September 17, 2012 - Revision of the NIH Guidelines to Include Synthetic Nucleic Acids and Clarification of Criteria for Section III-A-1-a Experiments
On March 4, 2009, the NIH Office of Biotechnology Activities (OBA), Office of Science Policy published a proposal in the Federal Register (March 2009, 74 FR 9411) to make two revisions to the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). One proposed revision was to address the biosafety considerations for research with synthetic nucleic acids. NIH proposed modifying the NIH Guidelines to cover explicitly certain basic and clinical research with nucleic acid molecules created solely by synthetic means. Another proposed revision was to modify the criteria for determining whether an experiment to introduce drug resistance into a microorganism must be reviewed by the Recombinant DNA Advisory Committee (RAC) and approved by the NIH Director (as a Major Action under Section III-A-1-a of the NIH Guidelines).
The ASM submitted comments to the proposed changes in the guidelines. Specifically, the ASM letter (April 9, 2009 - ASM Comments on Revisions to the NIH Guidelines for Research Involving Recombinant DNA Molecules) commenting on the 2009 proposed action expressed concern about the change in Section III-A-I because it changed and broadened the review for experiments involving deliberate transfer of a drug resistance trait to microorganisms.
On September 5, 2012, the NIH published a Final Action which sets forth the final revisions to the NIH Guidelines that 1) modify the scope of the NIH Guidelines to cover explicitly certain research with synthetic nucleic acids, and 2) clarify the criteria for NIH review of research involving the introduction of therapeutic drug resistance into microorganisms. The September 5 Federal Register (http://oba.od.nih.gov/oba/rac/fractions/77_FR_54584.pdf) notice describes changes made to several sections of the NIH Guidelines to address explicitly biosafety for certain types of basic and clinical research with synthetic nucleic acids. In light of these changes, the title of the NIH Guidelines will also be revised from NIH Guidelines for Research Involving Recombinant DNA Molecules to NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. (http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines_new.pdf)
The final revisions to the NIH guidelines represent a significant modification to the changes proposed in March of 2009. The NIH/OBA agreed with ASM and other comments that the phrase “not known to acquire the trait naturally” serves to identify the majority of experiments that potentially pose higher risk to public health and should be retained. The amended NIH Guidelines attempt to clarify whether a particular experiment involving the introduction of a drug resistance trait into a microorganism warrants review by the RAC and approval by the NIH Director under Section III-A-1-a of the NIH Guidelines. The current NIH Guideline criteria for determining whether an experiment requires review under Section III-A-1-a are being retained with clarifying language added regarding the assessment of whether a drug is therapeutically useful. The Federal Register notice and a FAQ detailing these revisions can be accessed on the NIH website.
These changes are effective March 5, 2013, six months from the date of publication. All ongoing and proposed experiments with synthetic nucleic acids that will be newly subject to these amended NIH Guidelines will need to be registered by the Principal Investigator with the Institutional Biosafety Committee by the effective date listed above. The six-month time frame was deemed sufficient to allow institutions to develop new procedures, as well as outreach and training for investigators whose research will now be subject to the NIH Guidelines.