The scope of noninvasive prenatal testing (NIPT) could expand in the future to include detailed analysis of the fetal genome. This will allow for the testing for virtually any trait with a genetic contribution, including “non-medical” traits. Here we discuss the potential use of NIPT for these traits. We outline a scenario which highlights possible inconsistencies with ethical decision-making. We then discuss the case against permitting these uses. The objections include practical problems; increasing inequities; increasing the burden of choice; negative (...) impacts on the child, family, and society; and issues with implementation. We then outline the case for permitting the use of NIPT for these traits. These include arguments for reproductive liberty and autonomy; questioning the labeling of traits as “non-medical”; and the principle of procreative beneficence. This summary of the case for and against can serve as a basis for the development of a consistent and coherent ethical framework. (shrink)

The scope of noninvasive prenatal testing (NIPT) could expand in the future to include detailed analysis of the fetal genome. This will allow for the testing for virtually any trait with a genetic contribution, including “non-medical” traits. Here we discuss the potential use of NIPT for these traits. We outline a scenario which highlights possible inconsistencies with ethical decision-making. We then discuss the case against permitting these uses. The objections include practical problems; increasing inequities; increasing the burden of choice; negative (...) impacts on the child, family, and society; and issues with implementation. We then outline the case for permitting the use of NIPT for these traits. These include arguments for reproductive liberty and autonomy; questioning the labeling of traits as “non-medical”; and the principle of procreative beneficence. This summary of the case for and against can serve as a basis for the development of a consistent and coherent ethical framework. (shrink)

It is likely that gene editing technologies will become viable in the current century. As scientists uncover the genetic contribution to personality traits and cognitive styles, parents will face hard choices. Some of these choices will involve trade‐offs from the standpoint of the individual's welfare, while others will involve trade‐offs between what is best for each and what is good for all. Although we think we should generally defer to the informed choices of parents about what kinds of children to (...) create, we argue that decisions to manipulate polygenic psychological traits will be much more ethically complicated than choosing Mendelian traits like blood type. We end by defending the principle of regulatory parsimony, which holds that when legislation is necessary to prevent serious harms, we should aim for simple rules that apply to all, rather than micro‐managing parental choices that shape the traits of their children. While we focus on embryo selection and gene editing, our arguments apply to all powerful technologies which influence the development of children. (shrink)

In July 2018, the Nuffield Council of Bioethics released its long-awaited report on heritable genome editing. The Nuffield report was notable for finding that HGE could be morally permissible, even in cases of human enhancement. In this paper, we summarise the findings of the Nuffield Council report, critically examine the guiding principles they endorse and suggest ways in which the guiding principles could be strengthened. While we support the approach taken by the Nuffield Council, we argue that detailed consideration of (...) the moral implications of genome editing yields much stronger conclusions than they draw. Rather than being merely ‘morally permissible’, many instances of genome editing will be moral imperatives. (shrink)

In this paper, we investigate how data about public preferences may be used to inform policy around the use of controversial novel technologies, using public preferences about autonomous vehicles (AVs) as a case study. We first summarize the recent ‘Moral Machine’ study, which generated preference data from millions of people regarding how they think AVs should respond to emergency situations. We argue that while such preferences cannot be used to directly inform policy, they should not be disregarded. We defend an (...) approach that we call ‘Collective Reflective Equilibrium in Practice’ (CREP). In CREP, data on public attitudes function as an input into a deliberative process that looks for coherence between attitudes, behaviours and competing ethical principles. We argue that in cases of reasonable moral disagreement, data on public attitudes should play a much greater role in shaping policies than in areas of ethical consensus. We apply CREP to some of the global preferences about AVs uncovered by the Moral Machines study. We intend this discussion both as a substantive contribution to the debate about the programming of ethical AVs, and as an illustration of how CREP works. We argue that CREP provides a principled way of using some public preferences as an input for policy, while justifiably disregarding others. (shrink)

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

Selection against embryos that are predisposed to develop disabilities is one of the less controversial uses of embryo selection technologies. Many bio-conservatives argue that while the use of ESTs to select for non-disease-related traits, such as height and eye-colour, should be banned, their use to avoid disease and disability should be permitted. Nevertheless, there remains significant opposition, particularly from the disability rights movement, to the use of ESTs to select against disability. In this article we examine whether and why the (...) state could be justified in restricting the use of ESTs to select against disability. We first outline the challenge posed by proponents of ‘liberal eugenics’. Liberal eugenicists challenge those who defend restrictions on the use of ESTs to show why the use of these technologies would create a harm of the type and magnitude required to justify coercive measures. We argue that this challenge could be met by adverting to the risk of harms to future persons that would result from a loss of certain forms of cognitive diversity. We suggest that this risk establishes a pro tanto case for restricting selection against some disabilities, including dyslexia and Asperger's syndrome. (shrink)

Non-invasive prenatal testing is at the forefront of prenatal screening. Current uses for NIPT include fetal sex determination and screening for chromosomal disorders such as trisomy 21. However, NIPT may be expanded to many different future applications. There are a potential host of ethical concerns around the expanding use of NIPT, as examined by the recent Nuffield Council report on the topic. It is important to examine what NIPT might be used for before these possibilities become consumer reality. There is (...) limited research exploring views of women on possible future uses of NIPT, particularly those of women who have undergone NIPT. In this study, we examined the views of women who undertook NIPT previously on the acceptability of and interest levels in using NIPT for a number of current and possible future applications. These included several medical conditions encompassing psychiatric, neurodevelopmental and adult-onset conditions as well as non-medical traits such as intelligence. One thousand women were invited to participate and 235 eligible surveys were received. Women generally reported an interest in using NIPT for medical conditions that severely impacted quality of life and with an onset earlier in life and stressed the importance of the accuracy of the test. Concerns were raised about the use of NIPT for non-medical traits. Respondents indicated that termination of pregnancy was not their only reason for testing, particularly in the case of sex. These results can further inform the ethical debate around the increasing integration of NIPT into healthcare systems. (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)

DNA databases have significant commercial value. Direct-to-consumer genetic testing companies have built databanks using samples and information voluntarily provided by customers. As the price of genetic analysis falls, there is growing interest in building such databases by paying individuals for their DNA and personal data. This paper maps the ethical issues associated with private companies paying for DNA. We outline the benefits of building better genomic databases and describe possible concerns about crowding out, undue inducement, exploitation, and commodification. While certain (...) objections deserve more empirical and philosophical investigation, we argue that none currently provide decisive reasons against using financial incentives to secure DNA samples. (shrink)

In vitro gametogenesis (IVG) might offer numerous research and clinical benefits. Some potential clinical applications of IVG, such as allowing opposite‐sex couples experiencing infertility to have genetically related children, have attracted support. Others, such as enabling same‐sex reproduction and solo reproduction, have attracted significantly more criticism. In this paper, we examine how different ethical principles might help us to draw lines and distinguish between ethically desirable and undesirable uses of IVG. We discuss the alleged distinction between therapeutic and non‐therapeutic uses (...) of assisted reproduction in the context of IVG, and show how it is both problematic to apply in practice and theoretically dubious. We then discuss how the ethical principles of reproductive justice and beneficence apply to IVG for opposite‐sex reproduction, same‐sex reproduction, and solo reproduction. We suggest that these principles generate strong reasons for the use of IVG for opposite‐sex and same‐sex reproduction, but not for solo reproduction. (shrink)

Spinal muscular atrophy (SMA) is the most common genetic disease that causes infant mortality. Its treatment and prevention represent the paradigmatic example of the ethical dilemmas of 21st‐century medicine. New therapies (nusinersen and AVXS‐101) hold the promise of being able to treat, but not cure, the condition. Alternatively, genomic analysis could identify carriers, and carriers could be offered in vitro fertilization and preimplantation genetic diagnosis. In the future, gene editing could prevent the condition at the embryonic stage. How should these (...) different options be evaluated and compared within a health system? In this paper, we discuss the ethical considerations that bear on the question of how to prioritize the different treatments and preventive options for SMA, at a policy level. We argue that despite the tremendous value of what we call ‘ex‐post’ approaches to treating SMA (such as using pharmacological agents or gene therapy), there is a moral imperative to pursue ‘ex‐ante’ interventions (such as carrier screening in combination with prenatal testing and preimplantation genetic diagnosis, or gene editing) to reduce the incidence of SMA. There are moral reasons relating to autonomy, beneficence and justice to prioritize ex‐ante methods over ex‐post methods. (shrink)

Here, a moral case is presented as to why sign languages such as Auslan should be made compulsory in general school curricula. Firstly, there are significant benefits that accrue to individuals from learning sign language. Secondly, sign language education is a matter of justice; the normalisation of sign language education and use would particularly benefit marginalised groups, such as those living with a communication disability. Finally, the integration of sign languages into the curricula would enable the flourishing of Deaf culture (...) and go some way to resolving the tensions that have arisen from the promotion of oralist education facilitated by technologies such as cochlear implants. There are important reasons to further pursue policy proposals regarding the prioritisation of sign language in school curricula. (shrink)

Genomic sequencing technologies (GS) pose novel challenges not seen in older genetic technologies, making traditional standards for fully informed consent difficult or impossible to meet. This is due to factors including the complexity of the test and the broad range of results it may identify. Meaningful informed consent is even more challenging to secure in contexts involving significant time constraints and emotional distress, such as when rapid genomic testing (RGS) is performed in neonatal intensive care units. In this article, we (...) propose that informed consent matters not for its own sake, but because obtaining it furthers a range of morally important goals, such as promoting autonomy, well‐being, and trust in medicine. These goals form the basis of a new framework [PROmoting Morally Important Consent Ends (PROMICE)] for assessing the ethical appropriateness of various informed consent models. We illustrate this framework with two examples: (a) a tiered and layered consent model for obtaining consent for GS, and (b) consent for RGS in critically ill newborns. We conclude that appropriately—rather than fully—informed consent provides the correct standard for genomic medicine and research. (shrink)

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

Preimplantation genetic diagnosis allows the detection of genetic abnormalities in embryos produced through in vitro fertilization. Current funding models in Australia provide governmental subsidies for couples undergoing IVF, but do not extend to PGD. There are strong reasons for publicly funding PGD that follow from the moral principles of autonomy, beneficence and justice for both parents and children. We examine the objections to our proposal, specifically concerns regarding designer babies and the harm of disabled individuals, and show why these are (...) substantially outweighed by arguments for subsidizing PGD. We argue that an acceptance of PGD is aligned with present attitudes towards procreative decision making and IVF use, and that it should therefore receive government funding. (shrink)

In this paper, we outline how one might conduct a comprehensive ethical evaluation of human brain organoid transplantation in animals. Thus far, ethical concerns regarding this type of research have been assumed to be similar to those associated with other transplants of human cells in animals, and have therefore not received significant attention. The focus has been only on the welfare, moral status, or mental capacities of the host animal. However, the transplantation of human brain organoids introduces several new ethical (...) issues. Many of these are related to uncertainty regarding whether or not brain organoids might be conscious. While these concerns might not be immediately relevant, they warrant closer scrutiny. We discuss how various ethical issues are relevant to different stages of human brain organoid transplantation and can guide the ethical evaluation of research. Our examination would broaden the horizons of the debate on the transplantation of brain organoids. (shrink)

Advances in biotechnology mean that it may soon be possible to recreate previously extinct species. This has led to an emerging debate within bioethics about whether we ought to reintroduce extinct species into our ecosystems. In this paper, we discuss the role that biodiversity could play in this debate. Many believe that biodiversity is a good that should be protected. We argue that if biodiversity is a good, then this suggests it should also be promoted, including by reintroducing previously extinct (...) species. We begin by outlining different ways in which biodiversity could be conceptualized, and then analyze various accounts of its value. We suggest no approach justifies an asymmetry between “protecting” biodiversity by conserving species alive today, and “creating” biodiversity by introducing previously extinct species. This suggests that if we have reasons stemming from biodiversity to protect species from extinction, we will have similar reasons to reintroduce previously extinct species. We close by asking whether arguments from biodiversity speak in favor of introducing some novel species into the ecosystem. (shrink)

Recently, Australia became the second jurisdiction worldwide to legalize the use of mitochondrial donation technology. The Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 allows individuals with a family history of mitochondrial disease to access assisted reproductive techniques that prevent the inheritance of mitochondrial disease. Using inductive content analysis, we assessed submissions sent to the Senate Committee as part of a programme of scientific inquiry and public consultation that informed drafting of the Bill. These submissions discussed a range of bioethical (...) and legal considerations of central importance to the political debate. Significantly, submissions from those with a first-hand experience of mitochondrial disease, including clinicians and those with a family history of mitochondrial disease, were in strong support of this legislation. Those in support of the Bill commended the two-staged approach and rigorous licencing requirements as part of the Bill’s implementation strategy. Submissions which outlined arguments against the legislation either opposed the use of these techniques in general or opposed aspects of the implementation strategy in Australia. These findings offer a window into the ethical arguments and perspectives that matter most to those Australians who took part in the Senate inquiry into mitochondrial donation. The insights garnered from these submissions may be used to help refine policy and guidelines as the field progresses. (shrink)

Lockdowns and quarantines have been implemented widely in response to the COVID-19 pandemic. This has been accompanied by a rise in interest in the ethics of ‘passport’ systems that allow low-risk individuals greater freedoms during lockdowns and exemptions to quarantines. Immunity and vaccination passports have been suggested to facilitate the greater movement of those with acquired immunity and who have been vaccinated. Another group of individuals who pose a low risk to others during pandemics are those with genetically mediated resistances (...) to pathogens. In this paper, we introduce the concept of genomic passports, which so far have not been explored in the bioethics literature. Using COVID-19 as an illustrative example, we explore the ethical issues raised by genomic passports and highlight differences and similarities to immunity passports. We conclude that, although there remain significant practical and ethical challenges to the implementation of genomic passports, there will be ways to ethically use them in the future. (shrink)

Many controversies in bioethics turn on questions of moral status. Some moral status issues have received extensive bioethical attention, including those raised by abortion, embryo experimentation, and animal research. Beyond these established debates lie a less familiar set of moral status issues, many of which are tied to recent scientific breakthroughs. This review article surveys some key developments that raise moral status issues, including the development of in vitro brains, part-human animals, “synthetic” embryos, and artificial womb technologies. It introduces the (...) papers in this Special Issue, contextualises their contributions to the moral status literature, and highlights some enduring challenges of determining the moral status of novel types of beings. (shrink)

In this article, we provide an ethical analysis of the first porcine cardiac xenotransplant, performed in Maryland, USA in early 2022. David Bennett was offered the experimental procedure after he was deemed ineligible for human heart transplantation and mechanical circulatory support, based on a history of non-compliance. It was reported that Mr Bennett’s previous instances of non-compliance were for medically non-life-threatening conditions years earlier, where the risks of non-compliance were not as high. We argue that, in Mr Bennett’s case, a (...) history of non-compliance in a different context, should not necessarily rule him ineligible for a potentially life-saving treatment now. Furthermore, using previous non-compliance to exclude individuals from donor organs may have the unintended effect of placing the burden of testing xenotransplantation on those who are already disadvantaged. We then argue that it is not enough to rely on patient consent to ethically justify xenotransplantation research. Taking a broad ethical perspective is crucial when mapping a clinical pathway for xenotransplantation. (shrink)

Although rapid genomic sequencing (RGS) is improving care for critically ill children with rare disease, it also raises important ethical questions that need to be explored as its use becomes more widespread. Two such questions relate to the degree of consent that should be required for RGS to proceed and whether it might ever be appropriate to override parents’ decisions not to allow RGS to be performed in their critically ill child. To explore these questions, we first examine the legal (...) frameworks on securing consent for genomic sequencing and how they apply to the specific context of RGS for critically ill children. We then use a tool from clinical ethics, the Zone of Parental Discretion, to explore two case studies and identify under which circumstances it might be appropriate for parental refusal of RGS to be overridden. We argue that RGS may be a context where, in addition to assessing the complexity of the test offered, it is ethically appropriate to consider an effect on patient outcomes when deciding the degree of consent required. We also suggest that there are some contexts where it may be ethically justified to perform RGS, even when it is actively against the wishes of the parents. More work is needed to examine exactly how ‘time-sensitive’ exceptions to current guidance on consent for genomic sequencing could be formulated and operationalised for RGS for critically ill-children. (shrink)

Genomic sequencing (GS) is increasingly used in paediatric medicine to aid in screening, research and treatment. Some health systems are trialling GS as a first-line test in newborn screening programmes. Questions about what to do with genomic data after it has been generated are becoming more pertinent. While other research has outlined the ethical reasons for storing deidentified genomic data to be used in research, the ethical case for storing data for future clinical use has not been explicated. In this (...) paper, we examine the ethical case for storing genomic data with the intention of using it as a lifetime health resource. In this model, genomic data would be stored with the intention of reanalysis at certain points through one’s life. We argue this could benefit individuals and create an important public resource. However, several ethical challenges must first be met to achieve these benefits. We explore issues related to privacy, consent, justice and equality. We conclude by arguing that health systems should be moving towards futures that allow for the sequential interrogation of genomic data throughout the lifespan. (shrink)