General Guidance and Recommendations for Ensuring a Safe Work Environment

• Encourage remote work when laboratory-based resources are not required (e.g., working on grant writing, data analysis, publications, literature reviews, etc.).
• Make accommodations for personnel who are members of a vulnerable population or have close family who are members of a vulnerable population at a higher risk of severe illness with COVID-19.
• Develop and implement laboratory-level plans that focus on creating safe workspaces and safe practices. All laboratories, including those active during reduced activities, must obtain administrative approvals (Department Chair and/or Dean) of plans that implement social distancing, staggered work schedules and proper protection and hygienic practices in laboratory and workspaces.
• Laboratory-level plans must include mitigation strategies, such as:
  • Creating a laboratory map to approximate scale (plan view) to include the entryway and detailing items such as laboratory furnishings, equipment and other obstructions to determine maximum room occupancy based on a minimum distance of six feet between personnel at any time. Due to the physical layout of many laboratories (e.g. narrow spaces) six feet many not always be achievable. In these cases, cloth facial coverings should be worn. General guidance: occupancy should not substantially exceed one person for each 250 sq. ft. of laboratory and workspace.
• Having your department/building/facility representative confirm your space assessment and the number of personnel you are proposing to allow in the space at a single time.
• For shared laboratory workspaces, working with the other faculty and facility representatives to establish definitive guidelines for the space.
• If your lab has five (5) or more people who will be conducting research, create a lab calendar to track who will work at what time.
•  Share your lab calendar with the appropriate unit representatives.
•  Post occupancy limits on the door, visible to those outside.
•  Post calendar on the door, visible to those outside.
•  Consider creating physical reminders to practice distancing such as using tape on the floor to mark out six-foot spaces
• Take steps to ensure that laboratory space is conducive to working safely.
• Ensure all laboratory spaces are clutter-free including, but not limited to, bench tops, aisles, tissue culture rooms, equipment rooms, etc.
• Ensure laboratory spaces are cleaned and disinfected according to established protocols for the SARS CoV-2 virus in addition standard disinfection protocols, which already are required.
• Disinfect commonly touched laboratory surfaces such as refrigerators, freezers, incubators, centrifuges, equipment controls, keyboards, etc., and workspaces after use.
• Obtain and maintain adequate supplies (e.g., disinfectant, disposable wipes) to support cleaning and disinfecting before restarting research activities. These supplies are available from UofSC Purchasing.
• Create protocols for disinfecting shared equipment and instruments before and after each use. When possible, avoid sharing commonly used items (e.g., pens, notebooks, pipettors, frequently used reagent bottles, etc.).
• Promote the use of recommended infection control measures required by the CDC (cloth facial coverings, frequent hand washing with soap and water, hand sanitizer when hand washing is not available, etc.). The UofSC Division of Communications and Public Affairs has prepared printable signs to assist with this (select the “COVID-19 Resources” category to quickly view all).
• Identify common use areas (e.g., break rooms and lobbies) where people are likely to congregate and interact. These areas should be closely monitored, and if social distancing cannot be maintained, they should be closed.
• Regularly check the comfort level of your employees, graduate students and other personnel with current work environments and address any concerns they raise or forward to the appropriate administrative unit for response.
• Create a contingency plan in the event of a possible or confirmed case of COVID-19 among laboratory personnel.

 

Resuming In-Person Human Subjects Research with IRB Approval

NOTE: Having visitors on campus is highly discouraged during the summer months (June – August), and only should occur in limited numbers in controlled circumstances. IRB approval must be obtained before bringing visitors to campus.

This guidance contains information about COVID-19 as it relates to the conduct of research and Institutional Review Board (IRB) review operations so faculty and staff can effectively and safely manage their ongoing research involving interactions with human subjects.

Plans to resume or initiate in-person human research activities on previously approved projects must be submitted as an amendment for IRB review and approval before such activities may begin.

Prior to seeking approval to initiate or resume in-person activities, efforts should be made to modify existing procedures to incorporate remote interactions to the greatest extent feasible. Such modifications include, but are not limited to:

• Use questionnaires, interviews or surveys delivered online, by telephone or Zoom rather than in-person.
• Email or mail screening and consent documents and other study material to participants.
• Consider requesting a waiver of documentation of signed consent (i.e. consent is obtained orally or by means other than a formal signed document).
• Consider changes to methods of payment to subjects.

Before bringing study subjects to campus, the Principal Investigator must submit an IRB Amendment application that includes a plan that addresses how safety measures will be implemented. At minimum, the plan should include:

• A screening process to determine the COVID-19 risk status of volunteers and staff (e.g. questionnaire regarding health status, recent travels, body temperature, etc.).
• Procedures for:
• maintaining social distancing requirements
• use of PPE, including what is required and how it will be obtained
• proper cleaning of materials, equipment and commonly touched areas where the activities will take place
• plan for scheduling visits to avoid overlap in appointments
• if included in the subject population, plans for handling visits by participants in high-risk categories (older adults and anyone with serious underlying medical conditions). Refer to CDC guidance for a full list.

For IRB-approved off-campus research that only can be conducted in-person, the revised research plan should follow the requirements of the location in which the research will be conducted, but must not be less than those recommended above. Off-campus research also may be subject to additional UofSC restrictions and/or requirements (e.g. travel).

Any changes to current research projects that are made without prior IRB approval must be reported to the IRB as a Protocol Deviation using the Reportable Event mechanism in eIRB.

Contact the IRB at the Office of Research Compliance if you have questions about resuming human subjects research or require assistance: lisaj@mailbox.sc.edu or NEWTONLA@mailbox.sc.edu.

2 June 2020; updated 30 September 2020 to remove time-sensitive summer information that is no longer relevant