The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules.
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On March 22, 2016, the NIH Office of Science Policy published a Federal Register notice detailing the revised procedures for the review of human gene transfer trials subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). These changes are effective April 27, 2016. The changes to the human gene transfer protocol review process are being made after NIH, in consultation with the Institute of Medicine, determined that the NIH Recombinant DNA Advisory Committee’s (RAC) review of individual human gene transfer trials should be limited to cases in which an oversight body (such as an Institutional Biosafety Committee or an Institutional Review Board) determines that a protocol would significantly benefit from RAC review.
A summary of the changes can be found in the following RAC Revisions Factsheet.