Research

Last Update: 05-14-2020 3:00 p.m.

The information provided below is intended to facilitate the gradual resumption of comprehensive research activities at EVMS in a manner consistent with state and federal guidelines, beginning with a ramping-up of critical research that was temporarily minimized (Stage One) and continuing with increasing research activities (Stage Two).

The Research Ramp-Up Plan has been developed with input by an EVMS COVID-19 working group, various Chairs, research leadership, and the Ramp-Up Task Force. The Plan mirrors plans being developed at many research institutions across the nation. The approach involves several critical procedures to be followed by the research community, in particular PPE usage, social distancing and health monitoring.

NOTE: These procedures and guidelines are fluid and subject to change depending on COVID-19 outbreaks, public health considerations and institutional, federal and state revisions in policies.

Stage One: May 15, 2020

Last Update: 05-14-2020 3:00 p.m.

The initial phase of comprehensive research resumption will focus on critical research that was temporarily paused or revised due to COVID-19 conditions. Critical research includes funded research projects (whether existing or new) and related activities such as no-cost extensions, applications for renewal and preparations for resubmission of competitive grant applications.

Resumption of research related to non-funded grant applications will be reviewed on a case-by-case basis. Consideration will also be given to requests for some new clinical studies. The initiation of new, non-funded studies is prohibited until later phases are approved institutionally. The phased approach is necessary due to limited research support services, including PPE and supply availability, and by the recognized need to limit the density of individuals in research spaces in compliance with Virginia Executive Orders and federal and state guidance.

Please note that activities previously approved as critical research laboratory support and maintenance remain approved, but researchers must adhere to the COVID-19 Research Ramp-Up Plan. NOTE: It is anticipated that Stage One will extend until Executive Order 55 is lifted or further revised.

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General Requirements

Last Update: 05-14-2020 3:01 p.m.

Approval Required

Approval of research for Stage One will require the completion of a Request for Research Ramp-Up (RRR) form by the investigator/Lab Director with review and approval by the Chair and Research Office. Investigators should utilize remote activities whenever possible.

Social/Physical Distancing

• Personnel present in laboratories and other research areas are limited to no more than two research personnel at any given time. Requests for more personnel in larger research spaces (i.e., larger labs over 1200 sq. ft.) will be considered on a case by case basis. Research may be conducted on a staggered or shift-based work schedule to help meet the required density restrictions. Graduate students (PhD and Masters) are permitted to conduct research under these density requirements. Non-EVMS employees or visitors are not permitted in research areas unless pre-approved by the Chair.
• A minimum of 6 feet distance should be maintained between personnel while in the lab and all other research areas, hallways, break areas and offices. For experimental manipulations that involve periodic interactions of individuals in proximity closer than 6 feet, such as animal surgeries and clinical exams, face masks and additional necessary PPE (eyewear, gloves, or face shields) should be utilized and the length of close interaction should be minimized.
• Research meetings should be conducted virtually whenever possible.

Personal Protective Equipment (PPE)

• Face masks (either surgical or cloth face coverings) must be worn in common areas at all times, including the lab, hallways, elevators, restrooms and building entryways. Each EVMS employee will be provided with 3 Cupron masks, but may also wear personal cloth face coverings. Face masks must be laundered in accordance with EVMS guidance provided in training materials and by EVMS Medical Group.
• Regular cloth lab coats must be worn at all times while in the research lab or core setting. Clean lab coats must be used when in non-research spaces, such as break areas, lounges, etc. Lab coats are not to be laundered at home and must be laundered regularly via a commercial vendor or at facilities on campus. There are several sites for washing lab coats on-site (Physiology Department, Human Anatomy Laboratory, Ultrasound Laboratory, Comparative Medicine Facility and Jones Room 310). Please check with staff in these facilities about washing availability.
• Nitrile or latex gloves and eye protection should be worn as situations warrant (e.g., working in close proximity for surgeries or sharing of instruments). EVMS is procuring an initial supply of gloves, masks, sanitizers and some lab coats. These will be available for pick-up in the EHS office in Lewis Hall.
• Find a complete overview of this guidance on the PPE Masking and Hand Hygiene page.

Safe Work Practices

• Lab benches and all touch surfaces (faucets, door handles, keyboards, common equipment, etc.) should be disinfected by staff at the beginning of each day, at periodic intervals during the day and before the end of daily operations. Disinfection wipes or spray will be provided if needed. A procedure for cleaning surfaces must be posted in the laboratory. EHS will provide guidance. Housekeeping will also provide disinfection of common entry touch surfaces (door handles) daily.
• Laboratory personnel must wash hands with soap and water before laboratory entry, after completion of work, and regularly throughout the day. Frequent use of hand sanitizers throughout the day is suggested when handwashing is not feasible.

Health Monitoring

• All research personnel (lab, clinical, other) will be required to complete an initial health screening survey to be approved for Stage One research and are required to self-monitor for COVID-19 health symptoms daily. The initial health survey will need to be completed in RedCap prior to entry to research areas. Research personnel who are sick or experiencing listed symptoms must notify Human Resources immediately and follow Occupational Health directives until cleared to return. Guidelines for the self-monitoring are included in the education and training resources on the Workplace Training course on Blackboard.
• Individuals with concerns and questions about returning to work should consult with their immediate supervisor or EVMS Human Resources.

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Additional Research Considerations

Last Update: 05-14-2020 3:02 p.m.

Vivarium Research

• Only activities (ordering, breeding, experimentation) in support of previously funded research that was paused due to COVID-19, and support for newly awarded research projects are allowed. Approval of the research by CompMed and the IACUC is required to ensure resources and staffing are available.
• All PPE requirements currently mandated by CompMed must be followed, in addition to PPE requirements listed above.
• All disinfection and sanitation requirements of CompMed must be followed.
• No ordering of animals for new pilot studies is permitted in Stage One.
• A Town Hall-type conference will be conducted soon after May 15 by CompMed for lab animal researchers to begin preparations for the gradual resumption of animal research.

Clinical (Human Subjects) Research

• Clinical research activities must obtain the approval of the departmental chair and EVMS Medical Group leadership prior to restarting clinical research.
• Researchers should prioritize the resumption of on-site research visits to pre-approved research studies that were paused due to COVID-19, pending approval by sponsors and the appropriate IRB. Previous allowances continue for patient (subject) visits related to health or critical care needs.
• Early priority should be focused on follow-up patients (subjects) first, followed by a gradual transition during late May through mid-summer for visitation by new subjects for screening or treatment as allowed by the clinical group.
• Investigators are still encouraged to conduct research with subjects remotely, whenever possible.
• New clinical research studies and screening will require evaluation and approval by the Chair and EVMS Medical Group leadership based on a judgment that conditions allow for increased volume.
• Investigators should follow the clinical department COVID-19 screening procedures for patients. These apply to subjects and will be required before entry into the clinic research areas.
• The number of staff will be limited in laboratory and clinical research spaces. The PPE requirements of the clinical department should be followed for staff and patients (subjects).

Community-related Research and Educational Research

• The requirements for PPE, social distancing in office and facility spaces, health screening and the prioritization for funded research, as described above, apply.
• Direct interactions with community groups is not permitted, but remote interactions are permissible with appropriate IRB approval.

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Stage Two: Sometime After June 10, 2020

Last Update: 05-14-2020 3:02 p.m.

Stage Two research activities will involve a gradual resumption of new research studies, pilot research, non-funded research and the expanded activity of previous laboratory and clinical research.

A date to initiate Stage Two research activities will be determined institutionally with recommendations from the Chairs, researchers and health providers.

Some determinants impacting the decision to start Stage Two activities are the availability of resources and the capacity to adhere to Stage One requirements, as well as the COVID-19 profile in the community.

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