Research with COVID-19 Specimens and SARS-CoV-2 Viral RNA, Lysates, Sequences and Expression of Virus Proteins

In light of the evolving coronavirus pandemic impacting public health worldwide and with so many innovative research technologies available in the UT Austin Community, it is likely that researchers from a broad spectrum of disciplines will mobilize to support efforts to test for COVID-19 and study the SARS-CoV-2 virus.

It is important for those planning this work to consider all factors that could lead to (or increase the likelihood of) an accidental exposure to infectious material before they commit to receiving these materials and starting this work. Both risk assessment and institutional biosafety approval of biosafety/biocontainment procedures is necessary to ensure that this work will be done safely and in compliance with applicable standards.

What is the Risk Group (RG) Classification for SARS-CoV-2 under the NIH Guidelines?
Appendix B of the NIH Guidelines provides the basis for the classification of biohazardous agents by Risk Group (RG). In Appendix B-II-D of the NIH Guidelines (April 2019), coronaviruses other than SARS-associated coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) are classified as RG-2 agents. SARS-CoV and MERS-CoV are listed as RG-3 agents. This classification reflected the state of knowledge prior to the emergence of the novel coronavirus SARS-CoV-2, and the Appendix is intended to serve as a resource and is not meant to be all-inclusive. At the present time both the NIH and CDC have determined that SARS-CoV-2 best meets the definition of a RG3 agent.

The IBC will also consider the SARS-CoV-2 virus to be RG-3 agent and will use this as a starting point in the risk assessments when reviewing research.

Please Note: Investigators should not receive or accept COVID-19 samples or related materials before a risk assessment is completed and approved by UT Austin’s Institutional Biosafety Committee (IBC).

Any UT Austin researcher who is planning to receive any biological specimens from COVID-19 patients or any other materials associated with the SARS-CoV-2 virus must have IBC approval.

Due to the CDC and NIH elevation of SARS-CoV-2 from RG-2 to RG-3, the IBC is asking that all new work involving COVID-19 specimens, SARS-CoV-2 viral RNA, lysates, sequences or the expression of viral proteins must be submitted as a separate new protocol and not as an amendment. This will avoid confusion and differentiate COVID-19 and SARS-CoV-2 activities from your other research activities. The new protocol will be approved with containment conditions and special precautions specific to your COVID-19 or SARS-CoV-2 research activities.

If you do not currently have an IBC eProtocol, please contact the UT Austin IBC to find out if you need to submit one for your work or go to the eProtocol link.

The IBC must review and approve the risk assessment and biocontainment plan for the proposed activities before shipment/transfer of COVID-19 specimens or SARS-CoV-2 virus RNA, sequences, or expression of viral proteins is initiated.

When assessing risk in laboratories working with SARS-CoV-2 viral RNA, lysates, or COVID-19 specimens, the CDC Interim Biosafety Guidelines for Handling and Processing Specimens Associated Coronavirus Disease 2019 (COVID-19) will be used in the risk assessment (see the link below). The IBC may also stipulate additional biosafety precautions based on the risk assessment of the facilities, modifications to and manipulations of the materials. At this time the NIH and CDC have determined that SARS-CoV-2 a Risk Group 3 agent. The IBC will also consider the SARS-CoV-2 virus to be RG-3 agent and will use this as a starting point in the risk assessments when reviewing research.

At this time, all clinical samples potentially infected with SARS-CoV-2 must be handled in a certified biological safety cabinet in a BSL-2 facility. Any additional precautions needed will be determined by the IBC.

Procedures that generate aerosols or concentrate virus will likely need additional precautions determined by the IBC risk assessments and mitigation measures based on the procedures performed, identification of the hazards involved in the process and/or procedures, the competency level of the personnel who perform the procedures, the laboratory equipment and facility, and the resources available.

The University can’t support any activities such as culturing the SARS-CoV-2 virus requiring BSL-3 containment at this time.

CDC revised 5/11/2020: Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19)

The RG classification for SARS-CoV-2 may change over time as additional information about the virus, such as potential treatments or the development of an effective vaccine, becomes available.

It is the Investigator’s responsibility to ensure that all of their study personnel (faculty and staff) receive appropriate training regarding proper screening for COVID-19, triage procedures for positive screens and proper use of personal protective equipment.

The UT IBC’s final determination of containment conditions for a project may add to or reduce some of the ABSA or CDC recommended practices, primary or secondary barriers, PPE and/or administrative controls described in these guidelines.

The Association for Biosafety and Biosecurity (ABSA International) has provided guidance for SARS-CoV-2 containment conditions.

Additional risk assessment and biocontainment resources:

Due to the important work our faculty is conducting in support of the coronavirus pandemic, the UT Austin IBC is committed to the rapid approval of new protocols involved in this effort. The IBC is convening meetings on an as needed basis to be able to approve COVID-19 related protocols as soon as they are ready for review.

  • Determine if lab space allows appropriate social distancing for research personnel (minimum of 6 ft).
    • If not, determine if research can be scheduled to have fewer researchers in the space at any one time. While fewer researchers in the space may reduce risks of infection, remember to avoid working alone in the lab.
  • Ensure the lab has a sign-in and out sheet posted to keep track of who has been in the lab, should contact tracing need to occur.
  • Researchers must wear gloves.
  • Researchers must cover their faces with a mask or cloth-covering unless they are in a private office or space.
  • Researchers must wipe down surface areas with 10% bleach, 70% alcohol or other acceptable disinfectant at the conclusion of lab work.
  • Researchers must thoroughly wash hands when exiting the lab.
  • Post lab signage that reminds researchers of the above requirements.