Keywords: Ethics
Precision pest management: Genome editing tools, specifically CRISPR/Cas9 and future prospects
35424Ankush Saini, Neha Sharma, Nidhi Sharma, et al., Pesticide Biochemistry and Physiology, 218. 2026-02-03 15:42:17.
The growing resistance to synthetic insecticides and Bt toxins, alongside persistent crop losses despite heavy pesticide application, highlights the urgent need for safer, sustainable and efficient pest management strategies. This review presents genome editing as a precise and versatile approach to reduce pest impact by altering fertility, feeding patterns or vulnerability, while protecting beneficial organisms. Among the genome editing tools, CRISPR/Cas9 (Clustered Regularly Interspaced Short Palindromic Repeats/CRISPR-associated protein 9) is one of the most promising genome editing techniques in insects. It facilitates targeted functional studies, integration with RNAi and dual-expression systems and gene drive applications. Deployment is envisioned in two phases, initial laboratory modification followed by regulated field release, with a strong emphasis on biosafety through terminator genes, marked individuals for gene flow monitoring, optimized dosages, stringent screening and long-term ecological surveillance, along with transparency and adherence to international safety protocols. Significant challenges encompass delivery efficiency, identification of edits, off-target mutations, dose-related efficacy and sterility, unstable transmission and resistance development. Innovations such as base and prime editing minimize unintended mutations by circumventing double-stranded breaks (DSBs), while paratransgenic strategies targeting gut symbionts offer supplementary avenues; plant-mediated insect gene editing emerges as a promising frontier. Overall, carefully regulated trials aligned with policy frameworks and stakeholder involvement are vital to assess effectiveness in natural environments and achieve targeted, dependable and ecologically responsible pest control.
CRISPR Mosquitoes That Can’t Bite
35031Science Techniz, 2025-08-09 19:49:44.
Scientists have used CRISPR gene editing to alter female mosquitoes so that their proboscis — the needle-like mouthpart used to pierce skin — develops like a male’s. The consequence is simple and profound: modified females can no longer pierce skin and therefore cannot take a blood meal or transmit human diseases like malaria and dengue. Researchers identified a gene involved in the developmental pathway that produces the female proboscis morphology. Using CRISPR-based edits, they altered that gene’s function so that genetically female mosquitoes develop a male-like mouthpart. Because males naturally do not bite (they feed on nectar), the modification removes the biting behavior without fundamentally disrupting other survival traits in lab tests. It’s important to stress that this is a high-level description intended to explain the concept, not a protocol or “how-to.” The work is complex, tightly regulated, and performed under strict laboratory and ethical oversight.
Can the world survive without mosquitoes and should we even try to find out?
34934Sowjanya Pedada, LA Post, 2025-06-17 15:08:22.
Scientists have developed gene editing technology that could wipe out malaria-carrying mosquitoes within subsequent generations, offering hope against diseases like Malaria, which kills nearly 600,000 people each year. But as field trials approach, bioethicists warn that deliberately driving a species to extinction raises profound questions about our right to reshape nature. Communities in hard-hit regions now face a difficult tradeoff: accept ecological risks or continue losing lives to preventable mosquito-borne diseases. Mosquito-borne diseases extend far beyond Malaria. Dengue infects up to 3.9 billion people annually across 132 countries, causing approximately 40,000 deaths each year. Zika, documented in 89 countries, can cause severe congenital disabilities like microcephaly. The CDC calls mosquitoes the “world’s deadliest animal,” responsible for over 700,000 deaths each year. In sub-Saharan Africa, scientists at Target Malaria have developed genetic modifications that render female mosquito offspring infertile, causing populations to collapse within a few generations in lab tests. “There are so many lives at stake,” said Alekos Simoni, a molecular biologist with the group. Their method uses male mosquitoes to spread ovary-disrupting genes throughout wild populations. Gene-driven mosquito extinction has ignited ethical debate. A recent study published in Science concluded that deliberately wiping out a species may be justifiable, but only under rare, extreme conditions. “These cases highlight the tension between the intrinsic value of a species and the benefits of eradicating a harmful pest,” said Clare Palmer, a bioethicist at Texas A&M. Environmental experts warn of ecological risks, but scientists stress that only a few mosquito species, mainly malaria-spreading Anopheles, would be targeted. “Extinction is not a likely outcome, nor even a desirable one,” said Tony Nolan of the Liverpool School of Tropical Medicine. “It’s not necessary to make the mosquito extinct to eliminate malaria.”
We finally may be able to rid the world of mosquitoes. But should we?
34901Dino Grandoni, Wall Street Journal, 2025-06-03 08:39:56.
They buzz, they bite, and they cause some of the deadliest diseases known to humanity. Mosquitoes are perhaps the planet’s most universally reviled animals. If we could zap them off the face of the Earth, should we? The question is no longer hypothetical. In recent years, scientists have devised powerful genetic tools that may be able to eradicate mosquitoes and other pests once and for all. Now, some doctors and scientists say it is time to take the extraordinary step of unleashing gene editing to suppress mosquitoes and avoid human suffering from malaria, dengue, West Nile virus and other serious diseases. “There are so many lives at stake with malaria that we want to make sure that this technology could be used in the near future,” said Alekos Simoni, a molecular biologist with Target Malaria, a project aiming to target vector mosquitoes in sub-Saharan Africa. Yet the development of this technology also raises a profound ethical question: When, if ever, is it okay to intentionally drive a species out of existence?
Should we wipe out the pests now that we can?
34885Miguel Ángel Criado, El Pais, 2025-06-02 18:47:38.
Felicola (Lorisicola) isidoroi is a creature that is probably either extinct or on the verge of being so. In the past, it must have been present throughout most of the Iberian Peninsula, but the last time scientists encountered one was in 1997. For biologists, this represents a loss of biodiversity. For everyone else, it’s just another bug. Felicola (L.) isidoroi is a louse that lives by sucking blood. Its unique feature is that its only host is the Iberian lynx. Specific to the most endangered feline on the planet, it shared the latter’s path to extinction until humans decided to save the feline, but not its parasite. The lynx recovery program includes deworming specimens released in the wild, a procedure that is also conducted in the event of a capture. Jesús María Pérez, a zoologist and expert in pests and parasites at the University of Jaén in southern Spain, believes that the louse is still a much rarer species than the lynx itself, and should also be saved because it is part of biodiversity: “As a unique product of evolution, it has incalculable value.” The dilemma posed by the lynx louse is the same one generated by many other parasites, pests, and species that, like some mosquitoes, are not pathogens themselves but vectors that carry the cause of various diseases. A few days ago, a group of biologists, ecologists and sociologists published an opinion piece in the journal Science whose title makes it clear what it’s about: Deliberate extinction by genome modification: An ethical challenge.
Applying the Protective Precautionary Principle to the Ethical Use of Gene Drive Technology for Anopheles gambiae Suppression in Malaria Control
34879Nucharee Wongsamut, Journal of Applied Animal Ethics Research, 2025-06-02 18:16:36.
Malaria contributes to poverty and illness, which further hinder productivity and income generation. Therefore, combating malaria is crucial for breaking the vicious cycle of poverty. Genome editing technologies, such as gene drives designed to suppress Anopheles gambiae mosquito populations, the vector for malaria, have emerged as potential tools in this fight. However, a significant ethical question arises: under what conditions is the use of gene drive technology to suppress Anopheles gambiae mosquito populations justified? This article argues that the Protective Precautionary Principle can serve as a suitable framework for morally assessing such cases. Within this framework, the use of gene drive technology for Anopheles gambiae population suppression would be permissible for laboratory research only. This limited scope minimizes the risk of unforeseen negative consequences, particularly for disadvantaged populations who may have fewer resources to protect themselves from such effects.
Gene editing, extinction and ethics: Why open conversation is key
34872Gabriela Harrod, ASU News, 2025-05-26 21:41:15.
In a new paper published in Science, researchers are challenging one of conservation’s deepest assumptions — that extinction is always a failure to be avoided. With new genome-editing tools making it technically possible to eliminate entire species, the question is no longer just scientific, but ethical: When, if ever, should we consider driving a species extinct on purpose? The study, titled “Deliberate extinction by genome modification: An ethical challenge,” brought together ethicists, conservation biologists, ecologists and social scientists to explore this complex question. ASU School of Life Sciences Professor James Collins co-authored the piece, which argues that while extinction should never be taken lightly, there may be “extremely rare and compelling” cases where it is justified. “This is a research area that is inherently counterintuitive,” Collins said. “At a time when biodiversity is more valued than ever, the idea that it could be ethically permissible to deliberately eradicate a species seems paradoxical. But we’re asking: Are there situations where it makes sense?” According to Gregory Kaebnick, a senior research scholar at The Hastings Center and the paper’s lead author, this conversation started over lunch during a National Academies meeting on gene drive research. Collins posed the idea that full extinction might mark an ethical line that genome-editing technologies shouldn’t cross. “The answer we offer in this new paper is, in effect, ‘almost, but not quite,’” Kaebnick said.
Deliberate extinction by genome modification: An ethical challenge
35544Gregory E. Kaebnick et al., Science, 388:707-709. 2025-05-15 10:35:25.
Among the ways that genome modification could be used to modify wild populations of organisms, the deliberate outcome of fully eradicating a species has received little critical attention. The lack of discussion leaves a difficult ethical question unresolved: When so much attention is given to the value of biodiversity and the conservation of species, what circumstances, paradoxically, might justify the deliberate, full extinction of a species? At least one species is now a preliminary candidate for full extinction, and cases under consideration for temporary suppression and local extinction might pose a risk of full extinction. We discuss three cases in which genome modification might be used to eradicate a species. Together, we argue, these cases suggest that deliberate full extinction might occasionally be acceptable, but only extremely rarely. The cases also highlight tensions within some widely held views about the conservation of species and the governance of genome editing.
For the Sake of 600,000 Children, Science Must Be Bold
34053Laurie Zoloth, The New York Times, 2024-12-16 14:36:13.
Bold ideas in science research used to thrill us; now they seem pretty threatening. When I have written about the ethics of genetically engineered mosquitoes to combat malaria, many of my friends have expressed alarm. “What if it goes badly wrong?” they ask. What if there are unintended consequences that ripple across ecosystems? What if this is one of those technologies that cross the line from innovative to utterly world-destroying And yet, one could also ask, what if we do nothing? For that question, at least we have an answer. A report last week from the World Health Organization reveals that 597,000 people died of malaria last year, overwhelmingly children under age 5, and an estimated 263 million people were sickened. Thousands of families cradled a baby dying from a preventable fever; thousands of pregnancies ended in stillbirth or maternal death. For a time in the early 2000s, it seemed as if the world was gaining ground against malaria, but progress has stalled, cases have risen and the hopes for its near-elimination by 2030 have been scuttled. Global warming, armed conflict and lack of funding are all factors. And while new vaccines certainly will help, they are limited in their effectiveness (they reduce the risk of severe malaria by 30 percent and require four separate clinic visits). For much of the world’s poor, we still rely on the 19th-century technology of bed nets and insecticide. For the past two decades, scientists have explored whether a new technology known as a gene drive might hold the tantalizing promise of eliminating malaria by targeting the mosquitoes that carry the deadly parasite. The reason the gene drive is so potentially revolutionary — but disturbing — is that it uses genetic engineering to introduce changes in mosquitoes that do not stop with one generation, but are preferentially inherited by all future generations.
Should We Unleash GMO Mosquitoes?
34051Brooke Borel and Anna Rothschild, Entanglements, 2024-12-16 14:26:29.
In this episode of Entanglements, hosts Brooke Borel and Anna Rothschild discuss the ethics and risks of genetically modified (GMO) mosquitoes. They explore differing expert opinions, focusing on technologies like gene drives and sterile males, examining ecological and safety concerns while debating whether releasing GMO insects is ultimately beneficial.
Russia’s Latest Target in Africa: U.S.-Funded Anti-Malaria Programs
32704Elian Peltier, The New York Times, 2024-10-22 15:00:57.
The scientists sifting through thousands of genetically modified mosquito larvae in a laboratory in Burkina Faso were trying to stop the spread of malaria, one of the biggest killers on the African continent. But in the pro-Russian propaganda telling of their work, the scientists, helped by funding from the Bill & Melinda Gates Foundation, were not protecting local people against malaria, they were infecting them. “Since these mosquitoes have arrived in Burkina, we’ve noticed an increase of malaria and dengue fever,” Egountchi Behanzin, a French-Togolese activist who often posts pro-Russian content, said in an interview. Mr. Behanzin could not cite any scientific evidence, and researchers say there are no grounds for such a claim. But his anti-Western messages, and his praise for Russia in Africa, are shared daily among his more than 600,000 followers on social media. His posts are seen as only one element in a recent pro-Russian disinformation operation that is targeting U.S.-funded health care programs in Africa. The attacks come at a time when ambitious initiatives and vaccines are being rolled out on a continent shaken by several epidemics, including a deadly outbreak of mpox. The apparent aim is to undermine public trust and bolster Russia’s steady attempt to weaken Western interests in Africa, according to U.S. and European officials.
To CRISPR or Not to CRISPR? Ethical Considerations in Gene-Editing Insects
31614Brendan Parent, Meghan Barrett, American Entomologist, 70:54-57. 2024-09-18 21:33:47.
Genetically modified corn has helped feed the world (Hernandes-Lopes et al. 2023). Genetically modified mosquitoes could help eliminate devastating diseases like malaria (Hammond and Galizi 2017). Plainly, gene editing can serve some important human interests. Still, many people object to it. While some concerns have little scientific validity, there are valid ethical concerns that should be addressed. A concern many people share is the potential impact of genetically edited insects on the environment. Gene drives are “selfish” genetic elements that are transmitted to progeny at unusually high rates and thus spread rapidly through populations. As a result, they are capable of modifying an entire population or species. The most widely discussed use of gene drives is in the prevention of malaria, the leading cause of human illness and death in many parts of the world (CDC 2021), where gene drives could be used to control mosquito populations. At present, however, there are no sure-fire strategies to “recall” a gene drive once it has been released (Hammond and Galizi 2017). Given the many unintended environmental impacts of other technological advancements and our uncertainties about the impacts of using gene drives (Ahmad et al. 2022), it makes sense to have similar concerns about this form of gene editing. Granted, it is possible that the extraordinary benefits to human life of such a gene drive, if successful, outweigh the risks of any unintended environmental consequences. This is particularly likely to be true if convincing measures like “terminator genes” can be employed to control genetically edited insect populations in the wild (Hammond et al. 2021). Given the serious promise and ethical concerns of this technology, the National Academy of Sciences has published guidelines for responsible research that include self-governance and government regulation, evaluating gene drives on a case-by-case basis (NASEM 2016). So, while risks of environmental harm are important, we can now see how they might not be decisive: first, the corresponding benefits might be very weighty; second, the risks might be mitigable.
New genetic editing technique can modify wild populations with less risk
31062Macquarie University, Phys.org, 2024-08-14 09:44:13.
A new technique developed by researchers from Macquarie University and the California Institute of Technology could allow scientists to more safely alter the genetic makeup of wild populations. The study is published in the journal Nature Communications. The researchers have proposed a new technique that aims to address some of the regulatory challenges and public concerns associated with existing genetic modification methods. Lead author Dr. Maciej Maselko from Applied Biosciences at Macquarie University says the technique, called an Allele Sail, would allow beneficial genetic changes to spread through a population without leaving "foreign DNA" behind. "Allele Sail offers a way to change the traits and fates of wild populations in ways that may be more acceptable, as the genetically modified part is introduced at low frequencies and usually won't last forever," he says. Genetic engineering could address major global challenges by altering the genetic makeup of certain wild populations—for example, to combat mosquito-borne illnesses such as malaria, or stop the spread of environmentally harmful invasive pests like cane toads. But there is genuine public concern about introducing genetic modification into wild populations, and many regulatory constraints. People are worried that modified organisms could contain foreign DNA that cause unpredictable ecological consequences over time; they worry that engineered genes could spread to other species with unknown impacts on ecosystems; and they also fear that once genetic modifications are introduced, they may not be able to be reversed. Traditional methods of genetic modification can also see a rapid spread of engineered genes within a population, raising both ecological and ethical questions. In response, many regulatory frameworks have been introduced to address genetic modification, presenting further challenges.
Otago GE Wasp Project Violates International Gene Drive Agreement
28874GE-Free NZ, Scoop, 2024-02-13 17:02:02.
Professor Dearden, Otago University, has received $11 million from the Ministry of Business, Innovation and Enterprise (MBIE) to engineer wasps using gene drive technology. He is only consulting with Māori and regulators, ignoring and side-lining the views of other concerned New Zealanders. Gene Drives using gene editing CRISPR (clustered regularly interspaced short palindromic repeat) technology. This genetic engineering causes a permanent modification of the organisms genome, which is passed on to all subsequent generations. Gene drives are designed to impact reproduction or kill the developing larvae. Due to the irreversibility of gene drives, any out-crossing across species could collapse the insect ecosystems affecting pollinators and food security. The approval of this gene drive application is a worldwide concern, as it overrides the decision on gene drives being considered at a global level through the UN Convention of Biodiversity (CBD). MBIE and researchers at the University of Otago have violated the agreement to work in unison with the international community. International concern has already been raised by the project.
Framing Challenges and Opportunities for Canada: Expert Panel on Regulating Gene-Edited Organisms for Pest Control
28486CCA (Council of Canadian Academies), Framing Challenges and Opportunities for Canada, 2023-11-21 11:21:00.
Gene-editing technologies are changing approaches to pest management. Rapidly evolving but unproven gene-editing tools could potentially mitigate the impacts of pests in public health, conservation, and agricultural contexts. The use of these tools, however, is accompanied by uncertainties about possible impacts on species and ecosystems, along with broader socioeconomic and cultural risks. Increased globalization and climate change are intensifying pest problems. These factors, combined with the waning effectiveness of many common pest-control tools, will contribute to growing pressure from both native and invasive pests if left unchecked. Opportunities to manage pests with greater effectiveness, lower costs, and increased safety therefore require consideration.
Transformative Novel Technologies and Global Environmental Governance
28377F. Rabitz, Cambridge University Press, 2023-11-13 09:55:21.
Transformative Novel Technologies are potential gamechangers for confronting climate change, biodiversity loss, and many other elements of the global environmental crisis, allowing us to achieve a more sustainable future. The contemporary and future international governance of these technologies has crucial implications for managing the global transition towards sustainability. This book is the first to present a comprehensive assessment of the impact of these technologies on international politics. The author examines the responses of international institutions to the emergence of these technologies, focusing on three broad domains: biotechnology, climate engineering, and mineral extraction in areas beyond national jurisdiction (the ocean floor or near-Earth asteroids). This book is aimed at a non-specialist, academic audience with interest in the international and environmental politics of sustainability and technology. This title is part of the Flip it Open Programme and may also be available Open Access. Check our website - Cambridge Core - for details.
Gene Drive Mosquitoes from Islamic Perspective: A Preliminary Discussion
28385N. M. Isa, Global Journal Al-Thaqafah, 13. 2023-11-11 10:14:15.
Gene drive mosquitoes could spread desired trait, such as female infertility within a wild population at a rate higher than the normal inheritance rate and could eventually wipe out the population. Consequently, this makes gene drive mosquitoes one of the promising approaches in controlling mosquito-borne diseases, such as malaria and dengue. Despite its potentials, the development of gene drive mosquitoes has raised ethical concerns, mainly on the issues of safety and efficacy, as well as tampering with nature. Little research has been conducted to explore religious perspectives on this new advancement. This article aims to fill that gap by exploring the ethics of gene drive mosquitoes from Islamic perspectives. This article outlines three aspects, namely the purposes, the potential benefits and harms, and the need of the technology that should be considered when discussing whether gene drive mosquitoes should be allowed from Islamic perspectives. © (2023), (Universiti Sultan Azlan Shah). All Rights Reserved.
Guerrilla eugenics: gene drives in heritable human genome editing
26475A. D. Cutter, J Med Ethics, 2023-07-04 08:15:56.
CRISPR-Cas9 genome editing can and has altered human genomes, bringing bioethical debates about this capability to the forefront of philosophical and policy considerations. Here, I consider the underexplored implications of CRISPR-Cas9 gene drives for heritable human genome editing. Modification gene drives applied to heritable human genome editing would introduce a novel form of involuntary eugenic practice that I term guerrilla eugenics. Once introduced into a genome, stealth genetic editing by a gene drive genetic element would occur each subsequent generation irrespective of whether reproductive partners consent to it and irrespective of whether the genetic change confers any benefit. By overriding the ability to 'opt in' to genome editing, gene drives compromise the autonomy of carrier individuals and their reproductive partners to choose to use or avoid genome editing and impose additional burdens on those who hope to 'opt out' of further genome editing. High incidence of an initially rare gene drive in small human communities could occur within 200 years, with evolutionary fixation globally in a timeframe that is thousands of times sooner than achievable by non-drive germline editing. Following any introduction of heritable gene drives into human genomes, practices intended for surveillance or reversal also create fundamental ethical problems. Current policy guidelines do not comment explicitly on gene drives in humans. These considerations motivate an explicit moratorium as being warranted on gene drive development in heritable human genome editing.
The attitudes of young adults towards mammalian predator control and Predator Free 2050 in Aotearoa New Zealand
26186L. Dickie and F. Medvecky, Australasian Journal of Environmental Management, 2023-06-09 12:31:11.
Predator Free 2050 (PF2050) is an ambitious goal that aims to remove three types of invasive mammals from New Zealand by 2050. It will require a significant amount of funding, research, and support. Young adults will have an important role to play for this programme to be successful. Therefore, understanding the awareness and attitudes of young adults towards PF2050, and predator control, is an essential consideration. A survey of 1479 18- to 24-year-olds was conducted in 2017. The results showed that a higher percentage of young adults than members of the broader public view the small, introduced mammals as threats to New Zealand’s environment. Furthermore, this study highlights support for the control of feral, stray, and domestic cats. More focused research on attitudes towards cats is recommended to gauge which control methods are approved of by young adults. Indeed, methods appear to be a key factor to young adults supporting PF2050. The aerial distribution of poison was largely viewed negatively, and moderate concern was expressed about the targeted animal’s welfare. Interestingly, young adults appeared to be open to the use of gene editing and gene drive, although they expressed caution. Targeted communication towards young adults on toxins and genetic methods is recommended. © 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
The boundary problem: Defining and delineating the community in field trials with gene drive organisms
25098N. de Graeff, I. Pirson, R. van der Graaf, A. L. Bredenoord and K. R. Jongsma, Bioethics, 2023-05-03 10:11:03.
Despite widespread and worldwide efforts to eradicate vector-borne diseases such as malaria, these diseases continue to have an enormous negative impact on public health. For this reason, scientists are working on novel control strategies, such as gene drive technologies (GDTs). As GDT research advances, researchers are contemplating the potential next step of conducting field trials. An important point of discussion regarding these field trials relates to who should be informed, consulted, and involved in decision-making about their design and launch. It is generally argued that community members have a particularly strong claim to be engaged, and yet, disagreement and lack of clarity exist about how this "community" should be defined and delineated. In this paper, we shed light on this "boundary problem": the problem of determining how boundaries of inclusion and exclusion in (GDT) community engagement should be drawn. As our analysis demonstrates, the process of defining and delineating a community is itself normative. First, we explicate why it is important to define and delineate the community. Second, we demonstrate that different definitions of community are used and intermingled in the debate on GDTs, and argue in favor of distinguishing geographical, affected, cultural, and political communities. Finally, we propose initial guidance for deciding who should (not) be engaged in decision-making about GDT field trials, by arguing that the definition and delineation of the community should depend on the rationale for engagement and that the characteristics of the community itself can guide the effective design of community engagement strategies.
Gene Drives as Interventions into Nature: the Coproduction of Ontology and Morality in the Gene Drive Debate
25114K. Boersma, B. Bovenkerk and D. Ludwig, NanoEthics, 17:4. 2023-04-22 10:10:41.
Gene drives are potentially ontologically and morally disruptive technologies. The potential to shape evolutionary processes and to eradicate (e.g. malaria-transmitting or invasive) populations raises ontological questions about evolution, nature, and wilderness. The transformative promises and perils of gene drives also raise pressing ethical and political concerns. The aim of this article is to arrive at a better understanding of the gene drive debate by analysing how ontological and moral assumptions are coproduced in this debate. Combining philosophical analysis with a critical reading of the gene drive literature and an ethnographic study of two leading research groups, the article explores the hypothesis that the development of and debate about gene drives are characterized by a particular intervention-oriented mode of coproduction. Based on the results of this exploration, we highlight the need for a broadening of the perspective on gene drives in which empirical, moral, and ontological concerns are addressed explicitly in their interplay rather than in (disciplinary) isolation from each other.
Evolution driven by genetic engineering should be known as ‘genetic welding’ to draw scientific and ethical scrutiny
24940S. Moore, AZO Life Sciences, 2023-03-29 10:13:27.
The advent of CRISPR-Cas9 technology has been revolutionary, but it has also been highly controversial. In an opinion paper published in the journal Trends in Genetics, evolutionary geneticist Asher Cutter highlights the importance of coining the term ‘genetic welding’ for the anthropogenic manipulation of genetic drive made possible by tools such as CRISPR-Cas9. Separating this process from other processes that influence evolution might be fundamental to ensuring proper consideration is given to the potential future outcomes of genetic welding.
What should we call evolution driven by genetic engineering? Genetic welding, says researcher
24897Cell Press, Phys Org, 2023-03-28 07:29:32.
With CRISPR-Cas9 technology, humans can now rapidly change the evolutionary course of animals or plants by inserting genes that can easily spread through entire populations. Evolutionary geneticist Asher Cutter proposes that we call this evolutionary meddling “genetic welding.” In an opinion paper publishing March 28 in the journal Trends in Genetics, he argues that we must scientifically and ethically scrutinize the potential consequences of genetic welding before we put it into practice.
Alleviating the burden of malaria with gene drive technologies? A biocentric analysis of the moral permissibility of modifying malaria mosquitoes
24800N. de Graeff, K. R. Jongsma and A. L. Bredenoord, Journal of Medical Ethics, 2023-02-28 08:33:28.
Gene drive technologies (GDTs) have been proposed as a potential new way to alleviate the burden of malaria, yet have also raised ethical questions. A central ethical question regarding GDTs relates to whether it is morally permissible to intentionally modify or eradicate mosquitoes in this way and how the inherent worth of humans and non-human organisms should be factored into determining this. Existing analyses of this matter have thus far generally relied on anthropocentric and zoocentric perspectives and rejected an individualist biocentric outlook in which all living organisms are taken to matter morally for their own sake. In this paper, we reconsider the implications of taking a biocentric approach and highlight nuances that may not be evident at first glance. First, we shortly discuss biocentric perspectives in general, and then outline Paul Taylor's biocentric theory of respect for nature. Second, we explore how conflicting claims towards different organisms should be prioritised from this perspective and subsequently apply this to the context of malaria control using GDTs. Our ethical analysis shows that this context invokes the principle of self-defence, which could override the pro tanto concerns that a biocentrist would have against modifying malaria mosquitoes in this way if certain conditions are met. At the same time, the case study of GDTs underlines the relevance of previously posed questions and criticism regarding the internal consistency of Taylor's egalitarian biocentrism.
The Anthropocene as the End of Nature? Why Recognizing Interventionism Is Key in Coming to Terms with the Anthropocene
24729K. Boersma, ENVIRONMENTAL ETHICS, 44:195-219. 2023-02-12 09:43:02.
In this article, I address and argue against the tendency to understand the anthropocene as inaugurating the end of nature. I conduct two key moves. First, by way of an engagement with the concept of anthropocene technology I explain how understanding the anthropocene as the end of nature prevents us from recognizing what the anthropocene is all about: interventionism. Secondly, I illustrate how a nondualist understanding of the human-nature relation allows us to recognize interventionism as the hallmark of the anthropocene without falling back into the hierarchical human-nature conceptions that underlie interventionism. A nondualist framework that conserves the human-nature distinction helps us in our ability to relate critically to contemporary science and technology in the anthropocene. I illustrate the conceptual narrative of the article through the specific case of gene drive technology development.
Social justice environmental activists move to block gene editing to control invasive species and promote biodiversity. Here’s why they’re misguided
24701S. Smyth, Genetic Literacy Project, 2023-02-07 12:46:02.
Control of invasive species has been extremely difficult with eradication virtually impossible. To control invasive plant species, chemicals are commonly used while in some instances removal of plants by hand, as Shiva advocates, is undertaken. Efforts to control invasive animals include poisoning and shooting. Needless to say, these ‘control techniques’ are inefficient and often harmful to the applicators. Advances in genetics potentially offer new solutions, using gene editing technology to create sterile populations. Sterility is a natural trait in mammals, which can be induced into invasive animals as a means of population control. Invasive pests can be captured, gene-edited to confer sterility in future generations and then released back into the wild. The offspring will gradually without the use of chemicals or hand labor contribute to reduced populations. Applying gene editing technologies is not an instantaneous solution, but they may be part of a long-term strategy.
Ethical dilemma: Should we get rid of mosquitoes?
24650Talya Hackett, TED-Ed, 2023-01-30 09:59:15.
Mosquitoes are responsible for more human deaths every year than any other animal, but very few of the 3,500 mosquito species actually transmit deadly diseases to humans. Scientists have been conducting experiments using engineered technologies called gene drives that could theoretically get rid of the most lethal mosquitoes. So, should we eradicate these pesky insects? Talya Hackett investigates.
Trust in science and scientists: Effects of social attitudes and motivations on views regarding climate change, vaccines and gene drive technology
24622H. G. W. Dixson, A. F. Komugabe-Dixson, F. Medvecky, J. Balanovic, H. Thygesen and E. A. MacDonald, Journal of Trust Research, 2023-01-10 09:31:54.
Trust in science and scientists (TSS) is an increasingly important topic with respect to how science is applied within society. However, its role regarding specific issues may vary depending upon other psychosocial factors. In this study, we investigated how trust interacts with social attitudes and motivations to shape views on scientific issues in New Zealand (N = 8,199; 74.7% New Zealand European, 55.1% female). The study went beyond TSS by including broader institutional trust alongside measures relating to support for inequality, status quo preservation and fear of the unknown. We focused on their effects on three issues: vaccines, climate change and genetic technology (gene drive). Although TSS was strongly associated with lower vaccine skepticism (B = -0.497, p < 0.01), and moderate support for gene drive (B = 0.231, p < 0.01), it had no meaningful effect on climate skepticism. Furthermore, trust differentially mediated the relationship between social motivations and responses to all three issues. Trust in science and scientists is therefore unlikely to represent a one-size-fits-all variable. We conclude that future research should consider what effects trust in institutions and TSS have with social attitudes and motivations over a range of technologies across the sciences.
Genes drive organisms and slippery slopes
24322D. B. Resnik, R. F. Medina, F. Gould, G. Church and J. Kuzma, Pathog Glob Health, 2022-12-22 08:58:12.
The bioethical debate about using gene drives to alter or eradicate wild populations has focused mostly on issues concerning short-term risk assessment and management, governance and oversight, and public and community engagement, but has not examined big-picture- 'where is this going?'-questions in great depth. In other areas of bioethical controversy, big-picture questions often enter the public forum via slippery slope arguments. Given the incredible potential of gene drive organisms to alter the Earth's biota, it is somewhat surprising that slippery slope arguments have not played a more prominent role in ethical and policy debates about these emerging technologies. In this article, we examine a type of slippery slope argument against using gene drives to alter or suppress wild pest populations and consider whether it has a role to play in ethical and policy debates. Although we conclude that this argument does not provide compelling reasons for banning the use of gene drives in wild pest populations, we believe that it still has value as a morally instructive cautionary narrative that can motivate scientists, ethicists, and members of the public to think more clearly about appropriate vs. inappropriate uses of gene drive technologies, the long-term and cumulative and emergent risks of using gene drives in wild populations, and steps that can be taken to manage these risks, such as protecting wilderness areas where people can enjoy life forms that have not been genetically engineered.
Gene drive technologies: navigating the ethical landscape
24074N. d. Graeff, Utrecht University, 2022-11-04 10:41:56.
Gene drives are technologies that modify a particular genetic element in animals or insects so that this genetic element does not follow the typical rules of heredity, and is passed onto future generations with an increased likelihood. Gene drive technologies could be used to tackle intractable problems such as vector-borne diseases like malaria or the biodiversity impact of invasive species. At the same time, the development and governance of gene drives raise a range of ethical questions and concerns that warrant proactive ethical evaluation. In the PhD thesis ?Gene drive technologies: navigating the ethical landscape?, Nienke de Graeff analyzes these questions and concerns. In Part I, she outlines the ?ethical landscape? of gene drive technologies by identifying the associated ethical challenges through literature review and empirical ethical research. Important challenges concern how the uncertainty and risks of these technologies should be navigated, whether it is morally permissible to intervene in nature in this way, and how the development, governance, and potential deployment of gene drive technologies should be guided. In Part II, De Graeff normatively analyzes various of these challenges and provides guidance to navigate them. In Part III, she stipulates recommendations for researchers and policymakers in the gene drive field as well as lessons learned for ethics parallel research as an approach for early ethical guidance of new and emerging technologies more generally.
Ethics of gene drive mosquitoes for malaria elimination
24071A. J. Roberts, McMaster University, 2022-10-24 10:34:04.
This thesis is concerned with presenting analyses regarding key ethical issues regarding and arising from the development and potential use of gene drive modified mosquitoes for the purpose of malaria elimination. Each of the chapters constituting this thesis offers a rigorously researched analysis which attempts to answer questions thus far unanswered in the academic literature. Chapter one explores whether the development and use of this technology can be fairly considered unethical in principle; concluding it cannot be. Chapter two explores the appropriate relationship between this technology and the precautionary principle, a prominent regulatory and governance principle which has been invoked as ostensible support for an indefinite global moratorium on all gene drive technology. The chapter concludes that the precautionary principle, at least as articulated by UNESCO, does not provide justification for a global moratorium on gene drive technology. In fact, the precautionary principle is likely unfit as a regulatory norm for some kinds of gene drive products and purposes. Chapter three was co-authored with Delphine Thizy, Global Stakeholder Engagement Manager for Target Malaria, one of the leading consortiums working on research and development of gene drive biotechnology for malaria control. Together we articulate the ethical principles selected to guide Target Malaria’s stakeholder engagement, as well as provide the rationale for their selection and expound upon some early lessons from their implementation. Chapter four offers an analysis with the goal of locating the ethically appropriate locus of political organization from which to seek permission for a gene drive modified organism release into the shared environment. The chapter considers the appropriateness of each of the following levels of political organization: consent of individuals, local communities, nation states, and international governance institutions. The conclusion arrived at, with some caveats, is that such a decision is most appropriately issued by a nation state.
Hurdles in responsive community engagement for the development of environmental biotechnologies
25089A. M. Normandin, L. M. Fitzgerald, J. Yip and S. W. Evans, Synthetic Biology, 7:ysac022. 2022-10-20 06:56:55.
Recent calls for engaging communities in biotechnology development do not draw enough attention to the hurdles that must be overcome for engagement strategies to effectively feed back into research design and conduct. These hurdles call into question many standard ways of operating and assessing in traditional scientific disciplines. The first steps in addressing these hurdles can be the most difficult. In reflecting on our own experiences in the early-stage development of environmental biotechnologies, we provide a set of techniques to help scientists and their collaborators learn to become more responsive to the needs and attitudes of communities with which they are engaging.Graphical Abstract
Justifying an Intentional Species Extinction: The Case of Anopheles gambiae
23662D. E. Callies and Y. Rohwer, Environmental Values, 31:193-210. 2022-10-01 06:16:34.
Each year, over 200 million people are infected with the malaria parasite, nearly half a million of whom succumb to the disease. Emerging genetic technologies could, in theory, eliminate the burden of malaria throughout the world by intentionally eradicating the mosquitoes that transmit the disease. In this paper, we offer an ethical examination of the intentional eradication of Anopheles gambiae, the main malaria vector of sub-Saharan Africa. In our evaluation, we focus on two main considerations: the benefit of alleviating the malaria burden, and the loss of value that would accompany the eradication of the species. We outline a typology of the different ways in which species are valued or could be valuable, then use that typology to appraise the value of the species in question. We argue that Anopheles gambiae has minor (and redundant) instrumental value, little final subjective value and no objective final value.
Exploring value change
25095T. E. de Wildt and V. J. Schweizer, Prometheus, 38. 2022-06-01 10:02:19.
This article aims to explore the use of cross-impact balances (CIB) to identify scenarios of value change. The possibility of value change has received little attention in the literature on value-sensitive design (VSD). Examples of value change include the emergence of new values and changes in the relative importance of values. Value change could lead to a mismatch between values embedded in technology and the way they are currently considered in society. Such a mismatch could result in a lack of acceptability of technologies, increasing social tensions and injustices. However, methods to study value change in the VSD literature are rare. CIB is a scenario tool that can study systems characterized by feedback loops that are hard to describe mathematically. This is often the case when aiming to define values and their relationships. We demonstrate the use of CIB to identify scenarios of value change using two cases: digital voice assistants and gene drive organisms. Our findings show that CIB is helpful in building scenarios of value change, even in instances where the operationalization of values is complex. CIB also helps us to understand the mechanisms of value change and evaluate when such mechanisms occur. Finally, we find that CIB is particularly useful for social learning and explanatory modelling. CIB can therefore contribute to the design of value-sensitive technologies.
Governing Gene Drive Technologies: A Qualitative Interview Study
23410N. de Graeff, K. R. Jongsma, J. E. Lunshof and A. L. Bredenoord, AJOB Empirical Bioethics, 13:107-124. 2022-04-04 12:10:12.
Gene drive technologies (GDTs) bias the inheritance of a genetic element within a population of non-human organisms, promoting its progressive spread across this population. If successful, GDTs may be used to counter intractable problems such as vector-borne diseases. A key issue in the debate on GDTs relates to what governance is appropriate for these technologies. While governance mechanisms for GDTs are to a significant extent proposed and shaped by professional experts, the perspectives of these experts have not been explored in depth.Methods A total of 33 GDT experts from different professional disciplines were interviewed to identify, better understand, and juxtapose their perspectives on GDT governance. The pseudonymized transcripts were analyzed thematically.Results Three main themes were identified: (1) engagement of communities, stakeholders, and publics; (2) power dynamics, and (3) decision-making. There was broad consensus amongst respondents that it is important to engage communities, stakeholders, and publics. Nonetheless, respondents had diverging views on the reasons for doing so and the timing and design of engagement. Respondents also outlined complexities and challenges related to engagement. Moreover, they brought up the power dynamics that are present in GDT research. Respondents stressed the importance of preventing the recurrence of historical injustices and reflected on dilemmas regarding whether and to what extent (foreign) researchers can legitimately make demands regarding local governance. Finally, respondents had diverging views on whether decisions about GDTs should be made in the same way as decisions about other environmental interventions, and on the decision-making model that should be used to decide about GDT deployment.Conclusions The insights obtained in this interview study give rise to recommendations for the design and evaluation of GDT governance. Moreover, these insights point to unresolved normative questions that need to be addressed to move from general commitments to concrete obligations.
Should we kill every mosquito on Earth?
20519J. Phelan, LiveScience, 2022-02-28 08:05:44.
Before you grab that can of bug spray, know this: While some mosquitoes are dangerous to us, not all are. Even those that are sometimes harmful tend not to feed on humans, preferring honeydew, plant sap and nectar, according to Mosquito Joe, a mosquito control company. There are around 3,500 mosquito species, but "only around 100 will potentially bite and spread disease to humans," Steven Sinkins, a professor in microbiology and tropical medicine at the Centre for Virus Research at the University of Glasgow in Scotland, told Live Science in an email. For instance, Culiseta mosquitoes often bite humans, but are not known to carry any debilitating diseases, while Toxorhynchites, which are common the world over and tend to live in forests, prefer nectar sugars to blood, according to Entomology Today. Therefore, it probably wouldn't be necessary to get rid of every mosquito species. Instead, we could target the more problematic ones, such as Aedes aegypti, which carry diseases such as yellow fever and Zika. A. aegypti is now ubiquitous, but it wasn't always this way. The species first spread out of Africa during the slave trade between the 15th and 19th centuries, through trade with Asia in the 18th and 19th centuries, and via troop movements during World War II, according to the World Mosquito Program, a nonprofit based in Australia.
Regulation of genetically engineered (GE) mosquitoes as a public health tool: a public health ethics analysis
20480Z. Meghani, Globalization and Health, 18:21. 2022-02-21 08:33:18.
In recent years, genetically engineered (GE) mosquitoes have been proposed as a public health measure against the high incidence of mosquito-borne diseases among the poor in regions of the global South. While uncertainties as well as risks for humans and ecosystems are entailed by the open-release of GE mosquitoes, a powerful global health governance non-state organization is funding the development of and advocating the use of those bio-technologies as public health tools.
An Ethical Overview of the CRISPR-Based Elimination of Anopheles gambiae to Combat Malaria
20442I. J. Wise and P. Borry, Journal of Bioethical Inquiry, 2022-02-17 09:30:10.
Approximately a quarter of a billion people around the world suffer from malaria each year. Most cases are located in sub-Saharan Africa where Anopheles gambiae mosquitoes are the principal vectors of this public health problem. With the use of CRISPR-based gene drives, the population of mosquitoes can be modified, eventually causing their extinction. First, we discuss the moral status of the organism and argue that using genetically modified mosquitoes to combat malaria should not be abandoned based on some moral value of A. gambiae. Secondly, we argue that environmental impact studies should be performed to obtain an accurate account of the possible effects of a potential eradication of the organism. However, the risks from the purposeful extinction of A. gambiae should not overtake the benefits of eradicating malaria and risk assessments should be used to determine acceptable risks. Thirdly, we argue that the eventual release of the genetically modified mosquitoes will depend on transparency, community involvement, and cooperation between different nations.
A preliminary framework for understanding the governance of novel environmental technologies: Ambiguity, indeterminateness and drift
20412F. Rabitz, M. Feist, M. Honegger, J. Horton, S. Jinnah and J. Reynolds, Earth System Governance, 12:100134. 2022-02-16 16:13:59.
We propose a conceptual framework to explain why some technologies are more difficult to govern than others in global environmental governance. We start from the observation that some technologies pose transboundary environmental risks, some provide capacities for managing such risks, and some do both. For “ambiguous” technologies, potential risks and risk management capacities are uncertain, unknown or even unknowable. Governance systems are indeterminate towards ambiguous technologies, as existing norms, rules, scripts and routines do not imply default solutions under institutional focal points. Indeterminateness can lead to institutional drift, with risks accordingly remaining unmitigated and risk management capacities remaining unexploited. We use the cases of solar geoengineering, gene drive systems and bioinformatics for illustrating this framework. As technological ambiguity may often be irresolvable, we conclude that it might force us to confront the limits to anticipatory global decision-making on matters of long-term environmental sustainability.
Articulating ethical principles guiding Target Malaria’s engagement strategy
20320A. J. Roberts and D. Thizy, Malaria Journal, 21:35. 2022-02-05 09:13:03.
Progress in gene drive research has engendered a lively discussion about community engagement and the ethical standards the work hinges on. While there is broad agreement regarding ethical principles and established best practices for conducting clinical public health research, projects developing area-wide vector control technologies and initiating ambitious engagement strategies raise specific questions: who to engage, when to engage, and how? When responding to these fundamental questions, with few best practices available for guidance, projects need to reflect on and articulate the ethical principles that motivate and justify their approach. Target Malaria is a not-for-profit research consortium that aims to develop and share malaria control and elimination technology. The consortium is currently investigating the potential of a genetic technique called gene drive to control populations of malaria vectoring mosquito species Anopheles gambiae. Due to the potentially broad geographical, environmental impact of gene drive technology, Target Malaria has committed to a robust form of tailored engagement with the local communities in Burkina Faso, Mali, and Uganda, where research activities are currently taking place. This paper presents the principles guiding Target Malaria’s engagement strategy. Herein the authors (i) articulate the principles; (ii) explain the rationale for selecting them; (iii) share early lessons about the application of the principles. Since gene drive technology is an emerging technology, with few best practices available for guidance, the authors hope by sharing these lessons, to add to the growing literature regarding engagement strategies and practices for area-wide vector control, and more specifically, for gene drive research.
Gene Editing Is Popular, But Controversial, Research Are
20387Relias, RELIAS MEDIA, 2022-02-01 09:18:26.
Gene drive research carries great potential for controlling insect vectors of devastating diseases, but there are multiple unresolved ethical concerns. Unanticipated “downstream” effects on ecosystems, or in organisms that carry the gene drive machinery, are possible. To help researchers balance risks and benefits for society and humanity, scientists involved in the Controlling and Countering Gene Editing in Mosquitoes research project developed a code of ethics for gene drive research. Today, gene drive researchers are focused on diseases that mosquitoes carry. The goal is to make a mosquito that cannot infect a person with malaria. “All of a sudden, it’s become a very hot research area. With the discovery of CRISPR, everybody wants to apply CRISPR to everything. But here is an area where it actually makes sense,” says lead author George J. Annas, JD, MPH, director of the Center for Health Law, Ethics, and Human Rights at Boston University.
Gene Drives in the U.K., U.S., and Australian Press (2015–2019): How a New Focus on Responsibility Is Shaping Science Communication
20217A. Stelmach, B. Nerlich and S. Hartley, Science Communication, 10755470211072245. 2022-01-25 16:28:49.
Gene drive is a controversial biotechnology for pest control. Despite a commitment from gene drive researchers to responsibility and the key role of the media in debates about science and technology, little research has been conducted on media reporting of gene drive. We employ metaphor and discourse analysis to explore how responsibility is reflected in the coverage of this technology in the U.S., U.K., and Australian press. The findings reveal a rhetorical strategy of trust-building by evoking the moral attributes of gene drive researchers. We discuss the implications of these findings for the communication of new technologies.
Ethical Considerations for Gene Drive: Challenges of Balancing Inclusion, Power and Perspectives
20139A. Kormos, G. C. Lanzaro, E. Bier, V. Santos, L. Nazare, J. Pinto, A. A. dos Santos and A. James, Frontiers in Bioengineering and Biotechnology, 2022-01-21 13:24:13.
Progress in gene-drive research has stimulated discussion and debate on ethical issues including community engagement and consent, policy and governance, and decision-making involved in development and deployment. Many organizations, academic institutions, foundations, and individual professionals have contributed to ensuring that these issues are considered prior to the application of gene-drive technology. Central topics include co-development of the technology with local stakeholders and communities and reducing asymmetry between developers and end-users. Important questions include with whom to conduct engagement and how to define community acceptance, develop capacity-building activities, and regulate this technology. Experts, academics, and funders have suggested that global frameworks, standards, and guidelines be developed to direct research in answering these important questions. Additionally, it has been suggested that ethical principles or commitments be established to further guide research practices. The challenging and interesting contradiction that we explore here is that the vast majority of these conversations transpire with little or no input from potential end-users or stakeholders who, we contend, should ultimately determine the fate of the technology in their communities. The question arises, whose concerns regarding marginalization, disempowerment, and inequity should be included in discussions and decisions concerning how inequities are perceived and how they may be addressed? At what stage will true co-development occur and how will opinions, perspectives and knowledge held by low-income country stakeholders be applied in determining answers to the questions regarding the ethics being debated on the academic stage? Our opinion is that the time is now.
Gene Editing in the Wild: Shaping Decisions through Broad Public Deliberation
19701M. K. Gusmano, G. E. Kaebnick, K. J. Maschke, C. P. Neuhaus and B. C. Wills, The Hastings Center Report, 51. 2021-12-14 19:46:28.
The essays in this special report grew out of a project funded by the National Science Foundation (with NSF award number 1827935). Gregory E. Kaebnick and Michael K. Gusmano were co-principal investigators on the project, and Karen J. Maschke and Carolyn P. Neuhaus were coinvestigators. Ben Curran Wills was project manager and research assistant. Genetic editing technologies have long been used to modify domesticated nonhuman animals and plants. Recently, attention and funding have also been directed toward projects for modifying nonhuman organisms in the shared environment—that is, in the “wild.” Interest in gene editing nonhuman organisms for wild release is motivated by a variety of goals, and such releases hold the possibility of significant, potentially transformative benefit. The technologies also pose risks and are often surrounded by a high uncertainty. Given the stakes, scientists and advisory bodies have called for public engagement in the science, ethics, and governance of gene editing research in nonhuman organisms. Most calls for public engagement lack details about how to design a broad public deliberation, including questions about participation, how to structure the conversations, how to report on the content, and how to link the deliberations to policy. We summarize the key design elements that can improve broad public deliberations about gene editing in the wild.
Deficits of Public Deliberation in U.S. Oversight for Gene Edited Organisms
19650J. Kuzma, Hastings Center Report, 51 Suppl 2:S25-s33. 2021-12-14 18:49:23.
Environmental releases of gene edited (GEdOs) and gene drive organisms (GDOs) will likely occur under conditions of high uncertainty and in complex socioecological systems. Therefore, public deliberation is especially important to account for diverse interpretations of safety, risks, and benefits; to draw on experiential and public wisdom in areas of proposed release; to ameliorate dangers of technological optimism; and to increase the public legitimacy of decisions. Yet there is a "democratic deficit" in the United States' oversight system for GEdOs and GDOs, as unconflicted experts, publics, and skeptical stakeholders are most often excluded from decision-making and unavailable to critically examine potential risks and benefits or raise broader concerns about socioeconomic or cultural impacts. This article argues for the need to open up decision-making for GEdOs and GDOs, discusses the challenges for doing so within the current oversight framework, and finally, proposes institutional, policy, and attitudinal changes that are likely important for overcoming barriers to public deliberation.
Public Deliberation about Gene Editing in the Wild
19648M. K. Gusmano, G. E. Kaebnick, K. J. Maschke, C. P. Neuhaus and B. C. Wills, Hastings Center Report, 51 Suppl 2:S2-s10. 2021-12-14 18:42:52.
Genetic editing technologies have long been used to modify domesticated nonhuman animals and plants. Recently, attention and funding have also been directed toward projects for modifying nonhuman organisms in the shared environment-that is, in the "wild." Interest in gene editing nonhuman organisms for wild release is motivated by a variety of goals, and such releases hold the possibility of significant, potentially transformative benefit. The technologies also pose risks and are often surrounded by a high uncertainty. Given the stakes, scientists and advisory bodies have called for public engagement in the science, ethics, and governance of gene editing research in nonhuman organisms. Most calls for public engagement lack details about how to design a broad public deliberation, including questions about participation, how to structure the conversations, how to report on the content, and how to link the deliberations to policy. We summarize the key design elements that can improve broad public deliberations about gene editing in the wild.
Empowering Indigenous Knowledge in Deliberations on Gene Editing in the Wild
19646R. Taitingfong and A. Ullah, Hastings Center Report, 51 Suppl 2:S74-s84. 2021-12-14 18:38:07.
Proposals to release genetically engineered organisms in the wild raise complex ethical issues related to their safe and equitable implementation. While there is broad agreement that community and public engagement is vital to decision-making in this context, more discussion is needed about who should be engaged in such activities and in what ways. This article identifies Indigenous peoples as key stakeholders in decisions about gene-editing in the wild and argues that engagement activities need not only include Indigenous peoples but also be designed, conducted, and analyzed in ways that confront longstanding power imbalances that dismiss Indigenous expertise. We offer specific recommendations to guide deliberative activities to not only be inclusive of Indigenous peoples but also to empower their diverse, situated knowledges. We call on those committed to the inclusive design of broad public deliberation to pursue strategies that shift dominant power dynamics to include Indigenous communities in more meaningful ways.
The Decision Phases Framework for Public Engagement: Engaging Stakeholders about Gene Editing in the Wild
19643S. K. Barnhill-Dilling, A. Kokotovich and J. A. Delborne, Hastings Center Report, 51 Suppl 2:S48-s61. 2021-12-14 18:30:37.
Some experts and advocates propose environmental biotechnologies such as genetic engineering, gene drive systems, and synthetic biology as potential solutions to accelerating rates of species loss. While these tools may offer hope for a seemingly intractable problem, they also present potential governance challenges for which innovative decision-making systems are required. Two of the perennial governance challenges include, when are broader stakeholder groups involved in these decisions and who exactly should be involved? We propose the decision phases framework-which includes research and development, regulatory review, and deployment, management, and monitoring-as a framework for identifying which stakeholders might be best suited for different phases throughout the innovation and deployment of emerging environmental biotechnologies for species protection.
Podcast: Malaria Gene Drive
19474S. Hartley, S. Neema and C. Opesen, University of Exeter Business School, 2021-11-25 15:15:30.
Professor Sarah Hartley and her two colleagues in Uganda, Stella Neema and Chris Opesen discuss gene drive research for malaria control. Funded by British Academy and Wellcome trust, their work is to understand the social science challenges around the development of this kind of technology and to consider how governance and ethics should be managed when dealing with a scientific breakthrough such as this.
Small-scale release of non-gene drive mosquitoes in Burkina Faso: from engagement implementation to assessment, a learning journey
18910L. Pare Toe, N. Barry, A. D. Ky, S. Kekele, W. Meda, K. Bayala, M. Drabo, D. Thizy and A. Diabate, Malaria Journal, 20:395. 2021-10-11 14:50:37.
This study provides a review of engagement activities relevant to field trials on non-gene drive genetically-modified mosquitoes as well as an assessment framework-using both qualitative and quantitative studies as well as an audit procedure. The latter was implemented to evaluate whether the release activities could proceed with the appropriate level of agreement from the community. RESULTS: This paper shows the importance of this first phase of work to innovate and learn about engagement processes for responsible research in the field of genetic approaches for malaria vector control. The function of these assessments is crucial for the learning agenda. The assessments demonstrated ways to increase understanding and ensure effective progress with field studies and, therefore, the pathway for responsible research.
Calling the latest gene technologies ‘natural’ is a semantic distraction — they must still be regulated
18752J. A. Heinemann, D. J. Paull, S. Walker and B. Kurenbach, The Conversation, 2021-09-22 13:41:22.
Legislators around the world are being asked to reconsider how to regulate the latest developments in gene technology, genome editing and gene silencing. Both the European Court of Justice and the New Zealand High Court have ruled that genome editing techniques should remain under the regulations specific to genetically modified organisms. But a few other countries, including Australia, have exempted some uses of these techniques from their regulations, based on similarities to what occurs in nature. The main argument is that the biochemical processes of editing are like the processes that cause natural mutations. The “equivalent to nature” narrative blurs the boundary between natural processes and technology.
Knowing and Controlling: Engineering Ideals and Gene Drive for Invasive Species Control in Aotearoa New Zealand
18025C. H. Ross, Nature Remade: Engineering Life, Envisioning Worlds, 2021-08-10 17:51:46.
On the islands of Aotearoa, also called New Zealand, invasive species have been a prominent and persistent concern for local ecosystems. Traditional methods of biological control, though, can be difficult to implement and often have harmful side- effects for the environment and human health. Recent developments in genetic engineering have led to the creation of a new technology called gene drive, which some have suggested may pro-vide a safer, easier alternative way to “restore damaged ecosystems and save endangered wildlife by genetically removing invasive species.” 1 While the promises of gene drive for invasive species control have attracted the attention of many in Aotearoa New Zealand interested in preserving or restoring the islands’ native environment, at the same time it has prompted calls for caution regarding their controllability and possible unintended consequences of their use. 2 However, the consideration of gene drive for the control of invasive species in Aotearoa New Zealand is more than just an issue of a controversial use of emerging biotechnology. At stake also are critical questions about what it means to know and control life. What are the kinds of knowledge that enable and underwrite the notions of controlling of life? If gene drive confers the power to control inva-sive species, who decides whether and how that control is exercised and with what responsibilities? And, crucially, what visions of the world are embedded in the aspirations of scientifically knowing and technologically controlling life?Controlling life has long been a central aspiration of the biological sciences. In the early twentieth century, aspirations to greater control over life manifested in rigorous laboratory experimentation, attempts to engineer organisms to be more amenable to human purposes, and explanatory commitments to a mechanistic conception of life. 3 Mechanistic approaches have been ubiquitous in biological practice aimed at bringing living things and their functions into the purview of human intention and volition by isolating, manipulating, and better understanding the function of more fundamental parts. 4 The widespread mechanistic approaches in biology
2021 WHO guidelines on genetically modified mosquitoes
18084M. Makoni, The Lancet Microbe, 2:e353. 2021-08-01 17:27:59.
On May 19, 2021, WHO updated its guidelines for research and development on genetically modified mosquitoes, which define the standards for decision-making about how and when testing should proceed and describe best practices to ensure that research done in a public health context is safe, ethical, and rigorous. TDR, WHO's Special Programme for Research and Training in Tropical Diseases, and the GeneConvene Global Collaborative, an initiative of the Foundation for the National Institutes of Health, developed the updated guidelines building on the 2014 recommendations, integrating the latest advancements in mosquito genetic modification. “Vector-borne diseases are a major global public health issue. Over 100 countries are endemic for diseases such as dengue, malaria, and Zika. Dengue alone puts 2·5 billion people at risk”, says John Reeder (TDR and Department of Research for Health, WHO). Attacking the mosquitoes is an effective way of controlling the transmission of these diseases, but it is a massive task. “We are badly in need of new technologies that will change the game and allow effective, widespread control”, Reeder told The Lancet Microbe.
A new tool in the global fight against malaria
17666S. Laux, Brighter World, 2021-07-08 19:56:20.
McMaster researchers with the Institute on Ethics & Policy for Innovation (IEPI) have played a key role in developing updated international guidelines that will inform research and development on genetically modified mosquitoes – an initiative that could significantly affect global efforts to eradicate mosquito-borne illnesses such as dengue fever, Zika virus and malaria. Released by the World Health Organization in late May, the guidelines describe best practices to ensure that the study of genetically modified mosquitoes is scientifically rigorous and meets essential standards of safety, effectiveness, accessibility and ethics. “The previous World Health Organization guidance for testing genetically modified mosquitoes was from 2014 – and since then, there have been multiple technological developments and considerable scientific progress,” explains Claudia Emerson, the director of IEPI and a professor of philosophy who, along with IEPI researchers Travis Ramsay and Aaron Roberts, developed the guidance’s chapter on ethical considerations. “Genetically modifying organisms isn’t new, at least not from an ethical or scientific perspective – but as the technology has developed over the years, especially with respect to mosquitoes, there has been a change in its perception and the receptivity to using it. It was important to update the guidance to reflect these changes.”
Living With the Limits of Our New Clerisy’s Knowledge
17306R. Fernandez, PJ Media, 2021-06-08 11:22:01.
We are living in a strange time when reason has fallen short of human expectations and there is, once again, pressure to place our trust in faith. Leighton Woodhouse hit the nail on the head when he argued that we have appointed a New Clerisy to rule over us, not because they are infallible but to save ourselves from the tide of uncertainty that seems to have engulfed our once seemingly confident global world. Unfortunately, the new clergy seem too fallible to take on trust. They flip-flop on expert advice and one scientist denounces the other on YouTube. Once things seemed more cut and dried. Once we were at the End of History. Science could predict the future more or less and the public hoped with increasing accuracy. Ever since the 17th century, the expectation was that the scientific revolution would supply the answers. As the frontier moved from the simple, computable problems of the early 20th century to complex systems — of which biotechnology, artificial intelligence, social networks, and eco-engineering are prime examples — they began to involve the management of uncertainty because it was difficult to control all the variables involved. The care with which some scientists have approached the subject of gene drives, a biological technology as powerful as “gain of function,” illustrates the challenges of dealing with uncertainties.
What is wrong in extinguishing a species? Charting the Ethical Challenges of using Gene-Drive Technologies to eradicate A. gambiae vector populations
17161M. Annoni and T. Pievani, Biolaw Journal-Rivista Di Biodiritto, 2021-05-31 19:04:09.
This article analyses three ethical arguments against the use of gene-drive technologies to control for, and possibly extinguish, a particular species of vector mosquitoes (Anopheles gambiae) causing the malaria infection. We conclude that none of these arguments is truly persuasive in the specific case and, therefore, that using gene-drive technologies to suppress or eradicate the population of Anopheles gambiae could be ethically justifiable provided certain cautions referring to ecological consequences, evolutionary effects and social engagement of local communities.
WHO releases new guidance for deployment of genetically modified mosquitoes
17130E. Henderson, News Medical Life Sciences, 2021-05-28 19:13:57.
The World Health Organization (WHO) has released new guidance for the deployment of genetically modified (GM) mosquitoes to combat vector-borne diseases like malaria and dengue. GM mosquitoes may carry a gene that kills female progeny and the technology can be used against the Aedes aegypti mosquito that carries dengue, chikungunya and Zika viruses. For malaria, genetic modification has focused on reducing the ability of the female Anopheles mosquito to carry the parasite that causes the disease. The WHO guidance, released this month, relates to research and development of GM mosquitoes as well as issues around effectiveness, safety, affordability and ethics. Presently, measures against mosquito vectors include the use of insecticides and elimination of the breeding spots of mosquito larva, said the guidance, developed in partnership with WHO collaborators such as the Special Programme for Research and Training in Tropical Diseases and the GeneConvene Global Collaborative.
Genetically modified mosquitoes; WHO issues new guidance for research
17084DTE Staff, Down To Earth, 2021-05-20 15:10:16.
Genetically-modified mosquitoes or GMMs have been used across the world to control mosquitoes. GMMs have been able to bring down the population of the Aedes aegypti by 90 per cent in countries like Brazil, the Cayman Islands, Panama and Malaysia. But there have never been any global protocols or standards on the breeding of GMMs. The World Health Organization has addressed this by setting essential standards for the research and development of GMMs. These standards are mainly about ethics, safety, affordability and effectiveness of GMMS. GMMs are male mosquitoes modified to carry a lethal gene. When they mate, the genes get passed on to their offspring. The gene prevents female offspring from building an essential protein and causes them to die before reaching maturity. GMMs could become a cost-effective and powerful tool to control mosquitoes. Over 40,000 people die from malaria and 100-400 million people get infected with dengue each year. They can reach mosquito populations and mosquito larval breeding sites that are currently expensive and difficult to reach. It can target specific mosquito species and thus avoid the ecological and environmental hazards of usual insecticides.
WHO issues new guidance for research on genetically modified mosquitoes to fight malaria and other vector-borne diseases
17076WHO, reliefweb, 2021-05-19 14:55:10.
New guidance from the World Health Organization (WHO) sets essential standards to inform future research and development on genetically modified mosquitoes, particularly in addressing issues relating to ethics, safety, affordability and effectiveness. Malaria and other vector-borne diseases, including dengue and Zika, affect millions globally. More than 400 000 people a year die from malaria alone. If proven safe, effective and affordable, genetically modified vector mosquitoes could be a valuable new tool to fight these diseases and eliminate their enormous health, social and economic burden. The guidance framework for testing genetically modified mosquitoes, developed in partnership with TDR, the Special Programme for Research and Training in Tropical Diseases, and the GeneConvene Global Collaborative, an initiative of the Foundation for the National Institutes of Health, describes best practices to ensure that the study and evaluation of genetically modified mosquitoes as public health tools is safe, ethical and rigorous. Current strategies for limiting transmission of mosquito-borne diseases are only partially effective. New, complementary approaches are needed to close the gaps in current vector control interventions, such as effective control of outdoor biting, and to provide alternatives to manage the increasing threat of insecticide resistance. Research suggests genetically modified mosquitoes could be a powerful and cost-effective tool to supplement existing interventions.
Guidance framework for testing of genetically modified mosquitoes, second edition
17049WHO, WHO-TDR, 2021-05-19 10:41:03.
For more than 2 decades, scientists have been working to harness the promise of molecular biology to develop genetically modified mosquitoes (GMMs) for use as public health tools to prevent the transmission of vector-borne diseases. Responding to a need for additional standards and guidance, the WHO Special Programme for Research and Training in Tropical Diseases (WHO-TDR) and the Foundation for the National Institutes of Health (FNIH) published in 2014 the first WHO Guidance framework for testing genetically modified mosquitoes. This revised version takes into account the technical progress made and lessons learned in this rapidly advancing field of research. Like the original guidance framework, it is intended to provide standards that foster quality and consistency in the processes for developing, testing and regulating these new genetic technologies. Best practices recommended in the 2021 guidance framework will further contribute to the comparability of results and credibility of conclusions in order to facilitate decision-making by countries interested in the potential use of GMMs as public health tools for the control of vector-borne diseases.
The legal regulation of gene drive technologies
16914C. Elves, Univeristy of Oxford, 2021-05-01 13:32:03.
Gene drive technologies purport to provide a panacea and yet in doing so present unprecedented risks that threaten to change, potentially irreversibly, the way in which we live in the world. Gene drive technologies raise questions about what ends societies ought to seek for their citizens, how they are constituted and how those ends might be attained. Despite this, current discussions surrounding gene drive technologies and their regulation focus almost exclusively on the technical implications. Drawing on the work of sociologists and STS scholars, this thesis argues that lawyers ought to think critically about the ways in which they go about developing their understandings of new technologies as regulatory objects. Lawyers need to evaluate and scrutinize the knowledge claims with which they are presented, and work to identify those extending beyond the required technical expertise, if the regulatory frames they build are to bear fidelity to the realities of the technology. This thesis draws out the regulatory disconnection generated by the current regulation of gene drive technologies through the existing European Union GMO regime. It then goes on to describe the ways in which regulatory reconnection might be achieved by constructing broader frames through which we describe gene drive technologies as a regulatory object. In thinking about how lawyers might go about broadening the frames that they build, this thesis takes examples from Public Health Law scholarship and legislation. In response to both the normative and epistemic lacunae highlighted above, this thesis develops an account of why and how ethical enquiry ought to play a significant role in informing our descriptions of gene drive technologies as regulatory objects. Furthermore, this thesis argues that ethical enquiry is capable of articulating questions to which technical experts must provide answers if we are to develop fuller understandings of the technologies we regulate. In this way, ethical enquiry can help lawyers bridge both the normative and epistemic gaps that they are so often faced with in the regulation of emerging technologies.
CRISPR-Cas and Its Wide-Ranging Applications: From Human Genome Editing to Environmental Implications, Technical Limitations, Hazards and Bioethical Issues
17324R. Piergentili, A. Del Rio, F. Signore, F. U. Ronchi, E. Marinelli and S. Zaami, Cells, 10:24. 2021-04-21 12:06:42.
The CRISPR-Cas system is a powerful tool for in vivo editing the genome of most organisms, including man. During the years this technique has been applied in several fields, such as agriculture for crop upgrade and breeding including the creation of allergy-free foods, for eradicating pests, for the improvement of animal breeds, in the industry of bio-fuels and it can even be used as a basis for a cell-based recording apparatus. Possible applications in human health include the making of new medicines through the creation of genetically modified organisms, the treatment of viral infections, the control of pathogens, applications in clinical diagnostics and the cure of human genetic diseases, either caused by somatic (e.g., cancer) or inherited (mendelian disorders) mutations. One of the most divisive, possible uses of this system is the modification of human embryos, for the purpose of preventing or curing a human being before birth. However, the technology in this field is evolving faster than regulations and several concerns are raised by its enormous yet controversial potential. In this scenario, appropriate laws need to be issued and ethical guidelines must be developed, in order to properly assess advantages as well as risks of this approach. In this review, we summarize the potential of these genome editing techniques and their applications in human embryo treatment. We will analyze CRISPR-Cas limitations and the possible genome damage caused in the treated embryo. Finally, we will discuss how all this impacts the law, ethics and common sense.
Experimenting with co-development: a qualitative study of gene drive research for malaria control in Mali
16639S. Hartley, K. Ledingham, R. Owen, S. Leonelli, S. Diarra and S. Diop, Social Science and Medicine, 2021-03-21 14:37:21.
Our findings suggest co-development is opening up previously expert-dominated spaces as researchers attempt to take responsibility for the societal implications of their work. However, its main function is as a project management tool to enable and instrumentally support technological development, field trials and eventual deployment. This function extends into areas which are traditionally the responsibility of the state, such as regulatory development, facilitated by Mali’s fragile political and economic situation. Paradoxically, co-development simultaneously depoliticises gene drive, masking power relations and closing down substantive debate and agency. Characterised by extreme poverty, conflict and weak institutions, Mali may become a site for technological experimentation where there is little interrogation of gene drive or its governance.
Ethics of Genome Editing
16622European Group on Ethics, European Group on Ethics in Science and New Technologies, 2021-03-19 18:16:09.
This Opinion addresses the profound ethical questions raised and revived by them. It analyses various domains of application, from human health to animal experimentation, from livestock breeding to crop variety and to gene drives. With its wide view across areas, it identifies underlying and overarching issues that deserve our concerted attention, among them, the different meanings that ought to be attributed to humanness, naturalness or diversity. This enables conclusions that provide panoramic perspectives complementing narrower, area-specific analyses. In the same vein, the Opinion is concerned with the global dimension of genome editing and its regulation and formulates recommendations with a particular focus on the international level.
The ethical scientist in a time of uncertainty
16620L. Zoloth, Cell, 184:1430-1439. 2021-03-18 17:59:56.
Using the example of gene drives for malaria control to explore the problem of deep uncertainty in biomedical research, I argue that profound uncertainty is an essential feature. Applying the language and presumptions of the discipline of philosophical ethics, I describe three types of uncertainty that raise ethical challenges in scientific research. Rather than mitigate these challenges with excessive precautions and limits on progress, I suggest that researchers can cultivate classic values of veracity, courage, humility, and fidelity in their research allowing science to proceed ethically under conditions of deep uncertainty.
Differentiated impacts of human interventions on nature: Scaling the conversation on regulation of gene technologies
18750J. A. Heinemann, D. J. Paull, S. Walker and B. Kurenbach, Elementa: Science of the Anthropocene, 9. 2021-03-17 13:35:29.
Biotechnology describes a range of human activities in medicine, agriculture, and environmental management. One biotechnology in particular, gene technology, continues to evolve both in capacity and potential to benefit and harm society. The purpose of this article is to offer a policy bridge from unproductive descriptions of gene technology to useful methods for identifying sources of significant biological and socioeconomic risk in complex food systems. Farmers and the public could be voluntarily and involuntarily interacting with new techniques of genome editing and gene silencing in entirely new ways, limiting the usefulness of previous gene technology histories to predict safety. What we believe is a more consistent, verifiable, and practical approach is to identify the critical control points that emerge where the scale effects of a human activity diverge between risk and safety. These critical control points are where technical experts can collaborate with publics with different expertise to identify and manage the technology. The use of technical terminology describing biochemical-level phenomena discourages publics that are not technical experts from contesting the embedded cultural perspectives and uncertainty in “scientific” concepts and prejudice the risk discourse by ignoring other issues of significance to society. From our perspective as gene technologists, we confront the use of pseudo-scale language in risk discourse and propose an escape path from clashes over whether risks that arise spontaneously (from nature) can be perfectly mimicked by gene technology to a discussion on how to best control the risks created by human activity. Scale is conceptually implicit and explicit in gene technology regulation, but there is no agreement about what scales are most useful to managing risk and social expectations. Both differentiated governance (risk-tiered) and responsible research and innovation models could accommodate the critical control points mechanism that we describe.
Ugandan stakeholder hopes and concerns about gene drive mosquitoes for malaria control: new directions for gene drive risk governance
16600S. Hartley, R. D. J. Smith, A. Kokotovich, C. Opesen, T. Habtewold, K. Ledingham, B. Raymond and C. B. Rwabukwali, Malaria Journal, 20:149. 2021-03-16 18:12:21.
The African Union’s High-Level Panel on Emerging Technologies identified gene drive mosquitoes as a priority technology for malaria elimination. The first field trials are expected in 5–10 years in Uganda, Mali or Burkina Faso. In preparation, regional and international actors are developing risk governance guidelines which will delineate the framework for identifying and evaluating risks. Scientists and bioethicists have called for African stakeholder involvement in these developments, arguing the knowledge and perspectives of those people living in malaria-afflicted countries is currently missing. However, few African stakeholders have been involved to date, leaving a knowledge gap about the local social-cultural as well as ecological context in which gene drive mosquitoes will be tested and deployed. This study investigates and analyses Ugandan stakeholders’ hopes and concerns about gene drive mosquitoes for malaria control and explores the new directions needed for risk governance.
Experts’ moral views on gene drive technologies: a qualitative interview study
16565N. de Graeff, K. R. Jongsma and A. L. Bredenoord, BMC Medical Ethics, 22:25. 2021-03-08 13:56:59.
Gene drive technologies (GDTs) promote the rapid spread of a particular genetic element within a population of non-human organisms. Potential applications of GDTs include the control of insect vectors, invasive species and agricultural pests. Whether, and if so, under what conditions, GDTs should be deployed is hotly debated. Although broad stances in this debate have been described, the convictions that inform the moral views of the experts shaping these technologies and related policies have not been examined in depth in the academic literature.
Hybrid mosquitoes? Evidence from rural Tanzania on how local communities conceptualize and respond to modified mosquitoes as a tool for malaria control
16567M. F. Finda, F. O. Okumu, E. Minja, R. Njalambaha, W. Mponzi, B. B. Tarimo, P. Chaki, J. Lezaun, A. H. Kelly and N. Christofides, Malaria Journal, 20:134. 2021-03-06 14:11:52.
Different forms of mosquito modifications are being considered as potential high-impact and low-cost tools for future malaria control in Africa. Although still under evaluation, the eventual success of these technologies will require high-level public acceptance. Understanding prevailing community perceptions of mosquito modification is, therefore, crucial for effective design and implementation of these interventions. This study investigated community perceptions regarding genetically-modified mosquitoes (GMMs) and their potential for malaria control in Tanzanian villages where no research or campaign for such technologies has yet been undertaken.
Renew Europe | The science & ethics of gene drive technology from a conservation & development perspective
16584Renew Europe, Renew Europe, 2021-03-05 15:18:26.
This hearing intends to examine gene-drive technology and its possible impacts, including unintended ones and reveal the complexity of an unknown technology with inherent uncertainties. Scientists from different backgrounds in the field of gene-drive research will present most recent scientific findings and allow us to exchange on a technical, but also ethical debate. Hosted by MEPs Soraya Rodríguez & Charles Goerens with a keynote speech by Commissioner for Envinronment Virginijus Sinkevičius.
A Code of Ethics for Gene Drive Research
16379G. J. Annas, C. L. Beisel, K. Clement, A. Crisanti, S. Francis, M. Galardini, R. Galizi, J. Grünewald, G. Immobile, A. S. Khalil, R. Müller, V. Pattanayak, K. Petri, L. Paul, L. Pinello, A. Simoni, C. Taxiarchi and J. K. Joung, The CRISPR Journal, 4:19:1-8. 2021-02-10 14:57:13.
A code of ethics can be a useful tool for all parties involved in the development and regulation of gene drives and can be used to help ensure that a balanced analysis of risks, benefits, and values is taken into consideration for the interest of society and humanity. We have developed a code of ethics for gene drive research with the hope that this code will encourage the development of an international framework that includes ethical guidance of gene drive research and is incorporated into scientific practice by gaining broad agreement and adherence.
In Our Image: The Ethics of CRISPR Genome Editing
16272J. C. Eissenberg, Biomolecular Concepts, 12:1-7. 2021-02-06 16:55:38.
Here, I discuss the ethics surrounding the transformative CRISPR/Cas9mediated genome editing technology in the contexts of human genome editing to eradicate genetic disease and of gene drive technology to eradicate animal vectors of human disease.
How to engage communities on a large scale? Lessons from World Mosquito Program in Rio de Janeiro, Brazil [version 2; peer review: 1 approved, 2 approved with reservations]
16361G. B. Costa, R. Smithyman, S. L. O'Neill and L. A. Moreira, Gates Open Research, 2021-02-04 19:26:09.
Here we discuss and analyse the framework for community engagement implemented by the WMP in Brazil, during the large-scale deployment of the method in the municipalities of Niterói and Rio de Janeiro, Brazil. Our experience indicates that the community engagement work for arboviruses control should be understood as an opportunity for local development. It is necessary, based on an integrated analysis of the territory, to understand that the actions for arboviruses control could be a catalyst for the necessary socioenvironmental, cultural and public health changes. Furthermore, it is essential to understand that community engagement goes beyond informing or asking for population consent, but it constitutes a possibility for dialogue and exchange between the various stakeholders present in the territories, to build on cooperation for mosquito-borne disease control.
Playing God and tampering with nature: popular labels for real concerns in synthetic biology
16201L. Carter, A. Mankad, E. V. Hobman and N. B. Porter, Transgenic Research, 2021-01-27 15:26:41.
We present the findings from a large Australian study (N = 4593) which suggests ‘playing God’ objections and their variants can be multilayered and, at times, accompanied by meaningful information about risk perceptions. We use qualitative analysis of ope
Co‐developing a common glossary with stakeholders for engagement on new genetic approaches for malaria control in a local African setting
16104E. Chemonges Wanyama, B. Dicko, L. Pare Toe, M. B. Coulibaly, N. Barry, K. Bayala Traore, A. Diabate, M. Drabo, J. K. Kayondo, S. Kekele, S. Kodio, A. D. Ky, R. R. Linga, E. Magala, W. I. Meda, S. Mukwaya, A. Namukwaya, B. Robinson, H. Samoura, K. Sanogo, Malaria Journal, 20:53. 2021-01-21 14:51:47.
Scientific terminologies are mainly lacking in local languages, yet when research activities involve international partnership, the question of technical jargon and its translation is crucial for effective and meaningful communication with stakeholders. Target Malaria, a not-for-profit research consortium developing innovative genetic approaches to malaria vector control, carried out a linguistic exercise in Mali, Burkina Faso and Uganda to establish the appropriate translation of its key terminology to local languages of sites where the teams operate.
Exploring Gene Drive Technologies in Agriculture, Biodiversity and Human Disease
15963The GBIRd Partnership and The GeneConvene Global Collaborative, Gene Drive Research Forum, 2021-01-14 21:37:12.
The GBIRd Partnership and The GeneConvene Global Collaborative recently collaborated through The Gene Drive Research Forum, to create and produce an engaging conversation between Drs. Fred Gould and Charles Godfray about gene drive technologies – the potential benefits and complicating factors for agriculture, biodiversity, and human disease.
Application of the Relationship-Based Model to Engagement for Field Trials of Genetically Engineered Malaria Vectors
15898A. Kormos, G. C. Lanzaro, E. Bier, G. Dimopoulos, J. M. Marshall, J. Pinto, A. Aguiar dos Santos, A. Bacar, H. Sousa Pontes Sacramento Rompão and A. A. James, The American Journal of Tropical Medicine and Hygiene, 2020-12-21 14:17:29.
Although guidelines and recommendations for engagement for gene drives have recently been described, we argue here that communities and stakeholders should lead the planning, development, and implementation phases of engagement. The RBM provides a new approach to the development of ethical, transparent, and effective engagement strategies for malaria control programs.
Scientists Set a Path for Field Trials of Gene Drive Organisms
15551M. Aguilera, UC San Diego News Center, 2020-12-17 14:41:55.
The modern rise of gene drive research, accelerated by CRISPR-Cas9 gene editing technology, has led to transformational waves rippling across science. Gene drive organisms (GDOs), developed with select traits that are genetically engineered to spread through a population, have the power to dramatically alter the way society develops solutions to a range of daunting health and environmental challenges, from controlling dengue fever and malaria to protecting crops against plant pests. But before these gene drive organisms move from the laboratory to testing in the field, scientists are proposing a course for responsible testing of this powerful technology. These issues are addressed in a new Policy Forum article on biotechnology governance, “Core commitments for field trials of gene drive organisms,” published Dec. 18, 2020 in Science by more than 40 researchers, including several University of California San Diego scientists.
Engineered Gene Drives: Ecological, Environmental, and Societal Concerns
15292J. Kuzma, GMOs: Implications for Biodiversity Conservation and Ecological Processes, 2020-12-02 17:07:26.
This chapter overviews the types, purposes, and potential impacts of gene drive organisms (GDOs) and discusses challenges with foreseeing and assessing these impacts prior to their environmental release. It concludes with a few examples of risk analysis methods and governance systems that scholars have proposed to cope with the novelty of GDOs and uncertainties associated with their use. With GDOs poised for release in the near future, it is urgent that technologists, ecologists, social scientists, ethicists, stakeholders, and publics work together to grapple with the immense challenges associated with assessments of GDOs and the design of governance systems to ensure their responsible development and potential use.
Transformation and slippage in co-production ambitions for global technology development: The case of gene drive
16634K. Ledingham and S. Hartley, Environmental Science & Policy, 116:78-85. 2020-11-24 17:41:43.
Co-production is an increasingly popular framework for knowledge generation, evaluation and decision making. Despite its potential to open up decisions and practices to the input of others, co-production regularly falls short of its transformative ambitions. Through documentary analysis, we investigate the meaning and dynamics of co-production as it stretches beyond the local into global research and technology spaces. We find that in the case of global gene drive, the meaning of co-production is extended in novel ways and underpinned by new possibilities for meaningful transformation. At the same time, we also identify a simultaneous resurfacing of reductive framings of collaboration. In the paper we present ‘slippage’ as a useful heuristic in helping to understand why co-production fails. We argue that if co-production in these new spaces is to achieve its transformative ambitions, there is a need to engage with new and entrenched knowledge hierarchies that contribute to this slippage.
Gene drives, species, and compassion for individuals in conservation biology
15072Y. Rohwer, Ethics, Policy and Environment, 2020-11-10 18:20:29.
In this paper I argue that these compassionate conservationists have a moral obligation to support the investigation and development of genetic modification technologies because of their potential to minimize suffering and eliminate killing in conservation. Furthermore, I will end the paper by suggesting that these genetic technologies can help avoid actions that could be damaging to one's moral character.
The ethical way to alter organisms
15033K. Esvelt, Boston Globe, 2020-11-09 15:42:31.
As my colleagues and I first described in 2014, we can use CRISPR genome editing to duplicate the most powerful form of “gene drive,” a ubiquitous natural phenomenon that happens when a genetic change is inherited more frequently than usual. Encode the CRISPR machinery next to a useful edit we’ve made in the genome, and genome editing will reoccur in every generation, replacing the original with the edited version without limit. In principle, releasing such organisms would gradually alter entire wild populations and associated ecosystems.
Ethics and vector-borne diseases
14904Geneva: World Health Organization, WHO Guidance, 2020-10-14 18:57:10.
The guidance was developed by an international group of experts in vector control, infectious disease ethics, maternal and child health, ecology and climate change, research and vaccine development, and public health communication. It examines a broad range of ethical considerations related to VBD prevention and control, including the social and environmental determinants of health; vector control methods, including emerging technologies; screening, surveillance and research; vaccine campaigns; and mass drug administration.
Bednets or Biotechnology: To Rescue Current Persons or Research for the Future?
14236D. E. Callies, Fudan Journal of the Humanities and Social Sciences, 14. 2020-08-13 13:44:08.
After an exploration of the duty to rescue and cost-effectiveness analysis, I suggest we look towards the literature on intergenerational justice for a justifiable answer to the question of how we ought to allocate our malaria resources.
Socrates Untenured: Ethics, Experts, and the Public in the Synthetic Age
13182C. Preston, ISSUES in Science and Technology, 2020-07-14 17:44:20.
C. Preston (2020). Three tools have transformed biotechnology over the past decade and a half. Gene reading has made it possible to quickly sequence the genome of any living creature. Gene synthesis has made it possible to construct DNA sequences in the lab from constituent chemicals. Gene editing has made it possible to place those sections into an existing DNA sequence at any point a technician chooses.
Genome Editing 2020: Ethics and Human Rights in Germline Editing in Humans and Gene Drives in Mosquitoes
13198G. J. Annas, American Journal of Law and Medicine, 46:143-165. 2020-07-12 18:17:19.
G. J. Annas (2020). American Journal of Law and Medicine. doi: 10.1177/0098858820933492. I begin with a discussion of so far disastrously unsuccessful attempts to regulate germline editing in humans, including a summary of the first application of germline genome editing in humans and its aftermath. I then turn to a discussion of setting ethical standards for a genomic technology that has not yet been deployed in nature—gene drives. Finally, I end by suggesting that human rights can and should be directly applicable to defining the ethics of genomic research.
ENSSER | Gene Drive Webinar Series
12568European Network of Scientists for Social and Environmental Responsibility, 2020-06-16 20:50:52.
This series of five Webinars by some of the authors of the interdisciplinary Gene Drive Report (2019) and were organised by four organisations of independent scientists: the European Network of Scientists for Social and Environmental Responsibility (ENSSER), Critical Scientists Switzerland (CSS), Vereinigung Deutscher Wissenschaftler (VDW), Sciences Citoyennes (SC). The series was aimed at a lay audience and were intended to address these questions. Does it really work? Is it being applied? What problems do gene drives address? What side effects can they have? Who has an interest in this? Should we do it? Are gene drives regulated by law? Are they a wise solution to these problems? Who decides?
Species Extinction & the Case for a Global Moratorium on Gene Drives
12454M. Imken, ARC, 2020-06-14 20:33:30.
One million species are currently threatened with extinction, and humanity faces the challenge of stopping the sixth mass extinction in the history of our planet. Yet a new technology called Gene Drive enables human beings to reprogram wild species by genetic engineering and to drive these species to self-destruction and extinction.
Gene drives: benefits, risks, and possible applications
12414A. Deplazes-Zemp, U. Grossniklaus, F. Lefort, P. Müller, J. Romeis, A. Rüegsegger, N. Schoenenberger and E. Spehn, Swiss Academies Factsheets, 15. 2020-06-05 19:48:13.
Gene drives are genetic elements that skew the pattern of inheritance of a given characteristic in sexually reproducing organisms. They can be used to spread a characteristic that can alter or even reduce the numbers of individuals in wild populations of a certain species. As they spread by being inherited from one generation to the next, they could persist in populations long-term. The spreading property of gene drives could be a source of great potential in areas as diverse as the control of disease vectors, invasive species, agricultural pests and predators of endangered species. However, the same property may make containment challenging and therefore may also pose novel environmental risks. The evaluation, distribution of risks and benefits and the fact that gene drives may be seen as a particularly profound interference with nature raises further novel ethical considerations.
Islands as Laboratories: Indigenous Knowledge and Gene Drives in the Pacific
12391R. I. Taitingfong, Human Biology, 91:179-188. 2020-06-01 18:19:55.
This article argues that the genetic engineering technology known as gene drive must be evaluated in the context of the historic and ongoing impacts of settler colonialism and military experimentation on indigenous lands and peoples. After defining gene drive and previewing some of the key ethical issues related to its use, the author compares the language used to justify Cold War–era nuclear testing in the Pacific with contemporary scholarship framing islands as ideal test sites for gene drive–modified organisms. In both cases, perceptions of islands as remote and isolated are mobilized to warrant their treatment as sites of experimentation for emerging technologies. Though gene drive may offer valuable interventions into issues affecting island communities (e.g., vector-borne disease and invasive species management), proposals to conduct the first open trials of gene drive on islands are complicit in a long history of injustice that has treated islands (and their residents) as dispensable to the risks and unintended consequences associated with experimentation. This article contends that ethical gene drive research cannot be achieved without the inclusion of indigenous peoples as key stakeholders and provides three recommendations to guide community engagement involving indigenous communities: centering indigenous self-determination, replacing the deficit model of engagement with a truly participatory model, and integrating indigenous knowledge and values in the research and decision-making processes related to gene drive.
Position Paper on Integrated Vector Management: Strengthening AU Members’ Regulatory Capacities for Responsible Research Towards Elimination of Malaria in Africa
12743African Union Development Agency - NEPAD, AUDA-NEPAD, 2020-06-01 13:48:16.
Africa continues to bear a heavy brunt of the malaria which is a disease transmitted by the female Anopheles mosquito. Thousands of lives, mostly of young children, are lost every year; which undermines efforts deployed at various levels for increased life expectancy and improved wellbeing for the socio-economic transformation of the continent. Accelerated changes and complementary tools are urgently needed to ensure effective elimination of malaria on the continent. Genetic engineering has been identified as one of such promising tools when applied to mosquito populations to reduce the transmission of the malaria parasite. The African Union Development Agency – NEPAD (AUDA-NEPAD), based on recommendations from the African Union High-Level Panel on Emerging Technologies (APET), continues to provide African Union Members States with the necessary support to ensure that research on and development of new genetically-based vector control tools are conducted in a responsible manner and in full compliance with safety requirements for human health and the environment for the benefit of African communities.
Bioethical issues in genome editing by CRISPR-Cas9 technology
11216F. B. Ayanoglu, A. E. Elcin and Y. M. Elcin, Turkish Journal of Biology, 44:110-120. 2020-04-02 15:13:15.
Genome editing technologies have led to fundamental changes in genetic science. Among them, CRISPR-Cas9 technology particularly stands out due to its advantages such as easy handling, high accuracy, and low cost. It has made a quick introduction in fields related to humans, animals, and the environment, while raising difficult questions, applications, concerns, and bioethical issues to be discussed. Most concerns stem from the use of CRISPR-Cas9 to genetically alter human germline cells and embryos (called germline genome editing). Germline genome editing leads to serial bioethical issues, such as the occurrence of undesirable changes in the genome, from whom and how informed consent is obtained, and the breeding of the human species (eugenics). However, the bioethical issues that CRISPR-Cas9 technology could cause in the environment, agriculture and livestock should also not be forgotten. In order for CRISPR-Cas9 to be used safely in all areas and to solve potential issues, worldwide legislation should be prepared, taking into account the opinions of both life and social scientists, policy makers, and all other stakeholders of the sectors, and CRISPR-Cas9 applications should be implemented according to such legislations. However, these controls should not restrict scientific freedom. Here, various applications of CRISPR-Cas9 technology, especially in medicine and agriculture, are described and ethical issues related to genome editing using CRISPR-Cas9 technology are discussed. The social and bioethical concerns in relation to human beings, other organisms, and the environment are addressed.
‘Gene Drive’ to curb malaria raises ethical questions as well
11220Gyanedra Nath Mitra, The Pioneer, 2020-03-25 15:23:14.
A new technology ‘Gene Drive’ for mosquito control is currently confined to the laboratory since it raises an ethical question, if such a technology could in future be misused to the detriment of humanity.
Regulation of GM Organisms for Invasive Species Control
6701H. J. Mitchell and D. Bartsch, Frontiers in Bioengineering and Biotechnology, 7:1-11. 2020-01-21 18:17:37.
Invasive species can cause significant harm to the environment, agriculture, and human health, but there are often very limited tools available to control their populations. Gene drives (GD) have been proposed as a new tool which could be used to control or eliminate such species. Here, GD describes a variety of molecular biology applications which all enable the introduction of genetic elements at a higher than expected frequency. These elements can change the genotypes in target populations rapidly with consequences either for (intrinsic) fitness or host-parasite interaction, or both. Beneficial applications are foreseen for human and animal health, agriculture, or nature conservation. This rapidly developing technology is likely to have major impacts in the fight against various diseases, pests, and invasive species. The majority of GD applications involve genetic engineering and novel traits. Therefore, applicants and GMO regulators need to interact to achieve the benefits in innovation while cautiously avoiding unacceptable risks. The release into the environment may include transboundary movement and replacement of target populations, with potential impact on human/animal health and the environment. This article summarizes knowledge-based discussions to identify information gaps and analyzes scenarios for responsible introduction of GD organisms into the environment. It aims to connect the latest scientific developments with regulatory approaches and decision-making.
Gene Drive Film
6665Save Our Seeds, 2020-01-16 16:39:24.
This is a video based on the findings in GENE DRIVES: A report on their science, applications, social aspects, ethics and regulations which you can find here. There was a Symposium on May 24, 2019 that covers the topics in the report and the presentations at that symposium can be found here.
The gene drive dilemma: We can alter entire species but should we?
6302J. Kahn, New York Times Magazine, 2020-01-08 20:03:00.
One early summer evening in 2018, the biologist Anthony James drove from his office at the University of California, Irvine, to the headquarters of the Creative Artists Agency, a sleek glass-and-steel high-rise in Los Angeles. There, roughly 200 writers, directors and producers — many of them involved in the making of science-and-technology thrillers — were gathered for an event called Science Speed Dating, where James and other scientists would explain their work. The sessions were organized, James told me, “in hopes of getting the facts at least somewhat straight.”
Scenario analysis on the use of rodenticides and sex-biasing gene drives for the removal of invasive house mice on islands
6221M. E. Serr, R. X. Valdez, K. S. Barnhill-Dilling, J. Godwin, T. Kuiken and M. Booker, Biological Invasions, 2020-01-06 21:34:59.
Since the 1960s conservation efforts have focused on recovering island biodiversity by eradicating invasive rodents. These eradication campaigns have led to considerable conservation gains, particularly for nesting seabirds. However, eradications are complex and lengthy endeavors and are even more challenging when humans are co-inhabitants of the targeted island. Furthermore, the method of eradication matters and recent proposals to consider genetic technologies for rodent eradication require specific scrutiny. One such technology is the potential use of a gene drive for biasing offspring sex ratios in invasive house mice, Mus musculus, that would spread and prevent the production of one sex, allowing die-off from lack of reproduction and natural attrition. Practitioners can gain insight into the potential for adoption of this technology from examining stakeholder engagement. This paper uses scenario analysis to address the eradication of rodents on inhabited and uninhabited islands, by specifically comparing the traditional approach of using rodenticides with sex-biasing gene drives. Concurrently the International Union for Conservation of Nature is assessing the risks and value of gene drives in general for conservation. Hence, we make the case that the ethical challenges with the use of gene drive sex-biasing techniques and the effectiveness of this tool will rely as much on its public acceptance and its democratic use as the actual science used to construct the technology.
Beyond Mendelian genetics: Anticipatory biomedical ethics and policy implications for the use of CRISPR together with gene drive in humans.
6227M. W. Nestor and R. L. Wilson, Journal of Bioethical Inquiry, 2020:1-12. 2020-01-03 21:43:18.
Clustered regularly interspaced short palindromic repeats (CRISPR) genome editing has already reinvented the direction of genetic and stem cell research. For more complex diseases it allows scientists to simultaneously create multiple genetic changes to a single cell. Technologies for correcting multiple mutations in an in vivo system are already in development. On the surface, the advent and use of gene editing technologies is a powerful tool to reduce human suffering by eradicating complex disease that has a genetic etiology. Gene drives are CRISPR mediated alterations to genes that allow them to be passed on to subsequent populations at rates that approach one hundred per cent transmission. Therefore, from an anticipatory biomedical ethics perspective, it is possible to conceive gene drive being used with CRISPR to permanently ameliorate aberrant genes from wild-type populations containing mutations. However, there are also a number of possible side effects that could develop as the result of combining gene editing and gene drive technologies in an effort to eradicate complex diseases. In this paper, we critically analyse the hypothesis that the combination of CRISPR and gene drive will have a deleterious effect on human populations from an ethical perspective by developing an anticipatory ethical analysis of the implications for the use of CRISPR together with gene drive in humans.
A typology of community and stakeholder engagement based on documented examples in the field of novel vector control
6032C. E. Schairer, R. Taitingfong, O. S. Akbari and C. S. Bloss, PLoS Neglected Tropical Diseases, 13:e0007863. 2019-12-30 20:46:44.
Background Despite broad consensus on the importance of community and stakeholder engagement (CSE) for guiding the development, regulation, field testing, and deployment of emerging vector control technologies (such as genetically engineered insects), the types of activities pursued have varied widely, as have the outcomes. We looked to previous CSE efforts for clarity about appropriate methods and goals. Our analysis yielded a typology of CSE, and related vocabulary, that describes distinctions that funders, organizers, and scholars should make when proposing or evaluating CSE. Methods We compiled available formal documentation of CSE projects, starting with projects mentioned in interviews with 17 key informants. Major features of these examples, including the initiators, target groups, timing, goals, and methods were identified using qualitative coding. Based on these examples, subcategories were developed for a subset of features and applied to the identified cases of CSE in the documents. Co-occurrence of subcategorized features was examined for patterns. Results We identified 14 documented examples CSE projects, which were comprised of 28 distinct CSE activities. We found no clear patterns with respect to timing. However, we found that grouping examples according to whether initiators or targets could enact the immediate desired outcome could help to clarify relationships between goals, methods, and targets.
Articulating ‘free, prior and informed consent’ (FPIC) for engineered gene drives
5800George, D. R., T. Kuiken and J. A. Delborne, Proceedings of the Royal Society B: Biological Sciences, 286:20191484.. 2019-12-19 14:30:32.
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.
Exterminator genes: The right to say no to ethics dumping
5654Bassey-Orovwuje, M., J. Thomas and T. Wakeford, Development, 62:121-127. 2019-12-17 18:09:38.
The scientific-industrial complex is promoting a new wave of genetically modified organisms, in particular gene drive organisms, using the same hype with which they tried to persuade society that GMOs would be a magic bullet to solve world hunger. The Gates Foundation claims that GDOs could help wipe out diseases such as malaria. Powerful conservation lobby groups claim GDOs will protect engendered species. Not only are the benefits from GDOs based, like their predecessors, on flawed ecological thinking, but they are backed by the same agri-business interests that have devastated agroecological farming systems. The rights of communities to say ‘no’ to new genetic technologies is being eroded, despite United Nations agreements, such as the Convention on Biological Diversity, which call for the free, prior and informed consent of affected communities to be respected. By exporting their field trials to countries with weak regulatory regimes and lowering of the standards of consent the Gates Foundation’s Target Malaria project has already been guilty of ethics dumping. These developments demonstrate the urgent need to democratize the development of new technologies.
A cross-sectional survey of biosafety professionals regarding genetically modified insects
5650O’Brochta, D. A., W. K. Tonui, B. Dass and S. James, Applied Biosafety, 2019:1-9. 2019-12-17 17:57:33.
Background:Genetic technologies such as gene editing and gene drive create challenges for existing frameworks used to assess risk and make regulatory determinations by governments and institutions. Insect genetic technologies including transgenics, gene editing, and gene drive may be particularly challenging because of the large and increasing number of insect species being genetically modified and the degree of familiarity with these organisms and technologies by biosafety officials charged with making containment decisions.Methods:An anonymous online survey of biosafety professionals was distributed to the membership of ABSA International, a global society of biosafety professionals, to investigate their perspectives on their preparedness to meet these new challenges.Results:Existing guidance used to make containment decisions for nongenetically modified insects was widely seen as adequate, and most respondents thought the available guidance for making containment decisions for genetically modified insects with and without gene drives was inadequate. Most respondents reported having less confidence in their decisions concerning containment of genetically modified insects compared to decisions involving genetically modified microbes, (noninsect) animals, and plants.Conclusions:These results reveal a need for additional support for biosafety professionals to improve the quality of and confidence in containment decisions regarding genetically modified insects with and without gene drive. These needs might be addressed by increasing training, updating existing guidance, creating new guidance, and creating a third-party accreditation entity to support institutions. Sixty percent of the respondents said they either would or might use a voluntary third-party accreditation service to support insect containment decisions.
Gene drives in Africa – A Podcast
5592Wakeford, T., etc Group, 2019-12-16 19:57:27.
In Episode #1 ETC's Tom Wakeford speaks with Ugandan lawyer and advocate Barbara Ntambirweki about gene drives, a powerful new genetic technology that can change species in the wild and make species go extinct.
Gene Drives and new genetic manipulation in agriculture
5995Terra de Direitos, 2019-10-23 15:43:54.
Gene drives are forms of genetic editing or manipulation of live organisms. They are the most dangerous forms of transgenics which edit genetic characteristics without necessarily including a new gene, but rather manipulating existing genes of live organisms, i.e. live organism genetic information microsurgery. The technique uses enzymes which “cut and paste” (such as CrisPR/Cas9) genes of organisms that reproduce sexually – such as plants like maize and mosquitoes – without necessarily introducing genes from other organisms or synthetic genes. Produced by the National Agroecology Articulation (ANA) Biodiversity Working Group, a body that congregates different social organizations and movements, the video seeks to explain in an educational way how this new biotechnology is looming as a threat to the environment, agricultural biodiversity and society.
Efforts to enhance safety measures for CRISPR/Cas-based gene drive technology in Japan
6035T. Tanaka, N. Tanaka, Y. Nagano, H. Kanuka, D. S. Yamamoto, N. Yamamoto, E. Nanba and T. Nishiuch, Journal of Environment and Safety, 2019-10-07 20:47:13.
Gene drive is a powerful system that can spread a desirable genetic trait into an entire species and/or population of a certain region, bypassing Mendelian rules of inheritance. Recently, one of the genome editing technologies, CRISPR/Cas, has been developed, making it easier to use gene drive in many different organisms. However, gene drive has potential risks that impact genetic diversity when organisms produced by CRISPR/Cas-based Gene Drive Technology (CCGDT) are accidentally released; therefore, a high degree of prudence is required when CCGDT is used. In Japan, a Working Group on Gene Drive has been established in the Academic Association for Promotion of Genetic Studies (AAPGS), and a Statement on the Handling of Gene Drive was issued to the public including research institute across Japan, after comprehensive and extensive discussions by the working group in order to reduce risks posed by CCGDT. A national-wide survey on CCGDT was implemented. The survey revealed that those in managerial positions including members and secretariats of institutional review boards on recombinant DNA, and biosafety officers are conscious of CCGDT, and efforts to grasp experimental plans involving CCGDT are made by utilizing an application form for recombinant DNA experiment. In contrast, potential risks of CCGDT are not understood by many researchers. All stakeholders need to disseminate potential risks and preventive measures regarding CCGDT to all researchers who may wish to use this technology. Researchers should use CCGDT upon understanding its potential risks and taking necessary measures. This report refers to how safety measures for CRISPR/Cas-based gene drive technology which has potential risks to ecological system has been discussed and results of national-wide questionnaire survey on gene drive in Japan based on the poster presentation at the Asian Conference on Safety & Education in Laboratory 2018.
Two unresolved issues in community engagement for field trials of genetically modified mosquitoes
13541D. B. Resnik, Pathogens and Global Health, 113:238-245. 2019-09-25 19:32:29.
There is an emerging consensus among scientists, ethicists, and public health officials that substantive and effective engagement with communities and the wider public is required prior to releasing genetically modified mosquitoes into the environment.
Gene Drive Mosquitoes: Ethics, Environment and Efficacy
18233L. Wilburn, ScienceInnovationUnion, 2019-09-20 17:06:38.
The Bill and Melinda Gates foundation has recently donated over $75 million to fund gene drive mosquito research by Target Malaria , a consortium that aims to develop technology for malaria control. The first planned release of gene drive mosquitoes is set to happen over the next two years in Burkina Faso, West Africa. But what exactly is gene drive, why do we need it and what are the wider implications of the technology? Malaria is a parasitic disease spread by the bite of the female Anopheles mosquito. Malaria can present as a range of symptoms including, mild fever, muscle pains (which can progress to severe malaria where the patient can experience severe anaemia and bleeding), renal failure, neurological disorders and death. In 2017, there were an estimated 219 million cases and 435,000 deaths attributed to malaria (1). Over 91% of these cases occurred in the Africa region, and children under the age of 5 were at the highest risk of contracting severe malaria. Fortunately, due to interventions such as insecticide-treated bed nets, indoor spraying of insecticides and improved medical infrastructure, from 2010-2017 malaria deaths were reduced by an estimated 28% (1). However, these control efforts may be severely jeopardised due to the rapid emergence of resistance to all insecticide classes and the most effective anti-malarial drugs (2, 3). Currently, there are only five classes of insecticides approved for public health use. In areas such as West Africa, there are multi-resistant mosquitoes which show resistance to all insecticide classes (4). Therefore, if the World Health Organisation (WHO) is to meet its goal of reducing global malaria by 90% by 2030, novel and effective strategies for malaria control must be identified (5). One such proposed strategy is gene drive mosquitoes.
Vereinigung Deutscher Wissenschaftler e.V. | Gene Drive Symposium-Critical Science Switzerland
6674Critical Scientists Switzerland; European Network of Scientists for Social and Environmental Responsibility; Vereinigung Deutscher Wissenschaftler, 2019-05-24 18:26:07.
Gene Drives: A report on their science, applications, social aspects, ethics and regulations
6670H. Dressel, Critical Scientists Switzerland; European Network of Scientists for Social and Environmental Responsibility; Vereinigung Deutscher Wissenschaftler, 2019-05-17 18:00:50.
Engineered Gene Drives are a new form of genetic modification that provides the tools for permanently modifying or potentially even eradicating species or populations in the wild. Unlike the previous genetically modified organisms (GMOs), gene drive organisms (GDOs) are not meant to stay where they are released, but instead are designed and purpose-built to spread and to drive their modified genes far and wide into wild populations.
Gene drives and the international biodiversity regime
18784F. Rabitz, Review of European, Comparative & International Environmental Law, 2019-05-17 17:30:54.
Gene drives are genetic modifications designed for rapidly diffusing traits throughout a target population. They are currently being proposed as biological control agents to combat, for instance, invasive alien species and disease vectors. They also raise concerns regarding their potential adverse effects on biological diversity. This text assesses gene drive governance under the Convention on Biological Diversity (CBD) and its Cartagena Protocol on Biosafety. While gene drives are directly relevant for the objectives of both agreements, their regulatory frameworks have not kept up with the pace of technological change. The focus of this article is on the analysis of gaps and inconsistencies within both agreements. It highlights numerous elements of the CBD and the Cartagena Protocol that raise challenges for gene drive governance, such as matters related to regulatory scope, transboundary movements, precaution and invasive alien species.
Gene drive organisms: What Africa should know about actors, motives and threats to biodiversity and food systems
5923Sirinathsinghji, E., African Centre for Biodiversity., 2019-05-13 16:51:45.
In this briefing paper, we set out the key issues that our governments should have addressed with African civil society before endorsing positions and setting the benchmark for Africa-wide policy. In this regard, we point out that, while the impetus for the AU position might well have been gene drive technologies proposed by the Gates-funded Target Malaria consortium, as a tool to reduce the transmission of malaria on the continent, the debate about gene drive organisms goes well beyond gene drive mosquitoes. Plans by gene drive developers target pests, pollinators, weeds and the speeding up of plant breeding programmes. The logic of using these technologies in agriculture relies on the continued deception that exceedingly complex problems in the food system in Africa can be resolved simply by new high-tech innovations, while downplaying their potential risks to biodiversity and livelihoods.
Does the U.S. public support using gene drives in agriculture? And what do they want to know?
3922Jones, MSD, Jason A.; Elsensohn, Johanna; Mitchell, Paul D.; Brown, Zachary S., Science Advances, 5:eaau8462. 2019-01-20 00:00:00.
Gene drive development is progressing more rapidly than our understanding of public values toward these technologies. We analyze a statistically representative survey (n = 1018) of U.S. adult attitudes toward agricultural gene drives. When informed about potential risks, benefits, and two previously researched applications, respondents’ support/opposition depends heavily (+22%/?19%) on whether spread of drives can be limited, non-native versus native species are targeted (+12%/?9%), or the drive replaces versus suppresses target species (±2%). The one-fifth of respondents seeking out non–GMO–labeled food are more likely to oppose drives, although their support exceeds opposition for limited applications. Over 62% trust U.S. universities and the Department of Agriculture to research gene drives, with the private sector and Department of Defense viewed as more untrustworthy. Uncertain human health and ecological effects are the public’s most important concerns to resolve. These findings can inform responsible innovation in gene drive development and risk assessment.
Gene drives as a response to infection and resistance
3919Hayirli, TCM, P.F., Infection and Drug Resistance, 12:229-234. 2019-01-17 00:00:00.
Vector-borne infectious diseases continue to be a major threat to public health. Although some prevention and treatment modalities exist for these diseases, resistance to such modalities, exacerbated by global climate change, remains a fundamental challenge. Developments in genomic engineering technologies present a new front in battling vector-borne illnesses; however, there is a lack of consensus over the scope and consequences of these approaches. In this article, we use malaria as a case study to address the developments and controversies surrounding gene drives, a novel genomic engineering technology. We draw attention to the themes of infection control, resistance, and reversibility using a science and technology studies framework. Unlike other current prevention and treatment modalities, gene drives have the capacity to alter not only single organisms but also entire species and ecologies. Therefore, broader public and scientific engagement is needed to inform a more inclusive discussion between clinicians, researchers, policy makers, and society.
Gene drive gone wild: exploring deliberative possibilities by developing One Health ethics
3898Capps, B, Law, Innovation and Technology, 11:231-256. 2019-01-16 00:00:00.
Gene editing may be used to engineer organisms that are better or worse adapted to survival. Coupled with gene drives ? molecular genetic strategies that perpetuate specific phenotypes in a target species ? it would now be possible to edit wild animal populations that impact on public health. It is generally agreed that community engagement should guide prospective gene drive field trials. However, the analysis in this article reveals that there is a tension between publics and the public interest: it is contentious to allow communities to decide policy when doing so will have consequences beyond their own interests, as surely gene drives will; conversely, it goes against ideal deliberation for the state to impose policy without this democratic condition. The gene drive controversy creates further dichotomies illustrative of this tension: giving effect to weighted decisions that discriminate between culture and nature, local and global, private and public, and present and future interests. In this article, an emerging concept of One Health ethics (OH) is employed to strengthen ethical engagement on the policy roadmap used to navigate the gene drive controversy. OH in practice has been shown to provide insightful solutions at the interface between animal and human health; and, in this article, that advantage is extended to the public good and public interest. In so doing, OH ethics ? as spelled out here ? is coextensive with public health ethics.
Knowledge engagement in gene drive research for malaria control
3918Hartley, ST, D.; Ledingham, K.; Coulibaly, M.; Diabate, A.; Dicko, B.; Diop, S.; Kayondo, J.; Namukwaya, A.; Nourou, B.; Toe, L. P., PLOS Neglected Tropical Diseases, 13:e0007233. 2019-01-16 00:00:00.
Scientists and funding bodies have made repeated calls for public engagement in gene drive. In 2016, the National Academies of Sciences, Engineering, and Medicine (NASEM) published its report, Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values. The report identified public engagement as a key area of responsible science, defining engagement as “seeking and facilitating the sharing and exchange of knowledge, perspectives, and preferences between or among groups who often have differences in expertise, power, and values”. Researchers are asked to participate in two-way engagement with publics (defined as stakeholders, communities, and the public) to allow their knowledge to contribute to technology development and align the technology with public values. In this viewpoint, we share our initial research findings in this area and propose a conceptual tool that contributes to the debate at this critical juncture.
The ethical landscape of gene drive research
3897Callies, DE, Bioethics, 33:1091-1097. 2019-01-15 00:00:00.
Gene drive technology has immense potential. The ability to bypass the laws of Mendelian inheritance and almost ensure the transmission of specific genetic material to future generations creates boundless possibilities. But alongside these boundless possibilities are major social and ethical issues. This article aims to introduce gene drive technology, some of its potential applications, and some of the social and ethical issues that arise during research into the technology. For example, is investigation into gene drives hubristic? Would applications of gene drives count as technological fixes? Or does research into such a technology sit on a slippery slope or lock us in to its full-scale use? Are there perverse effects of engaging in research, and, most importantly, who ought to be included in the decision-making process regarding research and field trials? Understanding the basic ethical landscape of this technology will prove invaluable to the public, scientists, and policy-makers as research moves forward.
CRISPR-Cas9. The greatest advancement in genetic edition techniques requires an ethical reflection
3913Gomez-Tatay, LA, J., Cuadernos De Bioetica, 30:171-185. 2019-01-11 00:00:00.
The adaptation of the CRISPR system as a genetic editing tool has led to a revolution in many fields of application, as this technique is considerably faster, easier to perform and more efficient than predecessor techniques. However, some of these applications raise objective ethical issues that must be addressed. In this paper we discuss, based on the most recent data, the different issues related to CRISPR applications on the germ line, its introduction in clinical trials, the genetic edition of animals and plants for human consumption and the novel gene drive.
Promises and perils of gene drives: Navigating the communication of complex, post-normal science
3892Brossard, DB, Pam; Gould, Fred; Wirz, Christopher D., Proceedings of the National Academy of Sciences of the United States of America, 116:7692-7697. 2019-01-10 00:00:00.
In November of 2017, an interdisciplinary panel discussed the complexities of gene drive applications as part of the third Sackler Colloquium on “The Science of Science Communication.” The panel brought together a social scientist, life scientist, and journalist to discuss the issue from each of their unique perspectives. This paper builds on the ideas and conversations from the session to provide a more nuanced discussion about the context surrounding responsible communication and decision-making for cases of post-normal science. Deciding to use gene drives to control and suppress pests will involve more than a technical assessment of the risks involved, and responsible decision-making regarding their use will require concerted efforts from multiple actors. We provide a review of gene drives and their potential applications, as well as the role of journalists in communicating the extent of uncertainties around specific projects. We also discuss the roles of public opinion and online environments in public engagement with scientific processes. We conclude with specific recommendations about how to address current challenges and foster more effective communication and decisionmaking for complex, post-normal issues, such as gene drives.
CRISPR ethics: Moral considerations for applications of a powerful tool
3891Brokowski, C. and Adli, M., Journal of Molecular Biology, 431:88-101. 2019-01-09 00:00:00.
With the emergence of CRISPR technology, targeted editing of a wide variety of genomes is no longer an abstract hypothetical, but occurs regularly. As application areas of CRISPR are exceeding beyond research and biomedical therapies, new and existing ethical concerns abound throughout the global community about the appropriate scope of the systems' use. Here we review fundamental ethical issues including the following: 1) the extent to which CRISPR use should be permitted; 2) access to CRISPR applications; 3) whether a regulatory framework(s) for clinical research involving human subjects might accommodate all types of human genome editing, including editing of the germline; and 4) whether international regulations governing inappropriate CRISPR utilization should be crafted and publicized. We conclude that moral decision making should evolve as the science of genomic engineering advances and hold that it would be reasonable for national and supranational legislatures to consider evidence-based regulation of certain CRISPR applications for the betterment of human health and progress. (C) 2018 Published by Elsevier Ltd.
A Question of Consent: Exterminator Mosquitoes in Burkina Faso
5538ETC group, 2019-01-08 20:10:07.
Target Malaria’s planned release of GMO mosquitos is step toward release of gene drive mosquitoes, a high-risk technology aimed at the elimination of entire species. Hundreds of organizations have demanded a moratorium on the use of this technology outside of strictly-controlled laboratories.
The Release of Genetically Engineered Mosquitoes in Burkina Faso: Bioeconomy of Science, Public Engagement and Trust in Medicine
3890Beisel, UG, J. K., African Studies Review, 62:164-173. 2019-01-08 00:00:00.
Malaria, which is transmitted by mosquitoes, continues to be responsible for a significant number of disease episodes and childhood deaths on the African continent. A variety of mosquito control strategies are currently inplace, but since case numbers are rising again, and drug and insecticide tolerance slow down progress made, there has been a push for innovative strategies. In August 2018, the National Biosafety Agency of Burkina Faso granted approval for the release of a maximum of 10,000 male Anopheles mosquitoes in experimental trials conducted by the multi-country consortium Target Malaria. These mosquitoes are rendered infertile through genetic modification, namely through “re-programming” of endonucleases that “cut through essential genes,” in this case, genes for fertility (Target Malaria 2019). The idea is that through the sterilization of male mosquitoes, the population of malaria-transmitting mosquitoes will be reduced, thereby decreasing the overall number of malaria infections.
Governing extinction in the era of gene editing
3928Monast, JJ, North Carolina Law Review, 97:1329-1358. 2019-01-06 00:00:00.
CRISPR-Cas9 genome-editing technology (“CRISPR”) offers a potential solution for some of the world’s critical conservation challenges. Scientists are harnessing CRISPR to expand genetic diversity of endangered species, control invasive species, or enhance species’ resiliency to a changing climate. Recreating extinct species is now realistic, as is engineering entirely new species. CRISPR also creates opportunities to address vector-borne infectious diseases such as malaria, dengue fever, and Zika using gene drive techniques that can spread genetic alterations through populations. ; While CRISPR is a powerful tool to address public health and conservation goals, it could allow scientists to bypass longstanding value choices underlying national and international conservation efforts and foster permanent ecosystem impacts before public policy can react. This Article argues that, while current conservation laws do not directly address many of the specific questions that arise with CRISPR, the Endangered Species Act (“ESA”) establishes a framework that can, and should, guide the use of gene editing. The proposal calls for: (1) a presumption against the release of genetically modified organisms that could cause species extinction, (2) exemptions for specific public health and environmental goals, and (3) updates to the ESA to clarify oversight of gene editing.
Gene drives in plants: opportunities and challenges for weed control and engineered resilience
3887Barrett, LGL, Mathieu; Kumaran, Nagalingam; Glassop, Donna; Raghu, S.; Gardiner, Donald M., Proceedings of the Royal Society B: Biological Sciences, 286:9. 2019-01-05 00:00:00.
Plant species, populations and communities are under threat from climate change, invasive pathogens, weeds and habitat fragmentation. Despite considerable research effort invested in genome engineering for crop improvement, the development of genetic tools for the management of wild plant populations has rarely been given detailed consideration. Gene drive systems that allow direct genetic management of plant populations via the spread of fitness-altering genetic modifications could be of great utility. However, despite the rapid development of synthetic tools and their enormous promise, little explicit consideration has been given to their application in plants and, to date, they remain untested. This article considers the potential utility of gene drives for the management of wild plant populations, and examines the factors that might influence the design, spread and efficacy of synthetic drives. To gain insight into optimal ways to design and deploy synthetic drive systems, we investigate the diversity of mechanisms underlying natural gene drives and their dynamics within plant populations and species. We also review potential approaches for engineering gene drives and discuss their potential application to plant genomes. We highlight the importance of considering the impact of plant life-history and genetic architecture on the dynamics of drive, investigate the potential for different types of resistance evolution, and touch on the ethical, regulatory and social challenges ahead.
Gene driving the farm: who decides, who owns, and who benefits?
3907Montenegro de Wit, M, Agroecology and Sustainable Food Systems, 43:1054-1074. 2019-01-05 00:00:00.
This commentary essay explores the social and ecological implications of gene-driving agriculture.
Sustainability as a framework for considering gene drive mice for invasive rodent eradication
3886Barnhill-Dilling, SKS, M.; Blondel, D. V.; Godwin, J., Sustainability, 11:1334. 2019-01-04 00:00:00.
Gene drives represent a dynamic and controversial set of technologies with applications that range from mosquito control to the conservation of biological diversity on islands. Currently, gene drives are being developed in mice that may one day serve as an important tool for reducing invasive rodent pests, a key threat to island biodiversity and economies. Gene drives in mice are still in development in laboratories, and wild release of modified mice is likely a distant reality. However, technological changes outpace the existing capacity of regulatory frameworks, and thus require integrated governance frameworks. We suggest sustainability-which gives equal consideration to the environment, economy, and society-as one framework for addressing complexity and uncertainty in the governance of emerging gene drive technologies for invasive species management. We explore the impacts of rodent gene drives on island environments, including potential conservation and restoration of island biodiversity. We outline considerations for rodent gene drives on island economies, including impacts on agricultural and tourism losses, and reductions in biosecurity costs. Finally, we address the social dimension as an essential space for deliberation that will be integral to evaluating the potential deployment of gene drive rodents on islands.
The ethics of genome editing in non-human animals: a systematic review of reasons reported in the academic literature
3906de Graeff, NJ, K. R.; Johnston, J.; Hartley, S.; Bredenoord, A. L., Philosophical Transactions of the Royal Society B-Biological Sciences, 374:1-25. 2019-01-04 00:00:00.
In recent years, new genome editing technologies have emerged that can edit the genome of non-human animals with progressively increasing efficiency. Despite ongoing academic debate about the ethical implications of these technologies, no comprehensive overview of this debate exists. To address this gap in the literature, we conducted a systematic review of the reasons reported in the academic literature for and against the development and use of genome editing technologies in animals. Most included articles were written by academics from the biomedical or animal sciences. The reported reasons related to seven themes: human health, efficiency, risks and uncertainty, animal welfare, animal dignity, environmental considerations and public acceptability. Our findings illuminate several key considerations about the academic debate, including a low disciplinary diversity in the contributing academics, a scarcity of systematic comparisons of potential consequences of using these technologies, an underrepresentation of animal interests, and a disjunction between the public and academic debate on this topic. As such, this article can be considered a call for a broad range of academics to get increasingly involved in the discussion about genome editing, to incorporate animal interests and systematic comparisons, and to further discuss the aims and methods of public involvement. This article is part of a discussion meeting issue 'The ecology and evolution of prokaryotic CRISPR-Cas adaptive immune systems'.
Informed consent and community engagement in open field research: lessons for gene drive science
3945Singh, JA, BMC Medical Ethics, 20:54. 2019-01-03 00:00:00.
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.
Two minutes to midnight-what international law can do about genome editing
3925Lee, TL, Asian Journal of Wto & International Health Law and Policy, 14:227-265. 2019-01-03 00:00:00.
With its ability to transform the ecosystem, gene drives, a powerful genome-editing technology, poses nuanced regulatory challenges. In particular, as gene drives can override the normal rule of inheritance, where the impacts of gene-drive modified organisms on the environment could be irreversible, leading to a permanent population change. Moreover, as these gene-drive modified organisms are designed to spread to large populations, they can also penetrate national and geographic borders, with global implications. Insofar as gene drive applications could be both potentially beneficial as well as hazardous to the world, this article seeks to explore ways in which international law could provide a useful platform to engage the relevant stakeholders in general, and encourage responsible science in specific.
An introduction to the proceedings of the environmental release of engineered pests: Building an international governance framewor
5646Brown, Z. S., L. Carter and F. Gould, BMC Proceedings, 12:10. 2018-12-17 17:44:54.
In October 2016, a two-day meeting of 65 academic, government and industry professionals was held at North Carolina State University for early-stage discussions about the international governance of gene drives: potentially powerful new technologies that can be used for the control of pests, invasive species and disease vectors. Presenters at the meeting prepared seven manuscripts elaborating on the ideas raised. This BMC Proceedings issue presents the collection of these peer-reviewed manuscripts.
Towards inclusive social appraisal: risk, participation and democracy in governance of synthetic biology
5642Stirling, A., K. R. Hayes and J. Delborne, BMC Proceedings, 12:15. 2018-12-17 17:05:25.
Frameworks that govern the development and application of novel products, such as the products of synthetic biology, should involve all those who are interested or potentially affected by the products. The governance arrangements for novel products should also provide a democratic mechanism that allows affected parties to express their opinions on the direction that innovation does or does not take. In this paper we examine rationales, obstacles and opportunities for public participation in governance of novel synthetic biology products. Our analysis addresses issues such as uncertainties, the considering of alternative innovations, and broader social and environmental implications. The crucial issues in play go beyond safety alone, to include contending social values around diverse notions of benefit and harm. The paper highlights the need for more inclusive social appraisal mechanisms to inform governance of Synthetic Biology and alternative products, and discusses a few practical methods to help achieve this goal.
Public engagement pathways for emerging GM insect technologies
5640Burgess, M. M., J. D. Mumford and J. V. Lavery, BMC Proceedings, 12(Suppl 8):12. 2018-12-17 17:02:52.
Policy and management related to the release of organisms generated by emerging biotechnologies for pest management should be informed through public engagement. Regulatory decisions can be conceptually distinguished into the development of frameworks, the assessment of the release of a specific modified organism, and implementation decisions such as location and timing. Although these decisions are often intertwined in practice, the negotiation takes place at different stages of technology development and suggests different roles for public engagement. Some approaches to public engagement are more appropriate for different purposes and situations, and it is not always obvious how to go about matching the approach to the purpose. In addition to the diverse technologies involved in generating modified organisms, there are diverse publics with particular interests and different kinds of knowledge. Institutional interests range from commercial development to public regulation and future uptake. Contextual features, such as agency mandates, may limit or structure the extent and approach to public engagement. Different convening groups (government agencies, public interest groups, academics, businesses) and the kind of decision that is being considered determine what kind of input is needed and how the engaging groups will be constituted. This paper considers how the context of the release of genetically modified insects for pest control requires expanding approaches to the design of the public engagement.
GM insect pests under the Brazilian regulatory framework: development and perspectives
5638Andrade, P. P., M. A. da Silva Ferreira, M. S. Muniz and A. de Casto Lira-Neto, BMC Proceedings, 12:15. 2018-12-17 17:00:23.
The emergence of new technologies for genetic modification has broadened the range of possible new products. The regulations of many countries that could benefit from these new products may not be prepared to assess risks and enable science-based decision-making. This is especially acute in the case of genetically modified insects with potential use in public health and agriculture. Modifications of the regulatory framework, sometimes necessary to allow a proper risk assessment of products from new technologies, are strongly influenced by political decisions derived from the balance of power and interest among stakeholders. This article discusses the genesis of the Brazilian regulatory framework, its applicability for the risk assessment of genetically modified insects and the scenarios that have shaped the two biosafety laws that established the basis for the use of modern biotechnology in the country. It is concluded that, for the adoption of the new technologies, it is important to carefully navigate the political tensions by seeking the engagement and empowerment of stakeholders supporting science-based decision-making in order to gather the necessary support for adoption of risk assessment as the basis for final decisions, allowing the use of new technologies.
Regulation of emerging gene technologies in India
5636Ahuja, V., BMC Proceedings, 12:14. 2018-12-17 16:57:35.
In India, genetically modified organisms (GMOs) and the products thereof are regulated under the “Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989” (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986. These Rules are implemented by the Ministry of Environment, Forest and Climate Change, Department of Biotechnology and State Governments though six competent authorities. The Rules, 1989 are supported by series of guidelines on contained research, biologics, confined field trials, food safety assessment, environmental risk assessment etc.
Population Engineering | Gene Drive by CRISPR-CAS9
5488SciToons, 2018-12-10 18:19:26.
The CRISPR-CAS9 genome editing technology is opening up previously inconceivable possibilities for the manipulation of organisms. Our ethical discussion appears to be far behind the pace of technological development. In this new SciToons video, we address how CRISPR-CAS9 can be used to change entire species using the concept of Gene Drive.
Ethics of sculpting evolution
7338K. Esvelt, PopTech, 2018-09-04 21:34:19.
How might supervillains take over the world, and what can we do about it? Kevin Esvelt, the first to identify the potential for CRISPR “gene drive” systems to alter entire populations of organisms, is calling for a new scientific method that is both open and gives beneficiaries a say in the process.
Letter: Gene Drive and Trust in Science
4547Boëte, C, GeneWatch, 2018-07-18 00:00:00.
In a recent paper, Emerson et al. present five principles for gene drive research that they argue should be adopted by its sponsors and supporters: 1) advancing quality science to promote the public good; 2) the promotion of stewardship, safety, and good governance principles; 3) transparency and accountability; 4) engaging thoughtfully with affected communities, stakeholders, and publics; and 5) fostering opportunities to strengthen capacity and education.1 Emerson et al. report that 13 organizations, including Bill & Melinda Gates Foundation and the U.S. Foundation for the National Institutes of Health (FNIH), have made a commitment to honor the five principles.
Editing nature: Local roots of global governance
4726Kofler, N.C., James P.; Kuzma, Jennifer; Marris, Emma; Esvelt, Kevin; Nelson, Michael Paul; Newhouse, Andrew; Rothschild, Lynn J.; Vigliotti, Vivian S.; Semenov, Misha; Jacobsen, Rowan; Dahlman, James E.; Prince, Shannon; Caccone, Adalgisa; Brown, Timothy, Science, 2018-07-05 00:00:00.
Gene Drives
6636SciLine, SciLine, 2018-04-25 20:09:28.
For many years now, scientists have been able to alter genes inside microbial, plant, and animal cells to change organisms’ traits, creating, for example, plants that produce their own protective insecticides and fish that grow to maturity almost twice as fast as normal. But while it has become practically routine for scientists to genetically alter individual organisms, a new set of advances promises something much more ambitious: the ability to propagate new genetic traits* into entire populations over just a few generations. Rapid, population-wide dissemination of new traits is challenging because in most sexually reproducing species, only half of an individual’s offspring will inherit any given version of a gene.
RealSciLine | Gene Drives Media Briefing
6513Rick Weiss, RealSciLine, 2018-04-25 16:07:20.
Gene drives represent a new take on genetic engineering offering previously impossible means of fighting disease-spreading insects and invasive species but also raising the specter of ecological disruption. This briefing reviews the current status of gene-drive technology, applications under consideration, and related ethical, legal, and regulatory issues.
The ethical implications of population suppression and the irreversibility of gene drives
14167J. Kim, International Journal of Life Sciences Research, 2018-04-01 14:11:25.
This paper aims to examine the current situation by presenting important ethical arguments that include Chardin’s principle of irreversibility and Weiss’ beliefs on intergenerational equity, ideals upheld by the United Nations
Regulating animals with gene drive systems: lessons from the regulatory assessment of a genetically engineered mosquito
13804Z. Meghani and J. Kuzma, Journal of Responsible Innovation, 5:S203-S222. 2018-01-24 15:52:57.
In this paper, we consider the question of whether the United States Food and Drug Administration is prepared to effectively regulate insects and other animals with gene drives. Given the profound impact that gene drives could have on species and ecosystems, their use is a highly contentious issue. The rigorous regulation of insects and other animals with gene drive systems is crucial.
Means and ends of effective global risk assessments for genetic pest management
4022Turner, GB, Camilla; Roda, Lucia, BMC Proceedings, 12:13. 2018-01-20 00:00:00.
The development and use of genetic technologies is regulated by countries according to their national laws and governance structures. Legal frameworks require comprehensive technical evidence to be submitted by an applicant on the biology of the organism, its safety to human, animal health and the environment in which it will be released. Some countries also require information on socio-economic and trade impacts. One of the key elements that assists decision-making under those legal frameworks is the use of risk assessments. The risk assessment paradigm of problem formulation based on risk hypothesis, and the assessment of plausible scientific pathways leading to potential environmental and human harms being realised, has been used widely to assess potential risks of genetic technologies to human health and the environment, from crops to mosquitoes. This paper uses the case study of a genetically modified self-limiting olive fly (Bactrocera oleae) for a first deliberate release in Spain to examine the regulatory processes and stakeholders involved in the assessment of risk. It is anticipated that existing risk assessment frameworks are equally applicable to gene drive technologies that may spread and persist in the environment and cross-national borders, but it is the governance structures surrounding the involvement of civil society in regulatory processes that must be administered in a more transparent and defined manner.
Can We Engineer Social Ecosystems?
5473Kevin Esvelt, TEDxCambridgeSalon, 2018-01-19 17:11:31.
Kevin Esvelt is director of the Sculpting Evolution group, which invents new ways to study and influence the evolution of ecosystems. By carefully developing and testing these methods with openness and humility, the group seeks to address difficult ecological problems for the benefit of humanity and the natural world. Prior to joining the MIT Media Lab, Esvelt wove many different areas of science into novel approaches to ecological engineering.
Development of community of practice to support quantitative risk assessment for synthetic biology products: contaminant bioremediation and invasive carp control as cases
4021Trump, BF, C.; Rycroft, T.; Wood, M. D.; Bandolin, N.; Cains, M.; Cary, T.; Crocker, F.; Friedenberg, N. A.; Gurian, P.; Hamilton, K.; Hoover, J.J.; Meyer, C.; Pokrzywinski, K.; Ritterson, R.; Schulte, P.; Warner, C. ; Perkins, E.; Linkov, I., Environmental Systems and Decisions, 38:517-527. 2018-01-19 00:00:00.
Synthetic biology has the potential for a broad array of applications. However, realization of this potential is challenged by the paucity of relevant data for conventional risk assessment protocols, a limitation due to to the relative nascence of the field, as well as the poorly characterized and prioritized hazard, exposure, and dose–response considerations associated with the development and use of synthetic biology-derived organisms. Where quantitative risk assessment approaches are necessarily to fulfill regulatory requirements for review of products containing genetically modified organisms, this paper reviews one potential avenue for early-stage quantitative risk assessment for biosafety considerations of synthetic biology organism deployment into the environment. Building from discussion from a March 2018 US Army Engineer Research and Development Center workshop on developing such quantitative risk assessment for synthetic biology, this paper reviews the findings and discussion of workshop participants. This paper concludes that, while synthetic biology risk assessment and governance will continue to refine and develop in the coming years, a quantitative framework that builds from existing practice is one potentially beneficial option for risk assessors that must contend with the technology’s limited hazard characterization or exposure assessment considerations in the near term.
The roles of ethics in gene drive research and governance
4019Thompson, PB, Journal of Responsible Innovation, 5:S159-S179. 2018-01-17 00:00:00.
Ethics research queries the norms and values that shape the goals and justification for gene drive projects, and that might lead to issue or opposition to such projects. A framework for organizing ethics research is offered. In addition to basic research ethics and risk assessment, gene drives will give rise to questions about the fiduciary responsibilities of scientists, democratizing technology, and the links between epistemology and social power relations. A final category of ethical issues covers the way in which research on norms and values is organized, funded and integrated into other aspects of a gene drive project.
Harnessing gene drive
3996Min, JS, Andrea L.; Najjar, Devora; Esvelt, Kevin M., Journal of Responsible Innovation, 5:S40-S65. 2018-01-14 00:00:00.
When scientists alter the genome of an organism, we typically reduce its ability to reproduce in the wild. This limitation has prevented researchers from rendering wild insects unable to spread disease, programing pests to ignore our crops, using genetics to precisely remove environmentally damaging invasive species, and much more. Gene drive occurs when a vertically transmitted genetic element reliably spreads through a population over generations despite providing no reproductive advantage to each host organism. Until recently, scientific efforts to take advantage of this natural phenomenon achieved only limited success. The advent of CRISPR genome editing has dramatically accelerated efforts to harness gene drive. Small groups of scientists may now be capable of unilaterally altering entire wild populations, and through them, the shared environment. Determining whether, when, and how to develop gene drive interventions responsibly will be a defining challenge of our time. Here we describe capabilities, safeguards, applications, and opportunities relevant to gene drive technologies.
Strengthening regulatory capacity for gene drives in Africa: leveraging NEPAD’s experience in establishing regulatory systems for medicines and GM crops in Africa
3975Glover, BA, Olalekan; Savadogo, Moussa; Timpo, Samuel; Lemgo, Godwin; Sinebo, Woldeyesus; Akile, Sunday; Obukosia, Silas; Ouedraogo, Jeremy; Ndomondo-Sigonda, Margareth; Koch, Muffy; Makinde, Diran; Ambali, Aggrey, BMC Proceedings, 12:1-10. 2018-01-13 00:00:00.
The New Partnership for Africa’s Development (NEPAD) Agency recognizes that Africa is in a period of transition and that this demands exploring and harnessing safe advances made in science-based innovations including modern biotechnology. To advance the science of biotechnology in Africa effectively, while at the same time safeguarding human health and the environment, the African Union (AU) adopted a High-Level Panel report on modern biotechnology entitled, Freedom to Innovate, which advocated for a coevolutionary approach where technology development goes hand in hand with regulation. Furthermore, most AU member states are Parties to the Cartagena Protocol on Biosafety (CPB), a legally binding international agreement negotiated, concluded and adopted within the framework of the Convention on Biological Diversity. This seeks to guide Parties in developing systems for the environmentally sound management of modern biotechnology applications. Currently, 49 AU Member States have signed and ratified the CPB, of which 12 have passed biosafety laws. African Union (AU) member states are at different stages in the development of regulatory frameworks for applications of modern biotechnology, which include genetically modified (GM) products and other emerging technologies. Biosafety regulatory frameworks comprise: biotechnology and/or biosafety policy; laws, regulations and guidelines; administrative systems; decision-making systems; and mechanisms for public engagement. To assist Member States to implement functional regulatory frameworks for both agriculture and health applications, the NEPAD Agency established the African Biosafety Network of Expertise (ABNE) and the African Medicines Regulatory Harmonization (AMRH). Currently, transgenic insects and GM crops are regulated by Competent National Authorities whose mandate derives from national biosafety laws. For GM crops, a lot of research has been conducted up to the confined field trial (CFT) and multi-location trials stages in a number of African countries. Burkina Faso has fully functional containment facilities for transgenic mosquitoes while Mali and Uganda are developing theirs. The Burkina Faso regulatory agency has granted permits and has already received sets of sterile mosquito eggs for trials in the contained facility. It is instructive to note that both ABNE and AMRH have worked with national and regional regulatory bodies in Africa to enhance their technical capacities for informed decision making, adoption of best practices, and compliance with international standards. It is against the backdrop of a rich blend of on-the-ground knowledge, experience, expertise, and insight into the context and political sensitivities of member states that the NEPAD Agency seeks to expand existing support. This would include capacity strengthening in the regulation of emerging technologies, such as the application of gene drives in the development of transgenic mosquito for the control of malaria transmission.
Genetically engineered mosquitoes, Zika and other arboviruses, community engagement, costs, and patents: Ethical issues
3993Meghani, ZB, Christophe, PLOS Neglected Tropical Diseases, 12:e0006501. 2018-01-11 00:00:00.
We discuss here key ethical questions raised by the use of GE insects, with the aim of fostering discussion between the public, researchers, policy makers, healthcare organizations, and regulatory agencies at the local, national, and international levels. We affect that goal by outlining a procedural approach to decision-making about the use of the biotechnology that goes beyond community engagement. The protocol we advocate for entails informed deliberations and decision-making at the community level. It is designed to ensure that the voices of the marginalized and vulnerable groups that would be disproportionately affected by the decision are heard during the community-wide discussions. Moreover, we make the case that the values embedded in the risk assessment should be identified so that the community can make an informed decision about the use of GE insects. In addition, we advocate for the involvement of a variety of actors whose responsibility would be to ensure that the community has the opportunity to make an informed decision based on deliberations about the use of the biotechnology.
Community engagement and field trials of genetically modified insects and animals
5913Neuhaus, C. P., Hastings Center Report, 48:25-36. 2018-01-01 16:29:11.
New techniques for the genetic modification of organisms are creating new strategies for addressing persistent public health challenges. For example, the company Oxitec has conducted field trials internationally?and has attempted to conduct field trials in the United States?of a genetically modified mosquito that can be used to control dengue, Zika, and some other mosquito-borne diseases. In 2016, a report commissioned by the National Academies of Sciences, Engineering, and Medicine discussed the potential benefits and risks of another strategy, using gene drives. Driving a desired genotype through a population of wild animals or insects could lead to irreversible genetic modification of an entire species. The NASEM report recommends community, stakeholder, and public engagement about potential uses of the technology, and it argues that the engagement should occur as research advances, well before gene drives are deployed. Yet what ?engagement? means in practice is unclear. This article seeks clarity on this problem by offering a justification for community engagement and drawing out implications of this argument for the implementation and desired outcomes of community engagement. Community engagement is essential when it comes to research that would release genetically modified insects or animals into the environment. By contrast, obtaining informed consent from people who live near such a proposed field trial is neither necessary nor sufficient. Drawing on the epistemic and moral arguments for deliberative democracy, I propose two discrete mechanisms of community engagement: community advisory boards and deliberative forums, neither of which has been systematically incorporated into research governance. The proposed mechanisms would engender respect for persons who live near field trials, even when the results of deliberation override some individuals? preferences. Community engagement foregrounds the community in our thinking about humans? relationship to nature, and it implies that deciding to release genetically modified insects or animals into the wild ought to be a collective decision, not one made by product developers, policy-makers, private companies, research funders, or scientists alone.
Making policies about emerging technologies
5909Kaebnick, G. E. and M. K. Gusmano, Hastings Center Report, 48:S2-S11. 2018-01-01 16:23:19.
Can we make wise policy decisions about still-emerging technologies?decisions that are grounded in facts yet anticipate unknowns and promote the public's preferences and values? There is a widespread feeling that we should try. There also seems to be widespread agreement that the central element in wise decisions is the assessment of benefits and costs, understood as a process that consists, at least in part, in measuring, tallying, and comparing how different outcomes would affect the public interest. But how benefits and costs are best weighed when making decisions about whether to move forward with an emerging technology is not clear. Many commentators feel that the weighing is often inadequate or inappropriate. Those who argue for a ?precautionary? approach to the weighing do so precisely because they feel the need for a restraint on the dominant decision-making tools and processes for assessing outcomes. This Hastings Center special report examines those tools and processes, taking the method known as cost-benefit analysis as a starting point. In U.S. governance, CBA, sometimes informed by risk assessment, is the most widely used and extensively studied method, and authoritative reports on genetic and reproductive technologies often use language suggestive of cost-benefit analysis. There is also a long-running debate about the role of values in CBA and other formal impact assessment mechanisms?and about how those mechanisms compare to the precautionary principle. The guiding idea in the report is to engage in a close examination of the strengths and limits of CBA for ensuring that emerging technologies are used in ways that square with the public's values, drawing on applications of synthetic biology to illustrate and sharpen the analysis and then considering corrections to CBA and some alternative methodologies that handle values differently.
Gene Drives Can Wipe Out Entire Species… Or Save Them
5516Gizmodo, 2017-12-17 19:16:41.
Bill Gates and other investors have poured millions into gene drives. So what is the technology and why are scientists worried about it?
Centre for Effective Altruism | Gene drive and the case for reforming research
5476K. Esvelt, N. Labenz, G. Church, Centre for Effective Altruism, 2017-06-17 17:50:19.
The wisdom with which we develop and deploy new technologies will define the future of our civilization. Why do we conduct reseearch in small teams of specialists who cannot reliably anticipate consequences on their own? Might it be better to share our best ideas and plans with others, actively inviting concerns, criticism, and possible improvements? Unfortunately, the current system has evolved to punish sharing. By highlighting the benefits of an open approach and the dangers of the status quo, gene drive may allow us to test a new approach and change the governing incentives. + Fireside Chat with George Church, Kevin Esvelt, Nathan Labenz
Ethical issues associated with vector-borne diseases. Report of a WHO scoping meeting, Geneva, 23–24 February 2017
34043Geneva: World Health Organization, Licence: CC BY-NC-SA 3.0 IGO, WHO Reference Number: WHO/HTM/NTD/VEM/2017. 2017-02-24 00:00:00.
Gene Drives: A scientific case for a complete and perpetual ban
4597Latham, J, GeneWatch, 2017-02-06 00:00:00.
One of the central issues of our day is how to safely manage the outputs of industrial innovation. Novel products incorporating nanotechnology, biotechnology, rare metals, microwaves, novel chemicals, and more, enter the market on a daily basis. Yet none of these products come with an adequate data set of scientific information. Nor do they come with a clear intellectual framework within which their risks can be placed, as disputes over the precautionary principle show. The majority of products receive no regulatory supervision at all. How will the product be disposed of? What populations and which ecosystems will be exposed in the course of its advertised uses? What will be the consequences of accidental, off-label or illegal uses? Typically, none of these kinds of questions are adequately asked by government regulatory agencies unless citizens actively prod them to do so.; ; In consequence of these defects, we expose our world to unique hazards with every product launch. In comparison with its tremendous importance, this is surely one of the least discussed issues of our day.
Sterile Insect Techniques, GE mosquitoes and gene drives
4595Hanson, J, GeneWatch, 2017-02-06 00:00:00.
One of the great temptations in any field is to promote your solution to a problem as the only solution. The recent application of gene drives to sterilize mosquitoes that transmit malaria or viruses like dengue and zika is an example of this tendency to first develop a technology and then look for applications that might justify its use.; ; For at least 70 years, scientists have been trying to sterilize insects to prevent them from spreading disease, especially mosquito-borne diseases like malaria, dengue and zika, an approach known as "sterile insect technique." Sterilizing some insects with irradiation has been successful in preventing their reproduction.[1] In the 1950s, it was used to rid the southeastern U.S. of the New World screwworm Cochliomyia hominivorax (Coquerel), a deadly parasite of livestock. During the next 43 years the technique was used to eradicate this screwworm from the U.S., Mexico, and Central America. Currently, the largest use of Sterile Insect Technique in the U.S. is for the control of Mediterranean fruit fly. Irradiated bollworms are also being released to control cotton boll weevils, and irradiated coddling moths are being released to help protect apples and pears.[2] Interestingly, Rachel Carson, in Silent Spring, warned that using the Sterile Insect Technique to control a population of insects that could rebuild from neighboring islands or other populations was especially challenging. Talking about a SIT effort to control houseflies in the Florida Keys, she wrote:; ; "In a test on an island in the Florida Keys in 1961, a population of flies was nearly wiped out within a period of only five weeks. Repopulation of course followed from nearby islands, but as a pilot project the test was successful....; ; One of the problems of sterilization by radiation is that this requires not only artificial rearing but the release of sterile males in larger number than are present in the wild population. This could be done with the screw-worm, which is actually not an abundant insect. With the housefly, however, more than doubling the population through releases could be highly objectionable [to the local people]."[3]
Ethical implications of fighting malaria with CRISPR/Cas9
4061Patrão Neves, MD, Christiane, BMJ Global Health, 2:e000396. 2017-01-19 00:00:00.
Genome editing is a new, cheap and versatile technique which has great promise to combat vector-borne diseases. The current ethical debate worldwide is mainly concentrating on the dangers of germline intervention and less so on the potential for fighting vector-borne diseases. ; Gene drive technology has been significantly boosted by the CRISPR/Cas9 gene editing tool which may be able to combat malaria by targeting specific stretches of vector DNA and editing genomes at precise locations, working like a molecular scissors. However, CRISPR/Cas9 is currently not a ‘silver bullet’ and needs further research and consideration of the ethical aspects and consequences of its use.; In September 2016, the UNESCO Chair of Bioethics at the Medical University of Vienna convened a meeting entitled ‘Fighting Malaria with CRISPR/ Cas9: Ethical Implications’, which gathered together infectious disease experts with a focus on malaria, entomologists and ethicists to discuss the advantages and disadvantages of genome editing applied to mosquitoes to fight malaria. ; Although there was no formal consensus, some general conclusions were reached, in particular that any ethical debate needs to involve African stakeholders living in malaria areas and to consider future generations and the environment. The precautionary principle should be taken into account in any discussion, as should be the human cost of doing nothing.
Principles for gene drive research
4041Emerson, CJ, Stephanie; Littler, Katherine; Randazzo, Filippo, Science, 358:1135. 2017-01-19 00:00:00.
The recent outbreak of Zika virus in the Americas renewed attention on the importance of vector-control strategies to fight the many vector-borne diseases that continue to inflict suffering around the world. In 2015, there were ?212 million infections and a death every minute from malaria alone (1). Gene drive technology is being explored as a potentially durable and cost-effective strategy for controlling the transmission of deadly and debilitating vector-borne diseases that affect millions of people worldwide, such as Zika virus and malaria. Additionally, its suitability is being evaluated for various potential applications in conservation biology, including a highly specific and humane method for eliminating invasive species from sensitive ecosystems (2, 3).
Agricultural pest control with CRISPR-based gene drive: time for public debate: Should we use gene drive for pest control?
4035Courtier?Orgogozo, VM, Baptiste; Boëte, Christophe, EMBO Reports, 18:878-880. 2017-01-13 00:00:00.
Gene drive based on the CRISPR/Cas-9 gene editing system is a powerful technology that promotes the inheritance of the gene drive tool itself via sexual reproduction and can therefore spread quickly through a population. It holds great potential for public health and humanitarian purposes, such as reducing the burden of vector-borne diseases like malaria. Here, we discuss another potential application of CRISPR-based gene drive, namely the control of pest species to increase crop production. We argue that gene drive-based pest control strategies should receive more attention from policymakers and the public given their enormous potential impact on the environment, their easy accessibility, and the current dearth of regulations.
Unintended consequences of 21st century technology for agricultural pest management
4075Young, SL, EMBO reports, 18:1478-1478. 2017-01-13 00:00:00.
Comment on Agricultural pest control with CRISPR-based gene drive: time for public debate by Courtier-Orgogozo et al.
Teilhard de Chardin’s oeuvre within an ongoing discussion of a gene drive release for public health reasons
4033Cartolovni, A, Life Sciences, Society and Policy, 13:18. 2017-01-11 00:00:00.
Within the domain of public health, vector-borne diseases are among the most vehemently discussed issues. Recent scientific breakthroughs in genome editing technology provided a solution to this issue in the form of a gene drive that might decrease and even eradicate vector-borne diseases. Gene drives are engineered, and designed genes that can break typical inheritance rules and be passed to almost all of the carrier’s offspring. This genome editing and gene drive technology has become a powerful tool for ecological and environmental engineering, through which man can manipulate his surroundings, adjusting it to himself and directly mastering evolution and the ecosystem. Although the gene drive technology has been perceived as promising in the public health domain, ecological implications of its use are not to be underestimated. The primary aim of this paper is to overcome the ongoing discussion which mostly focuses on whether priority should be given to the environment or to public health, and to find an adequate answer and solution. In this quest to find the proper answer and solution, Pierre Teilhard de Chardin’s thought might be useful, especially his concepts of the biosphere and the noosphere which may provide some clarifications as to why we are at the moment so cautious with gene drive technology and how we need to move towards a better common future on earth.
Eradicating Mosquitoes? The promise and peril of gene drive technologies.
4050Jun, B-O, Eubios Journal of Asian and International Bioethics, 27:113-116. 2017-01-08 00:00:00.
This paper discusses the ethical issues associated with genetic modification of mosquito species that are human disease vectors. The Oxitec genetically changed mosquito—a variant of a species called Aedes aegypti, OX513A, is taken as an example. The benefits and risks are discussed, and questions need to be discussed in public prior to release of this gene drive system
The End of the GMO? Genome Editing, Gene Drives and New Frontiers of Plant Technology
15368K. L. Hefferon and R. J. Herring, Review of Agrarian Studies, 7. 2017-01-01 21:40:33.
mprovements to agriculture will constitute one of the world’s greatest challenges in the coming century. Political and social controversies, as well as complications of plant breeding, intellectual property, and regulation, have compromised the promised impact of genetically engineered – typically transgenic – crops designated as “GMOs.” Genome editing is a new suite of molecular tools for assisting biologists identify genes that control agronomic traits such as drought tolerance and pest resistance, as well as to elucidate how expression of these genes is intertwined within the functional framework of the cell. This technology has recently gained momentum for its ability to accelerate the crop breeding process in an unprecedented fashion and expand the range of crop varieties with improved precision and lower costs. This review explains the basic concepts and provides examples of how genome editing could help address the United Nation’s Sustainable Development Goals with respect to food, agriculture, and medicine. It concludes with a discussion of the potential social impact of genome editing and gene drive. These effects are contingent on the resolution of novel ethical and regulatory challenges that add new layers of complexity to societal questions of appropriate technology, in agriculture and beyond. We expect these questions to replace the irresolvable GMO debate.
Gene drive and collective oversight
4594Esvelt, K, GeneWatch, 2017-01-01 00:00:00.
As one of the scientists who first described how CRISPR could create gene drive systems capable of altering wild; populations, I am morally responsible for the consequences. I'm writing to you in the hope that the people most; critical of the very idea can help. Bluntly, gene drive is an example of how the current scientific enterprise causes; our technological power to grow faster than our ability to ensure it is developed wisely. But because it affects the; shared environment, gene drive may also be the key to improving the system - namely, by causing it to favor; collective oversight. And to do that, we need your help.
Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values
6356U. S. National Academies of Sciences, Engineering, and Medicine, The National Academies Press, 2016-07-08 20:32:51.
Scientists have studied gene drives for more than 50 years. The development of a powerful genome editing tool in 2012, CRISPR/Cas9,1 led to recent breakthroughs in gene drive research that built on that half century’s worth of knowledge, and stimulated new discussion of the potential applications and implications of gene drive technologies. 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. Gene-drive modified organisms are on the horizon. The fast moving nature of this field is both encouraging and concerning. While gene-drive modified organisms hold promise for addressing difficult to solve, persistent challenges, such as the eradication of vector-borne diseases and the conservation of threatened and endangered species, these proposed applications are based on limited proof-of-concept studies. The presumed efficiency of gene-drive modified organisms may lead to calls for their release in perceived crisis situations, before there is adequate knowledge of their ecological effects, and before mitigation plans for unintended harmful consequences are in place. Responding to this fast moving field, the National Institutes of Health (NIH) and the Foundation for the National Institutes of Health (FNIH)2 asked the National Academies of Sciences, Engineering, and Medicine to convene a committee with a broad range of expertise to summarize the scientific discoveries related to gene drives and considerations for their responsible use. Proof-of-concept in a few laboratory studies is not sufficient in and of itself to support a decision to release gene-drive modified organisms into the environment. Laboratory and field research is needed to refine CRISPR/Cas9-based gene drives and other gene drive mechanisms, and to understand how gene drives might work under different environmental conditions and in a wide variety of organisms. The considerable gaps in knowledge about potential off-target (within the organism) and non-target (in other species or the environment) effects necessitate a collaborative, multidisciplinary approach to research, ecological risk assessment, development of public policy, and decision making for each proposed application of a gene drive technology. General principles to guide responsible practices for gene drives from the laboratory setting through to field release and monitoring are embedded as recommendations throughout the report.
Gene Drive Technology: Where is the Future?
6904National Academy of Sciences Engineering Medicine, BioScience Talks, 2016-06-29 14:38:31.
Gene drives have the potential to revolutionize approaches to major public health, conservation, and agricultural problems. For instance, gene drives might one day prevent mosquitoes from spreading a variety of deadly diseases, including Zika virus, malaria, and others. A form of genetic modification, the technology works by causing a particular genetic element to spread through populations, thereby making it possible to change species in the wild. Despite the significant promise, caution is warranted, says a new report from the National Academies of Sciences, Engineering, and Medicine's Committee on Gene Drive Research. According to the committee, gene drives raise a variety of ecological and regulatory questions that have yet to be answered. For this episode of BioScience Talks, we're joined by committee co-chair Dr. James P. Collins of Arizona State University and committee member Dr. Joseph Travis of Florida State University. They fill us in on the specifics of the report and on the future of gene drives.
Engineering the wild: Gene drives and intergenerational equity
6948J. Kuzma and L. Rawls, Jurimetrics, 56:279-296. 2016-03-01 16:08:02.
New genetic engineering methods are allowing scientists to insert genes into organisms that have the potential to spread themselves throughout natural populations upon the release of individuals carrying those genes. Gene drive technology is being researched and developed for purposes of reducing or eliminating human, ecological or agricultural pest populations, or immunizing other desirable or endangered species against pests and disease. The ability of humans to alter populations within ecosystems through genetic engineering raises issues associated with biodiversity and conservation that, in turn, may affect the abilities of current and future generations to use and enjoy the benefits of the natural world. Yet, children and future generations are not typically given voice in legal, policy, or ethical debates. This article examines several of the intergenerational equity issues posed by gene drive technologies. A typology of gene drive purposes and their potential ecological impacts is developed, followed by an examination of how they may intersect with concerns about intergenerational equity. To our knowledge, this analysis is the first to explore human intervention through genetically engineering populations in the wild and the impacts on future generations
Genome editing: intellectual property and product development in plant biotechnology
4102Schinkel, HS, S., Plant Cell Reports, 35:1487-1491. 2016-01-20 00:00:00.
Genome editing is a revolutionary technology in molecular biology. While scientists are fascinated with the unlimited possibilities provided by directed and controlled changes in DNA in eukaryotes and have eagerly adopted such tools for their own experiments, an understanding of the intellectual property (IP) implications involved in bringing genome editing-derived products to market is often lacking. Due to the ingenuity of genome editing, the time between new product conception and its actual existence can be relatively short; therefore knowledge about IP of the various genome editing methods is relevant. This point must be regarded in a national framework as patents are instituted nationally. Therefore, when designing scientific work that could lead to a product, it is worthwhile to consider the different methods used for genome editing not only for their scientific merits but also for their compatibility with a speedy and reliable launch into the desired market.
Driven to extinction? The ethics of eradicating mosquitoes with gene-drive technologies
4097Pugh, J, Journal of Medical Ethics, 42:578-581. 2016-01-15 00:00:00.
Mosquito-borne diseases represent a significant global disease burden, and recent outbreaks of such diseases have led to calls to reduce mosquito populations. Furthermore, advances in gene-drive' technology have raised the prospect of eradicating certain species of mosquito via genetic modification. This technology has attracted a great deal of media attention, and the idea of using gene-drive technology to eradicate mosquitoes has been met with criticism in the public domain. In this paper, I shall dispel two moral objections that have been raised in the public domain against the use of gene-drive technologies to eradicate mosquitoes. The first objection invokes the concept of the sanctity of life' in order to claim that we should not drive an animal to extinction. In response, I follow Peter Singer in raising doubts about general appeals to the sanctity of life, and argue that neither individual mosquitoes nor mosquitoes species considered holistically are appropriately described as bearing a significant degree of moral status. The second objection claims that seeking to eradicate mosquitoes amounts to displaying unacceptable degrees of hubris. Although I argue that this objection also fails, I conclude by claiming that it raises the important point that we need to acquire more empirical data about, inter alia, the likely effects of mosquito eradication on the ecosystem, and the likelihood of gene-drive technology successfully eradicating the intended mosquito species, in order to adequately inform our moral analysis of gene-drive technologies in this context.
What is a Gene Drive?
4715STAT, 2015-12-11 00:00:00.
This video produced by STAT, an e-news site focusing on health and medicine (https://www.statnews.com/). This video simply illustrates what geneticists mean by gene drive, and how homing-based gene drive work. (Note: it does not indicate that there are other mechanisms of gene drive.)
Playing God with mosquitoes? We humans have loftier aims.
4608Pugh, J, The Conversation, 2015-12-02 00:00:00.
In a startling development in “gene-drive” technology, a team of researchers at the University of California has succeeded in creating genetically modified mosquitoes incapable of spreading the malaria parasite to humans, and which could potentially spread this trait rapidly throughout mosquito populations in the wild.; ; This success has the potential to be translated into a huge global health benefit. Although global malarial deaths have been in decline over the past decade or so, the WHO estimates that malaria has been responsible for over 400,000 deaths this year alone.
National Academies of Science | Workshop: Science, Ethics, and Governance Considerations for Gene Drive Research – 2015
5544National Academy of Sciences Engineering Medicine, National Academy of Sciences, 2015-10-28 21:53:14.
Opinion: Is CRISPR-based gene drive a biocontrol silver bullet or global conservation threat?
4131Webber, BLR, S.; Edwards, O. R., Proceedings of the National Academy of Sciences of the United States of America, 112:10565-10567. 2015-01-09 00:00:00.
Scientists have recognized the potential for applying gene drive technologies to the control of invasive species for several years, yet debate about the application of gene drive has been primarily restricted to mosquitoes. Recent developments in clustered regularly interspaced short palindromic repeats (CRISPR)-Cas9 technology have restarted discussions of using gene drive for invasive species control.
Concerning RNA-guided gene drives for the alteration of wild populations
4139Esvelt, KMS, Andrea L.; Catteruccia, Flaminia; Church, George M., eLife, 3:e03401. 2014-01-17 00:00:00.
Gene drives may be capable of addressing ecological problems by altering entire; populations of wild organisms, but their use has remained largely theoretical due to technical; constraints. Here we consider the potential for RNA-guided gene drives based on the CRISPR; nuclease Cas9 to serve as a general method for spreading altered traits through wild populations; over many generations. We detail likely capabilities, discuss limitations, and provide novel; precautionary strategies to control the spread of gene drives and reverse genomic changes. The; ability to edit populations of sexual species would offer substantial benefits to humanity and the; environment. For example, RNA-guided gene drives could potentially prevent the spread of; disease, support agriculture by reversing pesticide and herbicide resistance in insects and weeds,; and control damaging invasive species. However, the possibility of unwanted ecological effects and; near-certainty of spread across political borders demand careful assessment of each potential; application. We call for thoughtful, inclusive, and well-informed public discussions to explore the; responsible use of this currently theoretical technology.
Guidance on the environmental risk assessment of genetically modified animals.
4171EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), EFSA Journal, 11:3200. 2013-01-09 00:00:00.
This document provides guidance for the environmental risk assessment (ERA) of living genetically modified (GM) animals, namely fish, insects and mammals and birds, to be placed on the European Union (EU) market in accordance with Regulation (EC) No 1829/2003 or Directive 2001/18/EC. It provides guidance for assessing potential effects of GM animals on animal and human health and the environment and the rationales for data requirements for a comprehensive ERA. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach. This document describes the six sequential steps for the ERA of GM animals, as indicated in Directive 2001/18/EC: (1) problem formulation including hazard and exposure identification; (2) hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk management strategies; and (6) an overall risk evaluation. The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority follows Annex II of Directive 2001/18/EC, considering specific areas of risk to be addressed by applicants and risk assessors during the ERA of GM fish, GM insects and GM mammals and birds. Each specific area of risk is considered in a structured and systematic way following the aforementioned six steps. In addition, this Guidance Document describes several generic cross-cutting considerations (e.g. choice of comparators, use of non-GM surrogates, experimental design and statistics, long-term effects, uncertainty analysis) that need to be accounted for throughout the whole ERA.
Ethical issues in field trials of genetically modified disease-resistant mosquitoes
13538D. B. Resnik, Developing World Bioethics, 14:37-46. 2012-07-29 19:12:07.
Mosquito-borne diseases take a tremendous toll on human populations, especially in developing nations. In the last decade, scientists have developed mosquitoes that have been genetically modified to prevent transmission of mosquito-borne diseases, and field trials have been conducted. Some mosquitoes have been rendered infertile, some have been equipped with a vaccine they transmit to humans, and some have been designed to resist diseases.
The Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety
5660Secretariat of the Convention on Biological Diversity, Convention on Biodiversity, 2011:1-16. 2011-12-17 18:41:08.
Adopted as a supplementary agreement to the Cartagena Protocol on Biosafety, the Supplementary Protocol aims to contribute to the conservation and sustainable use of biodiversity by providing international rules and procedures in the field of liability and redress relating to living modified organisms, as stated in its Article 1. The Protocol applies to damage resulting from living modified organism which find their origin in a transboundary movement (Article 3). The Supplementary Protocol provides a definition of ‘damage’, referring to an adverse effect on the conservation and sustainable use of biological diversity that is measurable or otherwise observable and significant, taking also into account risks to human health. It provides for an indicative list of factors that should be used to determine the significance of an adverse effect. The Supplementary Protocol requires in Article 4 that a causal link between the damage and the living modified organism be established. States must require the appropriate operator or operators to take response measures in the event of damage resulting from living modified organisms which find their origin in a transboundary movement, as set out in Article 5. The ‘operator’ is defined as any person in direct or indirect control of the living modified organism. The operator must also take response measures where there is a sufficient likelihood that damage will result if timely response measures are not taken. Response measures may also be taken by the competent authority, for example when the operator has failed to do so. In such cases, the competent authority may recover the expenses and costs of such measures from the operator. In addition to the obligation to provide for response measures, Parties may develop civil liability rules and procedures to address damage. The Supplementary Protocol defines ‘response measures’ as reasonable actions to prevent, minimize, contain, mitigate or otherwise avoid damage, as appropriate, or reasonable actions to restore biological diversity. In addition to imposing a requirement for response measures, the Supplementary Protocol obliges Parties to continue to apply existing legislation on civil liability or to develop specific legislation concerning liability and redress for material or personal damage associated with damage to the conservation and sustainable use of biological diversity, as defined in the Supplementary Protocol. As response measures can be imposed by the competent administrative authority, rather than by a judicial body, the Supplementary Protocol is known as having introduced an ‘administrative approach’ to liability and redress.
Ethical, legal and social aspects of the approach in Sudan
25823B. B. El Sayed, C. A. Malcolm, A. Babiker, E. M. Malik, M. A. H. El Tayeb, N. S. Saeed, A. H. D. Nugud and B. G. J. Knols, Malaria Journal, 8:S3. 2009-11-16 10:10:31.
The global malaria situation, especially in Africa, and the problems frequently encountered in chemical control of vectors such as insecticide resistance, emphasize the urgency of research, development and implementation of new vector control technologies that are applicable at regional and local levels. The successful application of the sterile insect technique (SIT) for the control of the New World screwworm Cochliomyia hominivorax and several species of fruit flies has given impetus to the use of this method for suppression or elimination of malaria vectors in some areas of Africa including Northern State of Sudan. The research and development phase of the Northern State feasibility study has been started. Sudanese stakeholders are working side-by-side with the International Atomic Energy Agency in the activities of this important phase. Several ethical, legal and social issues associated with this approach arose during this phase of the project. They need to be seriously considered and handled with care. In this paper, these issues are described, and the current and proposed activities to overcome potential hurdles to ensure success of the project are listed.
Cartagena Protocol on Biosafety to the Convention on Biological Diversity
5665Secretariat of the Convention on Biological Diversity, Convention on Biodiversity, 2000:1-19. 2000-12-17 18:48:56.
The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international agreement which aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on biological diversity, taking also into account risks to human health. It was adopted on 29 January 2000 and entered into force on 11 September 2003.
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