Final Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

Issuing agencies

Abstract

This notice sets forth final changes to NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) as initially outlined in a Federal Register notice issued on August 10, 2023. Following solicitation of public comments, the NIH is amending the NIH Guidelines to include specific considerations and requirements for conducting research involving gene drive modified organisms (GDMOs) in contained research settings. NIH is updating the NIH Guidelines to clarify minimum containment requirements, provide considerations for performing risk assessments, and define additional institutional responsibilities regarding Institutional Biosafety Committees (IBCs) and Biological Safety Officers (BSOs).