Genome editing in livestock could potentially be used in ways that help resolve some of the most urgent and serious global problems pertaining to livestock, including animal suffering, pollution, antimicrobial resistance, and the spread of infectious disease. But despite this potential, some may object to pursuing it, not because genome editing is wrong in and of itself, but because it is the wrong kind of solution to the problems it addresses: it is merely a ‘technological fix’ (...) to a complex societal problem. Yet though this objection might have wide intuitive appeal, it is often not clear what, exactly, the moral problem is supposed to be. The aim of this paper is to formulate and shed some light on the ‘technological fix objection’ to genome editing in livestock. I suggest that three concerns may underlie it, make implicit assumptions underlying the concerns explicit, and cast some doubt on several of these assumptions, at least as they apply to the use of genome editing to produce pigs resistant to the Porcine Reproductive and Respiratory Syndrome and hornless dairy cattle. I then suggest that the third, and most important, concern could be framed as a concern about complicity in factory farming. I suggest ways to evaluate this concern, and to reduce or offset any complicity in factory farming. Thinking of genome editing’s contribution to factory farming in terms of complicity, may, I suggest, tie it more explicitly and strongly to the wider obligations that come with pursuing it, including the cessation of factory farming, thereby addressing the concern that technological fixes focus only on a narrow problem. (shrink)

In “Human germline genome editing: On the nature of our reasons to genome edit,” Robert Sparrow (2022) presents a central claim and a secondary one. The central claim is that, for the foreseeable f...

Genome editing is revolutionising the field of genetics, which includes novel applications to food animals. Responsible research and innovation has been advocated as a way of ensuring that a wider-range of stakeholders and publics are able to engage with new and emerging technologies to inform decision making from their perspectives and values. We posit that genome editing is now proceeding at such a fast rate, and in so many different directions, such as to overwhelm attempts to (...) achieving a more reflective pace. An alternative location for reflection is during the much slower process of taking products from the lab to market. We suggest emphasising Responsible Innovation, putting the ‘I’ back into RRI, and encouraging companies to embrace an RRI approach. We review some previous attempts at developing industry-relevant frameworks for RRI. We then describe two examples of genome editing in livestock; hornless cattle and disease resistant pigs, and reflect on the sorts of questions that could be considered in these two genome editing examples. This paper seeks to take forward the discussion on RRI by extending it to bringing products to market in the context of genome edited livestock. (shrink)

A global socio‐bioethics is called upon to address the ethical challenges arising from the revolutionary gene editing technologies such as CRISPR‐Cas9, which offers the capability to rewrite the human genome. The ethical inquiry Françoise Baylis has undertaken in the book Altered Inheritance: CRISPR and the Ethics of Human Genome Editing (Harvard University Press, 2019) operates at individual, societal and global levels. Baylis has not only presented insights on how to practice “slow science” and achieve broad societal (...) consensus through empowering the public, but she also shown what a global socio‐bioethics approach can offer for the further development of bioethics. (shrink)

BackgroundHuman genome editing technologies offer much potential benefit. However, central to any conversation relating to the application of such technologies are certain ethical, legal, and social difficulties around their application. The recent misuse, or inappropriate use, by certain Chinese actors of the application of genome editing technologies has been, of late, well noted and described. Consequently, caution is expressed by various policy experts, scientists, bioethicists, and members of the public with regard to the appropriate use of (...) human germline genome editing and its possible future effect on future generations.Main textAs concerns about the applications of heritable genome editing have grown, so too have the questions around what is to be done to curtail ‘rogue actors’. This paper explores various ways in which to regulate genomic editing that are socially beneficial, while being cognisant of legal and ethical principles and rights values. This is done by evolving regulatory frameworks across jurisdictions in an attempt to raise issues, address common principles, and set responsible standards for stewardship of the novel technology.ConclusionsIt is suggested that robust and concrete regulatory measures be introduced that are culturally and contextually sensitive, inclusive, appropriate, and trustworthy – and are based on public empowerment and human rights objectives. Doing so will ensure that we are perfectly positioned to harness and promote the benefits that novel technologies have to offer, while safeguarding public health and curtailing the ambitions of rogue actors. This it is acknowledged is no easy task, so, as a point of departure, this paper sets out a path forward by means of certain, practical recommendations – by constructing genome editing regulation in a manner that both fulfils the desire to better progress human health and that can withstand legal and ethical scrutiny.The following observations and recommendations are made: Firstly, that a solution of effective, legitimate governance should consist of a combination of national and supranational legislative regulation or ‘hard’ law, in combination with ‘soft’ ethics, firmly anchored in and underpinned by human rights values. Second, that efforts to support legal and ethical solutions should be rigorous, practical, and robust, contribute to a reaffirmation of human rights in a contextually sensitive manner, and be transnational in reach. Lastly, that greater harmonisation across jurisdictions and increased public engagement be sought. This it is proposed will address the question of how to implement a normative framework which in turn can prevent future rogue actors. (shrink)

The prospect of using genome technologies to modify the human germline has raised profound moral disagreement but also emphasizes the need for wide-ranging discussion and a well-informed policy response. The Hinxton Group brought together scientists, ethicists, policymakers, and journal editors for an international, interdisciplinary meeting on this subject. This consensus statement formulated by the group calls for support of genome editing research and the development of a scientific roadmap for safety and efficacy; recognizes the ethical challenges involved (...) in clinical reproductive applications of genome editing but, importantly, rejects the idea that human reproductive germline modification is necessarily morally unacceptable; and highlights the importance of meaningful engagement in discussions of genome editing and the development of regulation and oversight mechanisms to govern future uses of such technologies. (shrink)

A central problem for the international governance of heritable germline gene editing is that there are important differences in attitudes and values as well as ethical and health care considerations around the world. These differences are reflected in a complicated and diverse regulatory landscape. Several publications have discussed whether reproductive uses would be legally permissible in individual countries and whether clinical applications could emerge in the context of regulatory gaps and gray areas. Systematic comparative studies that explore issues related (...) to the governance of this technology from different national and international perspectives are needed to address the lack of knowledge in this area. In this research report, we contribute to filling this gap by presenting views of stakeholders in the United Kingdom on challenges to the governance of heritable genome editing. We present findings from a multistakeholder study conducted in the United Kingdom between October 2016 and January 2018 and funded by the Wellcome Trust. This research included interviews, literature analysis, and a workshop. We involved leading U.K. scientists, in vitro fertilization clinicians, and representatives from regulatory bodies, patient organizations, and other civil societal organizations, as well as fertility companies. Part one of this article explores stakeholder perceptions of possible global developments in heritable genome editing and associated risks and governance challenges. Part two presents a range of policy options that were generated during the workshop in relation to the challenges discussed in part one. (shrink)

In this paper I argue that some human reproductive genome editing interventions can be therapeutic in nature, and thus that it is false that all such interventions just create healthy individuals. I do this by showing that the conditions established by a therapy definition are met by certain reproductive genome editing interventions. I then defend this position against two objections: (a) reproductive genome editing interventions do not attain one of the two conditions for something (...) to be a therapy, and (b) some reproductive genome editing interventions are therapeutic but in a nonstandard way. In the Conclusion I call for a more nuanced discussion of the nature of reproductive genome editing interventions. (shrink)

CRISPR is widely considered to be a disruptive technology. However, when it comes to the most controversial topic, germline genome editing (GGE), there is no consensus on whether this technology has any substantial advantages over existing procedures such as embryo selection after in vitro fertilization (IVF) and preimplantation genetic diagnosis (PGD). Answering this question, however, is crucial for evaluating whether the pursuit of further research and development on GGE is justified. This paper explores the question from both a (...) clinical and a moral viewpoint, namely whether GGE has any advantages over existing technologies of selective reproduction and whether GGE could complement or even replace them. In a first step, I review an argument of extended applicability. The paper confirms that there are some scenarios in which only germline intervention allows couples to have (biologically related) healthy offspring, because selection will not avoid disease. In a second step, I examine possible moral arguments in favour of genetic modification, namely that GGE could save some embryos and that GGE would provide certain benefits for a future person that PGD does not. Both arguments for GGE have limitations. With regard to the extended applicability of GGE, however, a weak case in favour of GGE should still be made. (shrink)

In the last 10 years, we have witnessed a blooming of targeted genome editing systems and applications. The area was revolutionized by the discovery and characterization of the transcription activator‐like effector proteins, which are easier to engineer to target new DNA sequences than the previously available DNA binding templates, zinc fingers and meganucleases. Recently, the area experimented a quantum leap because of the introduction of the clustered regularly interspaced short palindromic repeats (CRISPR)‐associated protein (Cas) system (clustered regularly interspaced (...) short palindromic sequence). This ribonucleoprotein complex protects bacteria from invading DNAs, and it was adapted to be used in genome editing. The CRISPR ribonucleic acid (RNA) molecule guides to the specific DNA site the Cas9 nuclease to cleave the DNA target. Two years and more than 1000 publications later, the CRISPR‐Cas system has become the main tool for genome editing in many laboratories. Currently the targeted genome editing technology has been used in many fields and may be a possible approach for human gene therapy. Furthermore, it can also be used to modifying the genomes of model organisms for studying human pathways or to improve key organisms for biotechnological applications, such as plants, livestock genome as well as yeasts and bacterial strains. (shrink)

How should we regulate genome editing in the face of persistent substantive disagreement about the moral status of this technology and its applications? In this paper, we aim to contribute to resolving this question. We first present two diametrically opposed possible approaches to the regulation of genome editing. A first approach, which we refer to as “elitist,” is inspired by Joshua Greene’s work in moral psychology. It aims to derive at an abstract theoretical level what preferences (...) people would have if they were committed to implementing public policies regulating genome editing in a context of ethical pluralism. The second approach, which we refer to as the democratic approach, defended by Francoise Baylis and Sheila Jasanoff et al., emphasizes the importance of including the public’s expressed attitudes in the regulation of genome editing. After pointing out a serious shortcoming with each of these approaches, we propose our own favored approach—the “enlightened democracy” approach—which attempts to combine the strengths of the elitist and democratic approaches while avoiding their weaknesses. (shrink)

Ethical statements and position papers on genome editing often refer to “the public” that should get involved, and a public discussion that should take place. It is not self-evident what this reference to the public means and why such a public engagement should take place. This chapter explores the concept of the public as discussed in key position papers on genome editing and puts it into relationship with the notion of the public in political theory. The (...) fuzzy notion of the public is presented in these statements on genome editing as a tool to solve problems and to allow for hitherto unheard points of view to be considered. It is sometimes understood as a general tool for reciprocal education and social self-determination. Other times still it is used in an instrumental way to gain public support and foster an environment friendly to research and innovation. There is disagreement about the aims, the reason, and the norms guiding public discussion and the possibility of a neutral form of communication. Last but not least awareness is required for the way the public debate is framed by the very use of “genome” and “editing” rather than other concepts. (shrink)

Biotechnology might contribute to solving food safety and security challenges. However, gene technology has been under public scrutiny, linked to the framing of the media and public discourse. The study aims to investigate people’s perceptions and acceptance of food biotechnology with focus on transgenic genetic modification versus genome editing. An online experiment was conducted with participants from the United Kingdom and Switzerland. The participants were presented with the topic of food biotechnology and more specifically with experimentally varied vignettes (...) on transgenic and genetic modification and genome editing. The results suggest that participants from both countries express higher levels of acceptance for genome editing compared to transgenic genetic modification. The general and personal acceptance of these technologies depend largely on whether the participants believe the application is beneficial, how they perceive scientific uncertainty, and the country they reside in. Our findings suggest that future communication about gene technology should focus more on discussing trade-offs between using an agricultural technologies and tangible and relevant benefits, instead of a unidimensional focus on risk and safety. (shrink)

Though genome editing is a powerful technology, germline GE engineering is strongly objectionable for a huge ethical challenge. The after-effects of the genome-edited babies incident have been emerging in China, whether technology or ethics. It is very noticeable that the case has been adverse effects on the application of GE technology in other fields, especially in GE crops. After the incident, research and development of GE crops was affected obviously. It is clear that GE crops and other (...) basic research and application related to GE technology should be encouraged and should not be treated differently. An ethically acceptable development route of GE technology needs to be established in China. (shrink)

Among the objections to the implementation of what I will call "genome editing in human reproduction" is that it does not address any unmet medical need, and therefore fails to meet an important criterion for introducing an unproven procedure with potentially adverse consequences. To be clear: what I mean by GEHR is the use of any one of a number of related biological techniques, such as the CRISPR-Cas9 system, deliberately to modify a functional sequence of DNA in a (...) cell of a human embryo, so that the modified sequence is replicated in the cells of a resulting child and may, without further intervention, be passed on to that child's biological descendants. It is... (shrink)

Natural genome editing from a biocommunicative perspective is the competent agent-driven generation and integration of meaningful nucleotide sequences into pre-existing genomic content arrangements, and the ability to (re-)combine and (re-)regulate them according to context-dependent (i.e. adaptational) purposes of the host organism. Natural genome editing integrates both natural editing of genetic code and epigenetic marking that determines genetic reading patterns. As agents that edit genetic code and epigenetically mark genomic structures, viral and subviral agents have been (...) suggested because they may be evolutionarily older than cellular life. This hypothesis that viruses and viral-like agents edit genetic code is developed according to three well investigated examples that represent key evolutionary inventions in which non-lytic viral swarms act symbiotically in a persistent lifestyle within cellular host genomes: origin of eukaryotic nucleus, adaptive immunity, placental mammals. Additionally an abundance of various RNA elements cooperate in a variety of steps and substeps as regulatory and catalytic units with multiple competencies to act on the genetic code. Most of these RNA agents such as transposons, retroposons and small non-coding RNAs act consortially and are remnants of persistent viral infections that now act as co-opted adaptations in cellular key processes. (shrink)

While somatic cell editing to treat disease is widely accepted, the use of human genome editing for “enhancement” remains contested. Scientists and policy-makers routinely cite the prospect of enhancement as a salient ethical challenge for human genome editing research. If preventive genome editing projects are perceived as pursuing human enhancement, they could face heightened barriers to scientific, public, and regulatory approval. This article outlines what we call “preventive strengthening research” (or “PSR”) to explore, (...) through this example, how working to strengthen individuals’ resistance to disease beyond what biomedicine considers to be the human functional range may be interpreted as pursuing human enhancement. Those involved in developing guidance for PSR will need to navigate the interface between preventive goals and enhancement implications. This article identifies and critiques three of these ideas in the interest of anticipating the wider emergence of PSR and the need for a normative approach for its pursuit. All three “candidate criteria” merit attention, but each also faces challenges that will need to be addressed as further research policy is developed. (shrink)

Heritable genome editing is officially here. ‘Lulu’ and ‘Nana’, born in China, are the first children whose genomes have been intentionally modified. A third gene edited baby may have already been born. Scientists in Russia are planning similar applications.1 We recently argued that HGE should be judged by the same ethical standards that we apply to other technologies.2 There is a moral imperative to improve the health of future generations, to reduce inequalities and improve standards of living. If (...) we can use HGE to achieve these aims, we should. We want to thank Sarah Chan, Peter Mills, Rachel Horton and Anneke Lucassen for their thoughtful criticisms of our paper. We would also like to thank the editors of the Journal of Medical Ethics for helping facilitate this detailed discussion. The moral questions posed by HGE, are complex, multifaceted and difficult. They required focused attention, which formats like this encourage. Our responses to each of the commentaries are detailed below We agree with the following points made in Horton and Lucassen’s paper ‘ The moral argument for heritable genome editing requires an inappropriately deterministic view of genetics ’.3 These are some of the reasons why we say HGE targeting polygenic diseases is likely decades away.2 The technical challenges seem daunting. But science can move quickly, and often does so in bounds. Our capacity to capture and analyse genetic data is rapidly expanding. Over the next 5 years, genomic …. (shrink)

In this paper, I will present the empirical version of the slippery slope argument (SSA) in the field of genome editing. According to the SSA, if we adopt germline manipulation of embryos we will eventually end up performing or allowing something morally reprehensible, such as new coercive eugenics. I will investigate the actual possibility of sliding towards eugenics: thus, I will examine enhancement and eugenics both in the classical and liberal versions, through the lens of SSA. In the (...) first part, I will discuss the classical eugenics from a historical perspective and conclude that classical eugenics is morally deplorable; but by currently accepting genome editing I argue that it is not possible to ‘slip’ into classical eugenics. Then, I will analyze liberal eugenics: I will consider Habermas’ and Sandel’s objections to liberal eugenics and genetic human enhancement. Subsequently, I will reply to these arguments affirming that, although it is not possible to refuse any form of genetic enhancement, liberal eugenics would not consider the principles of justice, non-maleficence, and non-instrumentalization; hence, it should be considered not morally acceptable. In addition, I will support the thesis according to which the possibility of relapsing into liberal eugenics is more likely than relapsing into classical eugenics. Then, I will present a strategy that, while avoiding falling into the undesirable scenarios related to SSA, still accepts some application of germline genome editing of embryos and gametes. In such a way, I will show that even if we accept the plausibility of a certain slip into an undesirable scenario, SSA does not offer conclusive reasons to forbid any use of germline genome editing technique in both therapeutic and enhancement fields. (shrink)

Although germline editing has been the subject of debate ever since the 1980s, it tended to be based rather on speculative assumptions until April 2015, when CRISPR/Cas9 technology was used to modify human embryos for the first time. This article combines knowledge about the technical and scientific state of the art, economic considerations, the legal framework and aspects of clinical reality. A scenario will be elaborated as a means of identifying key ethical implications of CRISPR/Cas9 genome editing (...) in humans and possible ways of dealing with them. Unlike most other discussions of CRISPR/Cas9 germline editing, which are generally based on deontological arguments, the focus in this case will be on a consequentialistic argument against certain applications of germline and somatic editing that takes not only the potential benefits and risks but also socioeconomic issues into consideration. The practical need for an indication catalogue, guidelines for clinical trials, and for funding of basic research will be pointed out. It will be argued that this need for regulatory action and discussion does not stem primarily from the fact that CRISPR/Cas9 germline editing is revolutionary in terms of its ethical implications and potential for human therapy, although this is the prevailing view in the current discussion. Understanding the value and interest dependency of arguments put forward by different stakeholders and learning from past debates related to similar technologies might prove a fruitful method of reaching judgments and decisions that come closer to a consensus upon which society as a whole can agree - which after all should be the true goal of an ethical debate and of bioethics. (shrink)

Editing human germline genes may act as boon in some genetic and other disorders. Recent editing of the genome of the human embryo with the CRISPR/Cas9 editing tool generated a debate amongst top scientists of the world for the ethical considerations regarding its effect on the future generations. It needs to be seen as to what transformation human gene editing brings to humankind in the times to come.

The article by Conrad et al. (AJOB Neuroscience, 2019, 10:1) does not take into account another, still hypothetical, procedure for cognitive enhancement (CE) which would be appropriate to consider in the surveys, i.e. the possibility to genetically enhance the cognitive abilities of a future individual using genome editing techniques. In this case, the conclusions of the article in the context of the “self-others difference” and “safety/naturalness” would be questioned. In fact, the results of the hypothetical surveys with the (...) variant “genome editing” could be significantly different from those obtained in the survey proposed by the authors: an individual would decide not for himself, but for the CE in a future child. In light of these considerations, we hold that the article highlights just the attitudes toward the principle of autonomy and redistributive justice; however, by introducing the new hypothetical scenario of CE with genome editing the attitudes toward the principles of beneficence and non-instrumentalisation could also be appreciated. Special attention to future generations is necessary to inform potential CE public policy, though using genome editing to enhance cognition abilities is just a future hypothetical perspective. (shrink)

First uniform description of all key levels of communication in the organismic kingdoms of plants, fungi, animals (bees and corals), bacteria and additionally the natural genome editing competences of viruses based on the most recent empirical data. The biocommunicative approach presented is based on the results of the philosophy of science discourse concerning coherent definitions of 'language' and 'communication'.

Contemporary genome editing techniques have made genomic intervention—from microorganism to human—more accessible, easier to use, and more accurate than previous methods. We argue that, notwithstanding its merits in treating and preventing disease in humans, genome editing represents a potential threat for domestic and international security, requiring an integrated approach in regulating, detecting, preventing, and mitigating the risk of its use for malicious purposes. Despite the global regulatory ambitions of the 2021 WHO framework, we see insufficient attention (...) given to the future prospect of dual-use genomic technology. Drawing parallels with the nuclear field, we suggest tentative practical steps for a way forward in dealing with genome editing technologies, such as: 1) adapting national (bio)security and defence strategies to include genome editing as a possible threat (with conceivable WMD potential); 2) enhancing the international dialogue on genome editing and raising the issue at the highest level; 3) working towards a global, legally binding verification mechanism; 4) tracking genome editing technologies. (shrink)

Gene editing tools are ‘revolutionizing’ microbiological research. Much of the public debate focuses on the possibility of human germ line applications. The use of genome editing to alter non-human animals, however, will have more immediate impacts on our daily lives. Genome edited animals are used for basic biological and biomedical research and could soon play a role in the livestock industry and ecosystem management. Genome editing thus provides an occasion to rethink societal narratives about (...) the relationships between humans and other animals. Even though the technique can be easily incorporated as an example into a conventional storyline about the development of the modern life sciences as striving for control over nature, it can also help to highlight the anthropocentric biases expressed in these narratives and demonstrate the continuities between humans and other animals. (shrink)

This paper explores the ethics of introducing genome-editing technologies as a new reproductive option. In particular, it focuses on whether genome editing can be considered a morally valuable alternative to preimplantation genetic diagnosis (PGD). Two arguments against the use of genome editing in reproduction are analysed, namely safety concerns and germline modification. These arguments are then contrasted with arguments in favour of genome editing, in particular with the argument of the child’s welfare (...) and the argument of parental reproductive autonomy. In addition to these two arguments, genome editing could be considered as a worthy alternative to PGD as it may not be subjected to some of the moral critiques moved against this technology. Even if these arguments offer sound reasons in favour of introducing genome editing as a new reproductive option, I conclude that these benefits should be balanced against other considerations. More specifically, I maintain that concerns regarding the equality of access to assisted reproduction and the allocation of scarce resources should be addressed prior to the adoption of genome editing as a new reproductive option. (shrink)

In a recent public engagement study on heritable human genome editing (HHGE) conducted among South Africans, participants approved of using HHGE for serious health conditions—viewing it as a means of bringing about valuable social goods—and proposed that the government should actively invest resources to ensure everyone has equal access to the technology for these purposes. This position was animated by the view that future generations have a claim to these social goods, and this entitlement justified making HHGE available (...) in the present. This claim can be ethically justified in the Ubuntu ethic (deriving from South Africa) as it (a) emphasizes the interests of the community, and (b) espouses a metaphysical conception of the community that transcends the present generation and includes past and future generations. On this basis, a compelling claim can be made on behalf of prospective persons in favor of equal access to HHGE. (shrink)

It is becoming increasingly evident that the driving forces of evolutionary novelty are not randomly derived chance mutations of the genetic text, but a precise genome editing by omnipresent viral agents. These competences integrate the whole toolbox of natural genetic engineering, replication, transcription, translation, genomic imprinting, genomic creativity, enzymatic inventions and all types of genetic repair patterns. Even the non-coding, repetitive DNA sequences which were interpreted as being ancient remnants of former evolutionary stages are now recognized as being (...) of viral descent and crucial for higher-order regulatory and constitutional functions of protein structural vocabulary. In this article I argue that non-randomly derived natural genome editing can be envisioned as (a) combinatorial (syntactic), (b) context-specific (pragmatic) and (c) content-sensitive (semantic) competences of viral agents. These three-leveled biosemiotic competences could explain the emergence of complex new phenotypes in single evolutionary events. After short descriptions of the non-coding regulatory networks, major viral life strategies and pre-cellular viral life three of the major steps in evolution serve as examples: There is growing evidence that natural genome-editing competences of viruses are essential (1) for the evolution of the eukaryotic nucleus, (2) the adaptive immune system and (3) the placental mammals. (shrink)

This paper analyses the activities of five organizations shaping the debate over the global governance of genome editing in order to assess current approaches to public engagement (PE). We compare the recommendations of each group with its own practices. All recommend broad engagement with the general public, but their practices vary from expert-driven models dominated by scientists, experts, and civil society groups to citizen deliberation-driven models that feature bidirectional consultation with local citizens, as well as hybrid models that (...) combine elements of both approaches. Only one group practices PE that seeks community perspectives to advance equity. In most cases, PE does little more than record already well-known views held by the most vocal groups, and thus is unlikely to produce more just or equitable processes or policy outcomes. Our exploration of the strengths, weaknesses, and possibilities of current forms of PE suggests a need to rethink both “public” and “engagement.”. (shrink)

Genome editing enables very accurate alterations to DNA. It promises profound and potentially disruptive changes in healthcare, agriculture, industry, and the environment. This paper presents a multidisciplinary analysis of the contemporary development of genome editing and the tension between continuity and change. It draws on the idea that actors involved in innovation are guided by “sociotechnical regimes” composed of practices, institutions, norms, and cultural beliefs. The analysis focuses on how genome editing is emerging in (...) different domains and whether this marks continuity or disruption of the established biotechnology regime. In conclusion, it will be argued that genome editing is best understood as a technology platform that is being powerfully shaped by this existing regime but is starting to disrupt the governance of biotechnology. In the longer term is it set to converge with other powerful technology platforms, which together will fundamentally transform the capacity to engineer life. (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)

One of the main fields of research in genome editing is the manufacture of transgenic organisms. If this includes genetically human components, then we must not only ask whether such techniques should be allowed, but also what the moral status of “cross species beings” with a genetically “human” component would be and whether the possibility to manufacture them affects the validity of bioethical arguments from species affiliation. In my chapter I want to show that the two latter questions (...) are less dramatic than it might seem, because most, if not all transgenic organisms are not real “interspecies beings”, but rather belong to one of the original species, or constitute a new species. As for the first question, possible epistemic uncertainties about the status of transgenic organisms call for a precautionary approach. (shrink)

Sperm, eggs and embryos are made up of more than genes, and there are indications that changes to non‐genetic structures in these elements of the germline can also be inherited. It is, therefore, a mistake to treat phrases like ‘germline inheritance’ and ‘genetic inheritance’ as simple synonyms, and bioethical discussion should expand its focus beyond alterations to the genome when considering the ethics of germline modification. Moreover, additional research on non‐genetic inheritance draws attention to a variety of means whereby (...) differences can be inherited in offspring generations that do not rely on differences in germline structures. Research on these diverse forms of inheritance challenges the notion that there is some special form of ethical concern that falls on germline interventions in general, and on interventions to the nuclear genome within the germline in particular. (shrink)

Germline genome editing is often disapproved of at the international policy level because of its possible threats to human dignity. However, from a critical perspective the relationship between this emerging technology and human dignity is relatively understudied. We explore the main principles that are referred to when 'human dignity' is invoked in this context; namely, the link with eugenics, the idea of a common genetic heritage, the principle of equal birth and broader equality and justice concerns. Yet the (...) concept is also used in favour of germline genome editing as it might improve the overall well-being of future generations. We conclude that dignity concerns do not justify a complete ban on safe heritable genome editing but should inform the implementation of side constraints to ensure that the value judgements about human traits that are inherent in this practice do not result in a diminished basic respect for those people affected by them. (shrink)

Ever since the publication of Derek Parfit’s Reasons and Persons, bioethicists have tended to distinguish between two different ways in which reproductive technologies may have implications for the...

The Guidelines for Stem Cell Research and Clinical Translation, recently issued by the International Society for Stem Cell Research (ISSCR), include a number of substantive revisions. Significant changes include: (1) the bifurcation of ‘Category 3 Prohibited research activities’ in the 2016 Guidelines into ‘Category 3A Research activities currently not permitted’ and ‘Category 3B Prohibited research activities’ in the 2021 guidelines and (2) the move of heritable human genome editing research out of the ‘prohibited’ category and into the ‘currently (...) not permitted’ category. These changes are noteworthy because of the absence of a clear demarcation line between the two categories insofar as, by definition, that which is ‘prohibited’ is ‘currently not permitted’, and vice versa. Permanence is not part of the definition of ‘prohibition’. In principle, a prohibition can be rescinded at any time. This begs the question ‘Why make a policy change that has no apparent practical effect?’ One hypothesis is that the recategorisation of specific ‘prohibited’ research activities as ‘currently not permitted’ is meant to seed intuitions about which prohibited research activities should ‘soon’ be permitted subject to specialised scientific and ethics review and approval. (shrink)

The aim of the presentation is to focus on the differences between two scientific contexts: the genetic engineering context of the 1970s, with specific attention paid to the use of the recombinant DNA technique to generate genetically modified molecules, and the current genome editing context, with specific attention paid to the use of CRISPR-Cas9 technology to modify human germ line cells genetically. In both events, scientists have been involved in discussions that have gone beyond mere professional deontology touching (...) on specific policy issues such as freedom of research, responsibility for the consequences of research, the right of the public to participate in the evaluation of the goals of research methods, the relationship between cost and benefit and possible social consequences. The comparison between these two scientific contexts suggests the need of handling such issues by defining procedures that meet the criteria of democracy and responsibility towards society. The underlying objective should be to effectively launch actions and interventions based not on a hierarchical approach but rather a reticular conception of knowledge. (shrink)

Following the Second Summit on Human Gene Editing in Hong Kong in 2018, where the birth of two girls with germline genome editing was revealed, the need for a responsible pathway to the clinical application of human germline genome editing has been repeatedly emphasised. This paper aims to contribute to the ongoing discussion on research ethics issues in germline genome editing by exploring key issues related to the initial applications of CRISPR in reproductive (...) medicine. Following an overview of the current discussion on bringing germline genome editing into clinical practice, we outline the specific challenges associated with such interventions and the features that distinguish them from conventional clinical testing of new medical treatments. We then review proposed ethical requirements for initial heritable genome editing, such as the absence of reasonable alternatives, the existence of sufficient and reliable preclinical data, appropriate informed consent, requirements related to safety, and long-term follow-up. (shrink)

In this commentary paper, we are taking one step further in questioning the central assumptions in the bioethical debates about reproductive technologies. We argue that the very distinction between “person affecting” and “identity affecting” interventions is based on a questionable form of material-origin essentialism. Questioning of this form of essentialist approach to human identity allows treating genome editing and genetic selection as more similar than they are taken to be in the standard approaches. It would also challenge the (...) idea that normative reasons we have in these two types of cases markedly differ in strength. (shrink)

Developed in the past two decades, the clustered regularly interspaced short palindromic repeats‐associated protein 9 (CRISPR‐Cas9) technique offers greater accessibility and efficiency in editing genes. Its immediate success has transformed medical research and treatment in productive ways, but has also left questions about ethical consequences in its wake. These are questions familiar to bioethical inquiry. How do we balance short‐term and long‐term benefits and risks? How do we promote just and equitable access to new medical interventions? How do we (...) protect respect for individual autonomy? These questions require a balance between protecting individuals' liberties and the good of the communities in which they live. In this essay, I am interested in how the principle of respect for autonomy can be interpreted in light of CRISPR‐Cas9. I argue that a relational autonomy framework forges a middle ground between the need to respect individual freedom to pursue genetic treatments and the need to acknowledge the networks of dependence that define our moral worlds. I identify three thematic areas that relational autonomy brings into greater focus: the importance of trust, the acknowledgment of vulnerability/dependence, and the promotion of justice. Autonomy understood relationally allows us to see individual freedom as tethered to communal well‐being. (shrink)

Public opinion can affect the adoption of genome editing technologies. In food production, genome editing can be applied to a wide range of applications, in different species and with different purposes. This study analyzed how the public responds to five different applications of genome editing, varying the species involved and the proposed purpose of the modification. Three of the applications described the introduction of disease resistance within different species, and two targeted product quality and (...) quantity in cattle. Online surveys in Canada, the US, Austria, Germany and Italy were carried out with a total sample size of 3698 participants. Using a between-subject design, participants were confronted with one of the five applications and asked to decide whether they considered it right or wrong. Perceived risks, benefits, and the perception of the technology as tampering with nature were surveyed and were complemented with socio-demographics and a measure of the participants’ moral foundations. In all countries, participants evaluated the application of disease resistance in humans as most right to do, followed by disease resistance in plants, and then in animals, and considered changes in product quality and quantity in cattle as least right to do. However, US and Italian participants were generally more positive toward all scenarios, and German and Austrian participants more negative. Cluster analyses identified four groups of participants: ‘strong supporters’ who saw only benefits and little risks, ‘slight supporters’ who perceived risks and valued benefits, ‘neutrals’ who showed no pronounced opinion, and ‘opponents’ who perceived higher risks and lower benefits. This research contributes to understanding public response to applications of genome editing, revealing differences that can help guide decisions related to adoption of these technologies. (shrink)

Background. South Africa (SA) currently has a golden opportunity to legislate on human heritable genome editing (HHGE), as the country is revising its assisted reproductive technology regulations. A set of sub-regulations that deals with HHGE, which could seamlessly slot into the current regulations, has already been developed. The principles underlying the proposed set of sub-regulations are as follows: HHGE should be regulated to improve the lives of the people and should not be banned; the well-established standard of safety (...) and efficacy should be used in the regulation of HHGE; quality of life is what matters, and not preserving a ‘normal’ genome; parents’ reproductive autonomy must be respected; and equality of access to approved HHGE technology should be promoted. Objectives. To ascertain whether the proposed set of sub-regulations that deals with HHGE is aligned with public opinion in SA, and SA’s Bill of Rights. Methods. Public opinion in SA is determined with reference to a deliberative public engagement study on HHGE conducted among South Africans, and the relevant rights in the Bill of Rights are interpreted with reference to recent case law. Results. This proposed set of sub-regulations that deals with HHGE is aligned with public opinion in SA, and SA’s Bill of Rights. Conclusion. Despite the legal and ethical complexities of HHGE, the proposed set of sub-regulations provides a targeted and effective legislative approach. They fit seamlessly into the country’s existing health law framework, creating specific legal standards for HHGE that align with both public opinion and the country’s Bill of Rights. (shrink)

The development of gene-editing technologies, such as the clustered regularly interspaced short palindromic repeats and associated Cas9 endonuclease system, coincides with a rapidly expanding knowledge of the role of genes in the human ageing process. This raises the prospect that, in addition to the treatment of genetic diseases and disorders, it may become possible to use gene-editing technologies to alter the ageing process and significantly extend the maximum human lifespan. Germline editing poses distinctive problems due to its (...) implications for individual members of future, unborn generations. In this essay, I wish to home in, narrowly, on a single ethical objection to extending the lifespan of future generations by editing the human germline. The objection suggests that to extend lifespans is to unethically inflict the harm of loneliness on future people. I claim that the argument rests on assumptions that ought to be rejected. (shrink)