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)

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)

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 success of assisted reproductive technologies (ARTs) worldwide has led to an accumulation of frozen embryos that are surplus to the reproductive needs of those for whom they were created. In these situations, couples must decide whether to discard them or donate them for scientific research or for use by other infertile couples. While legislation and regulation may limit the decisions that couples make, their decisions are often shaped by their religious beliefs. Unfortunately, health professionals, scientists and policy-makers are often (...) unaware of the way in which faith traditions view ART and decisions concerning the ‘fate’ of surplus embryos. In this paper scholars representing six major religious traditions provide a commentary on a hypothetical case concerning the donation or destruction of excess ART embryos. These commentaries provide a rich account of religious perspectives on the status of the human embryo and an insight into the relevance of faith to health and policy decisions, particularly in reproductive medicine, ART and embryo research. (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 9professional skills9, and in this sense are as relevant to efficient clinical practice as the biomedical and clinical sciences are to the diagnosis of a patient9s 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)

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)

Umbilical cord blood banking is one of many biomedical innovations that confront pregnant women with new choices about what they should do to secure their own and their child’s best interests. Many mothers can now choose to donate their baby’s umbilical cord blood (UCB) to a public cord blood bank or pay to store it in a private cord blood bank. Donation to a public bank is widely regarded as an altruistic act of civic responsibility. Paying to store UCB may (...) be regarded as a “unique opportunity” to provide “insurance” for the child’s future. This paper reports findings from a survey of Australian women that investigated the decision to either donate or store UCB. We conclude that mothers are faced with competing discourses that force them to choose between being a “good mother” and fulfilling their role as a “good citizen.” We discuss this finding with reference to the concept of value pluralism. (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)

Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the aim of (...) identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies. (shrink)

Aim To ascertain the quantity and nature of gifts and items provided by the pharmaceutical industry in Australia to medical specialists and to consider whether these are appropriate in terms of justifiable ethical standards, empirical research and views expressed in the literature.

Peer review of manuscripts for biomedical journals has become a subject of intense ethical debate. One of the most contentious issues is whether or not peer review should be anonymous. This study aimed to generate a rich, empirically-grounded understanding of the values held by journal editors and peer reviewers with a view to informing journal policy. Qualitative methods were used to carry out an inductive analysis of biomedical reviewers’ and editors’ values. Data was derived from in-depth, open-ended interviews with journal (...) editors and peer reviewers. Data was “read for” themes relevant to reviewer anonymisation and interactions among editors, reviewers, and authors. Editors and peer reviewers provided three arguments that would support a more open and interactive peer-review process. First, a number of participants emphasised the importance of not only ensuring the scientific quality of published research but also nurturing their colleagues and supporting their communities. Second, many spoke about the ongoing moral responsibilities that reviewers and editors felt toward authors. Finally, participants spoke at length about their enjoyment of social interactions and of the value of collective, rather than isolated, reasoning processes. Whether or not journal editors decide to allow anonymous review , the values of editors and reviewers need to be seriously addressed in codes of publication ethics, in the management of biomedical journals, and in the establishment of journal policies. (shrink)

Over the past decade, umbilical cord blood (UCB) has routinely been used as a source of haematopoietic stem cells for allogeneic stem cell transplants in the treatment of a range of malignant and non-malignant conditions affecting children and adults. UCB banks are a necessary part of the UCB transplant program, but their establishment has raised a number of important scientific, ethical and political issues. This paper examines the scientific and clinical evidence that has provided the basis for the establishment of (...) UCB banks. We also discuss the major ethical issues that UCB banks raise, including ownership of cord blood, processes for obtaining consent for its collection and storage, and confidentiality. Finally, we review other concerns about commercial non-altruistic banking, including concerns about social justice, equity of access and equity of care. (shrink)

Justifying involuntary psychiatric treatment on the basis of a judgment that a person lacks capacity is usually expressed in terms of a person’s ability to make a decision about his or her health and treatment. Typically, this relates to the ability to refuse treatment. Exactly what “capacity” means, however, and how one determines when another individual lacks capacity, or lacks sufficient capacity, in this context is particularly controversial, with the United Nations Committee on the Rights of Persons with Disabilities insisting (...) that involuntary treatment be abandoned altogether and capacity tests avoided.Capacity is a concept that has multiple meanings and applications across different disciplines and... (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)

BackgroundSocio-cultural perceptions surrounding death have profoundly changed since the 1950s with development of modern intensive care and progress in solid organ transplantation. Despite broad support for organ transplantation, many fundamental concepts and practices including brain death, organ donation after circulatory death, and some antemortem interventions to prepare for transplantation continue to be challenged. Attitudes toward the ethical issues surrounding death and organ donation may influence support for and participation in organ donation but differences between and among diverse populations have not (...) been studied.ObjectivesIn order to clarify attitudes toward brain death, organ donation after circulatory death and antemortem interventions in the context of organ donation, we conducted a scoping review of international English-language quantitative surveys in various populations.Study appraisalA search of literature up to October 2020 was performed, using multiple databases. After screening, 45 studies were found to meet pre-specified inclusion criteria.Results32 studies examined attitudes to brain death, predominantly in healthcare professionals. In most, around 75% of respondents accepted brain death as equivalent to death of the person. Less common perspectives included equating death with irreversible coma and willingness to undertake organ donation even if it caused death. 14 studies examined attitudes to organ donation following circulatory death. Around half of respondents in most studies accepted that death could be confidently diagnosed after only 5 min of cardiorespiratory arrest. The predominant reason was lack of confidence in doctors or diagnostic procedures. Only 6 studies examined attitudes towards antemortem interventions in prospective organ donors. Most respondents supported minimally invasive procedures and only where specific consent was obtained.ConclusionsOur review suggests a considerable proportion of people, including healthcare professionals, have doubts about the medical and ethical validity of modern determinations of death. The prognosis of brain injury was a more common concern in the context of organ donation decision-making than certainty of death. (shrink)

If James has a latent tuberculosis infection , he is at risk of developing active tuberculosis disease but he is not yet sick. LTBI is a liminal space between health and illness. Diagnosed with LTBI, James could be conceptualised as having a liminal body. Treatments for LTBI are available, but why would a person seek treatment for a disease he does not yet have? One thing is definite: James needs to be educated about the symptoms and severity of active tuberculosis (...) disease. (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)

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)

Volume 20, Issue 3, March 2020, Page 81-83.

Evidence-Based Medicine (EBM) has now been part of the dominant medical paradigm for 15 years, and has been frequently debated and progressively modified. One question about EBM that has not yet been considered systematically, and is now particularly timely, is the question of the novelty, or otherwise, of the principles and practices of EBM. We argue that answering this question, and the related question of whether EBM-type principles and practices are unique to medicine, sheds new light on EBM and has (...) practical implications for those involved in all EBM. This is because one's answer to the question (whether explicit or implicit) affects the amount and type of funding and attention received by EBM, the extent to which EBM, and the generation, judgment and use of evidence more generally, can be appropriated by certain groups and questioned by others, and the extent to which truly unique socio-political developments in evidence, and in medicine more generally, are recognized and harnessed. (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)

(2013). What to Think of Canine Obesity? Emerging Challenges to Our Understanding of Human–Animal Health Relationships. Social Epistemology: Vol. 27, No. 1, pp. 90-104. doi: 10.1080/02691728.2012.760662.

The practice of biobank networking—where biobanks are linked together, and researchers share human tissue samples—is an increasingly common practice both domestically and internationally. The benefits from networking in this way are well established. However, there is a need for ethical oversight in the sharing of human tissue. Ethics committees will increasingly be called upon to approve the sharing of tissue and data with other researchers, often via biobanks, and little guidance currently exists for such committees. In this paper, we provide (...) a structured approach to the ethical review of on-sharing of data and tissue for research purposes. (shrink)

Does reading poetry make you a better clinician?Can euthanasia be understood in terms of the meaning of a life?What is the moral and existential significance of ...

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)

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.

Corneal transplantation is the most common form of organ transplantation performed globally. However, of all organs, eyes have the highest rate of refusal of donation. This study explored the reasons why individuals decide whether or not to donate corneas. Twenty-one individuals were interviewed who had made a donation decision (13 refused corneal donation and eight consented). Analysis was performed using Grounded Theory. Refusal of corneal donation was related to concerns about disfigurement and the role of eyes in memory and communication. (...) The request for donation therefore raised concerns about a potential adverse change in the ongoing relationship with the deceased, even in death. For those who refused donation, these concerns overshadowed awareness of need or benefit of transplantation. Adjusting the donation message to be more congruent with the real, lived experience of corneal donation may to some extent “prepare” individuals when the donation question is raised. (shrink)

Evidence-based medicine has been rapidly and widely adopted because it claims to provide a method for determining the safety and efficacy of medical therapies and public health interventions more generally. However, as others have noted, EBM may be riven through with cultural bias, both in the generation of evidence and in its translation. We suggest that technological and scientific advances in medicine accentuate and entrench these cultural biases, to the extent that they may invalidate the evidence we have about disease (...) and its treatment. This creates a significant ethical, epistemological and ontological challenge for medicine. (shrink)

Philosophy has long been concerned with ‘moral status’. Discussions about the moral status of children, however, seem often to promote confusion rather than clarity. Using the creation of ‘savior siblings’ as an example, this paper provides a philosophical critique of the moral status of children and the moral relevance of parenting and the role that formative experience, regret and relational autonomy play in parental decisions. We suggest that parents make moral decisions that are guided by the moral significance they attach (...) to children, to sick children and most importantly, to a specific sick child (theirs). This moral valorization is rarely made explicit and has generally been ignored by both philosophers and clinicians in previous critiques. Recognizing this, however, may transform not only the focus of bioethical discourse but also the policies and practices surrounding the care of children requiring bone marrow or cord blood transplantation by better understanding the values at stake behind parental decision making. (shrink)

This second paper reports on a small ethnographic study of Argentine psychiatrists. A carefully selected group of six psychiatrists currently practicing in Buenos Aires participated in an in-depth semi-structured interview. The transcripts of the interviews were coded and a thematic analysis method was applied to construct a local theory of the professional values constructed by Argentine psychiatrists, and the circumstances in which such values were constructed. Our analysis indicated that Argentine psychiatrists constructed a number of values, frequently perceived as obligations (...) to their professional group and the needs of their patients. The two main strategies employed by Argentine psychiatrists were the diagnostic act and advocacy. We also identify that these values emerge in the context of recent broad historical and cultural inl uences upon the profession of psychiatry in Argentina, and the Argentine population in general. (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)

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)