This document details the minimum safety procedures that must be in place in order for UConn and UConn Health investigators to be approved by the Office of the Vice President for Research (OVPR) to reopen or initiate new human subjects research. Principal investigators (PIs) must tailor their safety plans to meet the needs of each individual research situation. Environmental Health and Safety (EHS) is available to answer safety related questions from PIs. If you have safety related questions, please email ehs@uconn.edu if your human subject research activities are conducted at the Storrs or regional campuses or call (860) 679-2723 if these activities are taking place at UConn Health.

Guiding principles:

• Careful planning is required to reduce opportunities for exposure.
• No individual project involving human subject research activities may be re-started without prior approval from the OVPR.
• Plan for and operate under the assumption that everyone is an asymptomatic virus carrier.
• Physical distancing is critical. The recommended minimum distance between individuals is six feet.
• The smallest number of study personnel possible should conduct approved research until UConn returns to normal operations. This may require the development of cohorts and non-overlapping shifts when scheduling.
• Research or components of studies that can be conducted without face-to-face interactions or interventions should continue to be conducted remotely.
• Guidelines will be continually updated as more information about COVID-19 becomes available. Updated guidance will be posted on the OVPR website and communicated to UConn/UConn Health faculty and staff. PIs are responsible for staying informed about changes that will impact human subjects research.
• If there is a second surge of infection, it may be necessary for research to be ramped down again. During safety planning, consider which studies can be easily halted or delayed. PIs should develop a continuity plan for another potential research ramp-down.
• Special attention must be paid to risks posed to more vulnerable research subjects (e.g., immunocompromised subjects, older adults with multiple chronic diseases) when evaluating the risks/benefits of subject visits to UConn research facilities.
• If the facility where the research is being conducted has specific requirements or policies related to COVID-19, then the more restrictive of those or the policies described in this guidance must be followed.

Specific recommendations:

Screening

All participants must be screened for COVID-19 symptoms and exposure. Ideally, participants will be screened prior to entering the research facility (e.g. phone, email, or web-based assessment on the day of the visit) or otherwise being engaged with study interactions or interventions.

Screening Questions

1. Have you or someone you live with been tested for or diagnosed with COVID-19 in the last four weeks?
2. Are you experiencing any of the following?

• Fever (100.4 or higher)
• Chills
• New or worsening shortness of breath or difficulty breathing
• New or worsening cough
• Muscle or body aches
• Sore throat
• Congestion or runny nose
• Nausea or vomiting
• Diarrhea
• New loss of smell or taste

If, such as is currently the case at UConn Health, all individuals entering the facility or building will be screened for COVID-19 symptoms and exposure, then additional screening would not be necessary. If a participant screens positive, then their appointment must be cancelled or rescheduled and the individual should be encouraged to contact their primary care physician and/or the UConn Health COVID Call Center at (860) 679-7560. Temperature screening is not required, but PIs may choose to adopt this measure if it is consistent with campus/building recommendations.

Facial Covering/PPE Requirements

1. A cloth facial covering or procedure mask must be worn by study personnel and by participants during face-to-face interactions and interventions when:
   • The participant responds NO to COVID-19 Screening AND
   • The participant is located in or from an area or facility with no or only isolated cases AND
   • The interventions are not aerosol generation procedures AND
   • At least six feet of physical distancing will be maintained at all times

Participants and study personnel may wear their own facial coverings. If participants do not provide their own coverings or if their covering fails to cover their nose and mouth, participants must be provided with a procedural mask. Similarly, procedural masks must be available for study personnel. Furthermore, study personnel must keep facial coverings in place regardless of whether participants are present. The use of physical barriers, such as plexiglass, should be considered as additional measures.

1. Study personnel must wear a procedure mask and face shield during face-to-face interactions and interventions with participants when:
   • The participant responds NO to COVID-19 Screening AND
   • The participant is located in or from an area or facility with no or only isolated cases AND
   • The interventions are not aerosol generation procedures AND
   • At least six feet of physical distancing will NOT be maintained at all times

Participants must continue to wear their own facial coverings or a procedure mask to the fullest extent possible. Participants should remove their mask only briefly (few minutes) if needed for study procedures. If participants do not provide their own covering or if their covering fails to cover their nose and mouth, participants must be provided with a procedural mask. Similarly, procedural masks must be available for study personnel. Furthermore, study personnel must keep facial coverings in place regardless of whether participants are present.

1. Study personnel must wear an N95, procedure mask, face shield, and gown during face-to-face interactions and interventions with participants when:
   • The participant is known or suspected to have COVID-19 OR
   • The participant is located in or from an area or facility with known or a high likelihood of cases and/or transmission OR
   • Study procedures will not allow the participant to wear a mask or face covering for an extended period of time OR
   • The interventions are aerosol generation procedures

If N95 masks are required, study personnel are required to complete EHS training and certification in order to gain approval for N95 mask usage as outlined in EHS’ Respirator Program Policies, Programs, and Procedures. Medical clearance is also required for study personnel who will be wearing N95 masks. For student personnel, this clearance can be obtained through UConn’s Student Health and Wellness; for other research staff, clearance can be obtained through an Occupational Medicine provider (Storrs and Regional Campus researchers can contact CorpCare in South Windsor). Please contact EHS with any questions pertaining to N95 mask usage.

Relevant Resources

• UConn Health PPE Guidance
• EHS’ Respirator Program Policies, Programs, and Procedures
• Respirator (N95 mask) program procedure for students

Cleaning/Disinfecting

1. Research procedure areas, data collection areas, and equipment must be carefully cleaned and disinfected prior to and following use by participants or study personnel. This will include a regular wipe down of shared research equipment and spaces (e.g., desktops) after each participant visit plus a wipe down of shared research equipment and spaces at the end of the day. If participants wish to also wipe down apparatus, they must be provided with disinfectant wipes and encouraged to wear gloves when using them. Please note that any cleaning done by participants does not substitute for the required cleaning by study personnel. If participants are using keyboards, study personnel should put a smooth covering over them. Participants using a shared piece of equipment should also be offered hand sanitizer containing at least 60% alcohol and gloves for optional use during the visit. Participants who choose to wear gloves should be provided with instructions on how to remove and dispose of gloves safely. Hand sanitizer should be available to participants throughout their study visit.

Relevant Resources

• EHS information sheet on glove removal and disposal
• CDC poster on glove removal

To allow for cleaning and ventilation, avoid scheduling immediate and consecutive participant visits to research spaces. If more than one clinic or procedural space is available, use a staggered schedule to alternate visits among rooms. Windows should be open when possible to aid in ventilation.

Other Considerations

If study personnel are visiting off-campus, non-UConn affiliated facilities (e.g., schools/camps, clinics, etc.), PIs must adhere to the rules for the site. In all cases, the more stringent of the UConn or site guidelines must be followed. Recommendations for study personnel and participants regarding the wearing of facial coverings/masks, maintaining physical distancing whenever possible, and frequent handwashing must always be followed. Research visits to study participants homes should only be conducted if they can be “contactless,” such as deliveries and pickups of samples. Research visits to long-term care facilities and nursing homes must be conducted in accord with state DPH guidelines.

UConn Storrs/Regional Campus PIs should contact EHS at ehs@uconn.edu with specific questions about research spaces; UConn Health investigators should contact (860) 679-2723.

References:

CDC Infection Control Guidance for Healthcare Professionals about Coronavirus (COVID-19)