Procedural legitimacy: co-developing a community agreement model for genetic approaches research to malaria control in Africa.

With reductions in the malaria burden stalling in the past years, gene drive holds promise as a novel way of reducing disease transmission. Governance and decision-making processes are pivotal aspects of the legitimate adoption of this technology. Here, the authors explore Target Malaria's journey in developing a community agreement model for the release of non-gene drive genetically modified mosquitoes. They describe the iterative development of the model, including consultations with experts, stakeholder engagement, and alignment with principles of procedural justice. Several challenges were identified during its development, including defining communities, ensuring adequate information, consultation, monitoring, and achieving a common decision between dissenting and consenting viewpoints. They underscore the complexity of developing a legitimate model and emphasize the importance of transparency, procedural legitimacy, and adherence to ethical principles. This paper does not describe the model itself, which will be the subject of another paper. Instead it focuses on the process, to share this experience with other projects-those working with gene drive, or any other projects requiring a community-level decision-making process. The model builds on Target Malaria's experience with the release of genetically modified sterile male mosquitoes, to address the challenges posed by modified mosquitoes which are fertile and would therefore be expected to persist longer in the environment and spread further than the sterile male mosquito strains. While the level of spread and persistence of these non gene drive, but fertile, modified mosquitoes are expected to be substantially lower than those of the gene drive mosquitoes, the process is an essential advance in accommodating the broader geographical and temporal concerns associated with the more permanent spread of gene drive mosquitoes. The work described here constitutes part of the evolution of a community agreement process that could be applied to proposals for releases of gene drive mosquitoes for malaria control. In describing this process, Target Malaria hopes to contribute to the ongoing dialogue on good practices for community agreement engagement in research for genetic vector control approaches and to share the experience of building legitimacy while designing such agreement models.