Clustered regularly interspaced short palindromic repeats genome editing has already reinvented the direction of genetic and stem cell research. For more complex diseases it allows scientists to simultaneously create multiple genetic changes to a single cell. Technologies for correcting multiple mutations in an in vivo system are already in development. On the surface, the advent and use of gene editing technologies is a powerful tool to reduce human suffering by eradicating complex disease that has a (...) class='Hi'>genetic etiology. Gene drives are CRISPR mediated alterations to genes that allow them to be passed on to subsequent populations at rates that approach one hundred per cent transmission. Therefore, from an anticipatory biomedical ethics perspective, it is possible to conceive gene drive being used with CRISPR to permanently ameliorate aberrant genes from wild-type populations containing mutations. However, there are also a number of possible side effects that could develop as the result of combining gene editing and gene drive technologies in an effort to eradicate complex diseases. In this paper, we critically analyse the hypothesis that the combination of CRISPR and gene drive will have a deleterious effect on human populations from an ethical perspective by developing an anticipatory ethical analysis of the implications for the use of CRISPR together with gene drive in humans. (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 light of the development of “CRISPR” technology, new promising advances in therapeutic and preventive approaches have become a reality. However, with it came many ethical challenges. The most recent worldwide condemnation of the first use of CRISPR to genetically modify a human embryo is the latest example of ethically questionable use of this new and emerging field. Monotheistic religions are very conservative about such changes to the human genome and can be considered an interference with God’s creation. (...) Moreover, these changes could cause perpetual changes to future generations. The Muslim scholars establish their decisions by addressing five foundations of Islamic law i.e. “maqāṣid al sharı̄`a”; the purposes of the law. These are dın̄, nafs, nasl, `aql and māl. To achieve this, the five principles should all be met before approval of an experiment like the Chinese embryo modifications; Qaṣd which is achieved in this case as it aims to protect the embryo from HIV. Yaqın̄ and Ḍarar were not satisfied as they require strong scientific certainty of the procedures, and evidence of safety. Ḍarūra by which the alternatives being compared; in this case more established and proven safe alternatives to protect the HIV transmission from the father are available, so this principle is not met. The final principle is `Urf, by which the social context of using any contemporary technology should be taken in consideration, and clearly this was not achieved. Collectively, germline changes are rejected from an Islamic perspective until the five principles are fulfilled. In the Chinese Twins gene editing case, there was clearly no justification or support for it according to the Muslim Jurisprudence laws. These laws and approaches can serve as an ethical checklist for such controversial research, especially in early stages of the research. (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)

Current debate and policy surrounding the use of genetic editing in humans often relies on a binary distinction between therapy and human enhancement. In this paper, we argue that this dichotomy fails to take into account perhaps the most significant potential uses of CRISPR-Cas9 gene editing in humans. We argue that genetic treatment of sporadic Alzheimer’s disease, breast- and ovarian-cancer causing BRCA1/2 mutations and the introduction of HIV resistance in humans should be considered within a new (...) category of genetic protection treatments. We find that if this category is not introduced, life-altering research might be unnecessarily limited by current or future policy. Otherwise ad hoc decisions might be made, which introduce a risk of unforeseen moral costs, and might overlook or fail to address some important opportunities. (shrink)

In 2015, a flourish of “alarums and excursions” by the scientific community propelled CRISPR/Cas9 and other new gene-editing techniques into public attention. At issue were two kinds of potential gene-editing experiments in humans: those making inheritable germ-line modifications and those designed to enhance human traits beyond what is necessary for health and healing. The scientific consensus seemed to be that while research to develop safe and effective human gene editing should continue, society's moral uncertainties about (...) these two kinds of experiments needed to be better resolved before clinical trials of either type should be attempted. In the United States, the National Academies of Science, Engineering and Medicine convened the Committee on Human Gene Editing: Scientific, Medical and Ethical Considerations to pursue that resolution. The committee's 2017 consensus report has been widely interpreted as “opening the door” to inheritable human genetic modification and holding a line against enhancement interventions. But on a close reading it does neither. There are two reasons for this eccentric conclusion, both of which depend upon the strength of the committee's commitment to engaging diverse public voices in the gene-editing policy-making process. (shrink)

A recent article on the front page of The Independent reported that the genetic ‘manipulation’ of IVF embryos is to start in Britain, using a new revolutionary gene-editing technique, called Crispr/Cas9. About three weeks later, on the front page of the same newspaper, it was reported that the National Health Service faces a one billion pound deficit only 3 months into the new year. The hidden connection between these reports is that gene editing could be used (...) to solve issues related to health care allocation. Improving the health of future generations might coincide with public health goals; it might improve the health of individuals and communities, and, if successful, might be seen as a public good. However, enhancing future generations will require In Vitro Fertilisation and Pre-implantation Genetic Diagnosis. Remarkably, the necessary involvement of women in an enhancing scenario has not been discussed by its proponents. The present discourse on moral obligations of future generations, although not referring to women, seems to imply that women might be required, morally, if not legally, to reproduce with IVF. Enhancing future generations will be gendered, unless the artificial womb is developed. These are challenging issues that require a wider perspective, of both women and men. Despite the lack of a unified feminist conclusion in the discussions about the merits and risks of human genome modification, there is an urgent need to clarify the role of women in this scenario. (shrink)

Recent research with human embryos, in different parts of the world, has sparked a new debate on the ethics of genetic human enhancement. This debate, however, has mainly focused on gene-editing technologies, especially CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats). Less attention has been given to the prospect of pursuing genetic human enhancement by means of IVF (In Vitro Fertilisation) in conjunction with in vitro gametogenesis, genome-wide association studies, and embryo selection. This article (...) examines the different ethical implications of the quest for cognitive enhancement by means of gene-editing on the one hand, and embryo selection on the other. The article focuses on the ethics of cognitive enhancement by means of embryo selection, as this technology is more likely to become commercially available before cognitive enhancement by means of gene-editing. This article argues that the philosophical debate on the ethics of enhancement should take into consideration public attitudes to research on human genomics and human enhancement technologies. The article discusses, then, some of the recent findings of the SIENNA Project, which in 2019 conducted a survey on public attitudes to human genomics and human enhancement technologies in 11 countries (France, Germany, Greece, the Netherlands, Poland, Spain, Sweden, Brazil, South Africa, South Korea, and United States). (shrink)

CRISPR-Cas9 genome editing can and has altered human genomes, bringing bioethical debates about this capability to the forefront of philosophical and policy considerations. Here, I consider the underexplored implications of CRISPR-Cas9 gene drives for heritable human genome editing. Modification gene drives applied to heritable human genome editing would introduce a novel form of involuntary eugenic practice that I term guerrilla eugenics. Once introduced into a genome, stealth genetic editing by a gene drive (...) class='Hi'>genetic element would occur each subsequent generation irrespective of whether reproductive partners consent to it and irrespective of whether the genetic change confers any benefit. By overriding the ability to ‘opt in’ to genome editing, gene drives compromise the autonomy of carrier individuals and their reproductive partners to choose to use or avoid genome editing and impose additional burdens on those who hope to ‘opt out’ of further genome editing. High incidence of an initially rare gene drive in small human communities could occur within 200 years, with evolutionary fixation globally in a timeframe that is thousands of times sooner than achievable by non-drive germline editing. Following any introduction of heritable gene drives into human genomes, practices intended for surveillance or reversal also create fundamental ethical problems. Current policy guidelines do not comment explicitly on gene drives in humans. These considerations motivate an explicit moratorium as being warranted on gene drive development in heritable human genome editing. (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)

Excerpt: 1. Introduction This chapter provides insight into the diverse ethical debates on genetics and epigenetics. Much controversy surrounds debates about intervening into the germline genome of human embryos, with catchwords such as genome editing, designer baby, and CRISPR/Cas. The idea that it is possible to design a child according to one’s personal preferences is, however, a quite distorted view of what is actually possible with new gene technologies and gene therapies. These are much more limited (...) than the editing and design metaphors suggest. Such metaphors are therefore highly problematic phrases in the context of new gene technologies, for two reasons. On one hand, to design a child of choice by modifying the genome would require modifying any gene of choice, which is more than can be done with current gene technologies, such as CRISPR/Cas. On the other hand, a modification of genes would need to be enough to create any characteristic of choice in the future child. The latter presupposes the assumption of genetic determinism. Moreover, the CRISPR/Cas technology can not only be used in a potentially therapeutic manner at the germline level. In addition, there is the (more likely) scenario of a future clinical therapeutic use of these new gene technologies for modifying the DNA sequence of other cells of the body (somatic genome editing). There is also the option of modifying the epigenome, that is, the spatial configuration of DNA (epigenome editing) (see table 1). Like genetics and genome editing, epigenetics has been at the center of recent popular scientific and ethical discourse as well as scientific debates. The concept of epigenetics has given rise to very different notions of inheritability and responsibility for health, which, however, are oftentimes based on scientifically controversial basic assumptions. That there continues to be covert genetic determinism in the form of epigenetic determinism (see table 2) in debates about epigenetics has been pointed out in ethical analyses of epigenetics. Neither genetic determinism nor epigenetic determinism has been confirmed scientifically. It is therefore important to recognize the concepts that are discussed (and sometimes harshly criticized) in debates about genome editing and epigenetics—for example, concepts about the causal role of DNA for our own life course. This importance is based on the fact that if we understand such controversial concepts, we will be able to remain critical when evaluating scientific knowledge and ethical arguments about genome editing and epigenetics. This chapter, therefore, explains some of these concepts. For an ethical analysis of epigenetics as well as of genome editing, it is necessary to understand and critically reflect upon the underlying concepts of genetic determinism and other, related -isms. The following section offers a detailed introduction to these -isms (section 2; see also table 2). Section 3 provides an ethical analysis of genome editing and epigenetics based on the explanations in section 2. Section 3 focuses on inheritability and responsibility, justice, safety, the problem of consent, and the effects of genome editing and epigenetics on embryos and future generations. This section does not discuss in detail further points that can be found in ethical debates about epigenetics as well as in ethical debates about genome editing. These points include (among others): • fear that the findings of epigenetics and that the methods of genome editing are misused—this also with respect to eugenics and enhancement; • naturalness—an issue we mention in passing a few times in the following analysis; • a possible connection between the genome/epigenome and the concept of human dignity, and the derived danger of instrumentalization and infringement of autonomy when intervening in the genome or epigenome. Since current discourse about ethical issues associated with genome editing focuses mainly on germline interventions, which are, for instance, interventions into a human embryo’s genome, we mainly focus on germline interventions when comparing the debates on genome editing and on epigenetics in section 3. (shrink)

"This title was first published in 2003.Developments in genetic science are opening up new possibilities for human beings; both the creation and the shaping of human life are now possible in the laboratory. As these techniques develop, questions are increasingly asked about how far everything that is scientifically possible should - morally, legally and socially - be pursued. Whilst much attention and policy-making has focussed on the development of regulation of technologies affecting human reproduction, regulation where (...) plants and animals are concerned is much more limited. In this book, developments in genetics are addressed in the broad sense by an international range of contributors. This includes not only issues such as eugenics and the modification of the human embryo, but also the genetic modification of plants and animals in the pursuit of commerce, agriculture and biomedical research. This book is published in association with the Society for Applied Philosophy"--Provided by publisher. (shrink)

In 2015 a team of scientists used a new gene-editing technique called CRISPR-Cas9 to edit the genome of 86 non-viable human embryos. The experiment sparked a global debate on the ethics of gene editing. In this paper; I first review the key ethical issues that have been addressed in this debate. Although there is an emerging consensus now that research on the editing of human somatic cells for therapeutic purpose should be pursued further; the prospect (...) of using gene-editing techniques for the purpose of human enhancement has been met with strong criticism. The main thesis that I defend in this paper is that some of the most vocal objections recently raised against the prospect of genetic human enhancement are not justified. I put forward two arguments for the morality of genetic human enhancement. The first argument shows how the moral and legal framework within which we currently claim our procreative rights; especially in the context of IVF procedures; could be deployed in the assessment of the morality and legality of genetic human enhancement. The second argument calls into question the assumption that the average level of human cognitive performance should have a normative character. (shrink)

The revolutionary potential of the CRISPR-Cas9 gene editing technique has created a resurgence in enthusiasm and concern in genetic research perhaps not seen since the mapping of the human genome at the turn of the century. Some such concerns and anxieties revolve around crossing lines between somatic and germline interventions as well as treatment and enhancement applications. Underpinning these concerns, there are familiar concepts of safety, unintended consequences and damage to genetic identity and the creation of (...) designer children through pursuing human enhancement and eugenics. In the policy realm, these morally laden distinctions and anxieties are emerging as the basis for making important and applied measures to respond to the fast-evolving scientific developments. This paper argues that the dominant normative framing for such responses is insufficient for this task. This paper illustrates this insufficiency as arising from a continued reliance on misleading genetic essentialist assumptions that generate groundless speculation and over-reactionary normative responses. This phenomenon is explicit with regard to prospective human genetic enhancements. While many normative theorists and state-of-the-art reports continue to gesture toward the influence of environmental and social influences on a person and their traits and capacities, this recognition does not extend to the substance of the arguments themselves which tend to revert to the debunked genetic determinist framework. Given the above, this paper argues that there is a pressing need for a more central role for sociological input into particular aspects of this “enhancement myth” in order to give added weight, detail and substance to these environmental influences and influence from social structures. (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)

Genetic engineering has been a topic of discussion for over 50 years, but it is only recently that gene editing has become a reality. CRISPR biotechnologies have made gene editing much safer, precise and feasible. We have witnessed the first cases of human germline genetic modification resulting in live births, conducted by He Jiankui. In this paper, we will analyse He Jiankui’s case in relation to one of the most difficult problems in procreative ethics (or (...) the ethics of future generations): the non‐identity problem. We believe that this analysis will help us to understand the ethics involved in gene editing and hopefully allow for a better, more philosophically grounded legislation on CRISPR and other gene‐editing technologies. (shrink)

International uproar followed the recent announcement of the birth of twin girls whose genomes had been edited with a breakthrough DNA editing-technology. This technology, called clustered regularly interspaced short palindrome repeats or CRISPR-Cas9, can alter any DNA, including DNA in embryos, meaning that changes can be passed to the offspring of the person that embryo becomes. Should we use gene editing technologies to change ourselves, our children, and future generations to come? The potential uses of CRISPR-Cas9 and other (...) gene editing technologies are unprecedented in human history. By using these technologies, we eradicate certain dreadful diseases. Altering human DNA, however, raises enormously difficult questions. Some of these questions are about safety: Can these technologies be deployed without posing an unreasonable risk of physical harm to current and future generations? Can all physical risks be adequately assessed, and responsibly managed? But gene editing technologies also raise other moral questions, which touch on deeply held, personal, cultural, and societal values: Might such technologies redefine what it means to be healthy, or normal, or cherished? Might they undermine relationships between parents and children, or exacerbate the gap between the haves and have-nots? The broadest form of this second kind of question is the focus of this book: What might gene editing--and related technologies--mean for human flourishing? In the new essays collected here, an interdisciplinary group of scholars asks age--old questions about the nature and well-being of humans in the context of a revolutionary new biotechnology--one that has the potential to change the genetic make-up of both existing people and future generations. Welcoming readers who study related issues and those not yet familiar with the formal study of bioethics, the authors of these essays open up a conversation about the ethics of gene editing. It is through this conversation that citizens can influence laws and the distribution of funding for science and medicine, that professional leaders can shape understanding and use of gene editing and related technologies by scientists, patients, and practitioners, and that individuals can make decisions about their own lives and the lives of their families. (shrink)

Recent scientific advances in the field of gene editing have led to a renewed discussion on the moral acceptability of human germline modifications. Gene editing methods can be used on human embryos and gametes in order to change DNA sequences that are associated with diseases. Modifying the human germline, however, is currently illegal in many countries but has been suggested as a ‘last resort’ option in some reports. In contrast, preimplantation genetic diagnosis is (...) now a well-established practice within reproductive medicine. Both methods can be used to prevent children from being born with severe genetic diseases. This paper focuses on four moral concerns raised in the debate about germline gene editing and applies them to the practice of PGD for comparison: Violation of human dignity, disrespect of the autonomy and the physical integrity of the future child, discrimination of people living with a disability and the fear of slippery slope towards immoral usage of the technology, e.g. designing children for specific third party interests. Our analysis did not reveal any fundamental differences with regard to the four concerns. We argue that with regard to the four arguments analyzed in this paper germline gene editing should be considered morally as acceptable as the selection of genomes on the basis of PGD. However, we also argue that any application of GGE in reproductive medicine should be put on hold until thorough and comprehensive laws have been implemented to prevent the abuse of GGE for non-medical enhancement. (shrink)

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 (...) class='Hi'>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)

Review of Francoise Baylis, Altered Inheritance: CRISPR and the Ethics of Human Genome Editing (2019).

With recent reports that a Chinese scientist used CRISPR-Cas9 to heritably edit the genomes of human embryos (i.e., germline editing) brought to term, discussions regarding the ethics of the technology are urgently needed. Although certain applications of germline editing have been endorsed by both the National Academy of Sciences (US) and the Nuffield Council (UK), this paper explores the ethical concerns related even to such therapeutic uses of the technology. Additionally, this paper questions whether the technology could ever (...) feasibly be contained to the therapeutic realm. Consequently, this paper necessarily considers the ethical concerns related to enhancement uses of the technology even if only therapeutic applications are initially considered. In light of the concomitant risks, this paper assesses the technology’s countervailing benefits to conclude they do not prevail given that similar outcomes can largely be achieved with existing technologies. Consequently, this paper recommends an international ban on germline editing. (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)

This focus issue considers the normative implications of the recent emergence in genome editing technology known as CRISPR (clustered regularly interspaced short palindromic repeats) or CRISPR‐associated protein 9. Originally discovered in the adaptive immune systems of bacteria and archaea, CRISPR enables researchers to make efficient and site‐specific modifications to the genomes of cells and organisms. More accessible, precise, and economic than previous gene editing technologies, CRISPR holds the promise of not only transforming the fields of genetics, agriculture, and (...) class='Hi'>human medicine, but also heralding a new era of democratized biotechnology. However, the speed with which developments in the field have progressed threatens to overwhelm our normative sensibilities about the long‐term practical and ethical implications. The contributors to this focus issue attempt to think through some of the more salient moral and practical consequences of CRISPR in the context of religious ethics, particularly as they relate to themes of autonomy, human flourishing, social justice, and the ethics of enhancement. (shrink)

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)

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.

This is a discussion of the reaction to the recent research article publication in the journal Protein & Cell by a group of scientists at Sun Yat-sen University using the CRISPR/Cas9 technique on editing non-viable human zygotes. Many commentators condemned the Chinese scientists for overstepping ethical boundaries long accepted in Western countries and accused China of having lax regulations on genomic research in general. We argue that not only did this research follow strict ethical standards and fully comply with (...) current regulations, but China also has a well-developed regulatory framework governing such research comparable to many developed countries. We see the reactions among Western commentators as a misunderstanding of the current situation and an expression of a lack of willingness to acknowledge China as an equal partner in the international debate about proper limits to the development of new biotechnologies. (shrink)

Informed by a search of the literature about the usage of genetic testing information (GTI) by insurance companies, this paper presents a practical ethical analysis of several distinct public policy options that might be used to govern or constrain GTI usage by insurance providers. As medical research advances and the extension to the Human Genome Project (2016, https://en.wikipedia.org/wiki/human_genome_project_-_write) moves to its fullness over the next decade, such research efforts will allow the full synthesis of human DNA to (...) be connected to predictive health dispositions. As testing costs fall, there will be ever more pressure for citizens to disclose GTI. Genetic testing information is integral to future medical care because it can be used to better assess individually tailored medical therapies as well as to allow a more informed risk analysis by the insurance industry, which in some countries such as the USA underwrites a majority of citizen medical expenses. As discussed in this examination, the revelation of people’s uniquely personal GTI to insurers has enormous societal implications. The major contribution of the paper is to offer policy makers and concerned citizens a nuanced articulation of the basic options to regulate GTI, with a special consideration for ethical fairness and equity. As genetic-based medicine blossoms and pressures to reduce healthcare costs increase, there will be an ever greater impetus for countries to revisit their genetic testing policies. Organizations and policy makers striving to create GTI oversights perceived to be both “fair and effective” need to be aware of the ethical perspectives discussed in this paper. (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)

The emergence of CRISPR/Cas9 technology has revolutionized gene editing and made both gene therapy and eugenic control of future human evolution plausible. This accessible book puts these developments in their historical and scientific contexts and analyzes the policy and ethical challenges they raise. It presents the case for altering the human germ-line to eliminate a large number of genetic diseases controlled by a single or few genes, while pointing out that gene therapy is likely (...) to ineffective for diseases with more complex causation. In parallel it explores the possibility of genetic enhancement in a similarly subscribed set of cases. But it also argues that, in general, genetic enhancement is ethically problematic and should be approached with caution. Given the success of CRISPR/Cas9 gene editing, and the explosion of related techniques, in practice it would be virtually impossible to ban germ-line editing for the future. A more useful goal is to regulate it with oversight that represents all stakeholders. That, in turn, requires an informed public discussion of these issues which this book aims to foster. (shrink)

Recently, Chinese researchers published the results of their research using a gene-editing technology on abnormal human zygotes. The research team believes this research has prospective clinical application, viz., for gene therapy for?-thalassemia, a white blood cell disorder, and plan to persist with further studies, despite technical problems in this experiment. The research has elicited international criticism from both scientific and bioethics domains, because it innovates beyond the current global consensus against human germ line modification. This paper (...) comments on some ethical issues presented by the research report and concludes that, under present circumstances, the Chinese research team did not meet a standard of scientific responsibility.Bangladesh Journal of Bioethics 2015 Vol.6 (1):22-26. (shrink)

With the advent of CRISPR gene-editing technology, designer babies have become a reality. Françoise Baylis insists that scientists alone cannot decide the terms of this new era in human evolution. Members of the public, with diverse interests and perspectives, must have a role in determining our future as a species.

In recent years, CRISPR-Cas9 has become one of the simplest and most cost-effective genetic engineering techniques among scientists and researchers aiming to alter genes in organisms. As Zika came to the fore as a global health crisis, many suggested the use of CRISPR-Cas9 gene drives in mosquitoes as a possible means to prevent the transmission of the virus without the need to subject humans to risky experimental treatments. This paper suggests that using gene drives or other forms (...) of genome editing in nonhumans (like mosquitos) for the purposes of disease prevention raises important issues about informed consent. Additionally, it examines the consequences this line of inquiry could have for the use of gene drives as a tool in public health and suggests that the guidance offered by informed consent protocols could help the scientific community deploy gene drives in a way that ensures that ongoing research is consistent with our ethical priorities. (shrink)

When the use of CRIsPR-Cas9 to edit DNA was first reported in 2012, it was quickly heralded by scientists, policymakers, and journalists as a transformative technology. CRISPR-Cas9 provides the means to change DNA in ways that either were not generally possible using previous genetic technologies or that were orders of magnitude more laborious or inefficient to undertake. CRISPR's possible applications were readily apparent and seemingly endless, from supercharging laboratory research to modifying insects that transmit disease to eliminating genetic (...) conditions. By 2015, Wired magazine was calling the discovery "The Genesis Engine."Against a backdrop of disappointing results from gene transfer... (shrink)

On April 3, 2015, a group of prominent biologists and ethicists called for a worldwide moratorium on human genetic engineering in which the genetic modifications would be passed on to future generations. Describing themselves as “interested stakeholders,” the group held a retreat in Napa, California, in January to “initiate an informed discussion” of CRISPR/Cas9 genome engineering technology, which could enable high-precision insertion, deletion, and recoding of genes in human eggs, sperm, and embryos. The group declared (...) that the advent of a technology that makes human germ-line genetic engineering plausible makes a corollary discussion of its ethical implications urgent. Echoing this sentiment, the National Academy of Sciences and the National Academy of Medicine have announced plans to convene an international summit in fall 2015 to assess the implications of CRISPR/Cas9. Yet the notion that the advent of this particular technology is the warrant for initiating a public discussion is remarkable, and so too is the idea that the experts who have brought it into being and are putting it to use are best positioned to define the terms of the debate. The relevant ethical questions are by no means specific, let alone subsidiary, to the CRISPR/Cas9 technology. They are longstanding questions about what features of human life ought not be taken as objects of manipulation and control. They are questions about our responsibilities to our children and our children's children, where the mark of our actions will be inscribed upon their bodies and their lives. (shrink)

For human germline gene editing to be a viable technique for preventing disease, it must meet a baseline level of safety. This commentary unpacks Sahotra Sarkar’s concept of specificity outlined in Cut and Paste Genetics, which he proposes as a guide for when human germline gene editing can be performed safely. The commentary raises conceptual questions to how specificity is intended to work and raises further epistemic questions for how evidenceEvidence meets the demands of specificity.

Despite the advent of CRISPR, safe and effective gene editing for human enhancement remains well beyond our current technological capabilities. For the discussion about enhancing human beings to be worth having, then, we must assume that gene-editing technology will improve rapidly. However, rapid progress in the development and application of any technology comes at a price: obsolescence. If the genetic enhancements we can provide children get better and better each year, then the enhancements granted to (...) children born in any given year will rapidly go out of date. Sooner or later, every modified child will find him- or herself to be “yesterday’s child.” The impacts of such obsolescence on our individual, social, and philosophical self-understanding constitute an underexplored set of considerations relevant to the ethics of genome editing. (shrink)

Gene-editing technologies, such as CRISPR/Cas9, are internationally ethically fraught. In the United States, policy surrounding gene-editing has yet to be implemented, while the science continues to speed ahead. However, it is not enough that policy be implemented: in order for policy to establish limits for the technology such that benefits are possible while threats are kept at bay, such policy must be ethical. In turn, the ethics of gene-editing is a culturally determined field of inquiry. This piece (...) presents a proposal for a study whose goal is to arrive at ethical policy recommendations for policymakers. To achieve this goal, this study proposes, what needs to be done is, first, to understand the full history and foundation of gene-editing by conducting a thorough legal, bioethical, and policy review for precedent assisted reproductive technologies and genetic reproductive technologies. Following this effort, an empirical study must be conducted involving careful surveys of key stakeholder groups on their knowledge and opinions of gene-editing. Such stakeholder groups must include bioethicists, medical geneticists, and lay persons, including those in the disability community. (shrink)

The current SARS-CoV-2 pandemic has killed thousands across the world. SARS-CoV-2 is the latest but surely not the last such global pandemic we will face. The biomedical response to such pandemics includes treatment, vaccination, and so on. In this paper, though, we argue that it is time to consider an additional strategy: the somatic enhancement of human immunity. We argue for this approach and consider bioethics objections we believe can be overcome.

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)

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)

The emergence of CRISPR/Cas9 technology has revolutionized gene editing and made both gene therapy and eugenic control of future human evolution plausible. This accessible book puts these developments in their historical and scientific contexts and analyzes the policy and ethical challenges they raise. It presents the case for altering the human germ-line to eliminate a large number of genetic diseases controlled by a single or few genes, while pointing out that gene therapy is likely (...) to ineffective for diseases with more complex causation. In parallel it explores the possibility of genetic enhancement in a similarly subscribed set of cases. But it also argues that, in general, genetic enhancement is ethically problematic and should be approached with caution. Given the success of CRISPR/Cas9 gene editing, and the explosion of related techniques, in practice it would be virtually impossible to ban germ-line editing for the future. A more useful goal is to regulate it with oversight that represents all stakeholders. That, in turn, requires an informed public discussion of these issues which this book aims to foster. (shrink)

BackgroundClustered Regularly Interspaced Short Palindromic Repeats-associated technology may allow for efficient and highly targeted gene editing in single-cell embryos. This possibility brings human germline editing into the focus of ethical and legal debates again.Main bodyAgainst this background, we explore essential ethical and legal questions of interventions into the human germline by means of CRISPR-Cas: How should issues of risk and uncertainty be handled? What responsibilities arise regarding future generations? Under which conditions can germline editing measures be (...) therapeutically legitimized? For this purpose, we refer to a scenario anticipating potential further development in CRISPR-Cas technology implying improved accuracy and exclusion of germline transmission to future generations. We show that, if certain concepts regarding germline editing are clarified, under such conditions a categorical prohibition of one-generation germline editing of single-cell embryos appears not to be ethically or legally justifiable.ConclusionThese findings are important prerequisites for the international debate on the ethical and legal justification of germline interventions in the human embryo as well as for the harmonization of international legal standards. (shrink)

The discovery of clustered regularly interspaced short palindromic repeats (CRISPR) and the CRISPR-mediated protein 9 (CRISPR-Cas9) immediately revealed numerous potential therapeutic applications. Although CRISPR-Cas9 will most likely be useful for addressing issues such as genetic diseases and related medical issues, use of this modality for germline modification generates complex ethical questions regarding the safety and efficacy, human genetic enhancement, and “designer” babies. In this article, the case of the He Jiankui affair is used as an example of (...) the potential for unregulated use of CRISPR-Cas9 technology. In 2018, Dr He Jiankui reported that he had successfully edited human embryos. This work clearly violates all international principles of bioethics. As such, the purpose of this paper is to explore the ethical challenges inherent in the use of CRISPR-Cas9 for human germline editing from the perspectives of the goals of Islamic law (Maqasid al Shari'a) and the major jurisprudential maxims (Qawaid Fiqhiyyah). We argue that from an Islamic standpoint, the therapeutic application of CRISPR-Cas9 for germline editing may be permissible if the safety and efficacy concerns are resolved and if the principles of Maqasid al-Shari'a are fulfilled. (shrink)

Focusing on present‐day possibilities raised by existing technology, I consider the normative aspects of genetically modifying the human germline from a utilitarian standpoint. With reference to a hypothetical case, I examine the probable consequences of permitting a well‐conceived attempt to correct a disease‐associated gene in the human germline using current CRISPR gene‐editing technology. I consider inter alia the likely effects on utility of creating healthy new lives, of discouraging adoption, and of kickstarting a revolution in (...) class='Hi'>human germline genetic modification (HGGM). I reject various objections to HGGM, including claims that the risks of genetic harm outweigh the likely benefits. From this utilitarian analysis, I conclude that strong grounds exist to support intervening in the human germline using current technology. Delay in commencing such work will impose a utility cost, because the longer we wait until commencing the HGGM revolution and moving towards a world of increased utility, the greater will be the quantity of suffering accrued meantime through genetically influenced disease. Nevertheless, considering residual safety concerns and the negative publicity engendered by an ethically problematic recent (2018) first attempt at HGGM, it seems prudent—and ultimately generative of the greatest amount of utility—to delay implementing HGGM for a modest period of time, in the order of 1–2 years. (shrink)

In recent years, humans’ ability to selectively modify genes has increased dramatically as a result of the development of new, more efficient, and easier genetic modification technology. In this paper, we argue in favor of using this technology to improve the welfare of agricultural animals. We first argue that using animals genetically modified for improved welfare is preferable to the current status quo. Nevertheless, the strongest argument against pursuing gene editing for welfare is that there are alternative approaches (...) to addressing some of the challenges of modern agriculture that may offer ethical advantages over genetic modification; namely, a dramatic shift towards plant-based diets or the development of in vitro meat. Nevertheless, we provide reasons for thinking that despite these possible comparative disadvantages there are important reasons for continuing the pursuit of welfare improvements via genetic modification. (shrink)

In this article, I explore the ethical dimensions of same-sex reproduction achieved through epigenome editing—an innovative and transformative technique. For the first time, I analyse the potential normativity of this disruptive approach for reproductive purposes, focusing on its implications for lesbian couples seeking genetically related offspring. Epigenome editing offers a compelling solution to the complex ethical challenges posed by traditional gene editing, as it sidesteps genome modifications and potential long-term genetic consequences. The focus of this article is to (...) systematically analyse the bioethical issues related to the use of epigenome editing for same-sex reproduction. I critically assess the ethical acceptability of epigenome editing with reproductive purposes from multiple angles, considering harm perspectives, the comparison of ethical issues related to gene and epigenome editing, and feminist theories. This analysis reveals that epigenome editing emerges as an ethically acceptable means for lesbian couples to have genetically related children. Moreover, the experiments of a reproductive use of epigenome editing discussed in this article transcend bioethics, shedding light on the broader societal implications of same-sex reproduction. It challenges established notions of biological reproduction and prompts a reevaluation of how we define the human embryo, while poses some issues in the context of gender self-identification and family structures. In a world that increasingly values inclusivity and diversity, this article aims to reveal a progressive pathway for reproductive medicine and bioethics, as well as underscores the need for further philosophical research in this emerging and fertile domain. (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)

Significant breakthroughs in genetic research promoted by the human genome project, advances in molecular biology and new reproductive technologies have improved the understanding and the possibility of genetic interventions as a potential medication for diseases caused by differentiated disorders, especially those that originated in irregularities in individual genes. The progress achieved in contemporary studies has created the likelihood that the man has the technical capacity to modify the genes that will be transmitted to the next generations as (...) well. These are the so-called hereditary genetic modifications, i.e. any biomedical interventions which could be expected to transform the genome which a person could transfer to their offspring. The author analyses in this paper why even the hints of transformations of genes that will be passed on to future generations cause deep bioethical, theological, legal and political debates and controversies. He also believes that in the era of rapid strengthening of the social and technical and technological effects of science, it is very important that scientists, in their perceptions and insights, which particularly in the field of humanities, do not have the character of value beliefs, do not go below the achieved civilization standards of ethical and moral culture and to reflect on different themes with due care and awareness of the dilemmas that they can encounter in their professional work. An adequate interdisciplinary, multidisciplinary and pluriperspective approach, as well as the awareness of the essential compatibility of scientific freedom and responsibility, should ultimately result in a different and more sophisticated attitude of the scientists themselves to the possibilities of their own discipline and the significance of its effects. (shrink)