Gene Drives on the Horizon Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values (2016) / Chapter Skim
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Just prior to the beginning of this study and since the committee was first convened, scientists published four proofs of concept -- one in yeast, one in fruit flies, and two in different species of mosquitoes -- that demonstrate the successful development of gene drives in the laboratory, at least in these organisms. Proposed applications for gene-drive modified organisms for basic research, conservation, agriculture, public health and other purposes will likely continue to expand as gene editing tools become more refined.
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, offspring h r With a ggene drive (right) , the o offspring will almost a always receive the targeted genetic element (s shown in dark purple)
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to develop gene-drive modified organisms. Preliminary evidence suggests that gene drives developed in the laboratory with CRISPR/Cas9 could spread a targeted gene through nearly 100% of a given population of yeast, fruit flies, or mosquitoes.
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4 Gene Drives on the Horizon e e TA ABLE S-1 Poten ntial Applications for Gene Drive Research s e Pub Health blic Control or al organisms tha carry infectious lter at s diseases that affect humans, s such as dengue, malaria, Chaagas, and Lyme didisease Control or al organisms tha directly cause i lter at infection or disease, su as Schistosom uch miasis Aedes aegypti A Control or al organisms tha serve as reservo of lter at oirs disease, such as bats and rode h ents Image Sourc US Centers for Disease ce: r Contr and Preventio rol on Ecosystem Conservation m Control or al organisms tha carry infectious diseases lter at s that threaten the survival of ot ther species Eliminate invvasive species tha threaten native at e ecosystems and biodiversity a Hem mignathus munro oi Alter organis that are threa sms atened or endangeered (‘Akiapōōlā'au honeycree eper) Image Source: US Fish and Wild U dlife Service Ag griculture Control or al organisms tha damage crops o lter at or carry crop diiseases Eliminate we eedy plants that c compete with cultivated cro ops Fruit da amage from spotted wing drrosophila infesta ation Image Source: US Department of Agriculture U f Basi Research ic Alter model organisms to carr out research on ry n gene drive fu unction and effect species biolog ts, gy, and mechani isms of disease DN Double Helix NA Image Source: National Institute of Health es
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CHARTING HUMAN VALUES Questions about gene drives rest on values at every step, from whether, why, and how research should be conducted to whether and where a gene-drive modified organism should be released into the environment. Three broad categories of concern were identified and explored: the potential benefits and harms of gene drive research for people, the potential impact of gene-drive modified organisms on the environment, and the use of gene drives and who will make decisions about them.
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PHASED TESTING AND SCIENTIFIC APPROACHES TO REDUCE GENE DRIVES' POTENTIAL HARMS Before field testing or environmental release of gene-drive modified organisms, it is crucial to establish a rich understanding of the target organism, its relationship with its environment, and potential unintended consequences. A phased testing pathway, such as the one outlined by the World Health Organization (WHO)
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The lack of guidance from the US federal government applicable to ecological risk assessment for gene drive research is a critical gap. PUBLIC ENGAGEMENT There is broad agreement on the importance of engaging affected communities, stakeholders, and broader publics in decision making about activities involving gene drives.
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However, some of these mechanisms may be inadequate for identifying immediate and long-term potential environmental and public health implications of individual gene drive applications because they lack clarity in their jurisdiction, they are challenged by the distinguishing characteristics of gene drives, or they provide insufficient structures for public engagement. Two distinguishing characteristics of gene drives, intentional spread of a genetic trait through a population and the potential for their effects on ecosystems to be irreversible, present increased uncertainties, making robust assessment of their risk more critical, but also more difficult.
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Responsible governance will need to be international and inclusive, with clearly defined global regulatory frameworks, policies, and best practice standards for implementation. Low- and middle-income countries where gene-drive modified organisms may be employed will certainly need to be involved in governance, recognizing that many countries lack the capacity to develop a comprehensive regulatory scheme for gene drives from scratch.
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Recommendation 9-3: The distinguishing characteristics of gene drives -- including their intentional spread and the potential irreversibility of their environmental effects -- should be used to frame the societal appraisal of the technology, and they should be considered in ecological risk assessment, public engagement, regulatory reform, and decision making. Recommendation 9-4: Proposed field tests or environmental releases of gene-drive modified organisms should be subject to ecological risk assessment and structured decision making processes.
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2015. Highly efficient Cas9-mediated gene drive for population modification of the malaria vector mosqui to Anopheles stephensi.
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