Clinical trials play a crucial role in generating evidence about healthcare interventions and improving outcomes for current and future patients. For individual trial participants, however, there are inevitably trade‐offs involved in clinical trial participation, given that trials have traditionally been designed to benefit future patient populations rather than to offer personalised care. Failure to understand the distinction between research and clinical care and the likelihood of benefit from participation in clinical trials has been termed the ‘therapeutic misconception’. The evolution of (...) the clinical trials landscape, including greater integration of clinical trials into healthcare and development of novel trial methodologies, may reinforce the significance of the therapeutic misconception and other forms of misunderstanding while at the same time (paradoxically) challenging its salience. Using cancer clinical trials as an exemplar, we describe how methodological changes in early‐ and late‐phase clinical trial designs, as well as changes in the design and delivery of healthcare, impact upon the therapeutic misconception. We suggest that this provides an impetus to re‐examine the ethics of clinical research, particularly in relation to trial access, participant selection, communication and consent, and role delineation. (shrink)

Ethics and Law for the Health Professions is a cross-disciplinary medico-legal book whose previouseditions have been widely used in the medical world. This new 3rd edition is fully revised with all ethics and law topics updated to reflect recent developments. New chapters include dealing specifically with children, health care and the environment, infectious diseases, public health, and ethics and chronic disease. All law sections have been extensively re-visited by Dr Cameron Stewart. Its special features are its focus on a clinically (...) relevant approach, and its recognition that health care professionals are often confronted by legal issues and ethical issues at the same time. Health professionals have to satisfy both, and their legal advisers need to be aware of the dilemmas this can present. This book is careful to distinguish between ethics and law. Its chapters take account of all the health professions, and their differing responsibilities, and cover a very wide range of the issues they face. (shrink)

There has been much debate regarding the 'double-effect' of sedatives and analgesics administered at the end-of-life, and the possibility that health professionals using these drugs are performing 'slow euthanasia.' On the one hand analgesics and sedatives can do much to relieve suffering in the terminally ill. On the other hand, they can hasten death. According to a standard view, the administration of analgesics and sedatives amounts to euthanasia when the drugs are given with an intention to hasten death. In this (...) paper we report a small qualitative study based on interviews with 8 Australian general physicians regarding their understanding of intention in the context of questions about voluntary euthanasia, assisted suicide and particularly the use of analgesic and sedative infusions (including the possibility of voluntary or non-voluntary 'slow euthanasia'). We found a striking ambiguity and uncertainty regarding intentions amongst doctors interviewed. Some were explicit in describing a 'grey' area between palliation and euthanasia, or a continuum between the two. Not one of the respondents was consistent in distinguishing between a foreseen death and an intended death. A major theme was that 'slow euthanasia' may be more psychologically acceptable to doctors than active voluntary euthanasia by bolus injection, partly because the former would usually only result in a small loss of 'time' for patients already very close to death, but also because of the desirable ambiguities surrounding causation and intention when an infusion of analgesics and sedatives is used. The empirical and philosophical implications of these findings are discussed. (shrink)

BackgroundBiobanks provide an important foundation for genomic and personalised medicine. In order to enhance their scientific power and scope, they are increasingly becoming part of national or international networks. Public trust is essential in fostering public engagement, encouraging donation to, and facilitating public funding for biobanks. Globalisation and networking of biobanking may challenge this trust.MethodsWe report the results of an Australian study examining public attitudes to the networking and globalisation of biobanks. The study used quantitative and qualitative methods in conjunction (...) with bioethical analysis in order to determine factors that may contribute to, and threaten, trust.ResultsOur results indicate a generally high level of trust in biobanks and in medical research more broadly. Key factors that can reduce perceived trustworthiness of biobanks are commercialisation and involvement in global networking.ConclusionsWe conclude that robust ethical oversight and governance standards can both promote trust in global biobanking and ensure that this trust is warranted. (shrink)

On March, 24, 2020, 818 cases of COVID-19 had been reported in New South Wales, Australia, and new cases were increasing at an exponential rate. In anticipation of resource constraints arising in clinical settings as a result of the COVID-19 pandemic, a working party of ten ethicists was convened at the University of Sydney to draft an ethics framework to support resource allocation decisions. The framework guides decision-makers using a question-and-answer format, in language that avoids philosophical and medical technicality. The (...) working party met five times over the following week and then submitted a draft Framework for consideration by two groups of intensivists and one group of academic ethicists. It was also presented to a panel on a national current affairs programme. The Framework was then revised on the basis of feedback from these sources and made publicly available online on April 3, ten days after the initial meeting. The framework is published here in full to stimulate ongoing discussion about rapid development of user-friendly clinical ethics resources in ongoing and future pandemics. (shrink)

Biomedical innovation and translation are increasingly emphasizing research using “big data.” The hope is that big data methods will both speed up research and make its results more applicable to “real-world” patients and health services. While big data research has been embraced by scientists, politicians, industry, and the public, numerous ethical, organizational, and technical/methodological concerns have also been raised. With respect to technical and methodological concerns, there is a view that these will be resolved through sophisticated information technologies, predictive algorithms, (...) and data analysis techniques. While such advances will likely go some way towards resolving technical and methodological issues, we believe that the epistemological issues raised by big data research have important ethical implications and raise questions about the very possibility of big data research achieving its goals. (shrink)

Non-financial interests, and the conflicts of interest that may result from them, are frequently overlooked in biomedicine. This is partly due to the complex and varied nature of these interests, and the limited evidence available regarding their prevalence and impact on biomedical research and clinical practice. We suggest that there are no meaningful conceptual distinctions, and few practical differences, between financial and non-financial conflicts of interest, and accordingly, that both require careful consideration. Further, a better understanding of the complexities of (...) non-financial conflicts of interest, and their entanglement with financial conflicts of interest, may assist in the development of a more sophisticated approach to all forms of conflicts of interest. (shrink)

Conduct of clinical research involving single patient subjects has a relatively long history. The notion of ‘N-of-1 trials’ first emerged in the 1980s, introducing a method for evaluating the impact of alternately exposing individuals ‘on’ and ‘off’ a particular treatment. In the years since, interest in conventional, randomised, ‘N-of-1 trials’ has fluctuated, though recent advancements in data science, remote monitoring technologies and, more broadly, the ‘personalised’ medicine era has seen renewed engagement with the methodology. Amongst patient cohorts with cancer conduct (...) of such trials has, for the most part, been uncommon, given the methodology is best suited to study of chronic, stable conditions. In recent years however, there has been growing attention within oncology research communities to the idea of ‘N-of-1 trials’. In part, this has been driven by the need to accommodate increasingly granular levels of molecular heterogeneity in cancer research. However, use of the label ‘N-of-1 trial’ has been applied to a variety of research endeavours involving single participants, with varying resemblance to conventional definitions of an ‘N-of-1 trial’. In this paper we review recent cases in which the term ‘N-of-1 trial’ has been operationalised in relation to clinical research amongst adult cancer populations. We then consider both the epistemic and ethical implications of individual-patient research endeavours in oncology. We conclude by noting the phenomenon represents a new frontier for those engaged in ethical oversight, as well as other stake-holders in cancer clinical research, including clinicians, researchers and health-care consumers. (shrink)

Qualitative studies on assisted reproductive technology commonly focus on the perspectives of participants living in major metropolises. In doing so, the experiences of those living outside major cities, and the unique way conditions of spatiality shape access to treatment, are elided. In this paper, we examine how location and regionality in Australia impact upon access and experience of reproductive services. We conducted twelve qualitative interviews with participants residing in regional areas across Australia. We asked participants to discuss their experience with (...) assisted reproduction services and the impacts of location on access, service choice, and experience of care, and analysed the data using reflexive thematic analysis, as outlined by Braun and Clarke (2006, 2019). Participants in this study reported that their location impacted the services available to them, required considerable time in travel, and reduced continuity of care. We draw on these responses to examine the ethical implications of uneven distribution of reproductive services in commercial healthcare settings which rely on market-based mechanisms. (shrink)

Suicide has long been the subject of philosophical, literary, theological and cultural–historical inquiry. But despite the diversity of disciplinary and methodological approaches that have been brought to bear in the study of suicide, we argue that the formal study of suicide, that is, suicidology, is characterized by intellectual, organizational and professional values that distinguish it from other ways of thinking and knowing. Further, we suggest that considering suicidology as a “social practice” offers ways to usefully conceptualize its epistemological, philosophical and (...) practical norms. This study develops the idea of suicidology as a social practice and considers the implications for research, practice and public discourse. (shrink)

Recent artificial intelligence (AI) advancements have precipitated profound ethical deliberations and societal concerns. These developments redefine the parameters of technology’s role in our daily lives and challenge our understanding of ethics in the context of AI-enabled processes. As AI systems become more integrated into various facets of human activity, from healthcare to finance and from social interactions to governance, the ethical implications of these technologies have become increasingly complex and pressing. In this paper, we aim to facilitate the understanding of (...) intelligence and Artificial Intelligence and delve into the transformative impact of the AI revolution on societal norms and ethical frameworks. We spotlight the critical ethical questions and concerns that arise as AI technologies become increasingly embedded in various aspects of human life. We provide a brief overview of ethical strategies in AI development and explore how implementing these strategies can mitigate potential risks, promote responsible innovation, and ensure the alignment of AI technologies with societal values. (shrink)

High-dose chemotherapy and autologous stem cell transplantation is used to treat some advanced malignancies. It is a traumatic procedure, with a high complication rate and significant mortality. ASCT patients and their carers draw on many sources of information as they seek to understand the procedure and its consequences. Some seek information from beyond orthodox medicine. Alternative beliefs and practices may conflict with conventional understanding of the theory and practice of ASCT, and ‘contested understandings’ might interfere with patient adherence to the (...) strict and demanding protocols required for successful ASCT.The present study, conducted in Sydney, Australia, examines narrative-style interviews with 10 sequentially recruited ASCT patients and nine of their carers conducted at the time of transplant and three months later. Transcripts were read for instances of mention of alternative advice, and for instances of contested understanding of information relevant to the transplant.Patients and carer pairs expressed closely concordant views about alternative advice. Five pairs were consulting alternative practitioners. Contested understanding was expressed in four domains—understandings of the transplant itself and its underlying theory, of the relationship between the components of the ‘transplant’, of the nature and role of stem cells, and of beliefs about bodily function and life-style. Contested understandings of the transplant treatment were expressed as predominantly personal interpretations of orthodox informationPatients and carers seemed to recognise that alternative and conventional systems were discordant, yet they were able to separate the two, and adhere to each practice without prejudicing their medical treatment. A single case of late, post-transplant repudiation of Western medicine is discussed to emphasise some of the possible determinants of dissonance when it does occur. (shrink)

Conflicts of interest are widely regarded as being morally, socially, and scientifically problematic in the many sectors, including in the health sector. There has been considerable attention paid to managing conflicts of interest in clinical practice, medical research and health policy through strategies such as recusal, disinvestment, and disclosure. While these efforts have been important, they are often based on a superficial account of “interests”, as few in healthcare and biomedical science have sought to unpack the concept. In this paper, (...) we argue that adopting an historically and philosophically informed account of interests can enrich our thinking about COI in healthcare and biomedical science, and lead to the improvement of COI management strategies. To support this claim, we first provide an overview of contemporary debates about COI in these domains. We then summarise the historical trajectory of the concept of “interest” and show how these insights can be used to inform the management of COI in healthcare and biomedical science using the example of physicians’ relationships with the pharmaceutical industry. In particular, we challenge assumed hierarchies of interests and call for increased attention to the multiplicities of interests, both financial and non-financial, that may at times converge and conflict. (shrink)

The moral importance of the ‘intention–foresight’ distinction has long been a matter of philosophical controversy, particularly in the context of end-of-life care. Previous empirical research in Australia has suggested that general physicians and surgeons may use analgesic or sedative infusions with ambiguous intentions, their actions sometimes approximating ‘slow euthanasia’. In this paper, we report findings from a qualitative study of 18 Australian palliative care medical specialists, using in-depth interviews to address the use of sedation at the end of life. The (...) majority of subjects were agnostic or atheistic. In contrast to their colleagues in acute medical practice, these Australian palliative care specialists were almost unanimously committed to distinguishing their actions from euthanasia. This commitment appeared to arise principally from the need to maintain a clear professional role, and not obviously from an ideological opposition to euthanasia. While some respondents acknowledged that there are difficult cases that require considered reflection upon one's intention, and where there may be some ‘mental gymnastics,’ the nearly unanimous view was that it is important, even in these difficult cases, to cultivate an intention that focuses exclusively on the relief of symptoms. We present four narratives of ‘terminal’ sedation – cases where sedation was administered in significant doses just before death, and may well have hastened death. Considerable ambiguities of intention were evident in some instances, but the discussion around these clearly exceptional cases illustrates the importance of intention to palliative care specialists in maintaining their professional roles. (shrink)

Ethical reasoning and decision-making may be thought of as 'professional skills', and in this sense are as relevant to efficient clinical practice as the biomedical and clinical sciences are to the diagnosis of a patient's problem. Despite this, however, undergraduate medical programmes in ethics tend to focus on the teaching of bioethical theories, concepts and/or prominent ethical issues such as IVF and euthanasia, rather than the use of such ethics knowledge (theories, principles, concepts, rules) to clinical practice. Not surprisingly, many (...) students and clinicians experience considerable difficulty in using what they know about ethics to help them make competent ethical decisions in their day-to-day clinical practice. This paper describes the development of a seminar programme for teaching senior medical students a more systematic approach to ethical reasoning and analysis and clinical decision-making. (shrink)

Conflicts of interest in health and medicine have been the source of considerable public and professional debate. Much of this debate has focused on financial, rather than non-financial COI, which is a significant lacuna because non-financial COI can be just as influential as financial COI. In an effort to explore the nature and effects of non-financial, as well as financial COI, we conducted semi-structured interviews with eleven Australian medical professionals regarding their experiences of, and attitudes towards, COI. We found that (...) this group of medical professionals saw non-financial interests—most notably the pursuit of status and respect and the avoidance of stigma—as potentially conflicting with other important interests. (shrink)

We describe the case of an eighty‐four‐year‐old man with disseminated lung cancer who had been receiving palliative care in the hospital and was found by nursing staff unresponsive, with clinically obvious signs of death, including rigor mortis. Because there was no documentation to the contrary, the nurses commenced cardiopulmonary resuscitation and called a code blue, resulting in resuscitative efforts that continued for around twenty minutes. In discussion with the hospital ethicist, senior nurses justified these actions, mainly citing disciplinary and medicolegal (...) concerns. We argue that moral harms arise from CPR performed on a corpse and that legal concerns about failing to perform it are unfounded. We contend that such efforts are an unintended consequence of managerialist policies mandating do‐not‐resuscitate orders and advance care plans and of defensive practices that can value the interests of institutions and practitioners over those of patients. Health management teaching should include managerialism and its pitfalls, while clinician training should prioritize ethical reasoning and legal knowledge over defensive practice. (shrink)

Recent discourses about the legitimacy of homeopathy have focused on its scientific plausibility, mechanism of action, and evidence base. These, frequently, conclude not only that homeopathy is scientifically baseless, but that it is “unethical.” They have also diminished patients’ perspectives, values, and preferences. We contend that these critics confuse epistemic questions with questions of ethics, misconstrue the moral status of homeopaths, and have an impoverished idea of ethics—one that fails to account either for the moral worth of care and of (...) relationships or for the perspectives, values, and preferences of patients. Utilitarian critics, in particular, endeavour to present an objective evaluation—a type of moral calculus—quantifying the utilities and disutilities of homeopathy as a justification for the exclusion of homeopathy from research and health care. But these critiques are built upon a narrow formulation of evidence and care and a diminished episteme that excludes the values and preferences of researchers, homeopaths, and patients engaged in the practice of homeopathy. We suggest that homeopathy is ethical as it fulfils the needs and expectations of many patients; may be practiced safely and prudentially; values care and the virtues of the therapeutic relationship; and provides important benefits for patients. (shrink)

In this Symposium on the Ethics and Epistemology of Big Data, we present four perspectives on the ways in which the rapid growth in size of research databanks—i.e. their shift into the realm of “big data”—has changed their moral, socio-political, and epistemic status. While there is clearly something different about “big data” databanks, we encourage readers to place the arguments presented in this Symposium in the context of longstanding debates about the ethics, politics, and epistemology of biobank, database, genetic, and (...) epidemiological research. (shrink)

The COVID-19 pandemic has, of necessity, demanded the rapid incorporation of virtual technologies which, suddenly, have superseded the physical medical encounter. These imperatives have been implemented in advance of evaluation, with unclear risks to patient care and the nature of medical practice that might be justifiable in the context of a pandemic but cannot be extrapolated as a new standard of care. Models of care fit for purpose in a pandemic should not be generalized to reconfigure medical care as virtual (...) by default, and personal by exception at the conclusion of the emergency. (shrink)

This article critically examines current responses to multi-drug resistant tuberculosis and argues that bioethics needs to be willing to engage in a more radical critique of the problem than is currently offered. In particular, we need to focus not simply on market-driven models of innovation and anti-microbial solutions to emergent and re-emergent infections such as TB. The global community also needs to address poverty and the structural factors that entrench inequalities—thus moving beyond the orthodox medical/public health frame of reference.

The debate about whether misoprostol should be distributed to low resource communities to prevent post-partum haemorrhage, recognised as a major cause of maternal mortality, is deeply polarised. This is in spite of stakeholders having access to the same evidence about the risks and benefits of misoprostol. To understand the disagreement, we conducted a qualitative analysis of the values underpinning debates surrounding community distribution of misoprostol. We found that different moral priorities, epistemic values, and attitudes towards uncertainty were the main factors (...) sustaining the debate. With this understanding, we present a model for ethical discourse that might overcome the current impasse. (shrink)

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...

Health care is provided in many contexts—not just hospitals, clinics, and community health settings. Different institutional settings may significantly influence the design and delivery of health care and the ethical obligations and practices of health care practitioners working within them. This is particularly true in institutions that are established to constrain freedom, ensure security and authority, and restrict movement and choice. We describe the results of a qualitative study of the experiences of doctors and nurses working within two women’s prisons (...) in the state of New South Wales (NSW), Australia. Their accounts make clear how the provision and ethics of health care may be compromised by the physical design of the prison, the institutional policies and practices restricting movement of prisoners and practitioners, the focus on maintaining control and security, and the very purpose of the prison and prison system itself. The results of this study make clear the impact that context has on professional practice and illustrate the importance of sociology and anthropology to bioethics and to the development of a more nuanced account of professional ethics. (shrink)

Peer review of manuscripts has recently become a subject of academic research and ethical debate. Critics of the review process argue that it is a means by which powerful members of the scientific community maintain their power, and achieve their personal and communal aspirations, often at others' expense. This qualitative study aimed to generate a rich, empirically‐grounded understanding of the process of manuscript review, with a view to informing strategies to improve the review process. Open‐ended interviews were carried out with (...) 35 journal editors and peer reviewers in the United Kingdom, the USA and Australia. It is clear from this research that relations of power and epistemic authority in manuscript review are complex and dynamic, and may have positive and negative features, and that even where power is experienced as controlling, restrictive and illegitimate, it can also be resisted. In conclusion, the manuscript review process is best thought of not in terms of simple dominance of reviewers and editors over authors, but rather as a shifting “net” of power relations. These complex power relations need to be understood if reviewers are to be encouraged to participate in the process and to do so in the the most ethical and effective manner. (shrink)

Rationale, aims and objectives: Bioethics and professionalism are standard subjects in medical training programmes, and these curricula reflect particular representations of meaning and practice. It is important that these curricula cohere with the actual concerns of practicing clinicians so that students are prepared for real-world practice. We aimed to identify ethical and professional concerns that do not appear to be adequately addressed in standard curricula by comparing ethics curricula with themes that emerged from a qualitative study of medical practitioners. Method: (...) Curriculum analysis: Thirty-two prominent ethics and professionalism curricula were identified through a database search and were analysed thematically. Qualitative study: In-depth, semi-structured interviews were conducted with 20 medical practitioners. Participants were invited to reflect upon their perceptions of the ways in which values matter in their practices and their educational experiences. The themes emerging from the two studies were compared and contrasted. Results: While representations of meaning and value in ethics and professionalism curricula overlap with the preoccupations of practicing clinicians, there are significant aspects of ‘real-world’ clinical practice that are largely ignored. These fell into two broad domains: ‘sociological’ concerns about enculturation, bureaucracy, intra-professional relationships, and public perceptions of medicine; and epistemic concerns about making good decisions, balancing different kinds of knowledge, and practising within the bounds of professional protocols. Conclusions: Our findings support the view that philosophy and sociology should be included in medical school and specialty training curricula. Curricula should be reframed to introduce students to habits of thought that recognize the need for critical reflection on the social processes in which they are embedded, and on the philosophical assumptions that underpin their practice. (shrink)

In an article somewhat ironically entitled “Disambiguating Clinical Intentions,” Lynn Jansen promotes an idea that should be bewildering to anyone familiar with the literature on the intention/foresight distinction. According to Jansen, “intention” has two commonsense meanings, one of which is equivalent to “foresight.” Consequently, questions about intention are “infected” with ambiguity—people cannot tell what they mean and do not know how to answer them. This hypothesis is unsupported by evidence, but Jansen states it as if it were accepted fact. In (...) this reply, we make explicit the multiple misrepresentations she has employed to make her hypothesis seem plausible. We also point out the ways in which it defies common sense. In particular, Jansen applies her thesis only to recent empirical research on the intentions of doctors, totally ignoring the widespread confusion that her assertion would imply in everyday life, in law, and indeed in religious and philosophical writings concerning the intention/foresight distinction and the Principle of Double Effect. (shrink)

In response to the COVID-19 pandemic, there has been a rapid growth in research focused on developing vaccines and therapies. In this context, the need for speed is taken for granted, and the scientific process has adapted to accommodate this. On the surface, attempts to speed up the research enterprise appear to be a good thing. It is, however, important to consider what, if anything, might be lost when biomedical innovation is sped up. In this article we use the case (...) of a study recently retracted from the Lancet to illustrate the potential risks and harms associated with speeding up science. We then argue that, with appropriate governance mechanisms in place, it should be quite possible to both speed up science and remain attentive to scientific quality and integrity. (shrink)

Social, political, and economic environments play an active role in nurturing professional virtue. Yet, these environments can also lead to the erosion of virtue. As such, professional virtue is fragile and vulnerable to environmental shifts. While physicians are often considered to be among the most virtuous of professional groups, concern has also always existed about the impact of commercial arrangements on physicians’ willingness and capacity to enact their professional virtues. This article examines the ways in which commercial arrangements have been (...) negotiated to secure medical virtue from real or perceived threats of erosion. In particular, we focus on the concern surrounding conflicts of interest arising from commercial arrangements that have developed as a result of neoliberal economic and social policies. The deregulation of medical markets and privatization of services have produced new commercial relationships that are often misunderstood by patients, publics, and physicians themselves. ‘Conflicts of interest’ policies have been introduced in an attempt to safeguard ethical conduct and medical practice. However, a number of virtue ethicists have critiqued these policies as inadequate for securing virtue. We examine the ways in which commercial arrangements have been seen to impact upon medical virtue, both historically and in the context of modern medicine. We then describe and critique current efforts to restore clinical virtue through both conflict of interest policies and through virtue ethics. Finally, we suggest some possible ways of addressing the corrosive effects of neoliberalism on medical virtue. (shrink)

This study explored paediatric nurses’ decision-making regarding resuscitation in patients with unequivocal signs of death and no Do Not Resuscitate (DNR) order. A cross-sectional survey was conducted between October 2023 and April 2024 across the paediatric wards of four Australian hospitals. Participants were asked to respond to two hypothetical clinical scenarios involving a three-year-old boy and a twelve-year-old girl, both clearly deceased—neither of whom had documented DNR orders. Participants indicated their intended resuscitation plan and reasoning for each scenario. Data were (...) analysed descriptively. All respondents (n = 26) (100 per cent) indicated that they would initiate resuscitation for the younger child, while 84.6 per cent (n = 22) would do so for the twelve-year-old. The absence of a DNR order and perceived duty of care were key reasons for their decisions. Findings reveal ethical, legal, and clinical challenges inherent to paediatric resuscitation decisions. This highlights the need for clearer policies, education, and support to guide determination of when resuscitation is appropriate. (shrink)

Concerns over conflicts of interest in academic research and medical practice continue to provoke a great deal of discussion. What is most obvious in this discourse is that when COIs are declared, or perceived to exist in others, there is a focus on both the descriptive question of whether there is a COI and, subsequently, the normative question of whether it is good, bad or neutral. We contend, however, that in addition to the descriptive and normative, COI declarations and accusations (...) can be understood as performatives. In this article, we apply J.L. Austin’s performative speech-act theory to COI discourses and illustrate how this works using a contemporary case study of COI in biomedical publishing. We argue that using Austin’s theory of performative speech-acts serves to highlight the social arrangements and role of authorities in COI discourse and so provides a rich framework to examine declarations, accusations and judgements of COI that often arise in the context of biomedical research and practice. (shrink)

In 2016, the Office of the State Coroner of New South Wales released its report into the death of an Australian woman, Sheila Drysdale, who had died from complications of an autologous stem cell procedure at a Sydney clinic. In this report, we argue that Mrs Drysdale's death was avoidable, and it was the result of a pernicious global problem of an industry exploiting regulatory systems to sell unproven and unjustified interventions with stem cells.

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)

The discovery of induced pluripotent stem (iPS) cells in 2006 was heralded as a major breakthrough in stem cell research. Since then, progress in iPS cell technology has paved the way towards clinical application, particularly cell replacement therapy, which has refueled debate on the ethics of stem cell research. However, much of the discourse has focused on questions of moral status and potentiality, overlooking the ethical issues which are introduced by the clinical testing of iPS cell replacement therapy. First-in-human trials, (...) in particular, raise a number of ethical concerns including informed consent, subject recruitment and harm minimisation as well as the inherent uncertainty and risks which are involved in testing medical procedures on humans for the first time. These issues, while a feature of any human research, become more complex in the case of iPS cell therapy, given the seriousness of the potential risks, the unreliability of available animal models, the vulnerability of the target patient group, and the high stakes of such an intensely public area of science. Our paper will present a detailed case study of iPS cell replacement therapy for Parkinson's disease to highlight these broader ethical and epistemological concerns. If we accept that iPS cell technology is fraught with challenges which go far beyond merely refuting the potentiality of the stem cell line, we conclude that iPS cell research should not replace, but proceed alongside embryonic and adult somatic stem cell research to promote cross-fertilisation of knowledge and better clinical outcomes. (shrink)

Little and colleagues’ paper describing a key aspect of cancer patients’ experience, that of “liminality,” is remarkable for giving articulation to a very common and yet mostly overlooked aspect of patient experience. Little et. al. offered a formulation of liminality that deliberately set aside the concept’s more common use in analysing social rituals, in order to grasp at the interior experience that arises when failing bodily function and awareness of mortality are forced into someone’s consciousness, as occurs with a diagnosis (...) of cancer. We set out the reasons as to why this analysis was so significant in 1998—but we also consider how the “liminality” described by Little and colleagues was a feature of modernity, founded on what we term “the mirage of settlement.” We argue that this mirage is impossible to sustain in 2022 amid the many forms of un-settling that have characterized late modernity, including climate change and COVID-19. We argue that many people in developed nations now experience liminality as a result of the being forced into the consciousness of living in a continued state of coloniality. We thus rejoin the social aspects of liminality to the interior, Existential form described by Little et. al. (shrink)