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NIH National Institutes of Health Proposed Changes Guidelines

Proposed Changes to the NIH Guidelines


In an August 10, 2023 Federal Register Notice, the National Institutes of Health (NIH) announced that it’s seeking public input on a proposal to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. The proposed amendments include specific considerations and requirements for conducting research involving gene drive modified organisms (GDMOs) in contained research settings.

The NIH defines a 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 NIH is proposing to specify minimum containment requirements for research involving GDMOs. The changes would include a requirement that experiments be conducted at a minimum of biosafety level 2 (BSL-2) containment to provide the appropriate laboratory practices, equipment, and special laboratory design to protect lab employees, the public, and local ecosystems.

In addition, the proposed changes specify considerations for risk assessments involving GDMOs. They include recommending an assessment of the specific types of manipulations based on factors including the intended function of the gene drive construct; the source of the genetic material in the construct; modifications to the construct; and whether it’s possible to predict the consequences of a construct, including the recognition of an unintended gene drive and the possible consequences of escape into the environment.

The revisions also require additional responsibilities regarding Institutional Biosafety Committees (IBCs) and Biosafety Officers related to research involving GDMOs. They include a requirement that IBCs have adequate expertise (e.g., on specific species containment, ecological or environmental risk assessment) and that IBC membership must include the Biosafety Officer. The IBC would also be required to assess the impact research could have on ecosystems. 

In addition to the changes regarding GDMOs, the NIH is proposing to replace the term “helper viruses” with the broader term “helper systems”. They are also proposing to reclassify West Nile Virus (WNV) and Saint Louis Encephalitis Virus (SLEV) from Risk Group 3 to Risk Group 2 agents for consistency with the containment guidance provided in Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th edition.

The NIH will accept comments on the proposal until October 10, 2023.  Comments must be submitted electronically to the Office of Science Policy.

For additional information on the proposed changes to the NIH Guidelines and how they might affect your organization, please email us at [email protected].

This blog was written by Beth Graham, Safety Partners’ Director of Quality, Research, and Training.


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