Amendments to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules Regarding Research Involving Gene Drive Modified Organisms

The NIH Guidelines were revised to include specific considerations and requirements for conducting research involving GDMOs in contained research settings. The update clarifies the minimum containment requirements for conducting research with GDMOs, describes considerations for performing risk assessments when working with GDMOs, and defines additional institutional responsibilities regarding Institutional Biosafety Committees (IBCs) and Biological Safety Officers (BSOs).   Full details are available in the Federal Register Notice outlining the final amendments.

Experiments involving GDMOs generated by recombinant or synthetic nucleic acid molecules shall be conducted at a minimum of Biosafety Level (BL) 2 (see Section III-D-8 of the NIH Guidelines). IBCs may require additional biosafety precautions, or a higher containment level based on their risk assessment of the specific research protocol.

To assist Institutional Biosafety Committees (IBCs), biosafety professionals, and investigators, NIH OSP has issued a reference document.

When an institution subject to the NIH Guidelines conducts research involving GDMOs, the institution must ensure that the IBC has adequate expertise (e.g., specific species containment, ecological or environmental risk assessment) to evaluate the research. In addition, when conducting such research, a BSO is mandatory and shall be a member of the IBC.

Due to the relatively recent advancements of gene drive technologies, IBCs at many institutions may not have access to institutional members with expertise in ecological or environmental impact assessment. The IBC may use ad hoc experts from outside the institution as appropriate when reviewing research with GDMOs.

When reviewing research with GDMOs, the IBC – in consultation with scientists knowledgeable of gene drive technologies, the environment, and ecosystems in the geographic area of the research (see Section V-N of the NIH Guidelines) – should assess the impact on ecosystems to determine whether a GDMO has a potential for serious detrimental impact on managed (agricultural, forest, grassland) or natural ecosystems.

A new section, Section III-D-8, has been added to the NIH Guidelines, which specifies that experiments involving GDMOs generated by recombinant or synthetic nucleic acid molecules must be conducted at a minimum of BL2. Section III-D-4 (Experiments Involving Whole Animals) and Section III–D–5 (Experiments Involving Whole Plants) have been amended to include references to the new Section III-D-8 for research with GDMOs and that the minimum containment required for such research is BL2.

In addition, Section III–E–3 (Experiments Involving Transgenic Rodents), which addresses only experiments that may be conducted under BL1 containment, has been amended to clarify that, since research with GDMOs must be conducted at a minimum of BL2, the generation of rodents containing a gene drive instead falls under Section III-D-8.

No. Under the NIH Guidelines, certain low risk research is exempt from the requirements for IBC registration, review, and approval (see Section III-F and Appendix C). Research with GDMOs must be conducted at a minimum of BL2, thus amendments have been made to Appendix C, specifically Appendices C–III–A and C–IV–A for Saccharomyces and Kluyveromyces host-vector systems, respectively, to clarify that experiments involving GDMOs are not exempt and are covered under Section III-D-8.

The NIH Guidelines specifically address contained research. As such, no changes have been made to the NIH Guidelines regarding field release research involving GDMOs.

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 NIHGuidelines@od.nih.gov.