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.

More and more areas of medicine involve subjects donating tissues to another — blood, organs, bone marrow, sperm, ova and embryos can all be transferred from one person to another. Within the technical frameworks of biomedicine, such fragments are generally treated as detachable things, severed from social identity once they are removed from a particular body. However an abundant anthropological and sociological literature has found that, for donors and patients, human tissues are not impersonal. They retain some of the values (...) of personhood and identity, and their incorporation often has complex effects on embodied identity. This article draws on feminist philosophy of the body to think through the implications of some of these practices. Specifically, it draws on the idea of intercorporeality, wherein the body image is always the effect of embodied social relations. While this approach is highly productive for considering the stakes involved in tissue transfer, it is argued that the concept of body image has been too preoccupied with the register of the visual at the expense of introceptive data and health/illness events. Empirical data around organ transplant and sperm donation are used to demonstrate that the transfer of biological fragments involves a profound kind of intercorporeality, producing identifications and disidentifications between donors and recipients that play out simultaneously at the immunological, psychic and social levels. (shrink)

The development of genomics has dramatically expanded the scope of genetic research, and collections of genetic biosamples have proliferated in countries with active genomics research programs. In this essay, we consider a particular kind of collection, national biobanks. National biobanks are often presented by advocates as an economic ‘‘resource’’ that will be used by both basic researchers and academic biologists, as well as by pharmaceutical diagnostic and clinical genomics companies. Although national biobanks have been the subject of intense interest in (...) recent social science literature, most prior work on this topic focuses either on bioethical issues related to biobanks, such as the question of informed consent, or on the possibilities for scientific citizenship that they make possible. We emphasize, by contrast, the economic aspect of biobanks, focusing specifically on the way in which national biobanks create biovalue. Our emphasis on the economic aspect of biobanks allows us to recognize the importance of what we call clinical labor—that is, the regularized, embodied work that members of the national population are expected to perform in their role as biobank participants—in the creation of biovalue through biobanks. Moreover, it allows us to understand how the technical way in which national biobanks link clinical labor to databases alters both medical and popular understandings of risk for common diseases and conditions. (shrink)

Multidisciplinary Perspectives on the Donation of Stem Cells and Reproductive Tissue Content Type Journal Article Category Symposium Pages 15-17 DOI 10.1007/s11673-011-9351-x Authors Catherine Waldby, School of Social and Political Sciences, University of Sydney, Sydney, Australia Ian Kerridge, Centre for Values, Ethics and the Law in Medicine, Medical Foundation Building (K25), University of Sydney, Sydney, NSW 2006, Australia Loane Skene, Faculty of Law and Faculty of Medicine, Dentistry and Health Studies, University of Melbourne, Melbourne, VA, Australia Journal Journal of (...) Bioethical Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529 Journal Volume Volume 9 Journal Issue Volume 9, Number 1. (shrink)

Australian prisons are overpopulated with people suffering from numerous health problems. COVID-19 presents a significant threat to prisoner health. This article examines the current regulatory responses from Australian state and territory governments to COVID-19 and a recent case which tested the human rights of prisoners during a pandemic.

BackgroundDelirium is highly prevalent in the general hospital patient population, characterized by acute onset, fluctuating levels of consciousness, and global impairment of cognitive functioning. Mental capacity, its assessment and subsequent consent are therefore prominent within this cohort, yet under-explored.AimThis study of patients with delirium sought to determine the processes by which consent to medical treatment was attempted, how capacity was assessed, and any subsequent actions thereafter.MethodA retrospective documentation review of patients identified as having a delirium for the twelve months February (...) 2013 to January 2014 was undertaken. Inclusion and exclusion criteria were used; demographic and descriptive data collected. A total of n=1153 patients were identified with n=310 meeting inclusion criteria.ResultA random sample of one hundred patients were subsequently reviewed. One third of patients had documentation relating to consent, while four patients had documentation relating to capacity. Median delirium duration was three days, with treatment refusal occurring in twenty-two patients and “duty of care” being used as an apparent beneficent related treatment framework in twelve patients.ConclusionsWhile impaired decision-making was indicated, the review was unable to indicate what patient characteristics flag the need for capacity assessment. Documentation relating to consent processes appeared deficient for this cohort. (shrink)

The identification and valorization of unacknowledged, feminized forms of economic productivity has been an important task for feminist theory. In this article, we expand and rethink existing definitions of labour, in order to recognize the essential economic role women play in the stem cell and regenerative medicine industries, new fields of biomedical research that are rapidly expanding throughout the world. Women constitute the primary tissue donors in the new stem cell industries, which require high volumes of human embryos, oöcytes, foetal (...) tissue and umbilical cord blood. Such material is generally given for free in the advanced industrial democracies, constituted as a surplus (‘spare’ embryos) or waste (umbilical cord ‘afterbirth’, cadaveric foetuses, poor quality oöcytes) whose generative powers should not be withheld from others. At the same time, among impoverished female populations in developing nations, such biological material is now often procured through frankly transactional relations, where women undertake risky procedures for small fees. In each case, female bodily productivity is mobilized to support bioeconomic research, yet the economic value involved in these relations is largely unacknowledged. In this article, we consider both the gift economy and the transactional economy for reproductive tissues as a form of labour. In order to fully conceptualize the specificities of feminized productivity in the bioeconomy, we distinguish between earlier feminist theories of reproductive labour and the emerging practices generated by stem cell research, which we term regenerative labour. We consider how historical transformations in the regulation of feminized labour and the technical repertoires of stem cell research renegotiate the productivity limits of female reproductive biology, opening it out to novel and profitable forms of surplus value and enrolling women in complex negotiations over their role in bioeconomic activity. (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)

Public-private partnerships are established to specifically harness the potential of Big Data in healthcare and can include partners working across the data chain—producing health data, analysing data, using research results or creating value from data. This domain paper will illustrate the challenges that arise when partners from the public and private sector collaborate to share, analyse and use biomedical Big Data. We discuss three specific challenges for PPPs: working within the social licence, public antipathy to the commercialisation of public sector (...) health data, and questions of ownership, both of the data and any resulting intellectual property or products. As a specific example we consider the case of the UK National Health Service providing patient data to Google’s DeepMind AI program to develop a diagnostic app for kidney disease. This article is an application of the framework presented in this issue of ABR. Please refer to that article for more information on how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end. We use four specific values to help analysis these issues: public benefit, stewardship, transparency and engagement. We demonstrate how the Deliberative Framework can support ethical governance of PPPs involving biomedical big data. (shrink)

This article develops a model of informed consent for fresh oöcyte donation for stem cell research, during in vitro fertilisation (IVF), by building on the importance of patients’ embodied experience. Informed consent typically focuses on the disclosure of material information. Yet this approach does not incorporate the embodied knowledge that patients acquire through lived experience. Drawing on interview data from 35 patients and health professionals in an IVF clinic in Australia, our study demonstrates the uncertainty of IVF treatment, and the (...) tendency for patients to overestimate their chances of success prior to the experience of treatment. Once in active treatment, however, patients identify their oöcytes as both precious and precarious. We argue that it is necessary to formally include embodied experience as a source of knowledge in informed consent procedures, both for gratuitous donation and for egg-sharing regimes. We recommend that at least one full cycle of IVF be completed before approaching women to divert eggs away from their own fertility treatment. (shrink)

Recent Developments Content Type Journal Article DOI 10.1007/s11673-010-9256-0 Authors Cameron Stewart, Centre of Health Governance, Law and Ethics, Sydney Law School, University of Sydney, Sydney, NSW Australia Bernadette Richards, Faculty of Law, University of Adelaide, Adelaide, South Australia Australia Journal Journal of Bioethical Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529.

This paper analyzes the transformations in anatomical representation introduced by the Visible Human Project, the first complete virtual anatomy object. By comparing the process of production of book based classical anatomy with that of the Visible Human Project, the paper identifies the medium specificity of anatomical knowledge, the extent to which its powers of demonstration and analysis are conditioned by the medium in which they take place. The paper argues that anatomy can be productively thought of as a kind of (...) writing practice, in which material flesh is written into different media as traces. Because the production of such traces always involves the destruction of the body involved the paper also interrogates the biopolitical hierarchies involved in anatomical knowledge. (shrink)

Recent Developments Content Type Journal Article DOI 10.1007/s11673-010-9256-0 Authors Cameron Stewart, Centre of Health Governance, Law and Ethics, Sydney Law School, University of Sydney, Sydney, NSW Australia Bernadette Richards, Faculty of Law, University of Adelaide, Adelaide, South Australia Australia Journal Journal of Bioethical Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529.

In recent years, there has been a rapid growth in the use of autologous stem cell-based interventions to treat a wide range of medical conditions, including those for which there is limited evidence of safety and efficacy. One justification for this growth in the use of unproven interventions is that clinicians should be free to innovate, as long as consumers are adequately informed about risks and benefits. In this essay, we systematically refute the strong claim that consumer and clinician autonomy (...) provide sufficient justification for clinical innovation with autologous stem cells. While we do not deny the importance of consumer and clinician autonomy, we argue that equal consideration needs to be given... (shrink)

Written in the anthropological tradition of ethnography, this is a comprehensive account of the radical American musical called experimentalism that arose early in the century and peaked in the 1950s and 1960s.

This article is concerned with developing a philosophical approach to a number of significant changes to academic publishing, and specifically the global journal knowledge system wrought by a range of new digital technologies that herald the third age of the journal as an electronic, interactive and mixed-media form of scientific communication. The paper emerges from an Editors' Collective, a small New Zealand-based organisation comprised of editors and reviewers of academic journals mostly in the fields of education and philosophy. The paper (...) is the result of a collective writing process. (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)

Ethical decision-making frameworks assist in identifying the issues at stake in a particular setting and thinking through, in a methodical manner, the ethical issues that require consideration as well as the values that need to be considered and promoted. Decisions made about the use, sharing, and re-use of big data are complex and laden with values. This paper sets out an Ethics Framework for Big Data in Health and Research developed by a working group convened by the Science, Health and (...) Policy-relevant Ethics in Singapore Initiative. It presents the aim and rationale for this framework supported by the underlying ethical concerns that relate to all health and research contexts. It also describes a set of substantive and procedural values that can be weighed up in addressing these concerns, and a step-by-step process for identifying, considering, and resolving the ethical issues arising from big data uses in health and research. This Framework is subsequently applied in the papers published in this Special Issue. These papers each address one of six domains where big data is currently employed: openness in big data and data repositories, precision medicine and big data, real-world data to generate evidence about healthcare interventions, AI-assisted decision-making in healthcare, public-private partnerships in healthcare and research, and cross-sectoral big data. (shrink)

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)

Sale of Sperm, Health Records, Minimally Conscious States, and Duties of Candour Content Type Journal Article Category Recent Developments Pages 7-14 DOI 10.1007/s11673-011-9347-6 Authors Cameron Stewart, Centre for Health Governance, Law and Ethics, Sydney Law School, University of Sydney, Sydney, NSW, Australia 2006 Bernadette Richards, Law School, University of Adelaide, Adelaide, SA, Australia 5005 Richard Huxtable, Centre for Ethics in Medicine, University of Bristol, Bristol, BS8 1TH UK Bill Madden, School of Law, University of Western Sydney, Sydney, NSW, (...) Australia Tina Cockburn, School of Law, Queensland University of Technology, Brisbane, QLD, Australia Journal Journal of Bioethical Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529 Journal Volume Volume 9 Journal Issue Volume 9, Number 1. (shrink)

The doctrine of consent is built upon presumptions of mental capacity. Those presumptions must be tested according to legal rules that may be difficult to apply to COVID-19 patients during emergency presentations. We examine the principles of mental capacity and make recommendations on how to assess the capacity of COVID-19 patients to consent to emergency medical treatment. We term this the CARD approach.