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)

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)

ABSTRACTExperts use their superior skills and understanding to mediate between evidence in some domain and non-experts. But how should we understand the proper relationship between experts and non-experts? In this paper, I present two ways of conceiving experts’ mediating role from the perspective of non-experts: the Authority View and the Advisor View. Jennifer Lackey has criticized the Authority View and defended the Advisor View. I defend an account of epistemic authority that avoids her criticisms while arguing the Advisor View lacks (...) the advantages she claims. Ultimately, I present a hybrid approach according to which whether we should treat experts as authorities or advisors varies depending upon the presence of certain epistemic and moral concerns. (shrink)

There is a bias in neuroscience toward localizing and modularizing brain functions. Single cell recording, imaging studies, and the study of neurological deficits all feed into the Gallian view that different brain areas do different things and the things being done are confined to particular processing streams. At the same time, there is a growing sentiment that brains probably don’t work like that after all; it is better to conceive of them as fundamentally distributed units, multi‐tasking at every level. This (...) sentiment, however, is much less congenial to the tried‐and‐true experimental protocols available today and to theorizing about the brain in general. This essay examines the tension between current experimental methods and large-scale views of the brain. We argue that this disconnection between experiment and what really are guiding theoretical metaphors seriously impedes progress in neuroscience. (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)

There is a bias in neuroscience toward localizing and modularizing brain functions. Single cell recording, imaging studies, and the study of neurological deficits all feed into the Gallian view that different brain areas do different things and the things being done are confined to particular processing streams. At the same time, there is a growing sentiment that brains probably don’t work like that after all; it is better to conceive of them as fundamentally distributed units, multi‐tasking at every level. This (...) sentiment, however, is much less congenial to the tried‐and‐true experimental protocols available today and to theorizing about the brain in general. This essay examines the tension between current experimental methods and large-scale views of the brain. We argue that this disconnection between experiment and what really are guiding theoretical metaphors seriously impedes progress in neuroscience. (shrink)

We examine the responses of South African multinational enterprises to corruption in African markets in the context of institutional voids. Corruption is a source of uncertainty and additional transactional costs for MNEs and it necessitates a strategic response. The research employs a qualitative study of a sample of MNEs with experience in internationalising into Africa. The results indicate that corruption in African markets is pervasive and closely associated with the institutional voids in these countries. MNEs see themselves as ‘institution takers’ (...) responding to countries’ institutional makeup at the organisational and individual level but fail to fully appreciate their impact on institutions both positively and negatively. Rather MNEs focus on strategic responses at the organisational level to address corruption operationally in the host country. We add to the existing literature by providing a dynamic framework of the complex webs of association between institutions, MNEs and corruption in conditions of economic underdevelopment. The research suggests that MNEs do not need to get caught in a vicious cycle whereby they perpetuate corruption in conditions of underdevelopment and institutional voids but instead can contribute towards a virtuous cycle through which they institutionalise ethical foundations. (shrink)

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)

Supported decision-making has been promoted at a policy level and within international human rights treaties as a way of ensuring that people with disabilities enjoy the right to legal capacity on an equal basis with others. However, little is known about the practical issues associated with implementing supported decision-making, particularly in the context of dementia. This study aimed to understand the experiences of people with dementia and their family members with respect to decision-making and their views on supported decision-making. Thirty-six (...) interviews were undertaken with fifty-seven participants across three states in Australia. Interpretative Phenomenological Analysis was used as the methodological approach, with relational autonomy as a theoretical perspective. We identified two overarching themes relating to participants’ experiences with decision-making: “the person in relationship over time” and “maintaining involvement.” Participant views on the practical issues associated with supported decision-making are addressed under the themes of “facilitating decision-making,” “supported decision-making arrangements,” “constraints on decision-making,” and “safeguarding decision-making.” While participants endorsed the principles of supported decision-making as part of their overarching strategy of “maintaining involvement” in decision-making, they recognized that progressive cognitive impairment meant that there was an inevitable transition toward greater involvement of, and reliance upon, others in decision-making. Social and contextual “constraints on decision-making” also impacted on the ability of people with dementia to maintain involvement. These themes inform our proposal for a “spectrum approach” to decision-making involvement among people living with dementia, along with recommendations for policy and practice to assist in the implementation of supported decision-making within this population. (shrink)

Supported decision-making has been promoted at a policy level and within international human rights treaties as a way of ensuring that people with disabilities enjoy the right to legal capacity on an equal basis with others. However, little is known about the practical issues associated with implementing supported decision-making, particularly in the context of dementia. This study aimed to understand the experiences of people with dementia and their family members with respect to decision-making and their views on supported decision-making. Thirty-six (...) interviews were undertaken with fifty-seven participants across three states in Australia. Interpretative Phenomenological Analysis was used as the methodological approach, with relational autonomy as a theoretical perspective. We identified two overarching themes relating to participants’ experiences with decision-making: “the person in relationship over time” and “maintaining involvement.” Participant views on the practical issues associated with supported decision-making are addressed under the themes of “facilitating decision-making,” “supported decision-making arrangements,” “constraints on decision-making,” and “safeguarding decision-making.” While participants endorsed the principles of supported decision-making as part of their overarching strategy of “maintaining involvement” in decision-making, they recognized that progressive cognitive impairment meant that there was an inevitable transition toward greater involvement of, and reliance upon, others in decision-making. Social and contextual “constraints on decision-making” also impacted on the ability of people with dementia to maintain involvement. These themes inform our proposal for a “spectrum approach” to decision-making involvement among people living with dementia, along with recommendations for policy and practice to assist in the implementation of supported decision-making within this population. (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.

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 his discussion of morals in the Third Book of the Treatise, Hume claims that the taking of what I shall call a general point of view is a necessary condition of the arousal of moral feelings. This aspect of Hume's theory has not received much attention from his commentators before now, although its implications for the theory as a whole might be regarded as significant.

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)

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.

During the early years of the COVID-19 pandemic, preclinical and clinical research were sped up and scaled up in both the public and private sectors and in partnerships between them. This resulted in some extraordinary advances, but it also raised a range of issues regarding the ethics, rigour, and integrity of scientific research, academic publication, and public communication. Many of the failures of scientific rigour and integrity that occurred during the pandemic were exacerbated by the rush to generate, disseminate, and (...) implement research findings, which not only created opportunities for unscrupulous actors but also compromised the methodological, peer review, and advisory processes that would usually identify sub-standard research and prevent compromised clinical or policy-level decisions. While it would be tempting to attribute these failures of science and its translation solely to the “unprecedented” circumstances of the COVID-19 pandemic, the reality is that they preceded the pandemic and will continue to arise once it is over. Existing strategies for promoting scientific rigour and integrity need to be made more rigorous, better integrated into research training and institutional cultures, and made more sophisticated. They might also need to be modified or supplemented with other strategies that are fit for purpose not only in public health emergencies but in any research that is sped-up and scaled up to address urgent unmet medical needs. (shrink)

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)

This article examines how scientists move from physical measurementsto actual observation of single-cell recordings in the brain. We highlight how easy it is to change the fundamental nature of ourobservations using accepted methodological techniques for manipulatingraw data. Collecting single-cell data is thoroughly pragmatic. Weconclude that there is no deep or interesting difference betweenaccounting for observations by measurements and accounting forobservations by theories.

In lieu of an abstract, here is a brief excerpt of the content:Diacritics 29.3 (1999) 40-62 [Access article in PDF] Syncretism and Its Synonyms: Reflections on Cultural Mixture Charles Stewart * The subject matter of anthropology has gradually changed over the last twenty years. Nowadays ethnographers rarely search for a stable or original form of cultures; they are usually more concerned with revealing how local communities respond to historical change and global influences. The burgeoning literature on transnational flows of ideas, (...) global institutions, and cultural mixture reflects this shift of attention. This increased awareness of cultural interpenetration has, furthermore, been instrumental in the critique of earlier conceptions of "culture" that cast it as too stable, bounded, and homogeneous to be useful in a world characterized by migrations (voluntary or forced), cheap travel, international marketing, and telecommunications. 1 Contemporary social theory has accordingly turned to focus on phenomena such as globalization, transnational nationalism, and the situation of diaspora communities. In this body of literature the word syncretism has begun to reappear alongside such related concepts as hybridization and creolization as a means of portraying the dynamics of global social developments.In what follows I consider some current attempts to theorize mixture before turning to examine the suitability, or not, of the terms listed above. Anthropologists and other social scientists have expressed ambivalence about all three terms--syncretism, hybridity, and creolization. I discuss these reservations before presenting a genealogical consideration of the single term syncretism. My purpose in considering the history of syncretism up to the present is not to enforce a standard usage confined to the domain of religion; nor is it my goal to promote syncretism to a position of primus inter pares in the company of all other terms for mixture. I see my approach instead as an attempt to illustrate historically that syncretism has an objectionable but nevertheless instructive past. If this past can be understood, then we are in a position to consciously reappropriate syncretism [Shaw and Stewart 2] and set the ethnographic study of cultural mixture on new tracks.This might seem too minimalist to readers who currently have no reservations about the term, but many anthropologists, on both sides of the Atlantic, have personally expressed to me strong reservations about ever employing the word syncretism. If asked why they hold this view, they are often unable to articulate a specific reason. Some, however, did express one or both of the following objections: (1) syncretism is a pejorative term, one that derides mixture, and/or (2) syncretism presupposes "purity" in the [End Page 40] traditions that combine. Both of these reservations will be considered below, but it is the broad disagreement within the anthropological community on the appropriateness of the very term syncretism that has stimulated this inquiry. Such ambivalence reflects basic uncertainties about how to conceptualize cultural mixture. Current Discussions of Mixture Cultures, if we still wish to retain this term (and I do), are porous; they are open to intermixture with other, different cultures and they are subject to historical change precisely on account of these influences. 2 This has no doubt always been the case. Certainly decolonization and the entry into a postmodernity where master narratives of purity and homogeneity are vulnerable to doubt have contributed to valorizing recognitions of mixture where formerly they had been stigmatized as inauthentic and hence uninteresting for anthropological study. Research in the Caribbean, in Sidney Mintz's view, started relatively late precisely because this region "was considered theoretically unfruitful... its peoples supposedly lacked culture, or were culturally bastardized" [303].Cultural borrowing and interpenetration are today seen as part of the very nature of cultures [Glissant 140-41; Rosaldo, Foreword xv]. To phrase it more accurately, syncretism describes the process by which cultures constitute themselves at any given point in time. Today's hybridization will simply give way to tomorrow's hybridization, the form of which will be dictated by historico-political events and contingencies. In examining cultural hybridity, writers such as Edward Said and James Clifford [Predicament 14-15] have lifted syncretism out of the framework of acculturation. Syncretism is no longer a transient "stage" which will disappear when, with time, assimilation occurs. As Said... (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.

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)

Offers a thorough, multidisciplinary picture of the informational challenges of our media ecosystem, as well as collaborative strategies for addressing them.

Recent Developments Content Type Journal Article DOI 10.1007/s11673-010-9235-5 Authors John Coggon, University of Manchester Centre for Social Ethics and Policy, Institute for Science, Ethics, and Innovation, School of Law Manchester UK Cameron Stewart, University of Sydney Centre for Health Governance, Law and Ethics, Sydney Law School Sydney NSW 2006 Australia Journal Journal of Bioethical Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529 Journal Volume Volume 7 Journal Issue Volume 7, Number 2.

Hawe et al. raise concerns about Human Research Ethics Committees (HRECs) taking a risk-averse and litigation-sensitive approach to ethical review of research proposals. HRECs are tasked with reviewing proposals for compliance with the National Statement on Ethical Conduct in Human Research for the purpose of promoting the welfare of participants. While these guidelines intentionally include a significant degree of discretion in HREC decision making, there is also evidence that HRECs sometimes request changes that go beyond the guidance provided by the (...) National Statement. When HRECs request changes outside their remit, inconsistencies between individual HRECs become more common, contributing to delays in ethical review and reducing the quality of HREC decision making. Improvements to the HREC regulatory system are needed to promote transparency and accountability. (shrink)