Core commitments for field trials of gene drive organisms

The authors invite all those interested in gene drive technologies who support these core commitments for field trials of gene drive organisms to become a signatory.

A GDO’s propensity to spread necessitates well-developed criteria for field trials to assess their potential impacts. We….outline commitments below that we deem critical for responsible conduct of a field trial and to ensure that these technologies, if they are introduced, serve the public interest.

Gene drive organisms (GDOs), whose genomes have been genetically engineered to spread a desired allele through a population, have the potential to transform the way societies address a wide range of daunting public health and environmental challenges. The development, testing, and release of GDOs, however, are complex and often controversial. A key challenge is to clarify the appropriate roles of developers and others actively engaged in work with GDOs in decision-making processes, and, in particular, how to establish partnerships with relevant authorities and other stakeholders. Several members of the gene drive community previously proposed safeguards for laboratory experiments with GDOs (1) that, in the absence of national or international guidelines, were considered essential for responsible laboratory work to proceed. Now, with GDO development advancing in laboratories (2–5), we envision similar safeguards for the potential next step: ecologically and/or genetically confined field trials to further assess the performance of GDOs. A GDO’s propensity to spread necessitates well-developed criteria for field trials to assess its potential impacts (6). We, as a multidisciplinary group of GDO developers, ecologists, conservation biologists, and experts in social science, ethics, and policy, outline commitments below that we deem critical for responsible conduct of a field trial and to ensure that these technologies, if they are introduced, serve the public interest.

In short:

Fair partnership and transparency:  Fair partnership among GDO developers, communities where GDOs may be released, regulators, and stakeholders and other experts is critical and will require substantial time and resources

Product efficacy and safety:  Evidence of laboratory efficacy will be demonstrated prior to a GDO release

Regulatory evaluation and risk/benefit assessment:  At a minimum, conducting GDO field trials requires adherence to existing, and often evolving, national (or, in some cases, subnational) regulations and regional and international agreements.

Monitoring and mitigation:  GDO developers should engage and partner with communities, regulators, evolutionary biologists, ecologists, and social scientists to prepare and participate in surveillance for effectiveness and safety, and to monitor unintended consequences before, during, and after release, with accountability to various partners delineated before a field trial.

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