Biosafety Consideration for GDMOs

In April 2024, the NIH released updated guidance on research involving gene drive modified organisms (GDMOs) to supplement the report “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules”.

A Gene drive modified organism is defined as “genetically engineered organism, where the modification is designed to spread rapidly through a population by using a mechanism called a “gene drive,” allowing the altered trait to be passed on to nearly all offspring.”

The new guidance outlines the following:

• All research involving GDMOs requires Stanford APB approval
• Thorough risk assessments should consider:
  1. The function of the genetic construct
  2. Source of genetic material
  3. What modifications are in place
  4. Potential for release into the environment and the consequences
• Research involving GDMOs should be conducted at a BSL2/ABSL2 or higher containment.
• Approval from the NIH OSP is required to allow work to be conducted at a lower containment level.
• Consider localized gene drive systems designed to serve as a biological or environmental risk mitigation strategy. Design your constructs with a failsafe and conduct research in an environment where release is unlikely.