NIH Guidelines Revision

the NIH posted the finalized proposal to amend the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to streamline the oversight of gene therapy research. This proposal, which was developed in conjunction with the Food and Drug Administration, included amending the NIH Guidelines to eliminate duplicative review and reporting requirements for human gene transfer protocols and refocuses the role of the NIH Recombinant DNA Advisory Committee (RAC) as a transparent forum for science, safety, and ethics of emerging biotechnologies. The RAC has been renamed the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC).

The roles and responsibilities of IBCs to review gene therapy protocols have been modified so that they are consistent with the review of other research covered under the NIH Guidelines. Gene therapy protocols remain subject to Food and Drug Administration (FDA) and other clinical trial regulations, and only after FDA, IBC, IRB, and other relevant approvals are in place can these protocols proceed.