Articulating ‘free, prior and informed consent’ (FPIC) for engineered gene drives

Abstract

Recent statements by United Nations bodies point to free, prior and informed consent (FPIC) as a potential requirement in the development of engineered gene drive applications. As a concept developed in the context of protecting Indigenous rights to self-determination in land development scenarios, FPIC would need to be extended to apply to the context of ecological editing. Without an explicit framework of application, FPIC could be interpreted as a narrowly framed process of community consultation focused on the social implications of technology, and award little formal or advisory power in decision-making to Indigenous peoples and local communities. In this paper, we argue for an articulation of FPIC that attends to issues of transparency, iterative community-scale consent, and shared power through co-development among Indigenous peoples, local communities, researchers and technology developers. In realizing a comprehensive FPIC process, researchers and developers have an opportunity to incorporate enhanced participation and social guidance mechanisms into the design, development and implementation of engineered gene drive applications.

Gene drive: progress and prospects

“…Much importance has been placed on ensuring future research is appropriately governed to encompass a variety of broader societal impacts, in addition to considering biosecurity and unwanted ecological and health impacts [35]. Such a consultative approach is stressed in the contribution by George et al [21], who also highlight the complexities surrounding the ethical considerations of releasing engineered gene drivers in nature. The importance of ensuring sufficient public and political confidence is also emphasized by Ritchie & Staunton [10], who argue that this is key to ensure wider uptake.…”

“…We need to consider not just the technical but also the ethical and societal aspects of synthetic gene drive. As Ritchie & Staunton [10] and George et al [21] argue, support from the communities affected by gene drive releases is critical to their successful implementation. It is absolutely essential that any future releases make major efforts to explain all relevant aspects of the project and gain the support of local stakeholders.…”

Ugandan stakeholder hopes and concerns about gene drive mosquitoes for malaria control: new directions for gene drive risk governance

“…International processes to develop risk governance frameworks can provide high-level guidelines but risk decision-making must be grounded in the local context and involve local stakeholders, communities and publics if it is to be robust, meaningful and legitimate. This type of engagement should accompany and complement (not replace) the community engagement work necessary for gaining a community’s prior, free and informed consent to participate in or host field trials [ 47 ]. In a modest step, this study brings Ugandan voices into the discussion about the hopes and concerns for gene drive mosquitoes which are planned to be released in field trials in Uganda.…”

Core commitments for field trials of gene drive organisms

“…Fair partnership among GDO developers, communities where GDOs may be released, regulators (government officials charged with making decisions about whether and how GDOs can be tested locally, even when the regulatory pathway for GDOs may not yet be fully defined), and stakeholders and other experts (6) is critical and will require substantial time and resources (9). These stakeholders will be engaged in all stages of trial preparation (10,11) and are integral to partners' understanding of existing and required scientific and regulatory capacities of each partner community or country and its political and cultural context. In addition, field site characteristics-such as disease incidence or pest exposure, vector or pest species distributions, and target population genetic background, ecology, and connectivity to surrounding populations-will require input from various stakeholders.…”