Interim Laboratory Biosafety Guidance for Research with SARS-CoV-2 and IBC Requirements under the NIH Guidelines

FAQs – Interim Laboratory Biosafety Guidance for Research with SARS-CoV-2 and IBC Requirements under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

What is the Risk Group (RG) Classification for SARS-CoV-2 under the NIH Guidelines?

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 RG2 agents. SARS-CoV and MERS-CoV are listed as RG3 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.

Table 1 in Appendix B of the NIH Guidelines provides the basis for the classification of biohazardous agents by RG. RG3 agents are those that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available.

At the present time, SARS-CoV-2 best meets the definition of a RG3 agent and Institutional Biosafety Committees (IBCs) should consider the agent to be RG3 as a starting point in their risk assessments when reviewing research subject to the NIH Guidelines.

The RG classification may change over time as additional information about the virus becomes available.

What is the appropriate Biosafety Level (BL) for handling SARS-CoV-2?

The Centers for Disease Control and Prevention (CDC) has issued Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). Laboratories working with SARS-CoV-2 should adhere to this guidance. IBCs may stipulate additional biosafety precautions based on their risk assessment of the specific modifications to and manipulations of the agent. At this time, IBCs should consider the agent to be RG3 as a starting point in their risk assessments when reviewing research subject to the NIH Guidelines.

In 2020 and 2021, NIH OSP has received multiple requests to lower containment from BL3 to BL2 for research with certain agents, including SARS-CoV-2.  Under Section III-D-1-b the NIH Guidelines, experiments involving the introduction of recombinant or synthetic nucleic acid molecules into RG3 agents will usually be conducted at BL3 containment.

Under Section IV-C-1-b-(2)-(a) of the NIH Guidelines, requests to lower the containment level below the minimum specified in Section III require review and approval from the NIH Office of Science Policy (OSP) in addition to approval from the IBC.  For further information please see FAQs- NIH OSP Review of Requests to Lower the Minimum Required Biosafety Containment Level for Research Subject to the NIH Guidelines.

What are acceptable practices for the remote conduct of IBC meetings?

Convening the IBC by teleconference or videoconference is permissible as these modes enable a live meeting to be conducted, thereby fulfilling the expectations of the NIH Guidelines. IBC requirements, such as a quorum present for the conduct of official IBC business and documentation of the meeting (e.g., meeting minutes), still apply regardless of the mode of convening.

Questions related to the NIH Guidelines may be addressed to NIHGuidelines@od.nih.gov.

Additional information about Coronavirus Disease 2019 (COVID-19) is available at:

https://www.cdc.gov/coronavirus/2019-ncov/index.html

https://www.nih.gov/health-information/coronavirus#!/detail/403327