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VCOM Carolinas Campus

COVID-19 Risk Mitigation Guidance

The guidance contained within this document applies to research in any VCOM operated lab whether on a VCOM campus, rented lab space, collaborative university or clinical partner site.  While researchers will be required to adhere to the guidance provided by the host site, VCOM has an obligation to ensure that faculty, staff and students are protected from unnecessary COVID-19 exposure regardless of outside authorities.  As such, please read this document carefully as it applies to ALL research involving VCOM faculty, staff or students. This guidance is based on the current best available information. Guidance and required documentation may change as new information becomes available.

According to the CDC, COVID-19 is still an active threat in this country. CDC Guidance recommends that fully vaccinated individuals without underlying high-risk health conditions wear masks in public indoor settings or areas of substantial or high transmission. In light of the continued threat of COVID-19, especially the B.1.617.2 (Delta) variant currently circulation, VCOM still requires researchers and their teams to follow safe practices as much as possible.

Researchers initiating new research protocols will be required to address COVID-19 risks by outlining additional procedures that will be implemented to prevent the potential transmission of COVID-19.  For human subjects protocols, this will be addressed in the IRB application documentation. For non-human subjects research, Principal Investigators will certify they have completed these requirements by signing a COVID-19 Research Certification (PDF), prior to beginning the study (upon grant award).

Prevention measures should be in place for research participants as well as investigators and personnel working in compact lab spaces. Each research team should evaluate the risks and benefits, carefully considering any additional precautions that must be taken before deciding to initiate research.  All research activities that can be conducted virtually should be conducted in that manner.  It is the Principal Investigator's responsibility to monitor conditions and to pause research or institute protective measures when warranted.  

Project-specific COVID prevention measures should consider and address the following:

  1. A statement on specific COVID-19 risks in the proposed research location and/or setting.  Consider the impact these risk factors will have on the study's variables and the validity of the data collected and overall study outcomes.
  2. General Procedures (following VCOM campus-specific procedures):
    • For research involving human subjects, consider and comply with local health department guidance on COVID-19 screening for person-to-person interactions and interventions.
    • Researchers are still encouraged to continue using virtual meeting tools, including phone and virtual teleconference, whenever possible.
    • If in-person meetings are essential, follow VCOM campus-specific procedures for COVID-19.
    • For those investigators physically located in space shared with other institutions (Virginia Tech, Gibbs Cancer Center, Auburn University, University of Louisiana Monroe and others), please ensure you have a  communication plan that adheres to all site-specific guidance.
  3. Plan to Require and/or Supply PPE for unvaccinated participants and research personnel as well as those vaccinated individuals who choose to utilize PPE.
  4. Plans for Disinfecting Equipment and Surfaces:
    • Document when to use hand wash station or hand sanitizing station, and who is required to maintain
    • Establish enhanced cleaning and disinfecting procedures for high contact surfaces in the lab and common areas, as well as all shared equipment and surfaces (e.g., shared desks, countertops and telephones)
  5. For human subjects research, discuss ways in which the conduct of the study might be impacted:
    • Recruitment:
      • Do you still have the ability to recruit participants for your study?
      • Does your recruitment strategy need to change?  Can it change?
      • Do you need new recruitment materials explaining COVID-19 related risks?
    • Informed Consent
      • Is there a virtual process or online tool for obtaining consent?
      • What is the investigator's role in the consent process?
      • Are you still allowed to use clinic facilities for consenting?
    • Researchers and research staff who will interact with participants should be vaccinated and willing to disclose vaccination status to participants.

    Risk reduction strategies will be discussed in the informed consent document signed by research participants.

In the event that a COVID-19 case is reported that originated with a participant or a member of the research team, the Principal Investigator is responsible for alerting the local health district (see additional resources below), as well as the VCOM IRB. For participants or investigators with a known exposure, all local health department guidelines must be followed.

Additional resources are available through the CDC.