August 10, 2023
Office of The Director, National Institutes of Health (OD)
NIH is seeking public input on a proposal to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. These amendments include specific considerations and requirements for conducting NIH-supported research involving gene drive modified organisms (GDMOs) in contained research settings. With respect to GDMOs, NIH proposes to:
The proposed changes detailed above are consistent with the recommendations contained in the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) report, Gene Drives in Biomedical Research.
In addition, NIH is proposing to:
Complete details on these proposed revisions may be found in the Federal Register. https://www.federalregister.gov/d/2023-17178
NIH will accept comments on the proposal until October 10, 2023. Comments must be submitted electronically at: https://osp.od.nih.gov/proposed-amendments-to-the-nih-guidelines-for-research-involving-recombinant-or-synthetic-nucleic-acid-molecules-nih-guidelines/
Comments may be submitted anonymously. You may also voluntarily include your name and contact information with the response. Other than name and contact information, please do not include in the response any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your response. After the Office of Science Policy (OSP) has finished reviewing the responses, the responses may be posted to the OSP website without redaction.
NIH Office of Science Policy