The use of genome embryo editing tools in reproduction is often touted as a way to ensure the birth of healthy and genetically related children. Many would agree that this is a worthy goal. The purpose of this paper is to argue that, if we are concerned with justice, accepting such goal as morally appropriate commits one to rejecting the development of embryo editing for reproductive purposes. This is so because safer and more effective means (...) exist that can allow many more prospective parents to achieve the same valued goal and that offer additional benefits. (shrink)

Many writers in bioethics, science, and medicine contend that embryo selection is a morally better way of avoiding genetic disorders then gene editing, as the latter has risks that the former does not. We argue that one reason to use gene editing is that in many cases it would be better for the person who would develop from the edited embryo, so that not to have done it would have been worse for that person. By contrast, (...) embryo selection is never better for the person who develops from the selected embryo. This reason to use gene editing has, however, been challenged on two grounds: first, that it makes no difference, morally, whether a bad effect is worse for someone, or a good effect better for someone; and, second, that beneficent gene editing would not be unequivocally better for the person who would develop from the edited embryo. We argue that both of these objections can be satisfactorily answered and thus that there is indeed a significant moral reason, at least in some cases, to use gene editing rather than embryo selection. (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)

Tendencies and efforts have shifted from genome description, DNA mapping, and DNA sequencing to active and profound re-programming, repairing life on genetic and molecular levels in some parts of contemporary life science research. Mirroring and materializing this atmosphere, various life engineering technologies have been used and established in many areas of life sciences in the last decades. A contemporary progressive example of one such technology is DNA editing. Novel developments related to reproductive technologies, particularly embryo editing, (...) prenatal human life engineering, and germline engineering need to be analyzed against the broader social and structural background. The crucial analytical scope for this paper is a specific field: the life-editing technologies used in reproductive medicine and performed experimentally on viable human embryos, particularly CRISPR/cas9 technology. This text argues that germline editing technologies, as a representative part of contemporary biomedicine, are merging ideas of treatment and enhancement to avoid future risks. Using this specific life manipulation of embryos and gametes, the text analyzes these processes within the concept of power over life—biopower and the specific governing rationality that imagines, classifies, and governs contemporary societies. The text specifically focuses on the potential to create, define, and manage future risks and uncertainties related to prenatal life. (shrink)

In the Hastings Center Report's July‐August 2022 issue, articles by Jessica Amalraj and Kavita Shah Arora and by Inmaculada de Melo‐Martín take up very different concerns under the broad topic of reproductive ethics and public policy. Amalraj and Arora call for public deliberation and consensus building to revise a Medicaid sterilization policy, and de Melo‐Martín argues that social resources should not be used to support reproductive embryo editing but should instead be put toward pre‐ and postnatal (...) interventions that, compared to embryonic genome editing, can help far more people have children who are healthy and genetically related to them. The third article, by Bryan Sisk and James M. DuBois, offers a framework to guide clinicians in their everyday communication with patients and their family members. Elsewhere in the issue are arguments about the responsibilities health care organizations have to address large societal problems affecting well‐being. (shrink)

In July 2018, the Nuffield Council on Bioethics released the report Genome editing and human reproduction: Social and ethical issues, concluding that human germline modification of human embryos for implantation is not ‘morally unacceptable in itself’ and could be ethically permissible in certain circumstances once the risks of adverse outcomes have been assessed and the procedure appears ‘reasonably safe’. The Nuffield Council set forth two main principles governing anticipated uses and envisions applications that may include health enhancements as a (...) public health measure. This essay provides a critique of three aspects in the Nuffield Council’s Report: its presumption of therapeutic efficacy, its inflation of parental rights to create a certain type of child, and its reliance on a specially commissioned report that appears to distort key definitions in international law. (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)

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)

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)

Assisted reproductive technologies have greatly increased our control over reproductive choices, leading some bioethicists to argue that we face unprecedented moral obligations towards progeny. Several models attempting to balance the principle of procreative autonomy with these obligations have been proposed. The least demanding is the minimal threshold model (MTM), according to which every reproductive choice is permissible, except creating children whose lives will not be worth living. Hence, as long as the future child is likely to have (...) a life worth living, prospective parents may be allowed to use preimplantation genetic diagnosis (PGD) to select embryos with genetic diseases or disabilities. Assuming a consequentialist person‐affecting view of morality, this paper investigates whether the MTM is an appropriate tool to guide procreative decisions given the continuous development of reproductive genetic technologies. In particular, I consider germline genome editing (GGE) and I argue that its application in human reproduction, unlike PGD, should be conceived as person‐affecting towards future progeny. I claim that even if we assume the plausibility of the MTM within PGD, we are committed to accepting that a greater moral obligation towards progeny should guide procreative decisions if GGE were available. In this case, the MTM should no longer be considered an appropriate instrument to guide procreative choices. Finally, I investigate when we face this greater moral obligation, concluding that it applies only when prospective parents have already engaged in the in vitro fertilization process. (shrink)

Given recent advancements in CRISPR‐Cas9 powered genetic modification of gametes and embryos, both popular media and scientific articles are hailing CRISPR’s life‐saving, curative potential for people with serious monogenic diseases. But claims that CRISPR modification of gametes or embryos, a form of germline engineering, has therapeutic value are deeply mistaken. This article explains why reproductive uses of CRISPR, and germline engineering more generally, do not treat or save lives that would otherwise have a genetic disease. Reproductive uses of (...) CRISPR create healthy people whose existence is not inevitable in the first place. Creating healthy lives has distinct and lesser moral value from saving or curing lives that would otherwise have genetic disease. The real value in reproductive uses of CRISPR is in helping a very limited population of people have healthy, genetically related children. This diminished value cannot compete with the concerns in opposition to germline engineering, nor is it worth the investment of research money. (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)

Genome Editing Techniques are seen to be at the frontier of current research in the field of emerging biotechnologies. The latest revolutionary development, the so-called CRISPR technology, represents a paradigmatic example of the ambiguity of such techniques and has resulted in an international interdisciplinary debate on whether or not it is necessary to ban the application of this technique by means of a moratorium on its use for human germline modifications, particularly in human embryos in the reproduction process. However, (...) given that other germline engineering techniques like mitochondrial DNA transfer techniques are already permitted and applied, the question arises what lies at the root of the apparent social unease about the modification of the human germline by Genome Editing Techniques like CRISPR. Against this background, the book seeks to make a substantial contribution to the current debate about a responsible and participatory framework for research on emerging biotechnologies by analysing underlying perceptions, attitudes, arguments and the reasoning on Genome Editing Techniques. (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)

Respect for autonomy is a central value in reproductive ethics, but it can be a challenge to fulfill and is sometimes an outright puzzle to understand. If a woman requests the transfer of two, three, or four embryos during fertility treatment, is that request truly autonomous, and do clinicians disrespect her if they question that decision or refuse to carry it out? Add a commitment to justice to the mix, and the challenge can become more complex still. Is it (...) unfair for insurance policies to exclude from coverage the costs of giving fertility to those who lack it or restoring fertility in those who have lost it? What does “just reproduction” look like in the face of multifarious understandings of both justice and autonomy and in light of increasingly complex and costly reproductive technologies? In today's dialogue about reproduction, medicine, and ethics in the United States, old ethical issues—such as whether women ought to be allowed to access pregnancy termination—are more contested than they have been in decades, while new technologies—like those used to edit the genes of human embryos—suggest that our species could face unprecedented questions about who should exist. As we considered the discussions accompanying these issues and contemplated a special report responding to them, we found ourselves consistently circling back to two ethical commitments: respect for autonomy and the pursuit of justice. As one of the nine essays in this collection asks, why should certain women receive help to establish a pregnancy while others are thrown in jail when they miscarry or their child is stillborn? Respect for autonomy is required where individuals have the ability to make fully informed and voluntary choices. Yet does respecting autonomy require acceding to all the choices of patients or consumers of medical care? We consider these and related questions in this special report from the Hastings Center Report. (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)

Medical science at its core aims to preserve health and eliminate disease, but a common theme in scientific discovery is the application of findings in ways that were not the primary intent. The development of diagnostic modalities to predict the health of resulting children has been a fundamental aim underpinning research into prenatal and preimplantation diagnostic modalities; however, the knowledge gained has in some cases been utilized for nonmedical purposes. As an example, amniocentesis developed to determine whether the pregnancy is (...) chromosomally normal also provides information about the sex of the fetus, which normally does not affect health. The emerging gene‐editing technologies that could be used to repair mutated disease‐causing genes in an embryo will presumably also be able to be used to alter traits unrelated to disease. And yet, I will argue, the desire to preserve the mystery of reproduction remains a central value in humans’ quest to reproduce. This yearning to maintain the mysteries will likely temper the development of strategies to alter our genome and affect the genetic identities of our offspring. In my experience as an obstetrician and reproductive endocrinology and infertility subspecialist, people want to have, not the best possible baby, but rather their own baby. (shrink)

In the year since He Jiankui announced the birth of twin girls whose genes were edited as embryos, reactions and revelations have continued, including the recent announcement that He and two colleagues have been sentenced to jail time and hefty fines. But what of Nana and Lulu, now infants, whose lives and futures are often missing in discussions of He's ethical violations? Their status remains a mystery. Other than learning that they were born prematurely by emergency C-section, we know nothing (...) about their well-being. We know even less about a third gene-edited child said to have been born last summer.Meanwhile, the controversy over He's reckless actions—and the debate about reproductive... (shrink)

According to what McMahan and Savulescu (2024) call the “popular position”, embryo selection is less ethically problematic than gene editing (other things being equal). The Two-Tier View, defended by McMahan and Savulescu, implies that the popular position is mistaken. The authors treat gene editing of embryos similarly to standard cases of medical treatments that promise expected benefits for the (subsequent) person even though gene editing also may create risks of harmful side effects for her. McMahan and (...) Savulescu assume that if gene editing is (successfully) done, it is better for the person who developed from the beneficently edited embryo. And, if the editing had not been done, although it was possible, that would have been worse for the same person in question. Thus, the comparator must always be a possible, even if unlikely, world in which she would have existed. That is why gene editing, in their view, resembles medical treatments. Therefore, assuming that standard medical treatments are not more ethically problematic than embryo selection, they conclude that (in general) gene editing should also be treated as not more problematic than embryo selection. In this paper, I am taking one step further than McMahan and Savulescu in questioning the central assumptions in the bioethical debates about new reproductive technologies. In the previous work, we argued that the very distinction between person-affecting and identity-affecting interventions is based on a questionable form of material-origin essentialism (Żuradzki and Dranseika 2022). Here, I argue that the bipartite distinction between person-affecting and impersonal reasons, as used by McMahan and Savulescu, insufficiently represents different possible counterfactual comparisons between real and merely possible outcomes. In particular, I argue that the evaluation of gene editing requires counterfactual comparisons to situations in which the benefited person might or might not exist. Such evaluation requires an additional class of reasons, let me call them “semi-person-affecting,” that cannot be reduced to either person-affecting or impersonal ones. This aspect of gene editing makes it dissimilar to standard cases of medical treatments. (shrink)

In “Reasons and Reproduction: Gene Editing and Genetic Selection,” McMahan and Savulescu (2024) contest the common notion that embryo selection is a morally better way of avoiding genetic condition...

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)

Technical advances in genome editing methods raise the question how autonomy should figure in theological ethical debates about genetic enhancements. Thinking primarily of the parents’ reproductive autonomy, several secular and theological thinkers argue parents should be allowed to ‘enhance’ an embryo genetically. Jürgen Habermas’s critique of enhancements in the name of the child’s autonomy, meanwhile, has been met with a critique of autonomy in theology. This article argues that theological views about God’s relationship to the creature provide (...) strong theological grounds for a new appropriation of autonomy. A liberal maximisation of individual choice is to be viewed critically, but more recent discourses on relational autonomy see certain forms of vulnerability contribute to a communal understanding of autonomy. This view dovetails with Habermas’s argument, according to which enhancements create too strong a temptation towards overly directive parenting—less in modifying an embryo than in the ensuing relationship to the child. (shrink)

The possibility of editing the genomes of human embryos has generated significant discussion and interest as a matter of science and ethics. While it holds significant promise to prevent or treat disease, research on and potential clinical applications of human embryo editing also raise ethical, regulatory, and safety concerns. This systematic review included 223 publications to identify the ethical arguments, reasons, and concerns that have been offered for and against the editing of human embryos using CRISPR-Cas9 (...) technology. We identified six major themes: risk/harm; potential benefit; oversight; informed consent; justice, equity, and other social considerations; and eugenics. We explore these themes and provide an overview and analysis of the critical points in the current literature. (shrink)

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

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

Ethically sound analyses of embryo genetic editing require more than simple assessments of safety considerations. After all, we as humans care deeply not only about our health, but also care profoundly about the kinds of societies we construct, the injustices that our actions produce, the responsibilities that we have toward others and ourselves, our self-understanding, the characters that we develop, our family relationships, and the world that we leave to our children and grandchildren.

Records the papers and commentaries, with an edited discussion, presented at an international consultation convened by the Council for International Organizations of Medical Sciences (CIOMS) to guide revision of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The Guidelines, first issued in 1982 and then revised in 1993, are being updated and expanded to address a number of new and especially challenging ethical issues. These include issues raised by international collaborative trials of drugs in developing countries, especially (...) expensive drugs, and the use of placebo controls in randomized clinical trials. Others arise from the complexity of research in human genetics, including stem-cell research, and in reproductive biology. Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials in developing countries, of short-duration zidovudine (AZT) therapy to reduce perinatal transmission of HIV. The International Ethical Guidelines for Biomedical Research Involving Human Subjects set out a code of research ethics that is widely used by ethical review committees and other bodies responsible for reviewing and overseeing the ethical design of studies and conduct of research. The revision of the Guidelines is being coordinated by CIOMS, in collaboration with WHO. The consultation centered on seven specially commissioned papers, authored by international experts that explore some of the more difficult issues in depth. Each is followed by an invited commentary, often expressing opposing views, and a summary of the issues or conclusions that emerged during the subsequent debate. The first paper, on justice in international research, deals with the question of whether proposals for research to be conducted in a developing country should make provision for future access of the population involved to the interventions under investigation. Also considered are questions that arise when research uses populations in developing countries to investigate interventions that will be of exclusive benefit to the industrialized world. Case studies of recent drug trials and their research protocols are discussed to illustrate circumstances in which use of populations in developing countries is justified or constitutes exploitation. Ethical challenges of the randomized controlled trial are considered in the second paper, which includes a discussion on the equitable distribution of benefits and risks, the use of placebo for controls, and the obligation to ensure that the participation of controls does not compromise their medical care or endanger their health. A paper on informed consent in international health research considers how cultural factors influence communication and language in the informed-consent process and respect for privacy and confidentiality in the research. Subsequent papers address issues in genetics research and reproductive biology, including the moral status of fetuses and the use of embryos in research, and examine the contribution which international human rights instruments can make in the application of the general principles of ethics to research involving human subjects. The final paper gives an overview of capacity building and the role of communities in international biomedical research. (shrink)

Singapore, a highly affluent island city-state located in Southeast Asia, has increasingly leveraged new assisted reproductive technologies (ART) to overcome its dismal fertility rates in recent years. A new frontier in ART is preimplantation genetic testing (PGT) for polygenic risk scores (PRS) to predict complex multifactorial traits in IVF (in vitro fertilisation) embryos, such as type 2 diabetes, cardiovascular diseases and various other characteristics like height, intelligence quotient (IQ), hair and eye colour. Unlike well-known safety risks with human genome (...) editing, there are negligible risks with PGT-P, because there are no man-made genetic modifications that can be transmitted to future generations. Nevertheless, the current efficacy of using PGT-P to select IVF embryos for either increased or decreased probability of developing specific polygenic traits is still far from certain. Hence, the regulatory safeguards proposed here will be based on the assumption that the efficacy of this new technology platform has already been validated. These include: (1) restricting the application of PGT-P only for prevention of clinically relevant polygenic disease traits, (2) securely blocking patients’ access to the raw genomic DNA sequencing data of their IVF embryos, (3) validating diagnosis of polygenic disease traits in the prospective parents/grandparents of IVF embryos, and restricting PGT-P only for preventing specifically diagnosed polygenic disease traits and (4) mandating rigorous and comprehensive genetic counselling for IVF patients considering PGT-P. There is an urgent and dire need to prevent abuse of the PGT-P technique, as well as protect the interests and welfare of patients if its clinical application is to be permitted in the country. (shrink)

Recent ethical and legal challenges have arisen concerning the rights of individuals over their IVF embryos, leading to questions about how, when the wishes of parents regarding their embryos conflict, such situations ought to be resolved. A notion commonly invoked in relation to frozen embryo disputes is that of reproductive rights: a right to have (or not to have) children. This has sometimes been interpreted to mean a right to have, or not to have, one's own genetic children. (...) But can such rights legitimately be asserted to give rise to claims over embryos? We examine the question of property in genetic material as applied to gametes and embryos, and whether rights over genetic information extend to grant control over IVF embryos. In particular we consider the purported right not to have one's own genetically related children from a property-based perspective. We argue that even if we concede that such (property) rights do exist, those rights become limited in scope and application upon engaging in reproduction. We want to show that once an IVF embryo is created for the purpose of reproduction, any right not to have genetically-related children that may be based in property rights over genetic information is ceded. There is thus no right to prevent one's IVF embryos from being brought to birth on the basis of a right to avoid having one's own genetic children. Although there may be reproductive rights over gametes and embryos, these are not grounded in genetic information. (shrink)

The majority of embryos created in natural reproduction die spontaneously within a few weeks of conception. Some have argued that, therefore, if one believes the embryo is a person (in the normative sense) one should find ‘natural’ reproduction morally problematic. An extension of this argument holds that, if one accepts embryo deaths in natural reproduction, consistency requires that one also accepts embryo deaths that occur in (i) assisted reproduction via in vitro fertilisation (IVF) and (ii) embryo (...) research. In a recent paper in this journal, Timothy Murphy criticises both the initial argument and its extension. Murphy argues that double-effect reasoning can justify embryo deaths both in natural reproduction and IVF, but not in embryo research. Thus, according to Murphy, one can, without being inconsistent, (1) believe the embryo is a person and accept natural reproduction and IVF, and (2) accept natural reproduction and IVF, while rejecting embryo research on the ground that it involves embryo deaths. I show that Murphy's argument is problematic because double effect cannot justify embryo deaths in standard IVF practices. The problem is that the proportionality criterion of double effect is not met by such practices. Thus, Murphy's argument fails to support (1) and (2). An implication of his argument failing to support (2) is that it does not defeat the position I have defended in the past—that if one accepts standard IVF practices one should also accept embryo research, including research with embryos created solely for that purpose. (shrink)

In an article in this journal, Katherine Drabiak argues that green lighting genome editing of human embryos is contrary to “fundamental human rights law.” According to the author, genome editing of human embryos violates what we should recognize as a fundamental human right to inherit a genome without deliberate manipulation. In this reply article, we assess Drabiak's legal analysis and show methodological and substantive flaws. Methodologically, her analysis omits the key international legal instruments that form the so‐called International (...) Bill of Rights and thus fails to provide a full and accurate account of the fundamental international human rights standards. Substantively, Drabiak invokes, as a basis for prohibiting gene editing of human embryos, a legal standard (the rights and integrity of the future child) that is unknown to international law. Contrary to Drabiak's account, genome editing of human embryos is not prohibited under international law. Indeed, the right to health and the right to benefit from scientific progress may be interpreted as the basis of a legal duty to provide equality of access to germline gene editing, once determined it is beneficial and safe to use. (shrink)

On September 27, 2016 people across the world looked down at their buzzing phones to see the AP Alert: “Baby born with DNA from 3 people, first from new technique.” It was an announcement met with confusion by many, but one that polarized the scientific community almost instantly. Some celebrated the birth as an advancement that could help women with a family history of mitochondrial diseases prevent the transmission of the disease to future generations; others held it unethical, citing medical (...) tourism and consequences for the future of the therapy. The child in question was actually born a few months earlier on April 6, 2016, but the research was published a few months later in the October edition of Fertility and Sterility. The mother carries DNA that could have given the baby Leigh Syndrome, a severe neurological disorder characterized by psychomotor regression that typically results in death between ages two and three.[1] Also known as subacute necrotizing encephalomyelopathy, Leigh Syndrome is caused by genetic mutations in mitochondrial DNA, which causes defective oxidative phosphorylation. Because people with this condition cannot re-form ATP, “demyleniation, gliosis, necrosis, spongiosis, or capillary proliferation”[2] can occur, thereby producing bilateral lesions across the central nervous system. The 36-year-old mother previously had four miscarriages and successfully birthed two children, both of whom survived less than six years due to the syndrome. For religious reasons, the mother opted for Spindle Nuclear Transfer instead of Pronuclear Transfer,[3] which many religious organizations oppose because it entails the destruction of fertilized eggs.[4] In Pronuclear Transfer, both the parent and donor egg are fertilized. The parent’s nuclear material is then removed from the egg containing mutated mitochondria and inserted into the fertilized donor egg—from which the original nuclear material has been removed and destroyed. Spindle Nuclear Transfer, on the other hand, removes the mother’s nuclear material from the egg with unhealthy mitochondria, then implants it into a donor’s egg. The newly created egg is then fertilized with the father’s sperm. This Spindle Nuclear Transfer was performed in Mexico by a team of doctors led by Dr. John Zhang, the founder of the New Hope Fertility Center in New York City. In their report, the doctors outline that five oocytes were successfully reconstituted, four of which developed into blastocysts. Only one was euploid: containing 46 XY chromosomes. Researchers then biopsied that blastocyst and found that the transmission rate of maternal mtDNA was, “5.10 ± 1.11% and the heteroplasmy level for 8993T>G was 5.73%.”[5] This indicates that at the blastocyst stage, around five percent of the mitochondria are from the original maternal egg with the mutation for Leigh Syndrome. After birth, they biopsied different tissues and found that they had an average of less than 1.60 ± 0.92% of transmitted mtDNA from the original maternal egg. The baby is reportedly doing well and the team of doctors concluded that “[h]uman oocytes reconstituted by SNT are capable of producing a healthy live birth. SNT may provide a novel treatment option in minimizing pathogenic mtDNA transmission from mothers to their babies."[6] Even when considered theoretically, Spindle Nuclear Transfer is controversial. Many doctors believe that the risks at this stage of research are too great. Dr. Trevor Stammers, a bioethicist at St. Mary’s University in London, points out: “We do not yet have a clear picture of the interaction between nuclear DNA and mitochondria.”[7] Others hold that faulty mitochondrial DNA can still be transferred during the procedure. Still more argue this technology could create problems because of germline modification.[8] Dr. Paul Knoepfler, a cell biologist at the UC Davis School of Medicine, explains: “Since this is uncharted territory and the children born from this technology would have heritable genetic changes, there are also significant unknown risks to future generations.”[9] However, proponents counter these arguments. They say the benefits outweigh the risks, as “mitochondrial replacement techniques [like Spindle Nuclear Transfer] would eliminate maternal transmission of mitochondrial disease… allowing a woman with a family history of mitochondrial diseases to ensure her children would not be affected.”[10] Additionally, experts say that no symptoms will occur if less than 20% of the transferred mitochondrial DNA is faulty.[11] And while opponents see potential germline modification as a problem, advocates answer that this could stop a family history of mitochondrial disease, which they deem a more serious concern. In this case specifically, however, there are more issues at hand. While the team of doctors did eliminate the possibility of germline modification by selecting a male embryo, there are other ethical concerns. Some argue that this case could be described as “medical tourism.” While New Hope Medical Clinic does maintain a branch in Mexico, Dr. Zhang stated that Mexico has “no rules.”[12] It is a country with underdeveloped regulations, making it difficult to confirm that doctors adhere to widely-held medical and ethical standards. Furthermore, while it is highly unlikely that the child will develop Leigh’s Syndrome, Dr. Dietrich Egli of the New York Stem Cell Foundation says the 5% mitochondrial transfer rate indicates that the technique “was not carried out well.”[13] He points to studies of embryos where the rate of mtDNA transfer was almost ten times lower. Spindle Nuclear Transfer is currently legal in the UK,[14] and many are hoping to see it legalized in the US, although Congress currently prohibits the FDA from considering applications that would entail trials in people.[15] While Dr. Zhang’s work is arguably revolutionary, many wonder if the manner in which this study was performed—in Mexico and with a high mitochondrial transfer rate—will impact the technology’s future in the US. Last week, Dr. Zhang presented the report to scientists gathered in Salt Lake City, saying that while science isn’t a race, it is “in a sense, a race for the family to find a cure, to find hope.”[16] Only time will tell if this study set back other families racing and hoping for a cure. References 1. "Leigh Syndrome." Genetics Home Reference, US National Library of Medicine, 25 Oct. 2016. Accessed 26 Oct. 2016. 2. McKusick, Victor A., and Ada Hamosh. "LEIGH SYNDROME; LS." Online Mendelian Inheritance in Man, Johns Hopkins University, 20 Jan. 2016. Accessed 30 Oct. 2016. 3. Zhang, J, H Liu, S Luo, A Chavez-Badiola, and Z Liu. "First live birth using human oocytes reconstituted by spindle nuclear transfer for mitochondrial DNA mutation causing Leigh syndrome." Fertility and Sterility, vol. 106, no. 3, 2016, pp. e375-76. Accessed 30 Oct. 2016. 4. Sample, Ian. "‘Three-parent’ babies explained: what are the concerns and are they justified?" The Guardian, 2 Feb. 2015. Accessed 30 Oct. 2016. 5. Zhang, et al. 6. Ibid. 7. Knapton, Sarah. "Three-parent babies: the arguments for and against." The Telegraph, 3 Feb. 2015. 8. Ibid. 9. Ibid. 10. "Mitochondrial Replacement Therapy FAQs." New York Stem Cell Foundation Research Institute, New York Stem Cell Foundation. Accessed 30 Oct. 2016. 11. Reardon, Sara. "‘Three-parent baby’ claim raises hopes — and ethical concerns." Nature, 28 Sept. 2016. Accessed 30 Oct. 2016. 12. Hamzelou, Jessica. "Exclusive: World’s first baby born with new “3 parent” technique." New Scientist, 27 Sept. 2016. Accessed 30 Oct. 2016. 13. Reardon, Sara. "‘Three-parent baby’ claim raises hopes — and ethical concerns." Nature, 28 Sept. 2016. Accessed 30 Oct. 2016. 14. "3-Person IVF: A Resource Page." Center for Genetics and Society, 24 Oct. 2016. Accessed 30 Oct. 2016. 15. Ritter, Malcolm. "Baby born with DNA from 3 people, first from new technique." Associated Press, 27 Sept. 2016. Accessed 30 Oct. 2016. 16. Chen, Daphne. "Controversy swirls around first three-parent baby." Deseret News, 19 Oct. 2016. Accessed 30 Oct. 2016. Works consulted Swetlitz, Ike. "FDA urged to approve ‘three-parent embryos,’ a new frontier in reproduction." STAT, 3 Feb. 2016. Accessed 30 Oct. 2016. (shrink)

The social interface between reproductive medicine and embryonic stem cell research has been investigated in a pilot study at a large IVF clinic in central China. Methods included observation, interviews with hospital personnel, and five in-depth qualitative interviews with women who underwent IVF and who were asked for their consent to the donation of embryos for use in medical (in fact human embryonic stem cell) research. This paper reports, and discusses from an ethical perspective, the results of an analysis (...) of these interviews. The participants talked of extreme social pressure to become pregnant. Once they had a baby, ‘spare’ embryos lost practical significance due to the Chinese one-child policy. In the context of decision making about donating embryos to research, the women used the clinical distinctions between ‘good and bad quality’ embryos and also between frozen and transferred embryos, as guiding moral distinctions. In the absence of concrete information about what sort of research their embryos should be used for, the women interviewed either refused consent (for fear that the embryo would be given to another couple) or accepted, expressing motives of solidarity with other women in a similar situation. This reveals that they filled the knowledge gap with an image of research improving fertility treatment. (shrink)

Traditionally reproduction, gestation and childbirth have all been regarded as being primarily a woman's domain. As natural reproduction occurs inside a woman's body, respect for autonomy and bodily integrity requires the pregnant woman to have the conclusive say over the fate of the embryo/fetus growing within her. Thus traditionally the ethics and law of reproduction is dominated by the importance of respecting women's reproductive choices. This paper argues that emerging technologies demand a radical rethink of ethics and law (...) in the area of reproduction. The creation and storing of embryos outside of a woman's body and maintaining a pregnancy in a brain dead woman's body and future possibilities such as ectogenesis and male pregnancy raise important issues that cannot simply be answered by appealing to the rights of women to control their bodies. There are those who argue that when reproduction or reproductive products exist outside of a woman's body each gamete donor should have an equal say over the fate of the embryo/fetus. Others, however, argue that giving an equal say to gamete donors in practice usually means allowing the male donor to veto the reproductive enterprise and this is unacceptable. As a result it has been suggested that women should be favoured when it comes to such reproductive choices. This paper examines both sides of this debate in order to answer the fundamental ethical and policy question: 'Is there any reason why women should necessarily retain control over reproduction rather than simply over their own bodies?'. (shrink)

This book brings together an international collection of experts in reproductive ethics, law, disability studies, and medicine to explore the challenging future of reproduction and children. From the medical to the social and from the financial to the legal, the authors explore the expanding impact of reproductive genetics on our society. New advances in genetic technologies are revolutionizing the practice of reproductive medicine. We have expanded our ability to detect genetic changes in embryos and fetuses in ways (...) that potentially allow to identify, treat, or prevent a growing range of diseases. The development of gene-editing technologies raises questions about the possibility of removing disease-causing variants from embryos before pregnancy implantation. The growing sophistication of prenatal genomic sequencing offers us glimpses into the whole genome of the developing fetus. And, the increasingly sophisticated science of 'gene matching' allows us greater and greater foreknowledge of how the genomes of two individuals will combine in a future child. This is an indispensable book on the newest developments in bioethics caused by the sciences. Chapter 5 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com. (shrink)

Forms, Souls, and Embryos allows readers coming from different backgrounds to appreciate the depth and originality with which the Neoplatonists engaged with and responded to a number of philosophical questions central to human reproduction, including: What is the causal explanation of the embryo's formation? How and to what extent are Platonic Forms involved? In what sense is a fetus 'alive,' and when does it become a human being? Where does the embryo's soul come from, and how is it (...) connected to its body? This is the first full-length study in English of this fascinating subject, and is a must-read for anyone interested in Neoplatonism or the history of medicine and embryology. (shrink)

On both sides of the debate on the use of embryos in stem cell research, and in reproductive technologies more generally, rhetoric and symbolic images have been evoked to influence public opinion. Human embryos themselves are described as either “very small human beings” or “small clusters of cells.” The intentions behind the use of these phrases are clear. One description suggests that embryos are already members of our community and share with us a right to life or at least (...) respectful treatment, whereas the other focuses on the differences between embryos and adult human beings with normal capacities, that is, their lack of sentience and of personal identity. The research on stem cells has been nicknamed “Frankenstein science” or presented as “research that could stop Parkinson disease.” Again, one description reminds us of scary science-fiction scenarios where the scientist is guilty of “playing God,” whereas the other description highlights the worth and potential benefits of the research outcomes. (shrink)

John Harris gives a comprehensive and generally valid defense of embryo research. Although nearly all his arguments are valid, one—the argument comparing natural reproduction to embryo research—is problematic in several important ways. I focus here on that argument.

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

Two conferences on genome editing held in December 2015 offer a lens through which to contrast bioethics policies in the United Kingdom and the United States. The Progress Educational Trust, which has no parallel in the United States, hosted the London conference and illustrates the close collaboration between government departments, scientific bodies, funding organizations, and lobby groups in the United Kingdom. The rhetoric of responsible regulation used in the United Kingdom protects not the embryo, but the practice of (...) embryo destruction, and advocates of embryo experimentation are eager to guide the debate about genome editing. It would be perilous for the international community to allow the United Kingdom to frame the debate in this way. (shrink)

With the emergence of clustered, regularly interspaced, short palindromic repeats (CRISPR)/CRISPR-associated protein 9 (Cas9) as one of the most promising new gene-editing techniques, scientists are now endeavoring to apply it to various domains. Among all the possible applications, gene editing in human embryos has received the most attention. Against this background, this article carries out a philosophical study on the ethical problems of human embryo gene editing or designing. Arguments against human embryo gene designing include (...) that parents should be prohibited from deciding their children’s future; commodifying children should be prohibited; the natural reproductive process should not be disturbed; and human embryo gene designing might foster discrimination. Arguments for human embryo gene designing include that parents should have the freedom to design their own babies and this freedom should not be limited; designing babies can promote the happy life of the baby; and totally forbidding embryo gene editing would drive the practice underground, where it would be performed illegally. This article analyzes all of these arguments and points out that all of them have some flaws. In order to draw a thoughtful conclusion, we turn to Confucianism and find a new perspective to determine whether designing babies with CRISPR technology is ethically permissible. (shrink)

The use of modern medical technologies and interventions involves ethical and legal dilemmas which are yet to be solved. For the religious Jews the answer lies in Halakhah. The objective of this paper is to unscramble the difficult conundrum possessed by the halakhalic standing concerning the use of human embryonic cell for research. It also aims to take contemporary ethical issues arising from the use of technologies and medical advances made in human reproduction and study them from an abstract philosophical (...) perspective. Instead of providing any Jewish practical ruling the paper have tried to incite, stimulate and encourage philosophical thoughts about the issue through the intensive understanding of traditional Jewish thoughts. In this paper, an objective as well as a deep-rooted study has been adopted about the use of human embryos for research and the Jewish adoption of assisted reproductive technologies through the prism of the knowledge of Halakhah, Torah and Talmud. The paper finds that the embryo research sits at the crossroads of many halakhalic issues. Judaism adopts the belief that God has created man in his own image. The Jews not being dogmatic decipher “the image” of the creator as the ability to discern and reason. It follows that Judaism does not subscribe to the notion that tampering with nature is prohibited. To the Jews the mitzvah for procreation is so great that they are open to reason and adopt newer medical advancement in procreation. The Jewish laws are not only for engagement in intellectual exercise or academic pursuit but subscribe to a higher order of moral conduct. The Jewish approach is not situational but also casuistic in resolving conflicting medical issues. (shrink)

In Canada, the Assisted Human Reproduction Act received royal assent on 29 March 2004. The approach proposed by the federal government responds to Canadians’ strong desire for an enforceable legislative framework in the field of reproduction technologies through criminal law. As a result of the widening gap between the rapid pace of technological change and governing legislation, a distinct need was perceived to create a regulatory framework to guide decisions regarding reproductive technologies.In this article the three main topics covered (...) in the new legislation are commented on: cloning, germline therapy, and purchase of gametes and embryos. Some important issues also covered in the new legislation, such as privacy and access to information, data protection, identity of donors, and inspection, will not be addressed. (shrink)

Biomedical technology is one of the most relevant and rapidly developing branches of science. In response to the major problems of bioethics and bio-law, bioethical dilemmas emerge in society, which constrain the abuse of new technologies. Medical discoveries, on the one hand, can greatly facilitate the life of humankind, but, on the other hand, the problem of interference in human nature actualizes the most fundamental questions concerning its ontology, the boundaries of permissible transformations, the responsibility of a scientist and a (...) specialist, applying the latest technologies, for remote and unpredictable consequences, due to the integrity and interconnectedness of various aspects of human nature. This paper presents the experience of generalizing the attitude of the main Islamic confessions and different approaches in the legislation of Islamic countries to the problem of editing the human embryo genome. Based on a review of scientific and religious literature, it is concluded that, although the Islamic world is increasingly using Western models of behavior, in matters of the permissibility of editing the human embryo genome from the point of view of Islamic bioethics, it is necessary to rely on the principles of Sharia and multidisciplinary knowledge. (shrink)