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How Will the 2019 Changes to the NIH Guidelines Affect Your Company’s Research?

Local recombinant DNA ordinances, including those of Boston, Cambridge, and Lexington to name a few, require compliance with the NIH Guidelines for Recombinant DNA Molecules (originally published in1986) as well as revisions and amendments to the Guidelines.  As you may know, the scope of the Guidelines was updated in 2013 to include work with synthetic nucleic acid molecules, and the Guidelines were renamed accordingly and are now called the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.  Are you familiar with the more recent changes to the Guidelines that were published in April 2019?

The April 2019 changes streamline the oversight of human gene transfer (HGT) research.  Because of the FDA’s regulatory authority and oversight of gene therapy trials, NIH has removed the duplicative oversight of gene therapy research from the Guidelines.  The revised Guidelines eliminate the NIH Recombinant DNA Advisory Committee (RAC) review, protocol registration, and reporting requirements associated with gene therapy research.

It should be noted that Institutional Biosafety Committees (IBCs) will still be responsible for reviewing and approving these protocols. However, the role of the IBC in reviewing HGT research has been modified to be consistent with the role of IBCs in reviewing other research covered by the Guidelines.  In addition, HGT trials will still be subject to the same oversight that all clinical trials receive.

The general role of the RAC has been refocused and is now closer to its original directive, which was to follow and provide advice on the science, safety and ethical issues associated with emerging biotechnologies. The Guidelines have been updated to reflect these changes and the RAC has been renamed the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC).

For more information about these revisions, or to find out how they affect your company’s research, please email [email protected].

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