Community Engagement and Field Trials of Genetically Modified Insects and Animals

Abstract

New techniques for the genetic modification of organisms are creating new strategies for addressing persistent public health challenges. For example, the company Oxitec has conducted field trials internationally—and has attempted to conduct field trials in the United States—of a genetically modified mosquito that can be used to control dengue, Zika, and some other mosquito‐borne diseases. In 2016, a report commissioned by the National Academies of Sciences, Engineering, and Medicine discussed the potential benefits and risks of another strategy, using gene drives. Driving a desired genotype through a population of wild animals or insects could lead to irreversible genetic modification of an entire species. The NASEM report recommends community, stakeholder, and public engagement about potential uses of the technology, and it argues that the engagement should occur as research advances, well before gene drives are deployed. Yet what “engagement” means in practice is unclear. This article seeks clarity on this problem by offering a justification for community engagement and drawing out implications of this argument for the implementation and desired outcomes of community engagement. Community engagement is essential when it comes to research that would release genetically modified insects or animals into the environment. By contrast, obtaining informed consent from people who live near such a proposed field trial is neither necessary nor sufficient. Drawing on the epistemic and moral arguments for deliberative democracy, I propose two discrete mechanisms of community engagement: community advisory boards and deliberative forums, neither of which has been systematically incorporated into research governance. The proposed mechanisms would engender respect for persons who live near field trials, even when the results of deliberation override some individuals’ preferences. Community engagement foregrounds the community in our thinking about humans’ relationship to nature, and it implies that deciding to release genetically modified insects or animals into the wild ought to be a collective decision, not one made by product developers, policy‐makers, private companies, research funders, or scientists alone.

The ethics of genome editing in non-human animals: a systematic review of reasons reported in the academic literature

“…While authors acknowledged that it would not be possible to seek consent from all humans who could potentially be impacted by the release of genome-edited mosquitoes, it was argued that release could nonetheless be justified if the public health benefits of the trial are important enough for the community [102]. It was suggested that one way to conduct field trials with genetically modified animals while respecting the interests of community members is to use community advisory boards and a community authority [107].…”

How Democracy Can Inform Consent: Cases of the Internet and Bioethics

“…9 Some ethicists have in fact proposed the use of mass consent forms in field trials. with GMOs, which have unforeseen impacts beyond the range of a given locale or population, since seeds, for example, can be disseminated by insects that travel widely, or by the wind.…”

“…As Carolyn Neuhaus has recently discussed, trials involving the release of genetically modified organisms such as insects or animals pose special difficulties here, since they tend to move beyond a given community, raising issues of who should be informed and how consent could be elicited. 9 Some ethicists have in fact proposed the use of mass consent forms in field trials. 10 But given the evident impracticality of securing such consent, what alternative procedures could respect the autonomy and dignity of people in such cases?…”

Barriers to inclusive deliberation and democratic governance of genetic technologies at the science-policy interface

“…Still, there are problematic gaps in NASEM's recommendations that need to be carefully considered moving forward. For example, Neuhaus [2018] points out that the vagueness of the definition of 'community engagement' that so haunted the Oxitec trials in the Florida Keys, is not adequately resolved in NASEM's report. Moreover, NASEM's report "fails to acknowledge the strong commercial drivers that may bring gene drives into use" [Thomas, 2016, n.p.].…”