The NIH Office of Science Policy (OSP) has revised the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. These Guidelines are the standard for oversight of research involving genetic engineering and gene therapy research. The revisions are effective April 25, 2019.

The revisions remove requirements for protocol submission, review, and reporting to the NIH OSP. Institutional review boards (IRBs) and institutional biosafety committees (IBCs) will no longer be required to provide determinations regarding the level of risk and novelty of the science for the NIH OSP to determine whether protocols require review by the NIH Recombinant DNA Advisory Committee (RAC). The revised review process eliminates regulatory oversight deemed to be duplicative with the existing oversight provided by the FDA and by IRBs and IBCs.

These recent revisions were first proposed on August 16, 2018. NIH Guidelines were previously revised in April of 2016 and again in April of 2019 largely to streamline review of gene therapy research.

Advarra is fully compliant with the 2019 version of NIH Guidelines. For more information about NIH Guidelines as well as IRB and IBC review for gene therapy studies, please contact Business Development.

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