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  • Washington Highlights

    NIH Publishes Final Changes to the NIH Guidelines and Updates the Role of the RAC

    Anurupa Dev, Director, Science Policy & Strategy
    Heather Pierce, Senior Director, Science Policy & Regulatory Counsel

    The National Institutes of Health (NIH) April 25 issued a notice of publication for revised NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (“NIH Guidelines”). In August 2018, the agency released proposed changes to the NIH Guidelines, which the AAMC responded to in a joint association letter.

    The revised NIH Guidelines have been updated to:

    1. Eliminate human gene transfer (HGT) protocol submission and reporting requirements to the NIH, and individual HGT protocol review by the Recombinant DNA Advisory Committee (RAC); and
    2. Modify the roles and responsibilities of investigators, institutions, Institutional Biosafety Committees (IBCs), the RAC, and the NIH.

    A detailed review of community input and the specific modifications to the NIH Guidelines are in the Federal Register. The RAC has also been renamed the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) to refocus the committee on a broader set of safety and ethical issues around emerging biotechnologies. The changes are described in a blog post by NIH Associate Director for Science Policy, Carrie Wolinetz, PhD.