Turning Listening into Action: A Proposal to Strengthen the NIH Guidelines

As an unrepentant policy fanatic, I love talking about details, whether it be the implications of a strategically placed “shall” or where data should be in controlled access. However, most of the time, policymaking requires being a good listener.  Listening is an underrated skill and is more than just waiting for your turn to speak.  Typically, the scientific, ethical, legal, and social issues at the forefront of biomedical research are so complex that it is essential we turn to experts and members of the public to hear their perspectives before we can develop a policy responsive to their needs. Listening to this input and incorporating it into policymaking is vital to our work and to ensuring our policies hit the mark.

A recent case study in listening involves the Novel and Exceptional Technology and Research Advisory Committee, or as we like to call them, the NExTRAC.  In 2020, we asked this committee to think through the different scenarios that may be used in gene drive research to advise on whether/how we should think about updating our existing biosafety policy framework.  During its deliberations, the Committee also did a lot of listening, consulting with subject matter experts, and holding a public workshop. Ultimately, the NExTRAC produced some very thoughtful recommendations in its final report to the NIH.

Based on our internal deliberations and the NExTRAC’s recommendations, NIH is turning this listening into action by proposing some policy updates. The proposal is to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to strengthen our infrastructure for ensuring this research continues to proceed responsibly. Specifically, the proposed revisions would incorporate specific considerations and requirements for NIH-supported research involving gene drive modified organisms in contained research settings. 

It is important to emphasize that all the proposed actions at this time focus on working with gene drive modified organisms in contained research settings. This research is already performed around the globe in labs with biosafety precautions in place. However, as technology evolves, we must make sure that our policies keep pace. Thanks to the work of the NExTRAC, we believe this proposal will allow researchers to safely proceed with contained gene drive research.  I encourage all interested stakeholders to view the full proposal and provide us with your feedback.  Comments on the full proposal will be accepted until October 10, 2023, and must be submitted electronically.  I look forward to hearing your thoughts!

Lyric Jorgenson, PhD
NIH Associate Director for Science Policy
About Lyric

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