NIH Revises the NIH Guidelines for Research Involving Recombinant DNA Molecules

The NIH Office of Biotechnology Activities (OBA) has finalized updates to the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) to explicitly cover certain types of basic and clinical research with nucleic acid molecules created solely by synthetic means. The updated guidelines, which go into full effect in March 2013 and will be known as the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, address the need for appropriate biosafety containment of an agent regardless of whether the technique used to create the organisms is recombinant or synthetic. These guidelines also address a National Science Advisory Board for Biosecurity (NSABB) recommendation to ensure that federal  biosafety guidelines are appropriate, adequate, and easily understood with respect to working with synthetic nucleic acids. The revisions also clarify the criteria for selection of certain experiments that involve the introduction of drug resistance into microorganisms for NIH review (see Section III-A-1 and III-B of the NIH Guidelines).

The updated NIH Guidelines will go into effect in March 2013. The changes were announced in the Federal Register (volume 77, no. 172, p.54584-97) on September 5, and published in the NIH Guide (NOT-OD-12-150) on September 11. Additionally, a copy of the revised NIH Guidelines can be found on the Office of Biotechnology Activities website, together with answers to frequently asked questions regarding the changes related to synthetic nucleic acid research and addressing experiments involving the introduction of drug resistance into microorganisms.

For any specific questions not addressed by the Guide notice and OBA website, please contact the NIH Office of Biotechnology Activities by e-mail (, telephone (301-496-9838), or fax (301-496-9839).

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