Recent calls for retraction of a large body of Chinese transplant research and of Dr Jiankui He’s gene editing research has led to renewed interest in the question of publication, retraction and use of unethical biomedical research. In Part 1 of this paper, we briefly review the now well-established consequentialist and deontological arguments for and against the use of unethical research. We argue that, while there are potentially compelling justifications for use under some circumstances, these justifications fail when unethical practices (...) are ongoing—as in the case of research involving transplantations in which organs have been procured unethically from executed prisoners. Use of such research displays a lack of respect and concern for the victims and undermines efforts to deter unethical practices. Such use also creates moral taint and renders those who use the research complicit in continuing harm. In Part 2, we distinguish three dimensions of ‘non-use’ of unethical research: non-use of published unethical research, non-publication, and retraction and argue that all three types of non-use should be upheld in the case of Chinese transplant research. Publishers have responsibilities to not publish contemporary unethical biomedical research, and where this has occurred, to retract publications. Failure to retract the papers implicitly condones the research, while uptake of the research through citations rewards researchers and ongoing circulation of the data in the literature facilitates subsequent use by researchers, policymakers and clinicians. (shrink)

Concern for human vulnerability seems to be at the heart of bioethical inquiry, but the concept of vulnerability is under-theorized in the bioethical literature. The aim of this article is to show why bioethics needs an adequately theorized and nuanced conception of vulnerability. We first review approaches to vulnerability in research ethics and public health ethics, and show that the bioethical literature associates vulnerability with risk of harm and exploitation, and limited capacity for autonomy. We identify some of the challenges (...) emerging from this literature: in particular, how to reconcile universal human vulnerability with a context-sensitive analysis of specific kinds and sources of vulnerability; and how to reconcile obligations to protect vulnerable persons with obligations to respect autonomy. We then briefly survey some of the theoretical resources available within the philosophical literature to address these challenges, and to assist in understanding the conceptual connections between vulnerability and related concepts such as harm, exploitation, needs, and autonomy. We also sketch out a taxonomy of sources and kinds of vulnerability. Finally, we consider the implications for policy evaluation of making vulnerability an explicit and central focus of bioethics. Our investigation is in the form of a broad survey motivating a research agenda rather than a detailed analysis. (shrink)

Biological dysfunction is regarded, in many accounts, as necessary and perhaps sufficient for disease. But although disease is conceptualized as all-or-nothing, biological functions often differ by degree. A tension is created by attempting to use a continuous variable as the basis for a categorical definition, raising questions about how we are to pinpoint the boundary between health and disease. This is the line-drawing problem. In this paper, we show how the line-drawing problem arises within “dysfunction-requiring” accounts of disease, such as (...) those of Christopher Boorse and Jerome Wakefield. We then provide several detailed examples to establish that biological dysfunction cannot provide a boundary. We examine potential ways of resolving the line-drawing problem, either by dropping one of the claims that generates it, or by appealing to additional criteria. We argue that two of these options are plausible, and that each of these can be applied with regard to different diseases. (shrink)

Overdiagnosis refers to diagnosis that does not benefit patients because the diagnosed condition is not a harmful disease in those individuals. Overdiagnosis has been identified as a problem in cancer screening, diseases such as chronic kidney disease and diabetes, and a range of mental illnesses including depression and attention deficit hyperactivity disorder. In this paper, we describe overdiagnosis, investigate reasons why it occurs, and propose two different types. Misclassification overdiagnosis arises because the diagnostic threshold for the disease in question has (...) been set at a level where many people without harmful disease are nonetheless diagnosed. We illustrate misclassification overdiagnosis using the example of chronic kidney disease. Misclassification occurs in diseases diagnosed using biomarkers or based on patient reported phenomena. Maldetection overdiagnosis arises because, at the time the diagnosis is made and despite the presence of a 'gold standard' diagnostic test, it is not possible to discriminate between harmful and non-harmful cases of the index disease. We illustrate maldetection overdiagnosis using the example of thyroid cancer. While there is some overlap between misclassification and maldetection overdiagnosis, this conceptual analysis helps to clarify the phenomenon of overdiagnosis and is a necessary first step in developing strategies to address the problem. (shrink)

Traditionally, physicians and parents made decisions about children’s health care based on western practices. More recently, with legal and ethical development of informed consent and recognition for decision making, children are becoming active participants in their care. The extent to which this is happening is however blurred by lack of clarity about what children — of diverse levels of cognitive development — are capable of understanding. Moreover, when there are multiple surrogate decision makers, parental and professional conflict can arise concerning (...) children’s ‘best interest’. Giving children a voice and offering choice promotes their dignity and quality of life. Nevertheless, it also presents with many challenges. Case studies using pseudonyms and changed situational identities are used in this article to illuminate the complexity of ethical challenges facing nurses in end-of-life care with children and families. (shrink)

Bioethics is a practically oriented discipline that developed to address pressing ethical issues arising from developments in the life sciences. Given this inherent practical bent, some form of advocacy or activism seems inherent to the nature of bioethics. However, there are potential tensions between being a bioethics activist, and academic ideals. In academic bioethics, scholarship involves reflection, rigour and the embrace of complexity and uncertainty. These values of scholarship seem to be in tension with being an activist, which requires pragmatism, (...) simplicity, certainty and, above all, action. In this paper I explore this apparent dichotomy, using the case example of my own involvement in international efforts to end forced organ harvesting from prisoners of conscience in China. I conclude that these tensions can be managed and that academic bioethics requires a willingness to be activist. (shrink)

Current practices of identifying and treating small indolent thyroid cancers constitute an important but in some ways unusual form of overdiagnosis. Overdiagnosis refers to diagnoses that generally harm rather than benefit patients, primarily because the diagnosed condition is not a harmful form of disease. Patients who are overdiagnosed with thyroid cancer are harmed by the psycho-social impact of a cancer diagnosis, as well as treatment interventions such partial or total thyroidectomy, lifelong thyroid replacement hormone, monitoring, surgical complications and other side (...) effects. These harms seem to outweigh any putative benefit of knowing about a cancer that would not have caused problems if left undiscovered. In addition to harms to patients, thyroid cancer overdiagnosis leads to significant opportunity costs at a societal level, due to costs of diagnosis and treatment. Unlike many other overdiagnosed cancers, accurate risk stratification is possible with thyroid cancer. At the individual patient level, use of this risk information might support informed choice and/or shared decision-making, as mandated by clinical ethics frameworks. And this approach might, to some extent, help to reduce rates of diagnosis and intervention. In practice, however, it is unlikely to stem the rising incidence and associated harms and costs of overdiagnosed thyroid cancer, especially in situations where health professionals have conflicts of interest. We argue in this article that thyroid cancer overdiagnosis may be usefully understood as a public health problem, and that some public health approaches will be readily justifiable and are more likely to be effective in minimising its harms. (shrink)

Trust is taken to be one of the foundational values in the doctor-patient relationship, facilitating access to the benefits of health care and providing a guarantee against possible harms. Despite this foundational role, some doctors betray the trust of their patients. Trusting involves granting discretionary powers and makes the truster vulnerable to the trustee. Patients trust medical practitioners to act with goodwill and to act competently. Some patients carry pre-existing vulnerabilities, for reasons such as gender, poverty, age, ethnicity, or disability, (...) and these vulnerabilities can be exacerbated when such patients extend their trust to a doctor. Gender stereotypes reduce women's ability to challenge and thereby assess their doctor's competency. In addition, women are more likely to be distrusted by their doctors and have their experiences of medical symptoms discounted. In this paper, we analyze two extreme examples of breaches of medical trust that exploited the vulnerability of women in the health care system: the "unfortunate experiment" at the National Women's Hospital in New Zealand and the Harold Shipman murders of elderly patients in the United Kingdom, examining the potential role of gender in the outcomes with regard to trust. Major breaches of medical trust such as these typically lead to government inquiries, revisions of ethical guidelines, and substantive policy change in an effort to re-establish public and patient trust. We argue that the medical profession has an ethical obligation to put mechanisms in place to protect vulnerable patients from abuses of trust, to monitor colleagues' competence, and to be prepared to blow the whistle to protect patients who are not in a position to recognize misplaced trust. Such mechanisms will act disprosportionately to reduce harm to women as patients. (shrink)

Bioethics, Volume 35, Issue 7, Page 623-633, September 2021.

Clinicians and policy makers the world over are embracing evidence-based medicine. The promise of EBM is to use summaries of research evidence to determine which healthcare interventions are effective and which are not, so that patients may benefit from effective interventions and be protected from useless or harmful ones. EBM provides an ostensibly rational and objective means of deciding whether or not an intervention should be provided on the basis of its effectiveness, in theory leading to fair and effective healthcare (...) for all. In this paper I closely examine these claims from the perspective of healthcare for women, using relevant examples. I argue that the current processes of evidence-based medicine contain a number of biases against women. These biases occur in the production of the research that informs evidence-based medicine, in the methods used to analyse and synthesise the evidence, and in the application of EBM through the use of guidelines. Finally, the biomedical model of health that underpins most of the medical research used by EBM ignores the social and political context which contributes so much to the ill-health of women. (shrink)

Many healthcare practices expose people to risks of harmful outcomes. However, the major theories of moral philosophy struggle to assess whether, when and why it is ethically justifiable to expose individuals to risks, as opposed to actually harming them. Sven Ove Hansson has proposed an approach to the ethical assessment of risk imposition that encourages attention to factors including questions of justice in the distribution of advantage and risk, people’s acceptance or otherwise of risks, and the scope individuals have to (...) influence the practices that generate risk. This paper investigates the ethical justifiability of preventive healthcare practices that expose people to risks including overdiagnosis. We applied Hansson’s framework to three such practices: an ‘ideal’ breast screening service, a commercial personal genome testing service, and a guideline that lowers the diagnostic threshold for hypertension. The framework was challenging to apply, not least because healthcare has unclear boundaries and involves highly complex practices. Nonetheless, the framework encouraged attention to issues that would be widely recognised as morally pertinent. Our assessment supports the view that at least some preventive healthcare practices that impose risks including that of overdiagnosis are not ethically justifiable. Further work is however needed to develop and/or test refined assessment criteria and guidance for applying them. (shrink)

This volume breaks new ground by investigating the ethics of vulnerability. Drawing on various ethical traditions, the contributors explore the nature of vulnerability, the responsibilities owed to the vulnerable, and by whom.

Breast cancer screening aims to help women by early identification and treatment of cancers that might otherwise be life-threatening. However, breast cancer screening also leads to the detection of some cancers that, if left undetected and untreated, would not have damaged the health of the women concerned. At the time of diagnosis, harmless cancers cannot be identified as non-threatening, therefore women are offered invasive breast cancer treatment. This phenomenon of identifying non-harmful cancers is called overdiagnosis. Overdiagnosis is morally problematic as (...) it leads to overall patient harm rather than benefit. Further, breast cancer screening is offered in a context that exaggerates cancer risk and screening benefit, minimises risk of harm and impedes informed choice. These factors combine to create pathogenic vulnerability. That is, breast cancer screening exacerbates rather than reduces women’s vulnerability and undermines women’s agency. This paper provides an original way of conceptualising agency-supporting responses to the harms of breast cancer overdiagnosis through application of the concept of pathogenic vulnerability. (shrink)

Medicine seeks to overcome one of the most fundamental fragilities of being human, the fragility of good health. No matter how robust our current state of health, we are inevitably susceptible to future illness and disease, while current disease serves to remind us of various frailties inherent in the human condition. This article examines the relationship between fragility and uncertainty with regard to health, and argues that there are reasons to accept rather than deny at least some forms of uncertainty. (...) In situations of current ill health, both patients and doctors seek to manage this fragility through diagnoses that explain suffering and provide some certainty about prognosis as well as treatment. However, both diagnosis and prognosis are inevitably uncertain to some degree, leading to questions about how much uncertainty health professionals should disclose, and how to manage when diagnosis is elusive, leaving patients in uncertainty. We argue that patients can benefit when they are able to acknowledge, and appropriately accept, some uncertainty. Healthy people may seek to protect the fragility of their good health by undertaking preventative measures including various tests and screenings. However, these attempts to secure oneself against the onset of biological fragility can cause harm by creating rather than eliminating uncertainty. Finally, we argue that there are good reasons for accepting the fragility of health, along with the associated uncertainties. (shrink)

The question of whether activism should be overtly embraced as part of the bioethicist's role deserves serious consideration. Like others, we agree that bioethics is inescapably partisan; bioethical deliberation is based on trying to determine morally relevant features of situations and morally justifiable outcomes. Where disagreement arises is over the degree to which bioethicists should be activists. Meyers argues for a somewhat circumscribed role, limited to action on ethically concerning institutional matters, for those who are financially independent of the institutions. (...) We take a broader view, arguing that some issues are so morally egregious that there is a duty to take a stand against them, even if the prospects of success are dim. There is a need for further debate, sharing of experiences, and analysis of case studies, to support bioethicists who take a stand. (shrink)

Inclusion in research is a question of both scientific validity of research results and just distribution of the benefits of medical research within a community. Therefore, inappropriate exclusions from research can be regulated as a matter of science or a matter of ethics. In this paper we examine the definitions of appropriate/fair inclusion in the Australian and U.S. regulatory systems and discuss the processes for interpreting and implementing these normative standards. In the second part of the paper, we present original (...) results from the first study of sex-specific research in Australia. One hundred and thirteen published papers were examined: 35 percent were classified as inappropriate sex-specific research, where exclusion was not biologically necessary, and/or there was no justification for the exclusion of one sex. Our results indicate that a scientific approach to inclusion, rather than one grounded in ethical review, is likely to be more effective in achieving appropriate sex-specific research. In the absence of effective regulation, we will continue to see research that discriminates unfairly and perpetuates gender stereotyping. (shrink)

Many health care systems include programs that allow patients in exceptional circumstances to access medical interventions of as yet unproven benefit. In this article we consider the ethical justifications for—and demands on—these special access programs (SAPs). SAPs have a compassionate basis: They give patients with limited options the opportunity to try interventions that are not yet approved by standard regulatory processes. But while they signal that health care systems can and will respond to individual suffering, SAPs have several disadvantages, including (...) the potential to undermine regulatory and knowledge-generation structures that constitute significant public goods. The “balance” between these considerations depends in part on how broadly SAPs are used, but also on whether SAPs can be made to contribute to the generation of knowledge about the effects of health interventions. We argue that patients should usually be required to contribute outcome data while using SAPs. (shrink)

In this paper we argue that surgeons face a particular kind of within-role conflict of interests, related to innovation. Within-role conflicts occur when the conflicting interests are both legitimate goals of professional activity. Innovation is an integral part of surgical practice but can create within-role conflicts of interest when innovation compromises patient care in various ways, such as by extending indications for innovative procedures or by failures of informed consent. The standard remedies for conflicts of interest are transparency and recusal, (...) which are unlikely to address this conflict, in part because of unconscious bias. Alternative systemic measures may be more effective, but these require changes in the culture of surgery and accurate identification of surgical innovation. (shrink)

Patient or public involvement in health research is increasingly expected as a matter of policy. In theory, PPI can contribute both to the epistemic aims intrinsic to research, and to extrinsically valued features of research such as social inclusion and transparency. In practice, the aims of PPI have not always been clear, although there has been a tendency to encourage the involvement of so-called ordinary people who are regarded as representative of an assumed patient perspective. In this paper we focus (...) on the epistemic potential of PPI, using theoretical work in epistemology to develop a nuanced account of patients’ experiential knowledge and how this might contribute directly to conceptual development, hypothesis generation and data interpretation. We also consider how some features of health research pose barriers to this kind of epistemic contribution. Drawing on Miranda Fricker’s idea of testimonial injustice, we explore how disciplinary indicators of credibility in clinical and academic health research contexts might be wrongly applied to those involved in PPI, undermining their potential to contribute. Finally we argue for a range of strategies to maximize opportunities for patients to engage with research teams and make epistemologically significant contributions to research. (shrink)

In this paper, we examine recent critiques of the debate about defining disease, which claim that its use of conceptual analysis embeds the problematic assumption that the concept is classically structured. These critiques suggest, instead, developing plural stipulative definitions. Although we substantially agree with these critiques, we resist their implication that no general definition of “disease” is possible. We offer an alternative, inductive argument that disease cannot be classically defined and that the best explanation for this is that the concept (...) is structured as a cluster. We further argue that we do not need to reject the possibility of defining the general concept “disease” to legitimate developing stipulative definitions of disease that are relative to particular purposes. A cluster definition of disease is compatible with contextually motivated definitions, which may be considered précisifications of the more general cluster concept. (shrink)

The aim of this book is to provide an accessible account of ethics in general practice, addressing concerns identified by practitioners. It contains many examples and allows the reader to gain practical insights into how to identify and analyze the ethical issues they encounter in everyday general practice.

Public health plays an important, albeit often unnoticed, role in protecting and promoting the health of populations. The activities of public health are complex, performed by multiple professionals, and range from the innocuous to the intrusive. Ethical analyses in public health reflect some of this complexity and fragmentation, with no one approach able to capture the full range of ethical considerations raised by public health activities. There are however, good reasons why we should pursue such analyses. Providing a robust ethical (...) framework for public health may promote the identity and function of public health, address some of the shortcomings of utilitarianism, and help to combat the threat that public health faces through lack of political will in many parts of the world.In this paper I argue that Alasdair MacIntyre’s account of practices and virtues can make a valuable contribution to public health ethics. The first part of the paper argues that public health may properly be described as the type of practice that provides an arena for the exercise of virtues. This is followed by an analysis of the three virtues of honesty, courage and justice in public health practice. Using virtue theory captures morally important elements of public health and helps to maintain awareness of significant moral values in the practice of public health. Such awareness is crucial in maintaining and defending the integrity of public health. (shrink)

Human uterus transplantation is currently under investigation as a treatment for uterine infertility. Without a uterus transplant, the options available to women with uterine infertility are adoption or surrogacy; only the latter has the potential for a genetically related child. UTx will offer recipients the chance of having their own pregnancy. This procedure occurs at the intersection of two ethically contentious areas: assisted reproductive technologies and organ transplantation. In relation to organ transplantation, UTx lies with composite tissue transplants such as (...) face and limb grafts, and shares some of the ethical concerns raised by these non-life saving procedures. In relation to ART, UTx represents one more avenue by which a woman may seek to meet her reproductive goals, and as with other ART procedures, raises questions about the limits of reproductive autonomy. This paper explores the ethical issues raised by UTx with a focus on the potential gap between women's desires and aspirations about pregnancy and the likely functional outcomes of successful UTx. (shrink)

ABSTRACT In this paper we argue that sex‐selective abortion (SSA) cannot be morally justified and that it should be prohibited. We present two main arguments against SSA. First, we present reasons why the decision for a woman to seek SSA in cultures with strong son‐preference cannot be regarded as autonomous on either a narrow or a broad account of autonomy. Second, we identify serious harms associated with SSA including perpetuation of discrimination against women, disruption to social and familial networks, and (...) increased violence against women. For these reasons, SSA should be prohibited by law, and such laws should be enforced. Finally, we describe additional strategies for decreasing son‐preference. Some of these strategies rely upon highlighting the disadvantages of women becoming scarce, such as lack of brides and daughters‐in‐law to care for elderly parents. We should, however, be cautious not to perpetuate the view that the purpose of women is to be the consorts for, and carers of, men, and the providers of children. Arguments against SSA should be located within a concerted effort to ensure greater, deeper social and cultural equality between the sexes. (shrink)

The interaction between evidence-based medicineand doctors' duty of care to patients iscomplex. One the one hand, there is surely anobligation to take account of the bestavailable evidence when offering health care topatients. On the other hand, it is equallyimportant to be aware of important shortcomingsin the processes and practices ofevidence-based medicine. There are tensionsbetween the population focus of evidence-basedmedicine and the duties that doctors have toindividual patients. Implementingevidence-based medicine may have unpredictableconsequences upon the overall quality of healthcare. Patients may have (...) a range of reasons forpreferring one form of treatment over another,not all of which are captured by currentformulations of evidence. This paper examinesthese issues, using relevant examples fromevidence-based medicine. (shrink)

Placebo-controlled surgical trials can provide important information about the efficacy of surgical interventions. However, they are ethically contentious as placebo surgery entails the risk of harms to recipients, such as pain, scarring or anaesthetic misadventure. This has led to claims that placebo-controlled surgical trials are inherently unethical. On the other hand, without placebo-controlled surgical trials, it may be impossible to know whether an apparent benefit from surgery is due to the intervention itself or to the placebo effect.

This paper raises questions about the epistemological foundations of evidence-based medicine . We argue that EBM is based upon reliabilist epistemological assumptions, and that this is appropriate - we should focus on identifying the most reliable processes for generating and collecting medical knowledge. However, we note that this should not be reduced to narrow questions about which research methodologies are the best for gathering evidence. Reliable processes for generating medical evidence might lie outside of formal research methods. We also question (...) the notion of the knower that is assumed by EBM. We argue that EBM assumes an enlightenment conception of knowers as autonomous, substitutable individuals. This conception is troubled by the way that clinicians learn the role of anecdote in health care and the role of patient choice, all of which bring into play features of clinicians and patients as situated individuals with particular backgrounds and experiences. EBM's enlightenment conception of the knower is also troubled by aspects of the way evidence is produced. Given these limitations, we argue that EBM should retain its reliabilist bent, but should look beyond formal research methodologies in identifying processes that yield reliable evidence for clinical practice. We suggest looking to feminist epistemology, with its focus on the standpoints of individual situated knowers, and the role of social context in determining what counts as knowledge. (shrink)

Objective We reviewed human–robot interaction (HRI) participatory design (PD) research with older adults. The goal was to identify methods used, determine their value for design of robots with older adults, and provide guidance for best practices. Background Assistive robots may promote aging-in-place and quality of life for older adults. However, the robots must be designed to meet older adults’ specific needs and preferences. PD and other user-centered methods may be used to engage older adults in the robot development process to (...) accommodate their needs and preferences and to assure usability of emergent assistive robots. Method This targeted review of HRI PD studies with older adults draws on a detailed review of 26 articles. Our assessment focused on the HRI methods and their utility for use with older adults who have a range of needs and capabilities. Results Our review highlighted the importance of using mixed methods and including multiple stakeholders throughout the design process. These approaches can encourage mutual learning (to improve design by developers and to increase acceptance by users). We identified key phases used in HRI PD workshops (e.g., initial interview phase, series of focus groups phase, and presentation phase). These approaches can provide inspiration for future efforts. Conclusion HRI PD strategies can support designers in developing assistive robots that meet older adults’ needs, capabilities, and preferences to promote acceptance. More HRI research is needed to understand potential implications for aging-in-place. PD methods provide a promising approach. (shrink)

Synthetic biology (synbio) involves designing and creating new living systems to serve human ends, using techniques including molecular biology, genomics, and engineering. Existing bioethical analyses of synbio focus largely on balancing benefits against harms, the dual-use dilemma, and metaphysical questions about creating and commercializing synthetic organisms. We argue that these approaches fail to consider key feminist concerns. We ground our normative claims in two case studies, focusing on the public good, who holds and wields power, and synbio research projects’ particularity (...) and context. Attention to feminist concerns is essential for synbio to realize its potential in ethically justifiable ways. (shrink)

Recently, concerns have been raised about the phenomenon of ‘overdiagnosis’, the diagnosis of a condition that is not causing harm, and will not come to cause harm. Along with practical, ethical, and scientific questions, overdiagnosis raises questions about our concept of disease. In this paper, we analyse overdiagnosis as an epistemic problem and show how it challenges many existing accounts of disease. In particular, it raises ques- tions about conceptual links drawn between disease and dysfunction, harm, and risk. We argue (...) that ‘disease’ should be considered a vague concept with a non-classical structure. On this view, overdiagnosed cases are ‘borderline’ cases of disease, falling in the zone between cases that are clearly disease, and cases that are clearly not disease. We then develop a pre ́cising definition of disease designed to provide practical help in preventing and limiting overdiagnosis. We argue that for this purpose, we can define disease as dysfunction that has a significant risk of causing severe harm to the patient. (shrink)

Throughout March and April 2020, debate raged about how best to allocate limited intensive care unit resources in the face of a growing COVID-19 pandemic. The debate was dominated by utility-based arguments for saving the most lives or life-years. These arguments were tempered by equity-based concerns that triage based solely on prognosis would exacerbate existing health inequities, leaving disadvantaged patients worse off. Central to this debate was the assumption that ICU admission is a valuable but scarce resource in the pandemic (...) context.In this paper, we argue that the concern about achieving equity in ICU triage is problematic for two reasons. First, ICU can be futile and prolong or exacerbate suffering rather than ameliorate it. This may be especially true in patients with COVID-19 with emerging data showing that most who receive access to a ventilator will still die. There is no value in admitting patients with poor prognostic indicators to ICU to meet an equity target when intensive critical care is contrary to their best interests. Second, the focus on ICU admission shifts focus away from important aspects of COVID-19 care where there is greater opportunity for mitigating suffering and enhancing equitable care.We propose that the focus on equity concerns during the pandemic should broaden to include providing all people who need it with access to the highest possible standard of end-of-life care. This requires attention to culturally safe care in the following interlinked areas: palliative care, communication and decision support and advanced care planning. (shrink)

Wendy Rogers ist Professorin für klinische Ethik und Catriona Mackenzie ist Professorin für Philosophie. Beide lehren an der Macquarie University in Sydney, Australien. Susan Dodds ist Professorin für Philosophie an der La Trobe University in Melbourne, Australien. Alle drei befassen sich seit Jahren intensiv mit feministischer Theorie, angewandter und biomedizinischer Ethik sowie mit Moralphilosophie.

OBJECTIVES: This article presents an original definition of surgical innovation and a practical tool for identifying planned innovations. These will support the responsible introduction of surgical innovations. BACKGROUND: Frameworks developed for the safer introduction of surgical innovations rely upon identifying cases of innovation; oversight cannot occur unless innovations are identified. However, there is no consensus among surgeons about which interventions they consider innovative; existing definitions are vague and impractical. METHODS: Using conceptual analysis, this article synthesizes findings from relevant literature, and (...) from qualitative research with surgeons, to develop an original definition of surgical innovation and a tool for prospectively identifying planned surgical innovations. The tool has been developed in light of feedback from health care professionals, surgeons, and policy makers. RESULTS: This definition of innovation distinguishes between variations, introduction of established interventions, and innovations in surgical techniques or use of devices. It can be applied easily and consistently, is sensitive to the key features of innovation, is prospective, and focuses on features relevant to safety and evaluation. The accompanying tool is deliberately broad so that appropriate supports may, if necessary, be provided each time that a surgeon does something "new". CONCLUSIONS: The definition presented in this article overcomes a number of practical challenges. The definition and tool will be of value in supporting responsible surgical innovation, in particular, through the prospective identification of planned innovations. (shrink)

Several foundational documents of bioethics mention the special obligation researchers have to vulnerable research participants. However, the treatment of vulnerability offered by these documents often relies on enumeration of vulnerable groups rather than an analysis of the features that make such groups vulnerable. Recent attempts in the scholarly literature to lend philosophical weight to the concept of vulnerability are offered by Luna and Hurst. Luna suggests that vulnerability is irreducibly contextual and that Institutional Review Boards (Research Ethics Committees) can only (...) identify vulnerable participants by carefully examining the details of the proposed research. Hurst, in contrast, defines the vulnerable as those especially at risk of incurring the wrongs to which all research ethics participants are exposed. We offer a more substantive conception of vulnerability than Luna but one that gives rise to a different rubric of responsibilities from Hurst's. While we understand vulnerability to be an ontological condition of human existence, in the context of research ethics, we take the vulnerable to be research subjects who are especially prone to harm or exploitation. Our analysis rests on developing a typology of sources of vulnerability and showing how distinct sources generate distinct obligations on the part of the researcher. Our account emphasizes that the researcher's first obligation is not to make the research participant even more vulnerable than they already are. To illustrate our framework, we consider two cases: that of a vulnerable population involved in international research and that of a domestic population of people with diminished capacity. (shrink)

Recently, concerns have been raised about the phenomenon of 'overdiagnosis', the diagnosis of a condition that is not causing harm, and will not come to cause harm. Along with practical, ethical, and scientific questions, overdiagnosis raises questions about our concept of disease. In this paper, we analyse overdiagnosis as an epistemic problem and show how it challenges many existing accounts of disease. In particular, it raises questions about conceptual links drawn between disease and dysfunction, harm, and risk. We argue that (...) "disease" should be considered a vague concept with a nonclassical structure. On this view, overdiagnosed cases are 'borderline' cases of disease, falling in the zone between cases that are clearly disease, and cases that are clearly not disease. We then develop a précising definition of disease designed to provide practical help in preventing and limiting overdiagnosis. We argue that for this purpose, we can define disease as dysfunction that has a significant risk of causing severe harm to the patient. (shrink)

Synthetic biology is a broad term covering multiple scientific methodologies, technologies, and practices. Pairing biology with engineering, synbio seeks to design and build biological systems, either through improving living cells by adding in new functions, or creating new structures by combining natural and synthetic components. As with all new technologies, synthetic biology raises a number of ethical considerations. In order to understand what these issues might be, and how they relate to those covered in ethics literature on synbio, we conducted (...) an interview study with practicing synthetic biologists affiliated with a synthetic biology centre in Australia. Scientists identified a range of ethical challenges germane to the field, including precarious employment, pressures from industry, gender inequity, and the negative effects of the hyping of synbio. These challenges differed markedly from those identified in the ethics literature, whose treatment of the harms and benefits of synbio remains largely speculative and abstract. In our discussion of the pragmatic, every day ethical issues synthetic biologists face, we illustrate how issues of waste or research integrity play pivotal roles in everything from lived experiences in the laboratory, to long-term research trajectories guiding the field. In a confirmation of the ethical relevance of our participant’s views on the field, we argue that the subjects they raise must be included in any ethical analysis of synbio as a field. (shrink)

Surgical advances can provide great benefits to patients but can come at a cost. The successes are often matched by failures that cause harm to patients. The risks of surgery create a strong ethical imperative for research to establish the safety and efficacy of new treatments. Surgical research is, however, challenging for a number of reasons including the lack of a clear boundary between variations in practice, innovation and research, its irreversible nature, the difficulty of performing placebo-controlled randomised trials, confounding (...) factors such as surgeon learning curves and conflicts of interest. In this chapter the ethical issues raised by surgical innovation are explored with the use of a case study based on the uptake of vaginal mesh to treat vaginal prolapse to highlight these issues (Sects. 12.1 and 12.2). In Sect. 12.3 the argument for the value of a structured approach to introducing innovations, such as that developed by the IDEAL Collaboration, which clarifies both ethical and methodological issues at each stage of research is proposed. This chapter recognises that ethical challenges extend beyond adequate ethical evaluation of the innovation in the care of individual patients to include broader issues such as justice in access to any new interventions. (shrink)

In this article we examine the role and ethics of communications in planning for an influenza pandemic. We argue that ethical communication must not only he effective, so that pandemic plans can be successfully implemented, communications should also take specific account of the needs of the disadvantaged, so that they are not further disenfranchised. This will require particular attention to the role of the mainstream media which may disadvantage the vulnerable through misrepresentation and exclusion.

Surgery is an increasingly common and expensive mode of medical intervention. The ethical dimensions of the surgeon-patient relationship, including respect for personal autonomy and informed consent, are much discussed; but broader equity issues have not received the same attention. This paper extends the understanding of surgical ethics by considering the nature of evidence in surgery and its relationship to a just provision of healthcare for individuals and their populations.

Our motivation for proposing a special issue of IJFAB on vulnerability is twofold. First, there is growing interest in the concept of vulnerability within both bioethics and feminist theory. Reflecting this interest, this special issue provides a forum for exploring the relevance for bioethics of feminist perspectives on vulnerability. Second, despite growing recognition within bioethics of the moral significance of vulnerability, the concept remains under-theorized in bioethical (and wider philosophical) discourse. Questions that are central to current debates but that require (...) further theoretical analysis include the following: What is vulnerability and what are the sources of vulnerability? What duties are owed .. (shrink)

The Routledge Handbook of Feminist Bioethics is an outstanding resource for anyone with an interest in feminist bioethics, with chapters covering topics from justice and power to the climate crisis. Comprising 42 chapters by emerging and established scholars, the volume is divided into six parts: Foundations of Feminist Bioethics Identity and Identifications Science, Technology and Research Health and Social Care Reproduction and Making Families Widening the Scope of Feminist Bioethics The volume is essential reading for anyone with an interest in (...) bioethics or feminist philosophy, and will prove an invaluable resource for scholars, teachers, and advanced students. (shrink)

Bioethics, Volume 36, Issue 6, Page 728-730, July 2022.