The Council on Governmental Relations (COGR), representing over 200 U.S. research universities and affiliated institutions, submitted comments to the National Institutes of Health (NIH) regarding proposed amendments to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. COGR supports the NIH's efforts to enhance safety and align its guidelines with the CDC’s Biosafety in Microbiological and Biomedical Laboratories, but offers detailed recommendations to further improve the amendments. A key concern centers on the definition of "gene drive," which COGR finds overly vague and potentially overbroad, risking misinterpretation and unnecessary containment requirements. COGR suggests NIH adopt a more precise definition from the National Academies and more clearly distinguish between genetically modified organisms (GMOs) and gene drive modified organisms (GDMOs), advocating for these distinctions to be reflected structurally in the guidelines to avoid regulatory confusion.
COGR also critiques redundancy and potential overlaps among sections addressing gene drive research, recommending consolidation or more explicit organizational strategies to facilitate compliance. Specific comments include the need for differentiated containment practices between organism types, clarification of exemptions for certain transgenic rodents, and support for proposed risk category reclassifications of select viruses. In conclusion, COGR reiterates its commitment to supporting effective, risk-based oversight while minimizing unnecessary administrative and cost burdens, expressing appreciation for the NIH’s openness to stakeholder input and offering further collaboration for optimal guideline refinement.
