April 25, 2019, the National Institutes of Health (NIH) finalized a 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. After a 60-day public comment period, the NIH Guidelines have been updated to reflect these changes and the RAC has been renamed the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC).
Please note that the roles and responsibilities of Institutional Biosafety Committees (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, Institutional Biosafety Committee, Institutional Review Boards, and other relevant approvals are in place can these protocols proceed.
Please also note the HGTprotocols@od.nih.gov mailbox previously listed in the NIH Guidelines is no longer operational. All questions should instead be sent to NIHGuidelines@od.nih.gov
For more information about these important changes, please see the following NIH resources.
- NIH Director’s Statement on Streamlining Gene Therapy Oversight
- Under the Poliscope Blog “Introducing the NExTRAC”
- Frequently Asked Questions (FAQs) on Revised NIH Guidelines
- NIH Office of Science Policy NIH Guidelines webpage
