The National Academies of Sciences, Engineering and Medicine (NAS) has released a study examining research into man-made gene drives, a type of gene editing that allows for the spread of gene modifications “throughout a population of organisms intentionally.” Titled Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values, the report focuses on techniques that use segments of bacterial DNA—such as clustered regularly-interspaced short palindromic repeats (CRISPR)—paired with a guide protein (CRISPR-associated protein 9, or Cas9) “to make targeted cuts in an organism’s genome.” Organisms modified using CRISPR-Cas9 then pass these changes to their offspring through sexual reproduction, a process that allows scientists to alter whole populations in an effort to eradicate insect-borne infectious diseases, for example.
Calling these developments “both encouraging and concerning,” the report seeks to provide “an independent, objective assessment of the state of knowledge and responsible practices for research, risk assessment, public engagement, and the development of public policies on gene drive technologies.” In particular, the study addresses, among other things, (i) human values and welfare, (ii) environmental considerations, (iii) scientific approaches to reducing potential risks, (iv) the need for ecological risk assessments, (v) avenues for public and stakeholder engagement, and (vi) governance of gene drives.
To mitigate potential drawbacks to gene drives, the NAS committee advocates “a phased testing pathway, such as the one outlined by the World Health Organization (WHO) for testing genetically modified mosquitoes,” as well as ecological risk assessments designed to “trace cause-and-effect pathways” and “quantify the probability of specific outcomes.” The study also notes that, in addition to finding new avenues for public engagement, researchers and policymakers must develop best practices for ensuring biosafety while working to resolve regulatory overlaps and loopholes.
“In the United States, regulation of gene-drive modified organisms will most likely fall under the Coordinated Framework for the Regulation of Biotechnology, which includes the U.S. Food and Drug Administration, the U.S. Department of Agriculture, and the U.S. Environmental Protection Agency,” explains the report summary. “The U.S. government will need to clarify the assignment of regulatory responsibilities for field releases of gene-drive modified organisms, including the roles of relevant agencies that are not currently included in the Coordinated Framework for the Regulation of Biotechnology.”
Citing the likely benefits of gene-drive modified organisms, the report offers support for basic and applied research and highly-controlled field trials, while urging researchers to “establish open-access, online reposi- tories of data on gene drives as well as standard operating procedures for gene drive research.” As the report overview concludes, “It is important to note that a one-size-fits-all approach to governance is not likely to be appropriate… Governance and regulation of gene drive research will need to be proportionate to the hazards posed by the specific activity, and evaluated on a case-by-case basis. Because of the existing uncertainties associated with gene drives, regulation will be needed that facilitates fundamental, applied, and translational research so that the potential harms and benefits of gene drives can be explored responsibly in laboratory and field studies.”