Expert Report

Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values (2016)

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Gene drives are systems of biased inheritance that enhance the ability of a genetic element to pass from an organism to its offspring through sexual reproduction. A wide variety of gene drives occur in nature. Researchers have been studying these natural mechanisms throughout the 20th century but, until the advent of CRISPR/Cas91 for gene editing, have not been able to develop a gene drive.

Since early 2015, laboratory scientists have published four proofs-of-concept showing that a CRISPR/Cas9-based gene drive could spread a targeted gene through nearly 100% of a population of yeast, fruit flies, or mosquitoes. Biologists have proposed using gene drives to address problems where solutions are limited or entirely lacking, such as the eradication of insect-borne infectious diseases and the conservation of threatened and endangered species.

In response to this fast-moving field, the National Institutes of Health (NIH) and the Foundation for the National Institutes of Health (FNIH)2 asked the National Academies of Sciences, Engineering, and Medicine to convene a committee with a broad range of expertise to investigate the state of knowledge regarding gene drives and considerations for their responsible use. The report concludes that proof-of-concept in a few laboratory studies to date is not sufficient to support a decision to release gene-drive modified organisms into the environment. The potential for gene drives to cause irreversible effects on organisms and ecosystems calls for a robust method to assess risks. A phased approach to testing, engagement of stakeholders and publics, and clarified regulatory oversight can facilitate a precautionary, step-by-step approach to research on gene drives without hindering the development of new knowledge.

1 CRISPR (Clustered regularly-interspaced short palindromic repeats) are segments of bacterial DNA that, when paired with a specific guide protein, such as Cas9 (CRISPR-associated protein 9), can be used to make targeted cuts in an organism's genome
2 The Defense Advanced Research Projects Agency and the Bill and Melinda Gates Foundation provided funding to NIH and FNIH, respectively, in support of this study. The study received additional support from the National Academy of Sciences Biology Fund.