The Revised NIH Guidelines 2016: Assessing the Impact on Human Gene Transfer Clinical Trials

By WIRB-Copernicus Group
Published: September 2017

The overwhelming majority of human gene transfer (HGT) clinical trials conducted in or from the United States are subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (the NIH Guidelines). This paper describes the impact of the revisions to the NIH Guidelines on the rate of RAC review of HGT protocols, on the rate of HGT protocol registration, and on the roles and responsibilities of local institutional regulatory oversight bodies in the revised review process.

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