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)

It is increasingly recognised that evidence generated using “real-world data” is crucial for assessing the safety and effectiveness of health-related interventions. This, however, raises a number of issues, including those related to the quality of RWD, and of the scientific methods used to generate evidence from it, and the potential for those gathering and using RWD be driven by commercial, political, professional or personal self-interest. 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 to demonstrate how those generating or using RWD can make use of values when deliberating about ethical issues. (shrink)

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

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)

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)

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)

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 pharmaceutical industry plays an increasingly dominant role in healthcare, raising concerns about “conflicts of interest” on the part of the medical professionals who interact with the industry. However, there is considerable disagreement over the extent to which COI is a problem and how it should be managed. Participants in debates about COI have become entrenched in their views, which is both unproductive and deeply confusing for the majority of medical professionals trying to work in an increasingly commercialized environment. We (...) used a modified meta-narrative review method to analyse debates about COI in the academic and grey literature. We found two Discourse Models: The Critical Discourse Model sees COI in health and biomedicine as a major problem that both can and should be addressed, while the Defensive Discourse Model argues that current efforts to control COIs are at best unnecessary and at worst harmful. Each model is underpinned by profoundly differing views about how society should be organized—in particular whether market forces should be encouraged or curtailed—and how the dangers associated with market forces should be managed. In order to make any headway, academics and policymakers must recognize that these debates are underpinned by profoundly differing worldviews. (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.

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)

Cancer is a major burden on populations and health systems internationally. The development of innovative cancer medicines is seen as a significant part of the solution. These new cancer medicines are, however, expensive, leading to limited or delayed access and disagreements among stakeholders about which medicines to fund. There is no obvious resolution to these disagreements, with stakeholders holding firmly to divergent positions. Access to cancer medicines was recently explored in Australia in a Senate Inquiry into the Availability of New, (...) Innovative, and Specialist Cancer Drugs in Australia. We analysed the resultant Senate Report to identify competing stakeholder values. Our analysis illustrates that there are four main “goods” prioritized by different stakeholders: 1) innovation, 2) compassion, 3) equity, and 4) sustainability. We observe that, with the exception of sustainability, all of these “goods” put pressure on payers to provide access to cancer medicines more quickly and based on less rigorous evaluation processes. We then explore the consequences of giving in to such pressure and suggest that deconstructing the implicit values in calls for “enhanced access” to cancer medicines is necessary so that more nuanced solutions to the challenge of providing access to these high cost medicines can be found. (shrink)

Consumer engagement in decisions about the funding of medicines is often framed as a good in and of itself and as an activity that should be universally encouraged. A common justification for calls for consumer engagement is that it enhances equity. In this paper we systematically critique this assumption. We show that consumer engagement may undermine equity as well as enhance it and show that a simple relationship cannot be assumed but must be justified and demonstrated. In concluding, we present (...) a number of challenges that need to be overcome in order for consumer engagement to contribute to health technology assessment in a morally and politically sound manner. (shrink)

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)

There is growing interest among pharmaceutical policymakers in how to “disinvest” from subsidized medicines. This is due to both the rapidly rising costs of healthcare and the increasing use of accelerated and conditional reimbursement pathways which mean that medicines are being subsidized on the basis of less robust evidence of safety and efficacy. It is crucial that disinvestment decisions are morally sound and socially legitimate, but there is currently no framework to facilitate this. We therefore reviewed the bioethics literature in (...) order to identify ethical principles and concepts that might be relevant to pharmaceutical disinvestment decisions. This revealed a number of key ethical considerations—both procedural and substantive—that need to be considered when making pharmaceutical disinvestment decisions. These principles do not, however, provide practical guidance so we present a framework outlining how they might be applied to different types of disinvestment decisions. We also argue that, in this context, even the most rigorous ethical reasoning is likely to be overridden by moral intuitions and psychological biases and that disinvestment decisions will need to strike the right balance between respecting justifiable moral intuitions and overriding unjustifiable psychological impulses. (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)

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)

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)

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)

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)

The news media is frequently criticised for failing to support the goals of government health campaigns. But is this necessarily the purpose of the media? We suggest that while the media has an important role in disseminating health messages, it is a mistake to assume that the media should serve the interests of government as it has its own professional ethics, norms, values, structures and roles that extend well beyond the interests of the health sector, and certainly beyond those of (...) the government. While considerable attention has been given to the ways in which uncritical publication of industry perspectives by news media can negatively impact on public understandings of health and health behaviours, we would argue that it is equally important that journalists not become the ‘lapdogs’ of government interests. Further, we suggest that the interests of public health may be served more by supporting the ongoing existence of an independent media than by seeking to overdetermine its purpose or scope. (shrink)

The phone-hacking scandal that led to the closure of the News of the World newspaper in Britain has prompted international debate about media practices and regulation. It is timely to broaden the discussion about journalistic ethics and conduct to include consideration of the impact of media practices upon the population's health. Many commercial organisations cultivate relationships with journalists and news organisations with the aim of influencing the content of health-related news and information communicated through the media. Given the significant influence (...) of the media on the health of individuals and populations, we should be alert to the potential impact of industry–journalist relationships on health care, health policy and public health. The approach taken by the medical profession to its interactions with the pharmaceutical industry provides a useful model for management of industry influence. (shrink)

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)

Conflicts of interest, stemming from relationships between health professionals and the pharmaceutical industry, remain a highly divisive and inflammatory issue in healthcare. Given that most jurisdictions rely on industry to self-regulate with respect to its interactions with health professionals, it is surprising that little research has explored industry leaders’ understandings of conflicts of interest. Drawing from in-depth interviews with ten pharmaceutical industry leaders based in Australia, we explore the normalized and structural management of conflicts of interest within pharmaceutical companies. We (...) contrast this with participants’ unanimous belief that the antidote to conflicts of interest with health professionals were “informed consumers.” It is, thus, unlikely that a self-regulatory approach will be successful in ensuring ethical interactions with health professionals. However, the pharmaceutical industry’s routine and accepted practices for disclosing and managing employees’ conflicts of interest could, paradoxically, serve as an excellent model for healthcare. (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)

While doctors generally enjoy considerable status, some believe that this is increasingly threatened by consumerism, managerialism, and competition from other health professions. Research into doctors’ perceptions of the changes occurring in medicine has provided some insights into how they perceive and respond to these changes but has generally failed to distinguish clearly between concerns about “status,” related to the entitlements associated with one’s position in a social hierarchy, and concerns about “respect,” related to being held in high regard for one’s (...) moral qualities. In this article we explore doctors’ perceptions of the degree to which they are respected and their explanations for, and responses to, instances of perceived lack of respect. We conclude that doctors’ concerns about loss of respect need to be clearly distinguished from concerns about loss of status and that medical students need to be prepared for a changing social field in which others’ respect cannot be taken for granted. (shrink)

Biobanks are increasingly being linked together into global networks in order to maximise their capacity to identify causes of and treatments for disease. While there is great optimism about the potential of these biobank networks to contribute to personalised and data-driven medicine, there are also ethical concerns about, among other things, risks to personal privacy and exploitation of vulnerable populations. Concepts drawn from theories of globalisation can assist with the characterisation of the ethical implications of biobank networking across borders, which (...) can, in turn, inform more ethically sophisticated responses. Using the China Kadoorie Biobank as a case study, we show how distinguishing between the subnational, transnational, supranational and extranational spheres of operation and influence can help researchers, institutions and regulators to understand and manage the ethical issues raised by the globalisation of biobanking. (shrink)

Health industries attempt to influence the public through the news media and through their relationships with expert academics and opinion leaders. This study reports journalists' perceptions of their professional roles and responsibilities regarding the relationships between industry and academia and research results. Journalists believe that responsibility for the scientific validity of their reports rests with academics and systems of peer review. However, this approach fails to account for the extent of industry-academy interactions and the flaws of peer review. Health journalists' (...) retention of a critical stance regarding industry-academia relationships will include advocacy for and adoption of mandatory reporting of these relationships. (shrink)

The Medical Innovation Bill continues its journey through Parliament. On 23 January 2015, it was debated for the final time in the House of Lords and with one final amendment, the House moved to support the Bill, which then moved to the House of Commons on 26 January. It will be debated again on 27 February 2015. The Bill’s purpose is to encourage responsible innovation in medical treatment. Although this goal is laudable, it is argued that the Bill is unnecessary (...) and has the potential to undermine the very cause it aims to advance. More useful for encouraging responsible innovation is the continued education of health-care professionals on how the law already supports practitioners who look to improve care through responsible innovation. (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.

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)

In the biomedical field, calls for the generation of new regulations or for the amendment of existing regulations often follow the emergence of apparently new research practices (such as embryonic stem cell research), clinical practices (such as facial transplantation) and entities (such as Avian Influenza/’Bird Flu’). Calls for regulatory responses also arise as a result of controversies which bring to light longstanding practices, such as the call for increased regulation of human tissue collections that followed the discovery of unauthorised post-mortem (...) organ retention. Whilst it seems obvious that new regulations should only be generated if existing regulations are inadequate (a practice referred to in this paper as ‘regulatory syncretism’), this does not always occur in practice. This paper examines the conceptual steps involved in generating regulatory responses to emerging phenomena. Two decision points are identified. First, a stance is taken as to whether the emerging phenomenon raises unique ethical or legal issues (exceptionalism versus non-exceptionalism). Second, the decision is made as to whether new regulation should be generated only for truly unique phenomena (syncretism versus asyncretism). It is argued here that it is important to make a careful assessment of novelty, followed by a reflective and deliberate choice of regulatory syncretism or asyncretism, since each type of regulatory response has advantages which need to be harnessed and disadvantages which need to be managed—something that can only occur if regulators are attentive to the choices they are making. (shrink)

The pharmaceutical industry has been criticised for pervasive misconduct. These concerns have generally resulted in increasing regulation. While such regulation is no doubt necessary, it tends to assume that everyone working for pharmaceutical companies is equally motivated by commerce, without much understanding of the specific views and experiences of those who work in different parts of the industry. In order to gain a more nuanced picture of the work that goes on in the “medical affairs” departments of pharmaceutical companies, we (...) conducted 15 semi-structured interviews with professionals working in medical departments of companies in Sydney, Australia. We show that this group of pharmaceutical professionals are committed to their responsibilities both to patients, research participants, and the public and to their companies. Despite the discrepancies between these commitments, our participants did not express much cognitive dissonance, and this appeared to stem from their use of two dialectically related strategies, one of which embraces commerce and the other of which resists the commercial imperative. We interpret these findings through the lens of institutional theory and consider their implications for pharmaceutical ethics and governance. (shrink)

Conflicts of interests are typically divided into those that are financial and those that are not. While there is general agreement that financial COIs have a significant impact on decisions and need to be declared and managed, the status of non-financial COIs continues to be disputed. In a recent BMJ feature article it was proposed that religious beliefs should be routinely declared as an interest. The article generated over 41 responses from the medical community and health researchers, which put forward (...) diverse and opposing views. In this paper, we analyse the discourse to shed further light on the reasons put forward for and against declaring religious beliefs. We argue for a middle path in which only material beliefs should be declared, and then only when there are no extenuating circumstances. To this end, we present a framework to help evaluate the materiality of interests that can be used for both financial and non-financial interests. Data are available in a public, open access repository. (shrink)