FAQs- NIH OSP Review of Requests to Lower the Minimum Required Biosafety Containment Level for Research Subject to the NIH Guidelines

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Background

As described in Section II-A-3 (Comprehensive Risk Assessment) of the NIH Guidelines, the Institutional Biosafety Committee (IBC) must approve the biosafety level (BL) for recombinant or synthetic nucleic acid molecules experiments described in Section III of the NIH Guidelines. Under Section IV-C-1-b-(2)-(a) of the NIH Guidelines, requests to lower the containment level below the minimum specified in that section require review and approval from the NIH Office of Science Policy (OSP) in addition to approval from the IBC.

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 of the NIH Guidelines, experiments involving the introduction of recombinant or synthetic nucleic acid molecules into RG3 agents will usually be conducted at BL3 containment and, at the present time, IBCs should consider SARS-CoV-2 to be RG3 as a starting point when conducting their risk assessments of the appropriate biosafety level. The FAQs below provide general information about containment lowering requests, which are applicable to research with SARS-CoV-2 as well as other research subject to the NIH Guidelines.

Can an investigator conduct research at a containment level below the minimum specified in Section III of the NIH Guidelines?

NIH OSP approval for containment lowering is required for all research subject to the NIH Guidelines except for situations outlined in Section IV-B-2-b in which the IBC has the authority to set and/or lower containment levels below the minimum specified in Section III without requesting approval from NIH OSP. Such work is covered under Section III-D-2-a and Section IV-B-2-b-(4).

Other than the situations described above, the IBC may not lower containment below the minimum specified in Section III without the approval of NIH OSP. Under Section IV-C-1-b-(2) (Minor Actions), NIH OSP may review and approve specific requests to lower the containment levels for experiments that are specified in Section III. If granted by NIH OSP, approval to lower containment is specific to the research conducted by the requesting investigator at the institution making the request.

What information should be submitted to NIH OSP in support of a request to lower containment?

The institution/IBC’s request to lower containment should include a full description of:

  • The agent and modifications to the agent (e.g., attenuated)
  • Section of the NIH Guidelines the work will fall under (e.g., Section III-D-1)
  • The biological system(s) and experimental manipulations that will be employed
    • All biological reagents (e.g., plasmids, cell lines, prokaryotic hosts) that will be used in the experiment
    • The types of experiments to be performed (e.g., tissue culture, animal work)
  • Proposed biosafety containment levels at which each of these operations will occur
  • Supporting documentation or data demonstrating the attenuation or loss of function of an agent (such as the documentation the IBC reviewed as part of its risk assessment)
  • Any other pertinent information

The material submitted could include the IBC registration document, however providing the information in another format is also acceptable.

In addition to review from NIH OSP, the research will still require approval from the IBC. An IBC may require additional containment above the minimum specified in the NIH Guidelines or set by NIH OSP for any research based on its risk assessment.

Requests for containment lowering along with supporting documentation may be sent to NIH OSP by emailing [email protected].

Additional information about the NIH Guidelines and IBCs is available on the NIH OSP website at /policies/biosafety-and-biosecurity-policy#tab2

Questions about the NIH Guidelines may be directed to NIH OSP staff at [email protected].