Technologies like CRISPR and gene drives are ushering in a new era of genetic engineering, wherein the technical means to modify DNA are cheaper, faster, more accurate, more widely accessible, and with more far-reaching effects than ever before. These cutting-edge technologies raise legal, ethical, cultural, and ecological questions that are so broad and consequential for both human and other-than-human life that they can be difficult to grasp. What is clear, however, is that the power to directly alter not just (...) a singular form of life but also the genetics of entire species and thus the composition of ecosystems is currently both inadequately regulated and undertheorized. In Gene Editing, Law, and the Environment, distinguished scholars from law, the life sciences, philosophy, environmental studies, science and technology studies, animal health, and religious studies examine what is at stake with these new biotechnologies for life and law, both human and beyond. (shrink)

The study examines the creation of gene-edited infants from the perspective of biopolitics. Through an analysis at the level of “body-power”, we show that the infants are a product of an advanced stage of biopolitics. On the other hand, considering the level of “space-power”, we indicate that the mechanism of space deepens the governance of population through biopower, leading to real conflicts between past and future in the present. The infants can be seen as “heterotopias of mirrors”, where super-reality (...) replaces the reality, culminating in a rational dilemma. We must also consider how to maintain our self-contemplation and naturalness when faced with the physical nature of humans and how to ensure that the state is fulfilling its role in regulating the use of gene-editing technology. Ultimately, we need to engage in a deeper rethinking and criticism of modernity to safeguard our values from being lost in the tide of modernization. (shrink)

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. (shrink)

In the wake of the advent of genome editing technology CRISPR-Cas9 (clustered regularly interspaced palindromic repeat (CRISPR)-associated protein 9), there has been a global debate around the implications of manipulating the human genome. While CRISPR-based germline gene editing is new, the debate about the ethics of gene editing is not – for several decades now, scholars have debated the ethics of making heritable changes to the human genome. The arguments that have been raised both for (...) and against the use of genetic technologies in human reproduction reiterate much of the arguments made in the pre-CRISPR debate. As such, it is instructive for South Africa to reflect on these arguments now, in considering our position on the regulation of the use of this novel biotechnology. There are two dominant schools of thought in this area, bioliberalism and bioconservatism. Bioconservatives raise concerns about the risks of genetic manipulation, and argue that it ought to be limited or prohibited to avert these risks to human health and human nature. Bioliberal scholars are more open to the prospect of genetic manipulation, because of its potential utility. In this article, I conclude that in liberal democracies such as our own, bioliberal arguments ought to be seriously considered when formulating policy on human genome editing because of the extent to which they resonate with our Constitutional values and human rights. I further suggest that there is a need for an enquiry into the relevance of African perspectives on the ethical questions that arise concerning germline genome editing. (shrink)

In late 2019, He Jiankui, the Chinese scientist who created the world's first gene‐edited babies, and two embryologists were sentenced to prison and fined. Thirteen months earlier, when the world first learned about the experiment, He and his colleagues drew swift and nearly uniform international condemnation for prematurely moving to human trials, for the risks they took with the children's health, and for He's secrecy. The organizing committee for the second genome editing summit said the experiment failed to (...) conform with international norms.” In the United States, the legal picture is complex. No doubt the specific experiment He performed would have run afoul of long‐standing research regulations due to its problems with informed consent and ethical review. But other laws also affect this kind of work, in particular, a budget rider that for the past four years has been included in federal appropriations legislation. (shrink)

The recent development of CRISPR/Cas9 technology has rekindled the ethical debate concerning human germline modification that has begun decades ago. This inexpensive technology shows tremendous promise in disease prevention strategies, while raising complex ethical concerns about safety and efficacy of the technology, human dignity, tampering with God’s creation, and human genetic enhancement. Germline gene editing may result in heritable changes in the human genome, therefore the question of whether it should be allowed requires deep and careful discussion from (...) various perspectives. This paper explores Islamic perspectives on the concerns raised and highlights the ethical principles in Islam that should be taken into consideration when assessing the permissibility of CRISPR/ Cas9-mediated human germline gene editing. As argued in this paper, human germline gene editing would be considered lawful for medical purpose under certain conditions. It should not be applied on humans until the safety and efficacy issues are resolved. Robust ethical guidelines and strict regulations are necessary to preserve human dignity and to prevent premature and misuse of the technology. Maqasid al-shariah’s principles of preservation of human life, lineage, and dignity and ‘preventing harm takes precedence over securing benefit’ are among the guiding principles in assessing the permissibility of CRISPR/Cas9-mediated human germline editing from an Islamic perspective. Further discussions are important to address the controversies as well as to explore the related ethical principles. (shrink)

Potential applications of genome editing in assisted reproductive technology (ART) raise a vast array of strong opinions, emotional reactions and divergent perceptions. Acknowledging the need for caution and respecting such reactions, we observe that at least some are based on either a misunderstanding of the science or misconceptions about the content and flexibility of the existing legal frameworks. Combining medical, legal and ethical expertise, we present and discuss regulatory responses at the national, European and international levels. The discussion has (...) an EU starting point and is meant as a contribution to the general international regulatory debate. Overall, this paper concludes that gene editing technologies should not be regulated autonomously. Rather, potential uses should be regulated under general, existing frameworks and where applicable by reference to sufficiently equivalent technologies and techniques already subject to specific regulation. To be clear, we do not argue for the hasty introduction of gene editing as a reproductive treatment option in the immediate future. We call for caution with regard to overreaching moratoria and prohibitions that will also affect basic research. We recommend flexible regulations that allow for further responsible research into the potential development of the technology. We call for an open and inclusive debate and argue that scientific communication should claim a more prominent role to counter the danger of widespread misinformation. A high level of transparency and accuracy should guide scientific communication while simultaneously global‐scale responsibility and governance should be fostered by promoting cross‐disciplinary thinking and multi‐level stakeholder involvement in legal and regulatory processes. (shrink)

Given some of the various possible impacts of clinical germline editing, we can expect robust disagreement about how best to regulate it. One can point to examples of the promise of editing: “rough...

The metaphor of “gene editing” has been employed widely in popular discussions of CRISPR technology. The editing metaphor obscures the physical mechanism of action in CRISPR techniques, and understates the present frequency of off-target effects. However, the editing metaphor may be a useful means to think about approaches to regulating the future use of CRISPR. Conceiving of CRISPR as an information technology recalls the highly computational, information-oriented context of genomic research in which CRISPR has emerged. More (...) importantly, the editing metaphor, while currently inaccurate, anticipates a future moment when CRISPR technology will be ubiquitous and extremely reliable. Contemporary deliberations about the regulation of CRISPR should keep in mind that the technology may become more powerful—and more susceptible to misuse—as the overall state of genomic science advances and applications of CRISPR become less expensive and more refined. (shrink)

Potential applications of genome editing in assisted reproductive technology (ART) raise a vast array of strong opinions, emotional reactions and divergent perceptions. Acknowledging the need for caution and respecting such reactions, we observe that at least some are based on either a misunderstanding of the science or misconceptions about the content and flexibility of the existing legal frameworks. Combining medical, legal and ethical expertise, we present and discuss regulatory responses at the national, European and international levels. The discussion has (...) an EU starting point and is meant as a contribution to the general international regulatory debate. Overall, this paper concludes that gene editing technologies should not be regulated autonomously. Rather, potential uses should be regulated under general, existing frameworks and where applicable by reference to sufficiently equivalent technologies and techniques already subject to specific regulation. To be clear, we do not argue for the hasty introduction of gene editing as a reproductive treatment option in the immediate future. We call for caution with regard to overreaching moratoria and prohibitions that will also affect basic research. We recommend flexible regulations that allow for further responsible research into the potential development of the technology. We call for an open and inclusive debate and argue that scientific communication should claim a more prominent role to counter the danger of widespread misinformation. A high level of transparency and accuracy should guide scientific communication while simultaneously global‐scale responsibility and governance should be fostered by promoting cross‐disciplinary thinking and multi‐level stakeholder involvement in legal and regulatory processes. (shrink)

The ethical issues associated with germline gene modification and embryo research are some of the most contentious in current international science policy debates. In this paper, we argue that new genetic techniques, such as CRISPR, demonstrate that there is an urgent need for China to develop its own regulatory and ethical framework governing new developments in genetic and embryo research. While China has in place a regulatory framework, it needs to be strengthened to include better compliance oversight and explicit (...) criteria for how different types of research should be reviewed by regulatory authorities. We also document a variety of opinions about the new technologies among the public, scholars, and policy makers. China needs to develop its own regulations in coordination with other countries; but it is unlikely that an international consensus will be achieved in this area, given the existing differences in regulations between countries. We should aim at harmonization, not necessarily complete consensus, and the perspective from China is vital when international norms are developed and harmonized. Chinese policy makers and researchers need to be aware of the international discussions, at the same time as the international community is aware of, and accommodates, Chinese positions on important policy options. (shrink)

In 2018, the Chinese scientist He Jiankui presented his research at the Second International Summit on Human Genome Editing in Hong Kong. While it was intended that he facilitate a workshop, he was instead called on to present his research in heritable human genome editing, where he made the announcement that he had taken great strides in advancement of his research, to the extent that he had gene-edited human embryos and that this had resulted in the live (...) births of two children. While his research ethic and methodology was interrogated, he insisted that two children, twin girls, had been born healthy and that there was another pregnancy (at the time) where birth of a third gene edited child would be imminent. This announcement generated a ripple effect in the scientific community and exposed the gaps in regulation and absence of law relating to the technology. This resulted in a flurry of activity and conversation around regulation of the technology, which scientists stated was not ready for human trials. This article reviews the Third Summit which was held in London in March 2023 and comments on the latest developments in the regulation of heritable human genome editing. (shrink)

The Streptococcus pyogenes CRISPR‐Cas system has gained widespread application as a genome editing and gene regulation tool as simultaneous cellular delivery of the Cas9 protein and guide RNAs enables recognition of specific DNA sequences. The recent discovery that Cas9 can also bind and cleave RNA in an RNA‐programmable manner indicates the potential utility of this system as a universal nucleic acid‐recognition technology. RNA‐targeted Cas9 (RCas9) could allow identification and manipulation of RNA substrates in live cells, empowering the (...) study of cellular gene expression, and could ultimately spawn patient‐ and disease‐specific diagnostic and therapeutic tools. Here we describe the development of RCas9 and compare it to previous methods for RNA targeting, including engineered RNA‐binding proteins and other types of CRISPR‐Cas systems. We discuss potential uses ranging from live imaging of transcriptional dynamics to patient‐specific therapies and applications in synthetic biology. (shrink)

This edited collection examines the ethical, legal, social and policy implications of genome editing technologies. Moreover, it offers a broad spectrum of timely legal analysis related to bringing genome editing to the market and making it available to patients, including addressing genome editing technology regulation through procedures for regulatory approval, patent law and competition law. In twelve chapters, this volume offers persuasive arguments for justifying transformative regulatory interventions regarding human genome editing, as well as the (...) various legal venues for introducing necessary or desirable changes needed to create an environment for realizing the potential of genome editing technology for the benefit of patients and society. (shrink)

The application of genetic editing techniques for the prevention or cure of disease is a highly promising tool for the future of humanity. However, its implementation contains a number of ethical and legal challenges that should not be underestimated. On this basis, some sectors have already asked for a veto on any intervention that modifies the human germ line, while supporting somatic line editing. In this paper, I will support that this suggestion makes no sense at all, because (...) the somatic/germ line disjunctive has no moral relevance and, therefore, it should not play any role in legal terms. I will provide a number of reasons to hold this assumption, such as the non‐sacred nature of the germ line, the difference between germ line and human genome modification, or the moral importance of the presence of a will to create modified descendants. While doing so, I will provide some examples of the different approaches to germ line editing adopted by different regulations so as to demonstrate that, contrary to what is sometimes stated, a general ban on this practice is not the rule, but the exception. Additionally, I will show how alternative options which currently exist, such as a selective ban based on criteria different to the germ line/somatic line distinction, match better with the need to conciliate research needs and legitimate ethical concerns. Finally, I will introduce some further suggestions to this same purpose. (shrink)

The distinction between germline and somatic gene editing is fundamental to the ethics of human gene editing. Multiple conferences of scientists, ethicists, and policymakers, and multiple professional bodies, have called for moratoria on germline gene editing, and editing of human germline cells is considered to be an ethical “red line” that either never should be crossed, or should only be crossed with great caution and care. However, as research on germline gene (...) class='Hi'>editing has progressed, it has become clear that not all germline interventions are alike, and that these differences make a significant moral difference, when it comes to ethical questions about research, regulation, clinical application, and medical justification. In this paper, I argue that, rather than lumping all germline interventions together, we should distinguish between revising, correcting, and transferring genes, and I assess the consequences of this move for the ethics of gene editing. (shrink)

This paper provides an ethical analysis of the controversy that arose from the CRISPR/Cas9 gene editing research involving human embryos that was conducted by a research team in Guangzhou, China, in 2015. It is argued that the researchers involved did not overstep ethical boundaries. This was confirmed to be the case in an international meeting of experts that was convened following the controversy. It is further argued that the controversy highlights the tension between two fundamentally different policies on (...) developing genome editing technology – one proactionary and the other precautionary. This paper argues for a third approach, based on the policy of “crossing the river by probing stones”. Such an approach is consistent with current international recommendations to prioritise basic and pre-clinical research, and to allow the application of genome editing technology to somatic human cells. However, the application of the technology in germline genetic modification for human reproduction or enhancement for medical purposes should not be allowed at present. This is because the attending risks are not well understood and could be excessive or extraordinary, with little or no prospect of benefit. In addition, this paper calls for norms and regulations to be developed for genetically modifying non-human living things. [End Page 307] Finally, the paper concludes with a letter that was sent by the author to the New York Times, setting out China’s fundamental stance on genetic modification involving humans and human derivatives. (shrink)

Every year, unfavorable environmental factors significantly affect crop productivity and threaten food security. Plants are sessile; they cannot move to escape unfavorable environmental conditions, and therefore, they activate a variety of defense pathways. Among them are processes regulated by stress‐associated proteins (SAPs). SAPs have a specific zinc finger domain (A20) at the N‐terminus and either AN1 or C2H2 at the C‐terminus. SAP proteins are involved in many biological processes and in response to various abiotic or biotic constraints. Most SAPs play (...) a role in conferring transgenic stress resistance and are stress‐inducible. The emerging field of SAPs in abiotic or biotic stress response regulation has attracted the attention of researchers. Although SAPs interact with various proteins to perform their functions, the exact mechanisms of these interactions remain incompletely understood. This review aims to provide a comprehensive understanding of SAPs, covering their diversity, structure, expression, and subcellular localization. SAPs play a pivotal role in enabling crosstalk between abiotic and biotic stress signaling pathways, making them essential for developing stress‐tolerant crops without yield penalties. Collectively, understanding the complex regulation of SAPs in stress responses can contribute to enhancing tolerance against various environmental stresses through several techniques such as transgenesis, classical breeding, or gene editing. (shrink)

This article presents and evaluates arguments supporting that an approval procedure for genome-edited organisms for food or feed should include a broad assessment of societal, ethical and environmental concerns; so-called non-safety assessment. The core of analysis is the requirement of the Norwegian Gene Technology Act that the sustainability, ethical and societal impacts of a genetically modified organism should be assessed prior to regulatory approval of the novel products. The article gives an overview how this requirement has been implemented in (...) the regulatory practice, demonstrating that such assessment is feasible and justified. Even in situations where genome-edited organisms are considered comparable to non-modified organisms in terms of risk, the technology may have—in addition to social benefits—negative impacts that warrant assessments of the kind required in the Act. The main reason is the disruptive character of the genome editing technologies due to their potential for novel, ground-breaking solutions in agriculture and aquaculture combined with the economic framework shaped by the patent system. Food is fundamental for a good life, biologically and culturally, which warrants stricter assessment procedures than what is required for other industries, at least in countries like Norway with a strong tradition for national control over agricultural markets and breeding programs. (shrink)

This essay discusses the new report, Heritable Human Genome Editing, by the National Academy of Medicine, the National Academy of Sciences, and the Royal Society. After summarizing the report, we argue that the report takes four quite bold steps away from prior reports, namely (1) rejecting an omnibus approach to heritable human genome editing (HHGE) in favor of a case‐by‐case analysis of possible uses of HHGE, accepting that HHGE is acceptable in some cases; (2) recognizing that the interest (...) in having children who are genetically related to both would‐be rearing parents is one that the regulation of HHGE should honor; (3) patterning a regulatory model for HHGE on the United Kingdom's approach to regulating mitochondrial replacement techniques; and (4) conveying skepticism that international regulation is possible while showing a strong preference for a default into national regulatory regimes for HHGE. (shrink)

New genomic techniques (NGTs) are powerful technologies with the potential to change how we relate to our food, food producers, and natural environment. Their use may affect the practices and values our societies are built on. Like many countries, the EU is currently revisiting its GMO legislation to accommodate the emergence of NGTs. We argue that assessing such technologies according to whether they are ‘safe enough’ will not create the public trust necessary for societal acceptance. To avoid past mistakes of (...) under- or miscommunication about possible impacts, we need open, transparent, and inclusive societal debate on the nature of the science of gene (editing) technologies, on how to use them, and whether they contribute to sustainable solutions to societal and environmental challenges. To be trustworthy, GMO regulation must demonstrate the authorities’ ability to manage the scientific, socio-economic, environmental, and ethical complexities and uncertainties associated with NGTs. Regulators and authorities should give equal attention to the reflexive and the emotional aspects of trust and make room for honest public and stakeholder inclusion processes. The European Group of Ethics in Science and Technology’s recent report on the Ethics of Genome Editing (2021) is important in calling attention to a series of fundamental issues that ought to be included in debates on the regulation and use of NGTs to ensure public trust in these technologies and in regulating authorities. With the great power of NGTs comes great responsibility, and the way forward must be grounded in responsible research, innovation, and regulation. (shrink)

We review the Nuffield Council on Bioethics 2018 report on germline gene editing and show how its shortcomings are part of an increasingly permissive climate among elite scientists that may well have emboldened the Chinese 'CRISPR babies' experiment. Without a robust and meaningful airing of the perils of human germline modification, these views are likely to encourage additional, more mainstream moves in the same dangerous direction.

This paper seeks to expand our appreciation of the gene editing tool, clustered regularly interspaced short palindromic repeats‐associated protein 9 (CRISPR‐Cas9), its function, its benefits and risks, and the challenges of regulating its use. I frame CRISPR's emergence and its current use in the context of 150 years of formal exploration of heredity and genetics. I describe CRISPR's structure and explain how it functions as a useful engineering tool. The contemporary international and domestic regulatory environment governing human genetic (...) interventions is reviewed and shown to be increasingly ineffective in its ability to restrain, guide, and optimize the emerging use of CRISPR. Several reasons for this lack of consensus are discussed. In conclusion, I suggest a number of public policy recommendations that might allow us to simultaneously embrace our most important moral values and manage the inevitable power CRISPR will come to have in our lives. (shrink)

Extensive conflicts of interest at both individual and institutional levels are identifiable in scientific research and healthcare in China, as in many other parts of the world. A prominent new case from China is He Jiankui’s experiment that produced the world’s first gene-edited babies and that raises numerous ethical, political, socio-cultural, and transnational questions. Serious financial and other COI were involved in He’s genetic adventure. Using He’s infamous experiment as a case study, this paper explores the wider issue of (...) financial and other COI in scientific research and healthcare in China, especially institutional conflict of interest and policy-related COI. Taking a socio-ethical perspective, it examines China’s state policies and its massive efforts to transform and commercialize scientific research, the lack of policies and oversight mechanisms for regulating COI, as well as major ethical issues arising from COI including the undermining of public trust. Some practical suggestions are offered for institutional reform and institutional development so that COI, particularly ICOI, can be avoided or more effectively managed in scientific research in China. (shrink)

This is the second edition of the textbook Bioethics in Canada. It is the most up to date bioethics textbook on the Canadian market. Twenty-nine of its 54 contributions are by Canadians. All the chapters carried over from the first edition are revised in full (especially the chapters on obligations to the global poor, on medical assistance in dying, and on public health). It comprises *new* chapters on emerging genetic technologies and on indigenous peoples' health. It contains *new* case studies (...) focusing on ethical issues and problems of relevance to Canadians. From the Preface: This anthology is designed for those teaching bioethics in colleges and universities in Canada. It comprises articles from researchers exploring the main problems of bioethics from a diversity of perspectives and ethical traditions. It includes in particular articles by Canadian researchers who appear in anthologies less often than they should. The hope is that the reader will, as a result, better appreciate the rich reservoir of talent present among those working in bioethics in Canada and Canadian bioethicists working abroad. In addition, this volume intentionally aims to educate the reader about the policies and laws regulating the most important and pressing bioethical problems facing Canadians. The hope is that the reader will develop a nuanced view of the nature, importance, and impact of bioethics in Canada. (shrink)

In the fall of 2018 Jiankui He shocked the international community with the following announcement: two female babies, “Lulu” and “Nana,” whose germlines had been modified by the cutting edge, yet profoundly unsafe CRISPR-Cas9 technology had been born. This event galvanized policy makers and scientists to advocate for more explicit and firm regulation of human germline gene editing. Recent policy proposals attempt to integrate safety considerations and public input to identify specific types of diseases that may be (...) safe targets for human GGE. This paper argues these policy proposals are inadequate in different ways. While Sarkar intends to incorporate input from the disability community for the purpose of deciding the value of human GGE, I argue that his strategy for doing so is inadequate. I’ll argue that an iterative, deliberative process is a more appropriate framework for allowing the disability community to inform policy on human GGE. Further policy proposals have been framed in terms of monogenetic or single-gene diseases. I argue that this way of conceptualizing disease is not what matters for deciding which disorders are viable candidates for human GGE. Instead, what matters is that the disease in question must have genes that have a high degree of causal control with respect to the disease and alternative nucleic acid sequences variants that are likely to produce traits deemed desirable must be identified. Previous policy proposals leave unspecified. What conditions must be met for satisfying condition should not be left to individual scientists to decide for themselves. The present proposal offers some guidance on this issue. (shrink)

GMOS and Political Stance: Global GMO Regulation, Certification, Labeling, and Consumer Preferences provides a foundational-to-current challenges resource for those involved in developing and applying regulations to these important resources. Beginning with basics of GMOs, the book first familiarizes the reader with the history, economic status, associated risks, global politics, and socio-economics of GMOs. From exploring the necessity of GMO regulations with the existing GMO technology as well as new gene editing technologies to discussion by GMO regulations experts (...) from different continents and countries, readers will find the information necessary to understand the laws, rules, regulations and policies at domestic and international scale. A last chapter delivers an update and future look on gene-edited food and feed and discusses the possibilities on the future risk assessment, legislation and regulation of gene-edited products. GMOS and Political Stance provides a unique and applicable synchronization of all regulatory information on GMOs to facilitate effective and efficient regulatory development and adherence." -- Amazon. (shrink)

The SynBioSecurity argument says that synthetic biology introduces new risks of intentional misuse of synthetic pathogens and that, therefore, there is a need for extra regulations and oversight. This paper provides an analysis of the argument, sets forth a new version of it, and identifies three developments that raise biosecurity risks compared to the situation earlier. The developments include a spread of the required know-how, improved availability of the techniques, instruments and biological parts, and new technical possibilities such as “resurrecting” (...) disappeared pathogens. It is first shown that the general argument from SynBioSecurity needs to be qualified and that many improvements to biosecurity have already been implemented, most notably in the United States. Second, I suggest a new strain of the argument: the situation that most branches of synthetic biology fall under the gene technology regulation in the European Union and that this regulation in its current form does not adequately address SynBioSecurity risks together provide a weighty reason to review and possibly refine the legislation as well as the supervisory practices. Ethically speaking, the rise in the relative risk of bioterrorism brings to the fore new extrinsic issues. (shrink)

For the first time in the history of civilization, humans have procured the power to rewrite nature's book of life. Following the discovery of CRISPR and other key scientific developments at the dawn of the twenty-first century, humankind has-for better or worse-reached the Rubicon of precise genetic manipulation, which existed only in science fiction until now. Those familiar with genome editing understand its colossal power and potential to become a global transformative agent that surpasses the impact of electricity, the (...) atomic bomb, or the Internet. REWRITING NATURE is an interdisciplinary odyssey through the law, science, and policy of genome editing-the most significant breakthrough of our generation. The volume addresses a critical need to bridge gaps between law, science, and policy, and challenges the conventional, false dichotomy frequently associated with mutually exclusive normative roles for science and law. Through exploration of heuristic inquiries into an array of interdisciplinary fields, the book seeks to ignite thoughtful dialogues about authentic-rather than manufactured or sensationalized-issues raised by the technology. This timely resource is intended for keen audiences focused on venturing beyond the headlines and talking points to develop a deeper understanding of the prospects and challenges of genome editing. (shrink)

Creating Future People offers readers a fast-paced primer on how new genetic technologies will enable parents to influence the traits of their children, including their intelligence, moral capacities, physical appearances, and immune systems. It deftly explains the science of gene editing and embryo selection, and raises the central moral questions with colorful language and a brisk style. Jonathan Anomaly takes seriously the diversity of preferences parents have, and the limits policymakers face in regulating what could soon be a (...) global market for reproductive technology. He argues that once embryo selection for complex traits happens it will change the moral landscape by altering the incentives available to parents. All of us will take an interest in the traits everyone else selects, and this will present coordination problems that previous writers on genetic enhancement have failed to consider. Anomaly navigates difficult ethical issues with vivid language and scientifically-informed speculation about how genetic engineering will transform humanity. Key Features: Offers clear explanations of scientific concepts Explores important moral questions without academic jargon Brings discoveries from different fields together to give us a sense of where humanity is headed. (shrink)

Emerging technologies such as artificial intelligence, gene editing, nanotechnology, neurotechnology and robotics, which were originally unrelated or separated, are becoming more closely integrated. Consequently, the boundaries between the physical-biological and the cyber-digital worlds are no longer well defined. We argue that this technological convergence has fundamental implications for individuals and societies. Conventional domain-specific governance mechanisms have become ineffective. In this paper we provide an overview of the ethical, societal and policy challenges of technological convergence. Particularly, we scrutinize the (...) adequacy of domain-specific governance mechanisms in the face of such integrated technologies and highlight their growing ineffectiveness. Furthermore, we propose a comprehensive governance framework that is anticipatory, inclusive, and resilient. Central to this framework is the principle of participatory governance, which calls for a proactive engagement of all stakeholders, including those from marginalized and vulnerable populations, ensuring that their voices and concerns shape the trajectory of technological development. The framework emphasizes the need for protective measures that preemptively address potential risks and inequities that may arise from the adoption and integration of emerging technologies. Based on a detailed analysis of case studies and current governance models, we present and discuss a set of ten actionable recommendations. These are designed to facilitate the transition towards a governance approach that not only respects individual autonomy and privacy, but also fosters a collective responsibility towards sustainable and fair technological progress. By placing human dignity, societal welfare and the protection of the most vulnerable at the center of technological innovation, we advocate for a future where convergence is synonymous with progress that is both ethically grounded and universally beneficial. (shrink)

The development of the CRISPR gene editing technique has been hyped as a technique that could fundamentally change scientific research and its clinical application. Unrecognized is the fact that it joins other technologies that have tried and failed under the same discourse of scientific hype. These technologies, like gene therapy and stem cell research, have moved quickly passed basic research into clinical application with dire consequences. Before hastily moving to clinical applications, it is necessary to consider basic (...) research and determine how CRISPR/Cas systems should be applied. In the case of single gene diseases, that application is expected to have positive impacts, but as we shift to more complex diseases, the impact could be unintentionally negative. In the context of common disabilities, the level of genetic complexity may render this technology useless but potentially toxic, aggravating a social discourse that devalues those with disabilities. This paper intends to define the issues related to disability that are associated with using the CRIPSR/Cas system in basic research. It also aims to provide a decision tree to help determine whether the technology should be utilized or if alternative approaches beyond scientific research could lead to a better use of limited funding resources. (shrink)

Recent developments in genomic technology, especially those enabling gene editing, promise to put an end to hitherto intractable medical problems and to usher us into the age of personalized medicine. These technologies, however, raise a number of serious ethical challenges. Given the global impact of this technology, recent international regulations emphasize the need for intercultural dialogue on these ethical issues. This paper concentrates on Islamic perspectives on human genetic modification. It examines Islamic juristic discourses on the issue of (...) genetic modification and highlights the different layers within these discourses. The paper identifies the main positions regarding human genetic modification along with the underlying arguments for each of them. In general, these positions are articulated in light of the nature as well as the intended objectives of the different procedures. The paper devotes special attention to the treatment-enhancement distinction and argues that within Islamic discourses this distinction is quite nuanced. The paper points out important substantive and methodological gaps and emphasizes the evolving nature of Islamic discourses on this issue. (shrink)

Creating Future People offers readers a fast-paced primer on how advances in genetics will enable parents to influence the traits of their children, including their children's intelligence, moral capacities, physical appearance, and immune system. It explains the science of gene editing and embryo selection, and motivates the moral questions it raises by thinking about the strategic aspects of parental choice. Professor Anomaly takes seriously the diversity of preferences parents have, and the limits policymakers face in regulating what will (...) soon be a global market for reproductive technology. Anomaly argues that once embryo selection for complex traits happens it will change the moral landscape by altering the incentives each person faces. All of us will take an interest in the traits everyone else selects, and this will present coordination problems that previous writers on genetic enhancement have failed to consider. Anomaly ends by considering how genetic engineering will transform humanity. Key Updates to the Second Edition · Significant revisions to the Preface and three separate chapters to include more details about what will be scientifically possible in the coming years and the moral issues these developments will raise · New and substantial coverage of embryo selection (guided by polygenic scores) for minimizing the risk of genetic diseases · Engagement with all important, new publications on the science of genetic enhancement. (shrink)

Might the 2018 birth of two designer babies in China write the opening paragraph for the next chapter in the history of eugenics? The worldwide scientific community has tacitly put a moratorium on human clinical application of CRISPR gene editing, waiting until unknown risks can become known. But this ethical agreement has been breached, and calls are now being heard for more rigorous regulations. Perhaps religious and spiritual leaders can join the bioethical chant: the yellow light of caution (...) is flashing. (shrink)

The use of genetic technologies within the equine industries has become increasingly common since the horse genome was published in 2009 (Wade et al. 2009). Testing for genes coding for disease in...

Objetivo del presente artículo es poner de relieve las contradicciones de la relación entre bioética y bioderecho que, lejos de ser un problema meramente teórico, tiene un impacto real en las reglamentaciones de las innovaciones en el campo de la biomedicina. Con el ánimo de demostrar esa fuerte conexión de la cuestión aparentemente teórica con la praxis, el ensayo, dotado de una metodología inductiva, moverá sus primeros pasos a partir de las técnicas de edición genética germinal. En la primera parte (...) del trabajo se aclararán matices científicos de dichas técnicas y se presentarán los primeros avances de la reglamentación jurídica que tienen su origen en el Consejo de Europa. Finalmente, a través de los límites y contradicciones de la reglamentación supuestamente biojurídica de la edición genética germinal se pondrá en evidencia la asimetría que domina en la relación entre bioética y bioderecho. ---The goal of this article is to stand out contradictions in the relationship among bioethics and biolaw that, far from being merely a theoretical quandary, has a real impact in the regulations of innovations in the biomedical field. Aiming to show that strong connection between the apparently theoretical question with the praxis, the essay, with an inductive methodology, goes straight showing the first steps of regulation of the germ-line gene editing. In the first part of the article, after a summary about the scientific highlights of germ-line gene editing, we undertake an investigation on the juridical regulation of germline-gene editing, based on the Council of Europe’s provisions. Finally, showing the limitations and contradictions of these supposedly biojuridical regulations, we highlight the dominant asymmetry in the relationship among bioethics and biolaw. (shrink)

The most recent work toward compiling a comprehensive database of adenosine‐to‐inosine RNA editing events suggests that the potential for RNA editing is much more pervasive than previously thought; indeed, it is manifest in more than 100 million potential editing events located primarily within Alu repeat elements of the human transcriptome. Pairs of inverted Alu repeats are found in a substantial number of human genes, and when transcribed, they form long double‐stranded RNA structures that serve as optimal substrates (...) for RNA editing enzymes. A small subset of edited Alu elements has been shown to exhibit diverse functional roles in the regulation of alternative splicing, miRNA repression, and cis‐regulation of distant RNA editing sites. The low level of editing for the remaining majority may be non‐functional, yet their persistence in the primate genome provides enhanced genomic flexibility that may be required for adaptive evolution. (shrink)

Regulatory agencies aim to protect the public by moderating risks associated with innovation, but a good regulatory regime should also promote justified public trust. After introducing the USDA 2020 SECURE Rule for regulation of biotech innovation as a case study, this essay develops a theory of justified public trust in regulation. On the theory advanced here, to be trustworthy, a regulatory regime must (1) fairly and effectively manage risk, must be (2) “science based” in the relevant sense, and (...) must in addition be (3) truthful, (4) transparent, and (5) responsive to public input. Evaluated with these norms, the USDA SECURE Rule is shown to be deeply flawed, since it fails appropriately to manage risk, and similarly fails to satisfy other normative requirements for justified trust. The argument identifies ways in which the SECURE Rule itself might be improved, but more broadly provides a normative framework for the evaluation of trustworthy regulatory policy-making. (shrink)

The multistep pathway of eukaryotic gene expression involves a series of highly regulated events in the nucleus and cytoplasm. In the nucleus, genes are transcribed into pre‐messenger RNAs which undergo a series of nuclear processing steps. Mature mRNAs are then transported to the cytoplasm, where they are translated into protein and degraded at a rate dictated by transcript‐ and cell‐type‐specific cues. Until recently, these individual nuclear and cytoplasmic events were thought to be primarily regulated by different RNA‐ and DNA‐binding (...) proteins that are localized either only in the nucleus or only the cytoplasm. Here, we describe multifunctional proteins that control both nuclear and cytoplasmic steps of gene expression. One such class of multifunctional proteins (e.g., Bicoid and Y‐box proteins) regulates both transcription and translation whereas another class (e.g., Sex‐lethal) regulates both nuclear RNA processing and translation. Other events controlled by multifunctional proteins include assembly of spliceosome components, spliceosome recycling, RNA editing, cytoplasmic mRNA localization, and cytoplasmic RNA stability. The existence of multifunctional proteins may explain the paradoxical involvement of the nucleus in an RNA surveillance pathway (nonsense‐mediated decay) that detects cytoplasmic signals (premature termination codons). We speculate that shuttling multifunctional proteins serve to efficiently link RNA metabolism in the cytoplasmic and nuclear compartments. BioEssays 23:775–787, 2001. © 2001 John Wiley & Sons, Inc. (shrink)

With the arrival of new methods of genome editing, especially CRISPR/cas 9, new perspectives on germline interventions have arisen. Supporters of germ line genome editing claim that the procedure could be used as a means of disease prevention. As a possible life-saving therapy, it provides benefits that outweigh its risks. Opponents of GGE claim that the medical and societal risks, especially the use of GGE for genetic enhancement, are too high. In our paper, we analyze the risks and (...) benefits of GGE. We show that the medical risk on an individual level might be reduced by further research in the near future so that they may be outweighed by the benefits. We also show that the societal risks of the procedure, i.e. genetic enhancement, are manageable by establishing a regulative framework before the GGE is implemented. Since the effects of modifying genes for the genepool of a given population are extremely difficult to model, the medical risks on the population level might be too high. (shrink)

Some suggest that gene editing human embryos to prevent genetic disorders will be in one respect morally preferable to using genetic selection for the same purpose: gene editing will benefit particular future persons, while genetic selection would merely replace them. We first construct the most plausible defence of this suggestion—the benefit argument—and defend it against a possible objection. We then advance another objection: the benefit argument succeeds only when restricted to cases in which the gene-edited (...) child would have been brought into existence even if gene editing had not been employed. Our argument relies on a standard account of comparative benefit which has recently been criticised on the grounds that it succumbs to the so-called ‘pre-emption problem’. We end by considering how our argument would be affected were the standard account revised in an attempt to evade this problem. We consider three revised accounts and argue that, on all three, our critique of the benefit argument stands. (shrink)

Timely effective regulation of genetic advances presents a challenge for justice systems. We used a 51-item battery to examine views on major genetics-related issues of those at the forefront of regulating this area – Supreme Court judges (N = 73). We also compared their views with those of other justice stakeholders (N = 210) from the same country (Romania). Judges showed greater endorsement and less variability in views on the use of genetic data and technologies than the other groups. (...) The agreement among the judges was strikingly strong for some controversial issues, including gene editing; patenting of genetic findings; and the State using genetic information for crime prevention. Judges and other lawyers recognized the need for amending the relevant laws. Without appropriate regulation, genetic science has a risk of propelling inequality rather than fulfilling its promise to improve people’s lives. (shrink)

The precautionary principle aims to influence decision‐making in contexts where some activity poses uncertain but potentially grave threats. This perfectly describes the controversy surrounding germline gene editing. This article considers whether the precautionary principle should influence how we weigh the risks and benefits of human germline interventions, focusing especially on the possible threats to the health of future generations. We distinguish between several existing forms of the precautionary principle, assess their plausibility and consider their implications for the ethics (...) of germline modification. We also offer a novel form of the precautionary principle: the sufficientarian precautionary principle. Some plausible versions of the precautionary principle recommend placing somewhat greater weight on avoiding threats to future generations than on achieving short‐term benefits. However, no plausible versions of the precautionary principle entail that we should outright reject the use germline gene editing in human reproduction and some, such as the sufficientarian version, might endorse its use. (shrink)

Graphical AbstractRecent waves of controversies surrounding genetic engineering have spilled into popular science in Twitter battles between reputable scientists and their followers. Here, a cautionary perspective on the possible blind spots and risks of CRISPR and related biotechnologies is presented, focusing in particular on the stochastic nature of cellular control processes.

If bioethical questions cannot be resolved in a widely acceptable manner by rational argument, and if they can be regulated only on the basis of political decision-making, then bioethics belongs to the political sphere. The particular kind of politics practiced in any given society matters greatly: it will determine the kind of bioethical regulation, legislation, and public policy generated there. I propose approaching bioethical questions politically in terms of decisions that cannot be “correct” but that can be “procedurally legitimate.” (...) Two procedures in particular can deliver legitimate bioethical decisions, once combined: expert bioethics committees and deliberative democracy. Bioethics so understood can exceed bioethics as a moral project or as a set of administrative principles to regulate medical practice; it can now aspire to a democratic project that involves ordinary citizens as far as reasonably possible. I advance this argument in four steps: (1) using the example of human germline gene editing, (2) I propose a general understanding of proceduralism, and (3) then combine two types and (4) conclude with a defense of majoritarian proceduralism. I develop this argument in terms of one example: germline gene editing. (shrink)