The University of Iowa

SAFETYmatters - Revised NIH rDNA Guidelines

All research at the University of Iowa must comply with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, or NIH Guidelines. On April 5th, 2024, the NIH updated its guidelines with a primary focus on gene drive technology. The NIH Guidelines define gene drive as “a technology whereby a particular heritable element biases inheritance in its favor, resulting in the heritable element becoming more prevalent than predicted by Mendelian laws of inheritance in a population over successive generations.” 

The amended NIH Guidelines specify that any experiment involving whole animals that contain gene drive technology have a minimum containment of ABSL-2. Guidance for conducting risk assessment on experiments involving gene drive technology is also included in the April 2024 update. Several other sections of the NIH Guidelines were modified to incorporate regulations for gene drive experiments.

In addition, the April 2024 NIH Guidelines update amends the Risk Group assignment for West Nile Virus (WNV) and Saint Louis Encephalitis Virus (SLEV) to Risk Group 2 (RG2). These changes are designed to make the NIH Guidelines more consistent with guidance in the biosafety in 6th edition of Microbiological and Biomedical Libraries.

You should expect to see minor changes when you submit your rDNA protocols as we incorporate the updated NIH Guidelines into eIBC. Overall, we expect either minimal or no impact for most researchers on campus. We will also be updating our online training course, Recombinant DNA (rDNA) Research, NIH Guidelines - W137BO, to reflect the amended guidelines. Based on the scope of these revisions and current campus policies, we do not expect researchers will need to re-take this rDNA training course.

If you have any questions regarding the April 2024 NIH Guidelines or the University of Iowa’s policies for rDNA research, please contact EHS staff. For a more comprehensive summary of the amendments to the NIH Guidelines, please check NOT-OD-24-093, Notice of Revisions to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. Alternatively, check the full version of the April 2024 NIH Guidelines.