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A CRISPR-Cas9-based transgene homing at the <jats:italic>doublesex<\/jats:italic> locus (<jats:italic>dsxF<\/jats:italic><jats:sup><jats:italic>CRISPRh<\/jats:italic><\/jats:sup>) has recently been shown to increase rapidly in frequency in, and suppress, caged laboratory populations of the malaria mosquito vector <jats:italic>Anopheles gambiae<\/jats:italic>. Here, problem formulation, an initial step in environmental risk assessment (ERA), was performed for simulated field releases of the <jats:italic>dsxF<\/jats:italic><jats:sup><jats:italic>CRISPRh<\/jats:italic><\/jats:sup> transgene in West Africa.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Building on consultative workshops in Africa that previously identified relevant environmental and health protection goals for ERA of gene drive in malaria vector control, 8 potentially harmful effects from these simulated releases were identified. These were stratified into 46 plausible pathways describing the causal chain of events that would be required for potential harms to occur. Risk hypotheses to interrogate critical steps in each pathway, and an analysis plan involving experiments, modelling and literature review to test each of those risk hypotheses, were developed.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Most potential harms involved increased human (n\u2009=\u200913) or animal (n\u2009=\u200913) disease transmission, emphasizing the importance to subsequent stages of ERA of data on vectorial capacity comparing transgenics to non-transgenics. Although some of the pathways (n\u2009=\u200914) were based on known anatomical alterations in <jats:italic>dsxF<\/jats:italic><jats:sup><jats:italic>CRISPRh<\/jats:italic><\/jats:sup> homozygotes, many could also be applicable to field releases of a range of other transgenic strains of mosquito (n\u2009=\u200918). In addition to population suppression of target organisms being an accepted outcome for existing vector control programmes, these investigations also revealed that the efficacy of population suppression caused by the <jats:italic>dsxF<\/jats:italic><jats:sup><jats:italic>CRISPRh<\/jats:italic><\/jats:sup> transgene should itself directly affect most pathways (n\u2009=\u200935).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Modelling will play an essential role in subsequent stages of ERA by clarifying the dynamics of this relationship between population suppression and reduction in exposure to specific potential harms. This analysis represents a comprehensive identification of plausible pathways to potential harm using problem formulation for a specific gene drive transgene and organism, and a transparent communication tool that could inform future regulatory studies, guide subsequent stages of ERA, and stimulate further, broader engagement on the use of population suppression gene drive to control malaria vectors in West Africa.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12936-021-03674-6","type":"journal-article","created":{"date-parts":[[2021,3,29]],"date-time":"2021-03-29T11:02:52Z","timestamp":1617015772000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":41,"title":["Systematic identification of plausible pathways to potential harm via problem formulation for investigational releases of a population suppression gene drive to control the human malaria vector Anopheles gambiae in West Africa"],"prefix":"10.1186","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7033-3463","authenticated-orcid":false,"given":"John B.","family":"Connolly","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8964-1784","authenticated-orcid":false,"given":"John D.","family":"Mumford","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8921-7422","authenticated-orcid":false,"given":"Silke","family":"Fuchs","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geoff","family":"Turner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Camilla","family":"Beech","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4253-396X","authenticated-orcid":false,"given":"Ace R.","family":"North","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5146-9640","authenticated-orcid":false,"given":"Austin","family":"Burt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,3,29]]},"reference":[{"key":"3674_CR1","volume-title":"World malaria report 2020: 20 years of global progress and challenges","author":"WHO","year":"2020","unstructured":"WHO. 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JDM:\u00a0Employment by Imperial College London; Member of Target Malaria not-for-profit research consortium; Research grants from Bill & Melinda Gates Foundation; Working Group and Hearing Expert for European Food Safety Authority; Travel grants from FNIH, World Health Organisation and International Atomic Energy Agency. SF:\u00a0Employment by Imperial College London in a position which is solely funded through a grant from the Bill & Melinda Gates Foundation; Member of Target Malaria not-for-profit research consortium; Travel grants from FNIH. GT:\u00a0Employment by Imperial College London in a position which is solely funded through a grant from the Bill & Melinda Gates Foundation, and was formerly funded solely through a grant from the Open Philanthropy Project Fund, an advised fund of Silicon Valley Community Foundation; Member of Target Malaria not-for-profit research consortium; Travel grants from FNIH; Former employee of Oxitec Ltd, an entity with commercial interests in genetic insect technologies. 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AB:\u00a0Employment by Imperial College London; Principle Investigator of the Target Malaria not-for-profit research consortium, which receives core funding from the Bill & Melinda Gates Foundation and from the Open Philanthropy Project Fund, an advised fund of Silicon Valley Community Foundation.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"170"}}