BACKGROUND The development of the CRISPR/Cas9 gene editing system has generated new possibilities for the use of gene drive constructs to reduce or suppress mosquito populations to levels that do not support disease transmission. Despite this prospect, social resistance to genetically modified organisms remains high. Gene drive open field research thus raises important questions regarding what is owed to those who may not consent to such research, or those could be affected by the proposed research, but whose consent is not solicited. The precise circumstances under which informed consent must be obtained, and from whom, requires careful consideration. Furthermore, appropriate engagement processes should be central to any introduction of genetically modified mosquitos in proposed target settings. DISCUSSION In this work, international guidance documents on informed consent and engagement are reviewed and applied to the genetically modified mosquito research context. Five analogous research endeavours that involve area-wide / open field experiments are reviewed. The approach of each in respect to the solicitation of individual informed consent and community engagement are highlighted. CONCLUSIONS While the solicitation of individual informed consent in host settings of gene drive field trials may not be possible or feasible in some instances, local community and stakeholder engagement will be key to building trust towards the proposed conduct of such research. In this regard, the approaches taken by investigators and sponsors of political science field research and weather modification field research should be avoided. Rather, proponents of gene drive field research should look to the Eliminate Dengue field trials, cluster randomised trials, and pragmatic clinical trials for guidance regarding how the solicitation of individual informed consent of host communities ought to be managed, and how these communities ought to be engaged.

中文翻译：

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知情同意和社区参与开放领域研究：基因驱动科学课程。

背景技术CRISPR / Cas9基因编辑系统的发展为使用基因驱动构建体将蚊子种群减少或抑制到不支持疾病传播的水平提供了新的可能性。尽管有这种前景，社会对转基因生物的抵抗力仍然很高。因此，基因驱动开放领域研究提出了一些重要问题，这些问题归结于那些可能不同意这些研究的人，或者可能受到拟议研究影响但未征得其同意的人。必须仔细考虑在什么情况下必须获得知情同意，以及从何人那里获得知情同意。此外，在拟议的目标环境中，任何引入转基因蚊子的工作都应以适当的参与过程为中心。讨论在这项工作中，审查了有关知情同意和参与的国际指导文件，并将其应用于转基因蚊子研究的背景。回顾了涉及区域/开放领域实验的五项类似的研究工作。着重介绍了各自在征求个人知情同意和社区参与方面的方法。结论虽然在某些情况下在基因驱动田间试验的宿主环境中征求个人知情同意可能是不可能或不可行的，但当地社区和利益相关方的参与对于建立对此类研究的拟议信任至关重要。在这方面，应避免政治学实地研究和天气变化实地研究的研究者和赞助者采取的方法。相当，