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Genomic screening at population scale generates many ethical considerations. One is the normative role that people’s preferences should play in determining access to genomic information in screening contexts, particularly information that falls beyond the scope of screening. We expect both that people will express a preference to receive such results and that there will be interest from the professional community in providing them. In this paper, we consider this issue in relation to the just and equitable design of population screening (...) programs like reproductive genetic carrier screening (RGCS). Drawing on a pluralistic public health ethics perspective, we claim that generating and reporting information about genetic variants beyond the scope of the screening program usually lacks clinical, and perhaps personal, utility. There are both pragmatic and ethical reasons to restrict information provision to that which fits the stated purpose of the program. (shrink)

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Multiple studies show that periodic reanalysis of genomic test results held by clinical laboratories delivers significant increases in overall diagnostic yield. However, while there is a widespread consensus that implementing routine reanalysis procedures is highly desirable, there is an equally widespread understanding that routine reanalysis of individual patient results is not presently feasible to perform for all patients. Instead, researchers, geneticists and ethicists are beginning to turn their attention to one part of reanalysis—reinterpretation of previously classified variants—as a means of (...) achieving similar ends to large-scale individual reanalysis but in a more sustainable manner. This has led some to ask whether the responsible implementation of genomics in healthcare requires that diagnostic laboratories routinely reinterpret their genomic variant classifications and reissue patient reports in the case of materially relevant changes. In this paper, we set out the nature and scope of any such obligation, and analyse some of the main ethical considerations pertaining to a putative duty to reinterpret. We discern and assess three potential outcomes of reinterpretation—upgrades, downgrades and regrades—in light of ongoing duties of care, systemic error risks and diagnostic equity. We argue against the existence of any general duty to reinterpret genomic variant classifications, yet we contend that a suitably restricted duty to reinterpret ought to be recognised, and that the responsible implementation of genomics into healthcare must take this into account. (shrink)

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The concept of autonomy plays a central role in bioethics,1 but there is no consensus as to how we should understand it beyond a general notion of self-determination. The conception of autonomy deployed in applied ethics2 can have crucial ramifications when it is applied in real-world scenarios, so it is important to be clear. However, this clarity is often lacking when autonomy is discussed in the bioethics literature. In this paper we outline three different conceptions of autonomy, and argue that (...) a substantive, perfectionist approach meets the theoretical requirements for an account of autonomy and also provides practical guidance. As Rebecca Walker argues, bioethics requires a more conceptually adequate account... (shrink)

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Clinical ethics has developed significantly in Europe over the past 15 years and remains an evolving process. While sharing our experiences in different European settings, we were surprised to discover marked differences in our practice, especially regarding the position and role of patients. In this paper, we describe these differences, such as patient access to and participation or representation in ethics consults. We propose reasons to explain these differences, hypothesizing that they relate to the historic and sociocultural context of implementation (...) of clinical ethics consultation services (Cecs), as well as the initial aims for which each structure was established. Then, we analyse those differences with common ethical arguments arising in patient involvement. We conclude that there is no unique model of best practice for patient involvement in clinical ethics, as far as Cecs reflect on how to deal with the challenging ethical issues raised by patient role and position. (shrink)

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The classification of techniques used in mitochondrial donation, including their role as purported germ-line gene therapies, is far from clear. These techniques exhibit characteristics typical of a variety of classifications that have been used in both scientific and bioethics scholarship. This raises two connected questions, which we address in this paper: how should we classify mitochondrial donation techniques?; and what ethical implications surround such a classification? First, we outline how methods of genetic intervention, such as germ-line gene therapy, are typically (...) defined or classified. We then consider whether techniques of mitochondrial donation fit into these, whether they might do so with some refinement of these categories, or whether they require some other approach to classification. To answer the second question, we discuss the relationship between classification and several key ethical issues arising from mitochondrial donation. We conclude that the properties characteristic of mitochondrial inheritance mean that most mitochondrial donation techniques belong to a new sub-class of genetic modification, which we call ‘conditionally inheritable genomic modification’. (shrink)

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In their analysis of how much fetal genetic information prospective parents should be able to access, Bayefsky and Berkman determine that parents should only be able to access information th...

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Background We aimed to examine the ethical concerns Singaporeans have about sharing health-data for precision medicine and identify suggestions for governance strategies. Just as Asian genomes are under-represented in PM, the views of Asian populations about the risks and benefits of data sharing are under-represented in prior attitudinal research. Methods We conducted seven focus groups with 62 participants in Singapore from May to July 2019. They were conducted in three languages and analysed with qualitative content and thematic analysis. Results Four (...) key themes emerged: nuanced understandings of data security and data sensitivity; trade-offs between data protection and research benefits; trust in the public and private sectors; and governance and control options. Participants were aware of the inherent risks associated with data sharing for research. Participants expressed conditional support for data sharing, including genomic sequence data and information contained within electronic medical records. This support included sharing data with researchers from universities and healthcare institutions, both in Singapore and overseas. Support was conditional on the perceived social value of the research and appropriate de-identification and data security processes. Participants suggested that a data sharing oversight body would help strengthen public trust and comfort in data research for PM in Singapore. Conclusion Maintenance of public trust in data security systems and governance regimes can enhance participation in PM and data sharing for research. Contrary to themes in much prior research, participants demonstrated a sophisticated understanding of the inherent risks of data sharing, analysed trade-offs between risks and potential benefits of PM, and often adopted an international perspective. (shrink)

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Reproductive genetic carrier screening (RCS), when offered to anyone regardless of their family history or ancestry, has been subject to the critique that it is a form of eugenics. Eugenics describes a range of practices that seek to use the science of heredity to improve the genetic composition of a population group. The term is associated with a range of unethical programmes that were taken up in various countries during the 20th century. Contemporary practice in medical genetics has, understandably, distanced (...) itself from such programmes. However, as RCS becomes more widespread, gains public funding and uses expanded gene panels, there are concerns that such programmes could be perceived as eugenic either in intent or outcome. The typical response to the eugenics critique of RCS is to emphasise the voluntary nature of both participating in screening and making subsequent reproductive choices. While safeguarding individuals’ freedom to choose in relation to screening is essential, we consider this response inadequate. By examining the specific ethical wrongs committed by eugenics in the past, we argue that to avoid the perception of RCS being a form of eugenics it is essential to attend to the broader normative context in which reproductive decisions occur. Furthermore, ethical RCS programmes must recognise and respond to their potential to shift societal norms that shape individual reproductive choices. (shrink)

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The use of genomic testing in pregnancy is increasing, giving rise to questions over how the information that is generated should be offered and returned in clinical practice. While these tests provide important information for prenatal decision-making, they can also generate information of uncertain significance. This paper critically examines three models for approaching the disclosure of variants of uncertain significance (VUS), which can arise from forms of genomic testing such as prenatal chromosomal microarray analysis (CMA). Contrary to prevailing arguments, we (...) argue that respect for reproductive autonomy does not justify adopting a model on which an offer to disclose VUS is a routine part of genetic counselling. Instead, we contend that a commitment both to solidarity between healthcare providers and pregnant women and to the acceptance of a novel principle of caution under normative uncertainty means that we should instead adopt a model of VUS disclosure that imposes a strong presumption against offering to disclose VUS. The upshot of this is that it should be standard practice to only offer to disclose VUS when this is requested by the woman undergoing CMA. We defend our position against claims that arise from an alleged right to such information and that a presumption against an offer will lead to inequity. (shrink)

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Non-invasive prenatal testing is an emerging form of prenatal genetic testing that provides information about the genetic constitution of a foetus without the risk of pregnancy loss as a direct result of the test procedure. As with other prenatal tests, information from NIPT can help to make a decision about termination of pregnancy, plan contingencies for birth or prepare parents to raise a child with a genetic condition. NIPT can also be used by women and couples to test purely ‘for (...) information’. Here, no particular action is envisaged following the test; it is motivated entirely by an interest in the result. The fact that NIPT can be performed without posing a risk to the pregnancy could give rise to an increase in such requests. In this paper, we examine the ethical aspects of using NIPT ‘purely for information’, including the competing interests of the prospective parents and the future child, and the acceptability of testing for ‘frivolous’ reasons. Drawing on several clinical scenarios, we claim that arguments about testing children for genetic conditions are relevant to this debate. In addition, we raise ethical concerns over the potential for objectification of the child. We conclude that, in most cases, using NIPT to test for adult-onset conditions, carrier status or non-serious traits presenting in childhood would be unacceptable. (shrink)

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Clinical ethics committees (CECs) in the United Kingdom (UK) have developed significantly over the past 15 years. The issue of access to and participation in clinical ethics consultation by patients and family members has, however, gone largely unrecognized. There are various dimensions to this kind of contact, including patient notification, consent and participation. This study reports the first specific investigation of patient contact with UK CECs. A questionnaire study was carried out with representatives from UK CECs. Results suggest that patient (...) participation in clinical ethics consultation is low and unlikely to change significantly in the near future. Attitudes towards patients having a role in clinical ethics consultation are mixed, with a variety of reasons put forward both for and against patient participation. These results are discussed in the light of common themes in the literature and the practical and political context of clinical ethics support in the UK. (shrink)

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The law often calls on the concept of public interest for assistance. Privacy law makes use of this concept in several ways, including to justify consent waivers for secondary research on health information. Because the law sees information privacy as a means for individuals to control their personal information, consent can only be set aside in special circumstances. Ballantyne and Schaefer argue that only public interest, and only a broad conception of public interest, can do the special ‘normative justificatory work’ (...) to override consent requirements. Other, similar-sounding concepts, such as public benefit, public good and social value, also provide useful services. But none more so than public interest. In fact, they argue, public interest is the superior concept precisely because it can capture those concepts as well as a range of other interests. Our response focuses on this claim. We argue their strategy is not as promising as it might first seem. Ballantyne and Schaefer construe the important role that public interest plays in this context as their endpoint. They claim that unless the concept is open and content-rich, it will lose some of its importance. But by refusing to place limits around it, their inquiry leads us back to a catch-all concept that lacks clear focus or meaning. In reply, we argue that, for practically minded theorists, a narrow conception of public interest is more useful. Further, the narrowing of public interest in this context can be achieved by first analysing it in its legal, rather than ethical, sense. (shrink)

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This editorial examines the evolving role of patients in European clinical ethics consultation services. While patient involvement has been theoretically supported in North America but often neglected in practice, European approaches show varying levels of patient participation - from committee membership to consultation involvement to full participation in ethical deliberations. Through analysis of a case involving end-of-life care and several commissioned papers exploring different national contexts, the authors highlight how patient involvement varies across Europe based on different healthcare systems and (...) cultural contexts. They note that while no single model of patient involvement is superior, ethics consultation without patient and family participation may miss critical perspectives needed for inclusive ethical deliberation. The authors conclude that practical considerations around consent, participation procedures and documentation need to be addressed as patient involvement increases, while acknowledging that cultural diversity across Europe will lead to different mechanisms for including patient voices. (shrink)

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Sahan et al draw much needed attention to the ethical complexity encountered by clinical laboratory scientists. They point out that, on the one hand, clinical laboratories are increasingly required to analyse ‘much broader swathes’ of genomic information than had previously been the case and to consider how best to report—or not report—the results that arise. On the other hand, they also note how clinical laboratory services are supporting genomic testing that is transitioning from specialist to mainstream services, such that questions (...) of whether and how to report genomic information must ‘accommodate the considerations of an expanded multidisciplinary team (MDT)’.1 These two factors, among others, increase both the ‘range and complexity’ of ethical dilemmas faced by clinical laboratory scientists. This trajectory will continue in line with trends towards further mainstreaming of genomic medicine, and the use of genomic sequencing (generating ‘much broader swathes’ of information) over more targeted approaches. In this challenging environment, Sahan et al contend that the notion of ‘ethical preparedness’ (EP) has a crucial role to play. Here ‘EP’ is understood as a state of both systems and individuals that is characterised by the ‘capability, opportunity and motivation to respond to the ethical issues arising in a particular clinical situation, as well as being able to anticipate ethical concerns in advance in areas where practice is rapidly evolving’.1 Notably, cultivating the …. (shrink)

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Empirical evidence suggests that some health professionals believe consent procedures for the emerging technology of non-invasive prenatal diagnosis (NIPD) should become less rigorous than those currently used for invasive prenatal testing. In this paper, we consider the importance of informed consent and informed choice procedures for protecting autonomy in those prenatal tests which will give rise to a definitive result. We consider whether there is anything special about NIPD that could sanction a change to consent procedures for prenatal diagnosis or (...) otherwise render informed decision-making less important. We accept the claim that the absence of risk of miscarriage to some extent lessens the gravity of the decision to test compared with invasive methods of testing. However, we also claim that the definitive nature of the information received, and the fact that the information can lead to decisions of great significance, makes NIPD an important choice. This choice should only be made by means of a rigorous and appropriately supported decision-making process (assuming that this is what the pregnant woman wants). We conclude that, on balance, consent procedures for NIPD should mirror those for invasive testing, albeit without the need to emphasise procedure-related risk. (shrink)

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Evidence suggests that one reason doctors provide certain interventions in assisted reproductive technologies (ART) is because of patient demand. This is particularly the case when it comes to unproven interventions such as ‘add‐ons’ to in vitro fertilisation (IVF) cycles, or providing IVF cycles that are highly unlikely to succeed. Doctors tend to accede to demands for such interventions because patients are willing to do and pay ‘whatever it takes’ to have a baby. However, there is uncertainty as to what moral (...) weight should be placed on patient‐led demands in ART, including whether it is acceptable for such demands to be invoked as a justification for intervention. We address this issue in this paper. We start by elucidating what we mean by ‘patient‐led demand’ and synthesise some of the evidence for this phenomenon. We then argue that a doctor's professional role morality (PRM) yields special responsibilities, particularly in commercialised healthcare settings such as ART, because of the nature of professions as social institutions that are distinct from markets. We argue on this basis that, while there may be reasons (consistent with PRM) for doctors to accede to patient demand, this is not always the case. There is often a gap in justification between acceding to patient‐led demands and providing contested interventions, particularly in commercial settings. As a result, acceding to demand in such settings needs a strong justification to be consistent with PRM. (shrink)

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Criminal behaviour is but one behavioural tendency for which a genetic influence has been suggested. Whilst this research certainly raises difficult ethical questions and is subject to scientific criticism, one recent research project suggests that for some families, criminal tendency might be predicted by genetics. In this paper, supposing this research is valid, we consider whether intervening in the criminal tendency of future children is ethically justifiable. We argue that, if avoidance of harm is a paramount consideration, such an intervention (...) is acceptable when genetic selection is employed instead of genetic enhancement. Moreover, other moral problems in avoiding having children with a tendency to criminal behaviour, such as the prospect of social discrimination, can also be overcome. (shrink)

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This target article considers the ethical implications of providing prenatal diagnosis (PND) and antenatal screening services to detect fetal abnormalities in jurisdictions that prohibit abortion for these conditions. This unusual health policy context is common in the Latin American region. Congenital conditions are often untreated or under-treated in developing countries due to limited health resources, leading many women/couples to prefer termination of affected pregnancies. Three potential harms derive from the provision of PND in the absence of legal and safe abortion (...) for these conditions: psychological distress, unjust distribution of burdens between socio-economic classes, and financial burdens for families and society. We present Iran as a comparative case study where recognition of these ethical issues has led to the liberalization of abortion laws for fetuses with thalassemia. We argue that physicians, geneticists and policymakers have an ethical and professional duty of care to advocate for change in order to ameliorate these harms. (shrink)

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Reproductive genetic carrier screening provides information about people's chance of having children with certain genetic conditions. Severity of genetic conditions is an important criterion for their inclusion in carrier screening programmes. However, the concept of severity is conceptually complex and underspecified. We analyse why severity is an important concept in carrier screening and for reproductive decision-making and show that assessments of severity can also have normative societal implications. While some genetic conditions are unambiguously associated with a high degree of suffering, (...) there are many factors that contribute to how severe a condition is perceived to be, and perspectives will vary. Attempts to classify genetic conditions according to their severity tend to prioritise biomedical information at the expense of incorporating qualitative aspects of the impact of genetic conditions on people's lives. Further complexity arises because some genotypes can present with variable phenotypes and because some conditions are not always experienced in the same way by all people who have them. To acknowledge this complexity, we argue that an understanding of severity needs to distinguish between the severity of a genetic condition—requiring a generalised approach for purposes of policy development and programme design—and the severity of an instance of a genetic condition in a particular person. Families making reproductive decisions also require access to diverse experiences of the qualitative aspects of living with genetic conditions. As a result, reproductive carrier screening programmes must recognise and respond to the complexity inherent in determining the severity of genetic conditions. (shrink)

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Recent scientific advances mean the widespread introduction of non-invasive prenatal diagnosis (NIPD) for chromosomal aneuploidies may be close at hand, raising the question of how NIPD should be introduced as part of antenatal care pathways for pregnant women. In this paper, the authors examine the ethical implications of three hypothetical models for using NIPD for aneuploidy in state-funded healthcare systems and assess which model is ethically preferable. In comparing the models, the authors consider their respective timings; how each model would (...) fit with current screening and diagnostic tests offered to pregnant women; the implications of offering NIPD at different stages of pregnancy; and the potential for each model to support reproductive autonomy and informed decision-making. The authors conclude by favouring a model that would be offered at 11–13 weeks gestation, alongside existing combined screening, provided that this is accompanied by measures to maximise informed decision-making, for example, provision of adequate pretest and post-test counselling. (shrink)

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Reproductive genetic carrier screening is increasingly being offered more widely, including to people with no family history or otherwise elevated chance of having a baby with a genetic condition. There are valid reasons to reject a prevention-focused public health ethics approach to such screening programs. Rejecting the prevention paradigm in this context has led to an emphasis on more individually-focused values of freedom of choice and fostering reproductive autonomy in RCS. We argue, however, that population-wide RCS has sufficient features in (...) common with other public health screening programs that it becomes important also to attend to its public health implications. Not doing so constitutes a failure to address the social conditions that significantly affect people’s capacity to exercise their reproductive autonomy. We discuss how a public health ethics approach to RCS is broader in focus than prevention. We also show that additional values inherent to ethical public health—such as equity and solidarity—are essential to underpin and inform the aims and implementation of reproductive carrier screening programs. (shrink)

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Johnson and colleagues (2015) report a retrospective review of the experience of an ethics consultation service at a single, highly specialized children's hospital over an 11-year period. Despite i...

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Implementing whole genome sequencing (WGS) in paediatric settings demands sensitive and nuanced examination. Critical reflection as to how and when to use this technology is particularly important. This commentary on Anderson et al's (2017) evaluation of the Genome Clinic study, which involved paediatric clinical WGS, provides an opportunity for such reflection. I scrutinise three issues raised in the study: (1) the non-separation of the choice over agreeing to diagnostic WGS and whether to receive adult-onset SVs; (2) the value of deliberation (...) regarding paediatric WGS and (3) the place of best interests in debates over returning adult-onset SVs. (shrink)

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In healthcare broadly, and especially in genetic (and now genomic) medicine, there is an ongoing debate about whether patients have a right not to know (RNTK) information about their own health. The extensive literature on this topic is characterised by a range of different understandings of what it means to have a RNTK,1–9 and how this purported right relates to patient autonomy. Ben Davies considers whether obligations not to place avoidable burdens on a publicly funded healthcare system might form the (...) basis for an obligation to acquire relevant health information, and hence refute the RNTK. He also makes the interesting argument that an obligation to know does not necessarily limit the RNTK. Davies summarises the more prominent arguments against the RNTK, including harm-to-others arguments that focus on potential harms to individuals related to the patient. However he then considers the RNTK in the context of the obligations that people have to each other within a publicly funded healthcare system. So rather than focusing on harms to specific individuals, Davies’ argument is instead based on the wrong of needlessly consuming public healthcare resources. If a person avoids health-related information and thereby exacerbates their health problems, this makes them more complex and expensive to treat. Davies argues that this constitutes …. (shrink)

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Background: Personal genomic testing (PGT) offers individuals genetic information about relationships, wellness, sporting ability, and health. PGT is increasingly accessible online, including in emerging markets such as Australia. Little is known about what consumers expect from these tests and whether their reflections on testing resonate with bioethics concepts such as autonomy. Methods: We report findings from focus groups and semi-structured interviews that explored attitudes to and experiences of PGT. Focus group participants had little experience with PGT, while interview participants had (...) undergone testing. Recordings were transcribed and analyzed using thematic analysis. Findings were critically interpreted with reference to bioethics scholarship on autonomy. Results: Fifty-six members of the public participated in seven focus groups, and 40 individuals were interviewed separately. Both groups valued the choice of PGT, and believed that it could motivate relevant actions. Focus group themes centered on the perceived value of choices, knowledge enabling action and knowledge about the self. Interview themes suggest that participants reflexively engage with their PGT information to make meaning, and that some appreciate its shortcomings. Critical interpretation of findings shows that while consumers of PGT are able to exercise a degree of autonomy in choosing, they may not be able to achieve a substantive conceptualization of autonomy, one that promotes alignment with higher-order desires. Conclusions: PGT consumers can critically reason about testing. However, they may uncritically accept test results, may not appreciate drawbacks of increased choice, or may overestimate the potential for information to motivate behavioral change. While consumers appear to be capable of substantive autonomy, they do so without ongoing support from companies. PGT companies promote a problematic (“default”) account of autonomy, reliant on empowerment rhetoric. This leaves consumers vulnerable to making decisions inconsistent with their higher-order desires. As PGT expands, claims about its power and value need to be carefully drawn. (shrink)

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Precision medicine is an emerging approach to treatment and disease prevention that relies on linkages between very large datasets of health information that is shared amongst researchers and health professionals. While studies suggest broad support for sharing precision medicine data with researchers at publicly funded institutions, there is reluctance to share health information with private industry for research and development. As the private sector is likely to play an important role in generating public benefits from precision medicine initiatives, it is (...) important to understand what the concerns are and how they might be mitigated. This study reports outcomes of a deliberative method of citizen engagement in Singapore that asked whether sharing precision medicine data with private industry would be permissible, and if so, under what circumstances. Findings from this citizens’ jury suggest sharing with industry would be permissible under certain conditions that are set out in nine recommendations. Implications of the recommendations and their underlying assumptions for policy decision makers are discussed. This study aligns with prior international studies which found conditional acceptance for data sharing with private industry, a public benefit requirement, specific reluctance to share with insurance companies and an emphasis on accountability and transparency to demonstrate trustworthiness. However, our results differ from prior studies in that opt-in consent did not dominate the deliberations as jurors were able to set it aside as an assumed prerequisite for participation in a precision medicine programme. (shrink)

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This chapter provides a comprehensive overview of the ethical issues associated with population screening from the perspective of public health. Key principles and frameworks for ethical analysis are explained and discussed, including assessment of individual and collective interests in public health. Ethical dimensions of population screening are examined with close attention to complex overlapping ethical tensions. Section one briefly describes what is meant by ‘screening’ and reviews criteria for introducing screening programmes, section two presents examples of programmes and section three (...) presents and critiques ethical issues arising from screening. (shrink)

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This open peer commentary examines the concept of authenticity in bioethics, specifically in the context of medical interventions for children with ADHD. The authors explore the philosophical foundations of authenticity, drawing from existentialist and perfectionist philosophical traditions. They argue that while the concept of authenticity can be complex and contextual, it remains a valuable tool for moral assessment in medical ethics. The commentary critically engages with the original article by Singh, agreeing that authenticity is inherently relational and context-dependent, while also (...) defending its potential theoretical usefulness. The authors suggest that bioethicists should continue to explore authenticity as a concept, balancing theoretical considerations with empirical studies of contextual decision-making, and recognizing the nuanced ways in which individuals understand and experience their own sense of self. (shrink)

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Background: When a genetic mutation is identified in a family member, internationally, it is usually the proband’s or another responsible family member’s role to disclose the information to at-risk relatives. However, both active and passive non-disclosure in families occurs: choosing not to communicate the information or failing to communicate the information despite intention to do so, respectively. The ethical obligations to prevent harm to at-risk relatives and promote the duty of care by genetic health professionals is in conflict with Privacy (...) laws and professional regulations that prohibits disclosure of information to a third party without the consent of the proband. In New South Wales, Australia, amendments to Privacy legislation permits such disclosure to living genetic relatives with the process defined under guidelines although there is no legal duty to warn. This study assessed NSW GHP’s awareness and experience of the legislation and guidelines. Methods: An online survey collected demographics; theoretical knowledge; clinical scenarios to assess application knowledge; attitudes; confidence; experience with active non-disclosure. A link to correct answers was provided after completion. Knowledge scores above the median for non-parametric data or above the mean for parametric data were classified as ‘good’ or ‘poor’. Chi square tests assessed associations between confidence and knowledge scores. Results: While many of the 37 participants reported reading the guidelines, there was limited awareness of their scope and clinical application; that there is no legal duty to warn; and that the threat does not need to be imminent to warrant disclosure. No association between confidence and ‘good’ theoretical or applied clinical knowledge was identified. Uncertainty of their professional responsibility was identified and in the several case examples of active non-disclosure that were reported this uncertainty reflected the need for further understanding of the guidelines in regard to the processes required before disclosure was initiated. Conclusions: There is a need for further education and training about the guidelines associated with the legislation that would be relevant to support disclosure. The findings may inform future strategies to support introduction of policy changes in other jurisdictions where similar regulatory regimes are introduced. (shrink)

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This open peer commentary critiques Cwik's approach to categorizing germline gene editing interventions. The authors argue that Cwik's framework, which prioritizes technical categories and dimensions to map the "ethical terrain," is fundamentally flawed by putting the technical aspects before ethical considerations. They identify four key problems with his approach: it is arbitrary in its categorizations, relies on dynamic membership that changes with scientific knowledge, requires extensive technical expertise that many bioethicists lack, and most importantly, approaches the analysis "back-to-front" by starting (...) with technical rather than ethical distinctions. The authors argue that ethical assessment should begin with examining the goals and justifications of an intervention, rather than its technical specifications. They use the example of mitochondrial replacement therapy to illustrate how classification should proceed from ethical considerations to technical ones, not vice versa. The commentary concludes that while Cwik offers a complex framework, it is both incorrectly structured and impractical to use consistently. (shrink)

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This clinical ethics case examines whether healthcare providers have an obligation to inform patients about animal-derived ingredients in medications, specifically focusing on a hospitalized patient who may object to porcine-derived heparin on religious grounds. The ethics committee concluded that healthcare providers have a moral obligation to disclose this information to all patients, not just those presumed to have religious or ethical objections, to allow for informed decision-making. While acknowledging practical challenges around information delivery and increased costs of synthetic alternatives, they (...) recommended developing systematic approaches like information leaflets and staff education to address this issue. The committee emphasized there should be no moral distinction between religious and ethical objections to animal products, and that the healthcare system needs to work with faith and advocacy groups to better serve patients' needs while balancing medical necessity with personal beliefs. (shrink)

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This clinical ethics case examines whether to continue prescribing Adderall, an unlicensed drug in the UK, to a 30-year-old American patient with uncertain diagnosis who claims benefit from the medication. The ethics committee analyzed key tensions: balancing the patient's preference and reported benefits against diagnostic uncertainty and medical best practices, weighing short-term functioning against long-term risks of an addictive medication, and considering resource allocation implications of prescribing an unlicensed drug. While acknowledging the patient's positive response to Adderall, the committee recommended (...) trying UK-approved medications first while working to establish a clearer diagnosis and building a stronger doctor-patient relationship, rather than simply continuing to prescribe based on patient preference alone. (shrink)

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The introduction of novel diagnostic techniques in clinical domains such as genomics and radiology has led to a rich ethical debate on how to handle unsolicited findings that result from these innovations. Yet while unsolicited findings arise in both genomics and radiology, most of the relevant literature to date has tended to focus on only one of these domains. In this article, we synthesize and critically assess similarities and differences between “scanning the body” and “sequencing the genome” from an ethical (...) perspective. After briefly describing the novel diagnostic contexts leading to unsolicited findings, we synthesize and reflect on six core ethical issues that relate to both specialties: terminology; benefits and risks; autonomy; disclosure of unsolicited findings to children; uncertainty; and filters and routine screening. We identify ethical rationales that pertain to both fields and may contribute to more ethically sound policies. Considerations of preserving public trust and ensuring that people perceive healthcare policies as fair also support the need for a combined debate. (shrink)

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Medicine has always existed in a marketplace, and there have been extensive discussions about the ethical implications of commerce in health care. For the most part, this discussion has focused on health professionals’ interactions with pharmaceutical and other health technology industries, with less attention given to other types of commercial influences, such as corporatized health services and fee-for-service practice. This is a significant lacuna because in many jurisdictions, some or all of healthcare is delivered in the private sector. Using the (...) exemplar of Assisted Reproductive Technologies (ART), this paper asks: what, if any, responsibilities do doctors have to challenge the distorting influence of commerce in healthcare, other than those arising from their own interactions with health technology companies? ART provides a good focus for this question because it is an area of practice that has historically been provided in the private sector. First, we describe a range of concepts that offer helpful heuristics for capturing how and when doctors can reasonably be said to have responsibilities to resist commercial distortion, including: complicity, acquiescence, wilful ignorance, non-wilful ignorance, and duplicity. Second, we present ways that individual doctors can act to stop questionable behaviour on the part of their colleagues, clinics/corporations, and their profession. Third, we note that there are many situations where change cannot be achieved by individuals acting alone, and so we consider the responsibilities of health professionals as collectives as well as the role that professional bodies and regulators should play. (shrink)

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Innovation is a key driver of care provision in assisted reproductive technologies (ART). ART providers offer a range of add‐on interventions, aiming to augment standard in vitro fertilization protocols and improve the chances of a live birth. Particularly in the context of commercial provision, an ever‐increasing array of add‐ons are marketed to ART patients, even when evidence to support them is equivocal. A defining feature of ART is hope—hope that a cycle will lead to a baby or that another test (...) or intervention will make a difference. Yet such hope also leaves ART patients vulnerable in a variety of ways. This article argues that previous attempts to safeguard ART patients have neglected how the use of add‐ons in commercial ART can exploit patients’ hopes. Commercial providers of ART should provide add‐ons only free of charge, under a suitable research protocol. (shrink)

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The results of tests carried out using next-generation genomic sequencing (NGS) possess a peculiar and perhaps unique ‘diagnostic durability’. Unlike most other forms of testing, if genomic results or data are stored over time, then it remains possible to interrogate that information indefinitely, without having to retest the patient. Another peculiar property of genomic results is that their interpretations are subject to change within relatively short time frames. For instance, a genomic variant that is of uncertain significance (VUS) at the (...) time of testing may shortly afterwards come to be understood as pathogenic (P) or benign (B). Moreover, variant classifications might be downgraded from likely pathogenic to VUS or B, or regraded from B to VUS. These two properties of genomic testing have important implications for the responsible implementation of genomic testing in healthcare. One of these is that they prompt the question whether diagnostic laboratories are morally required to routinely reinterpret their genomic variant classifications and reissue patient reports in the case of materially relevant changes. We take up this question in our paper, in which we argue against the existence of any general duty to reinterpret genomic variant classifications (as had been argued for by Appelbaum et al 1). Still, we maintain that a restricted duty to reinterpret ought to be recognised.2 We thank the authors of the commentaries on our paper for their attention to our argument and for their thoughtful responses to (and expansions of) our position. Oerlemans et al address …. (shrink)

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This open peer commentary critically examines the concept of unqualified medical confidentiality in the context of clinical genetics. The authors challenge two key assertions about maintaining absolute confidentiality: first, that preventing information sharing is the most effective way to minimize harm, and second, that individuals will take more responsibility for their health under strict confidentiality. Using a case study of a genetic condition with familial implications, they argue for a "qualified confidentiality" approach specific to clinical genetics. The commentary highlights the (...) unique nature of genetic information, which often has direct implications for family members. The authors suggest that in certain medical contexts, particularly those involving inheritable conditions, a more nuanced approach to confidentiality might better protect the health interests of multiple individuals, balancing patient privacy with potential preventative benefits for at-risk family members. (shrink)

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This open peer commentary examines whether ethical theory is necessary for effective clinical ethics consultation. While acknowledging that knowledge of ethical theories can be helpful, it argues that high-quality critical engagement - rather than theoretical knowledge - is fundamental for good clinical ethics consultation. Drawing parallels with healthcare ethics education, the commentary suggests that critical analysis and reasoning skills can achieve key consultation functions while avoiding pitfalls like superficial application of theory or disconnection from moral intuitions.

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Health Technology Assessment (HTA) has traditionally focused on efficacy, safety, and cost-effectiveness. There has long been concern, however, that this is determined by the goals of healthcare providers/payers, not patients. As a result, HTA arguably fails to reflect the overall value of health technologies—including their “non-clinical” or “personal” utility to patients and their families. The use of genomic testing in clinical care is one domain where this problem is evident, as the personal utility of results is often especially significant. As (...) such, there are growing calls for HTA frameworks to adopt personal utility as a distinct element of value when assessing clinical genomic tests. We agree that personal utility is important to HTA in clinical genomics. However, against a trend toward comprehensive conceptions of personal utility within HTA, we advocate for a restrictive approach to assessing the value of personal utility in the case of clinical genomic testing. (shrink)

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It is unarguable that the implementation and use of noninvasive prenatal testing (NIPT) should be critical and appropriate. After all, decisions that influence when and how to have children have ut...

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Publics are key stakeholders in population genomic screening and their perspectives on ethical considerations are relevant to programme design and policy making. Using semi-structured interviews, we explored social views and attitudes towards possible future provision of personalised genomic risk information to populations to inform prevention and/or early detection of relevant conditions. Participants were members of the public who had received information on their personal genomic risk of melanoma as part of a research project. The focus of the analysis presented here (...) is participants’ views regarding ethical considerations relevant to population genomic screening more generally. Data were analysed thematically and four key themes related to ethical considerations were identified: personal responsibility for health: ‘forewarned is forearmed’; perceptions of, and responses to, genetic fatalism; implications for parenting and reproduction; divided views on choosing to receive genomic risk information. Ethical considerations underlying these themes include the valorisation of information and choice, paternalism, non-directiveness and increasing responsibilisation of individuals in health and healthcare. These findings arguably indicate a thin public conceptualisation of population genomic testing, which draws heavily on how these themes tend to be described in existing social discourses. Findings suggest that further public engagement is required to increase complexity of debate, to consider the appropriate place of individual and social interests in population genomic testing. Further discernment of relevant ethical approaches, drawing on ethical frameworks from both public health and clinical settings, will also assist in determining the appropriate implementation of population genomic screening for complex conditions. (shrink)

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This target article considers the ethical implications of providing prenatal diagnosis and antenatal screening services to detect fetal abnormalities in jurisdictions that prohibit abortion for these conditions. This unusual health policy context is common in the Latin American region. Congenital conditions are often untreated or under-treated in developing countries due to limited health resources, leading many women/couples to prefer termination of affected pregnancies. Three potential harms derive from the provision of PND in the absence of legal and safe abortion for (...) these conditions: psychological distress, unjust distribution of burdens between socio-economic classes, and financial burdens for families and society. We present Iran as a comparative case study where recognition of these ethical issues has led to the liberalization of abortion laws for fetuses with thalassemia. We argue that physicians, geneticists and policymakers have an ethical and professional duty of care to advocate for change in order to ameliorate these harms. (shrink)

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This editorial introduces a special issue of Bioethics focusing on the ethical implications of synthetic biology for human health. It highlights the proactive approach of synthetic biology researchers in engaging with ethical considerations early on, hoping to avoid public backlash similar to that experienced with genetically modified foods. The editorial outlines the key ethical questions raised by synthetic biology, including its implications for the moral status of life, conceptualization of risks and benefits, and potential impacts on future generations. The editorial (...) summarizes the contributions of various authors who explore different ethical perspectives on synthetic biology. These perspectives range from examining issues of social justice and biodiversity to philosophical debates about the creation of life and the nature of health and disease. The editors aim to provide a multifaceted analysis of synthetic biology's potential benefits and concerns, ultimately hoping to inform future policy-making and public discourse about this emerging technology. (shrink)

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This clinical ethics case examines a complex situation involving a 17-month-old child with multiple serious medical conditions who requires mechanical heart support. The ethics committee grappled with several key issues: whether to relist the child for heart transplant given his poor prognosis and severe neurological impairment, how long to continue mechanical heart support knowing it cannot be a long-term solution, and how to communicate with parents who want "everything done" for their child. The committee recommended against relisting for transplant given (...) the child's poor prognosis and need to fairly allocate scarce organs. However, they advised continuing mechanical support temporarily while working with the parents to establish clear criteria for eventual withdrawal of support and transition to palliative care. They emphasized the need for compassionate, frank discussions with the parents about quality of life and preparing for their child's death, while acknowledging how difficult these conversations will be following their previous loss of a child to similar conditions. (shrink)

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This clinical ethics case study examines whether to perform predictive genetic testing on a 5-year-old boy for Li-Fraumeni Syndrome (LFS), a serious cancer predisposition condition identified in his recently deceased father. The consulting ethics committee analyzed key tensions: balancing the mother's desire for testing to manage uncertainty against guidelines favoring delay until the child can participate in decision-making, weighing parental authority versus the child's future autonomy, and addressing professional disagreement between clinical and laboratory teams. While testing may be justified since (...) screening is already underway, the committee recommended thoroughly exploring the mother's reasoning and timing considerations while ensuring good communication and support for all parties involved. (shrink)

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This is the fifth of a series of case studies provided and discussed by UK clinical ethics committees. This paper summarises discussion of a case presented by the Central and North West London Foundation NHS Trust Clinical Ethics Committee. The case concerns a 55-year old woman with Alzheimer's disease admitted to a psychiatric hospital following concerns that she was not receiving adequate care at home. Issues discussed include subjective judgements of 'adequate care', deprivation of liberty and assessment of 'best interests'. (...) The case is ethically and legally complex, with multiple stakeholders and a range of options for legal intervention. The Committee's response is provided and a practical solution advised. (shrink)

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This clinical ethics case examines whether to provide a blood transfusion to a severely injured Jehovah's Witness patient who initially agreed to the transfusion but changed her mind after speaking with a friend. The ethics committee analyzed several key issues: how to handle information from friends about a patient's religious beliefs when unconscious, the validity of advance directives, concerns about potential coercion in the patient's change of mind, and how to balance respect for religious beliefs against immediate medical needs. The (...) committee recommended that while unconscious, life-saving treatment should proceed given limited verifiable information about the patient's wishes. Once conscious, if the patient maintains a competent refusal after thorough discussion of risks and consideration of possible coercion, her decision should be respected even if it conflicts with medical recommendations. They emphasized the importance of consulting hospital Jehovah's Witness liaison services and documenting all discussions while exploring non-blood alternatives when possible. (shrink)

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This clinical ethics case discusses whether a pregnant paramedic who was bitten by an assailant can compel him to undergo HIV and hepatitis C testing against his will. The ethics committee considered several key issues: balancing the paramedic's right to know her exposure risk against the assailant's right to refuse testing, the special considerations of her pregnancy, and whether healthcare workers deserve additional protections given their occupational risks. While acknowledging the unfairness to the paramedic, the committee concluded that testing without (...) consent would be inappropriate, though they recommended exploring other options like improved communication with the assailant about testing and possible legal avenues. They emphasized that respecting the assailant's refusal does not mean the paramedic's rights are subordinate, but rather reflects the ethical principle that competent individuals can refuse medical interventions. (shrink)

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This is the tenth of a series of case studies provided and discussed by UK clinical ethics committees. This paper summarises discussion of a case presented by the Gloucestershire Hospitals NHS Foundation Trust Clinical Ethics Committee. The case concerns a 67-year old woman who presents at the emergency department with chest pain. Her daughter films a resuscitation attempt on her mobile phone. The acceptability of a relative recording a patient's treatment is the focus of this case study. The committee's discussion (...) and recommendations involve consideration of the interests of the patient, family, and staff, as well as issues of patient autonomy, privacy concerns, and staff well-being. (shrink)

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This open peer commentary explores the ethical implications of direct-to-consumer (DTC) genomics through an analysis of an online educational project in the United Kingdom. The paper examines several key ethical concerns, including the lack of clinical integration in DTC genetic testing, the challenges of interpreting genetic information without professional guidance, and the problematic concept of "empowerment" promoted by genomics companies. Using a case study of a participant who underwent DTC genetic testing, the commentary highlights issues such as the difficulty of (...) understanding genetic risk, the potential psychological impact on individuals and their families, and the need for careful consideration of how genetic information is shared. While acknowledging potential benefits like increased health awareness and new social connections, the paper ultimately calls for more robust theoretical and empirical research to create a comprehensive ethical framework for personal genomics, emphasizing the importance of critically examining the broader implications of these emerging technologies. (shrink)

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