Informed consent in field trials of gene-drive mosquitoes.

The US National Academies' (NAS) recent report 'Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values' examines the requirements of responsible conduct in research involving gene drives in non-human organisms. Many of the complex ethical issues raised by the introduction of gene drive technologies for mosquito population control have been anticipated during the development and field-testing of earlier-generation genetic engineering approaches with mosquitoes. One issue-the requirement for informed consent in field trials-is not addressed explicitly in the NAS' report. Some commentators have presumed that informed consent should play a role as a protection for research participants in studies of genetically modified mosquitoes. Others have argued that there are no human subjects of field trials, so the informed consent requirement does not apply. It is both ethically and practically important that these presumptions are adequately scrutinized to ensure that any applications of informed consent in these trials are properly justified. We argue that informed consent from individual research participants in gene drive trials may be required: (1) when blood and other forms of clinical data are collected from them, as will likely be the case in some studies involving epidemiological endpoints, such as the incidence of new infections with dengue and malaria; (2) when they participate in social science and/or behavioral research involving the completion of surveys and questionnaires; or (3) when their home or property is accessed and the location recorded as a spatial variable for the release or collection of mosquitoes because the precise location of the household is important for entomological reasons and these data constitute identifiable private information at the household level. Importantly, most regulations and guidelines allow these requirements to be waived or modified, to various degrees, according to the judgment of Institutional Review Boards.