We are forwarding an important announcement from the NIH Office of Science Policy (OSP) regarding the recent amendments to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (r/sNAs). These updates include critical information on the containment and risk assessment requirements for Gene Drive Modified Organisms (GDMOs), adjustments to the Risk Group categorization for certain viruses, and additional responsibilities for Institutional Biosafety Committees and Biological Safety Officers. Please review the detailed information below to ensure compliance and safety in your research practices.
If you have any questions, please contact IBC@research.ucla.edu.
Dear IBC Chairs, Contacts and Biosafety Officers,
Today, the NIH Office of Science Policy issued an amended version of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). The NIH Guidelines have been revised to include specific considerations and requirements for conducting research involving Gene Drive Modified Organisms (GDMOs) in contained research settings. The update stipulates the minimum containment requirements for conducting research with GDMOs (Biosafety Level 2), describes considerations for performing risk assessments when working with GDMOs, and defines additional institutional responsibilities regarding Institutional Biosafety Committees (IBCs) and Biological Safety Officers (BSOs). Full details are available in the Federal Register Notice outlining the final amendments.
Additional changes include amending the Risk Group (RG) categorization of West Nile Virus (WNV) and Saint Louis Encephalitis Virus (SLEV) in Appendix B to RG2 to be consistent with the biosafety recommendations in the 6th Edition of the Biosafety in Microbiological and Biomedical Laboratories (BMBL).
The amended NIH Guidelines (April 2024) and other information of relevance to IBCs is now available on the NIH Office of Science Policy Website at: https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy#tab2/
To assist Institutional Biosafety Committees (IBCs), biosafety professionals, and investigators in implementation of these changes, OSP has developed a reference document to help ensure the safe and responsible conduct of research involving GDMOs.
Please see the announcement below for additional details.
Questions about the NIH Guidelines and IBCs may be sent to the address on the front page of the NIH Guidelines: NIHGuidelines@od.nih.gov.
Please contact us if you have any questions.
Dr. Kathryn Harris
April 4, 2024
NIH Publishes Revisions to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
NIH has revised the NIH Guidelines to specify biosafety practices for research involving gene drive modified organisms (GDMOs) in contained research settings. These revisions include:
- Specifying the minimum containment requirement for research involving GDMOs;
- Articulating considerations for risk assessment and additional responsibilities for Institutional Biosafety Committees (IBCs) and Biosafety Officers
NIH previously published a Request for Information (RFI) in August 2023 seeking public input on proposed revisions. The proposed revisions were informed by recommendations contained in the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) report, Gene Drives in Biomedical Research.
The revised version of the NIH Guidelines is available at https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.htm. To assist IBCs, biosafety professionals, and investigators with implementation of these changes, OSP has developed a reference document to help ensure the safe and responsible conduct of research involving GDMOs in contained research settings.
Questions may be sent to SciencePolicy@od.nih.gov. Also, please consider following us on X @NIH_OSP.