Notice Number: NOT-OD-19-106
Key Dates
Release Date: April 25, 2019
Issued by
OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH (OD)
Purpose
On August 16, 2018, the NIH Director issued a statement describing a proposal to streamline the federal framework for oversight of gene therapy. This proposal, which was developed in conjunction with the Food and Drug Administration, included amending the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to eliminate duplicative review and reporting requirements for human gene transfer protocols. The statement also describes NIH’s effort to refocus the role of the NIH Recombinant DNA Advisory Committee (RAC) to be closer to its original mandate 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).
It is important to note that while NIH is streamlining individual protocol reporting requirements, robust oversight over gene therapy trials will continue as Federal and local oversight (e.g., FDA, Institutional Review Boards, Institutional Biosafety Committees) must continue to review and approve these trials before any research with human participants can be initiated.
More information about the final revisions can be found in the Federal Register. The revisions described in the Federal Register are effective immediately. The complete version of the amended NIH Guidelines can be found at: https://osp.od.nih.gov/biotechnology/nih-guidelines/
Inquiries
Please direct inquiries about this Notice to:
National Institutes of Health
Office of Science Policy
[email protected]
and Human Services (HHS)
