Updates to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
The National Institutes of Health (NIH) has issued revisions to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules which go into effect on September 30th, 2024.
What are the changes?
The 2024 version of the NIH Guidelines now include the following:
- New requirements for conducting research using Gene Drive Modified Organisms (GDMOs) in contained research settings.
- Replacement of the term “helper viruses” with the broader term “helper systems.”
- West Nile Virus (WNV) and Saint Louis Encephalitis Virus (SLEV) have been reclassified as risk group 2 agents for consistency with containment guidance provided in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th edition.
More details can be found here: https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.htm
What does this mean for researchers?
The Institutional Biosafety Committee (IBC) uses the NIH Guidelines to review all research that uses biological material and biohazards. Research that is considered GDMO will be reviewed by the Biosafety Officer and the IBC utilizing risk assessments before any work is approved.
Link to Biosafety Considerations for Contained Research Involving Gene Drive Modified Organisms
How to maintain compliance?
All research submitted to the IBC through the eIBC platform will undergo review taking into consideration the updates to the NIH Guidelines. GDMO research will be documented in eIBC on a new form page of the bioregistration.
Any questions, please contact ibc@northwestern.edu