Revision of the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) to Include Synthetic Nucleic Acids and to Clarify Criteria for Section III-A-1-a Experiments


Notice Number:  NOT-OD-12-150

Key Dates

Release Date:  September 11, 2012

Issued by

National Institutes of Health (NIH)

Purpose

This Notice 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.

Background

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). 

Purpose

As outlined in the September 5, 2012, Federal Register notice, changes are 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.  The amended NIH Guidelines also provides greater clarity with respect to 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.  While the current criteria for determining whether an experiment requires review under Section III-A-1-a are being retained, additional clarifying language is being added regarding the assessment of whether a drug is therapeutically useful.

The Federal Register notice detailing these revisions can be accessed here.

Implementation

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. 

Inquiries

Please direct all inquiries to:

Office of Biotechnology Activities
Office of Science Policy
National Institutes of Health
6705 Rockledge Drive, Suite 750
Bethesda, MD 20892
Telephone: (301) 496-9838
FAX: (301) 496-9839
Email: oba@od.nih.gov


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