • Logistics for special shared equipment, if varied from established practice (e.g. how to reserve) should be explained.

Personnel Responsibilities

 
  • Confidentially survey study Coordinators to ensure they are comfortable with performing in-person study visits vis-à-vis COVID-19 risks
  • State personnel responsibilities and how they will know their roles.
  • Document standard safety rules and point to relevant existing guidance.

Cleaning Plan

 

  • Provide a plan for how the offsite location will be cleaned/sanitized.
  • PIs and personnel are advised that given the desire to maximize physical distancing, additional cleaning duties are expected of personnel. Areas to be considered: vehicle used in transport, touch spots, research equipment, among others.

Human Research Protection Plan

  • Explain steps to be taken to ensure that participants are protected against COVID-19 exposure.
  • Explain how you intend to manage research participants who test positive for COVID-19.
  • Ensure participants receive information regarding potential COVID-19 exposure risk by having them read and sign a COVID addendum to the consent form
  • If the project involves community-based research techniques such as data collection and/or interviews, describe updated safety procedures.

Research Specimen Plan

 

  • Explain steps to be taken to ensure safety in handling research specimens.
  • If the study involves collection and/or handling of COVID-19 specimens, describe the safety procedures to be implemented.
  • Ensure all staff have completed relevant safety training,  e.g. Safe Shipping of Biohazards

 

 

PPE,

Materials and Supplies Plan

  • Define needs for appropriate PPE and cleaning materials.
  • Document materials required before study launch.
  • State how the lab/study is procuring necessary PPE and/or specific cleaning materials.
  • Indicate if support is needed and specify for what PPE or other materials
 
  • How staff, equipment, PPE, and disinfection supplies will travel off site
  • How will specimens be handled and returned to campus

APPENDIX B: COVID-19 Symptom Check

COVID Symptom Check (from Updated Guidance for Screening of Research Participants)

 

  • In the past 30 days, have you or someone you live with been diagnosed with COVID-19? [YES / NO]
  • In the past 14 days, have you had unprotected close contact with someone diagnosed with COVID-19? (close contact = within 6ft for 15 minutes or longer (unprotected = without face covering) [YES / NO]
  • In the past 14 days, have you had any of these symptoms not explained by a pre-existing condition (e.g. allergies):
    • Fever, Chills, Shivering/Shakes ((T > 37.8o C/100o F) [YES / NO]
    • Cough [YES / NO]
    • Sore Throat [YES / NO]
    • Runny or congested nose [YES / NO]
    • Difficulty breathing or shortness of breath [YES / NO]
    • Unexplained muscle aches [YES / NO]
    • Feeling unusually weak or fatigued [YES / NO]
    • Loss of sense of smell or taste [YES / NO]
    • Diarrhea (defined as > 3 loose stools in 24 hours) [YES / NO]
    • Eye redness with or without discharge (“pink eye”) [YES / NO]

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

If the answer to all the screening questions above is NO, proceed to the additional question below:

  • Do you live or have regular unprotected close contacts with individuals at increased risk of severe illness from COVID-19 (close contact = within 6ft for 15 minutes or longer; unprotected = without face covering):
    • Older adults (age 65 years and older) [YES / NO]
    • People of any age with the following conditions:
      • Cancer [YES / NO]
      • Chronic kidney disease [YES / NO]
      • COPD (chronic obstructive pulmonary disease)  [YES / NO]
      • Immunocompromised state (weakened immune system) from solid organ transplant [YES / NO]
      • Obesity (body mass index [BMI] of 30 or higher)  [YES / NO]
      • Serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies [YES / NO]
      • Sickle cell disease [YES / NO]
      • Type 2 diabetes mellitus [YES / NO]

If the answer to any of these additional questions is YES, the research staff should consider options for reducing risks of exposure and refer to the research program PI for approval before proceeding with the in-person visit.