Minimizing Impact of New NIH Recombinant DNA Advisory Committee Review Process on Early Phase Human Gene Therapy Studies

By WIRB-Copernicus Group
Published: September 2017

On April 27, 2016, the new NIH Guidelines for Research with Recombinant and Synthetic Nucleic Acid Molecules (the NIH Guidelines) detailing revision to the NIH Recombinant DNA Advisory Committee (RAC) process took effect. Here we describe the new process and detail some strategies to minimize the impact of the changes on early phase human gene transfer studies.

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