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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 (SHAPES) 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. Published version The development of the Framework and its application to the six Domain papers was funded and supported by the Singapore National Medical Research Council Research, Innovation and Enterprise 2020 Grant.

Oncologists have an important role to play in debates about access to high cost cancer medicines. But in order for oncologists to be able to fulfil this role they need to have a solid understanding of the contexts of debates about access to high cost medicines, of the parameters that everyone can agree upon, and of the points of disagreement that need to be resolved. In this article, we offer a conceptual framework that oncologists (and other stakeholders) could use to guide more focused, systematic and ultimately mutually beneficial discussions about the subsidization of high cost cancer medicines.

Conflicts of interest (COI) 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 11 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 (such as patient care). NHMRC Career Development Fellowship (APP1036539)

Over the past decade ‘social egg freezing’ has emerged as a technology of hope that purports to empower women by enabling them to continue their careers or find the right partner without the fear of jeopardising their fertility. This technology has been promoted and celebrated by fertility companies, bioethicists, clinicians, and multi-national corporations such as Apple and Facebook. While critical questions have been raised, they tend to focus on ethical and legal issues, such as informed consent and patient autonomy. This paper uses Foucault’s notion of dispositif as analytic lens to examine the entanglement of the commercial arrangements of fertility companies, the discursive use of hope in promoting these services, and effects on professional medical care. Drawing on socio-political analyses of hope, this paper examines the potential financial conflicts of interest facing clinicians and the way discourses of hope might mask problematic financial relations and lack of evidence of effectiveness.

Rationale, aims, and objectives: Increasing the appropriateness of prescribing has long been a focus of government, non-government, and professional organizations. Progress towards this is made difficult by the fact appropriate prescribing remains inconsistently defined and is the subject of ongoing intense disagreement. In this study, we attempted to understand why this is the case within the context of oncology and haematology. Methods: We performed a qualitative empirical analysis of semi-structured interviews with 16 Australian oncologists and haematologists. Results: We found that oncologists framed appropriate prescribing in terms of the following inter-related, and at times opposed, values: civic mindedness, hope and compassion, realism, and virtue in motivation. Conclusions: These values cannot be ranked a priori, and therefore, any definition of appropriate prescribing must be aligned with what communities want from their health system. When one value is privileged over another in any specific context, a compelling argument must be provided to justify the choice. In an era of shared decision making, patient rights, and high-cost medicines, we need to reassess what we mean by appropriate prescribing in cancer care. Refereed/Peer-reviewed

Although the concept of 'conflict of interest' (COI) arises in many contexts in healthcare, it is often poorly understood, and commonly accepted, definitions are often circular, self-contradictory and unable to provide procedural guidance. To overcome such confusion and imprecision, we offer a reformulation of COI that carefully defines interests, clarifies their scope and articulates a simple, non-punitive approach to managing them. We define an 'interest' as 'a commitment, goal, obligation or duty related to a particular social role or practice'. We show how in a particular setting multiple interests can be at play, which can be either financial or non-financial, with the latter often being the most potent drivers of behaviour. We define a 'conflict of interest' as the condition that arises when two coexisting interests directly conflict with each other: that is, when they are likely to compel contrary and incompatible outcomes. COI therefore reflect objective states of affairs rather than internal mental states; they do not imply moral error; and they are identified through public rather than private processes involving ethical dialogues among relevant stakeholders. Once a COI has been identified, responses must be determined based on the seriousness of the conflict and the conditions that generated it. Such responses may be minimal or they may require a formal disengagement from one of the conflicting interests. The framework described, reflects the rich diversity of interests in modern societies, is universally applicable and provides simple, readily applicable guidelines for the identification and management of conflicts arising between them.

There are increasing demands on regulators and insurers internationally to provide access to medicines more quickly, and often on the basis of less robust evidence of safety, efficacy or cost-effectiveness than have traditionally been required. These demands arise from a number of sources, including those advocating for access to medicines for patients with life-threatening diseases, rare diseases, or subsets of common diseases and where entire populations are threatened in the context of public health emergencies. In response to these demands, policymakers have instituted a number of initiatives aimed at speeding up access to medicines, which we refer to collectively as “accelerated access” programs. While there are strong arguments for accelerated access programs, these programs also raise a number of socio-political, epistemic and moral issues. Some of these issues are common to all types of accelerated access programs, while others are specific to particular types of accelerated access. Here, we offer a conceptual framework that highlights ethically relevant similarities and differences among different kinds of accelerated access processes for the purpose of enabling ethically and politically-informed policy making.

Objective The aim of the present study was to determine Australian community views on factors that influence the distribution of health spending in relation to medicines. Methods A cross-sectional web-based survey was performed of 3080 adults aged ≥18 years. Participants were asked to rank, in order of importance, 12 criteria according to which medicines funding decisions may be made. Results Of all respondents, 1213 (39.4%) considered disease severity to be the most important prioritisation criterion for funding a new medicine. This was followed by medicines treating a disease affecting children (13.2%) and medicines for cancer patients (9.1%). Medicines targeting a disease for which there is no alternative treatment available received highest priority from 8.6% of respondents. The remaining eight prioritisation criteria were each assigned a top ranking from 6.6% to 1.7% of respondents. Medicines targeting a disease for which there is no alternative treatment available were ranked least important by 7.7% of respondents, compared with 2.4%, 1.9% and 1.0% for medicines treating severe diseases, diseases affecting children and cancer respectively. ‘End-of-life treatments’ and ‘rare disease therapies’ received the least number of highest priority rankings (2.0% and 1.7% respectively). Conclusions These results provide useful information about public preferences for government spending on prescribed medicines. Understanding of public preferences on the funding of new medicines will help the Pharmaceutical Benefits Advisory Committee and government determine circumstances where greater emphasis on equity is required and help inform medicines funding policy that best meets the needs of the Australian population. What is known about this topic? There is increased recognition of the importance of taking into account public preferences in the heath technology assessment (HTA) decision-making process. What does this paper add? The Australian public view the severity of disease to be the most important funding prioritisation criterion for medicines, followed by medicines used to treat children or to treat cancer. What are the implications for practitioners? The general public are capable of giving opinions on distributional preferences. This information can help inform medicines funding policy and ensure that it is consistent with the values of the Australian population.

In Australia, the growing assisted reproductive technologies (ART) industry has recently received some public criticism. Much of this criticism centres on the concern that doctors are increasingly motivated by profit, rather than patient interests. These concerns appear to suggest that the growing business of ART generates conflicts of interest (COI) for clinicians. While media reports may be rhetorically compelling, claims that ART practice is distorted by COI must be supported by empirical evidence. This preliminary study sought to engage with people involved with the ART industry and map out their concerns related to COI in ART. A small convenience sample of eight professionals was interviewed. Here, we present the major themes uncovered, including a richer understanding of the 'interests' of various parties involved in Australian ART. We then propose a strategy for how this topic could be constructively explored.

Although randomized controlled trials remain the scientific ideal for determining the efficacy and safety of new treatments, they are sometimes insufficient to address the evidentiary requirements of regulators and payers. This is particularly the case when it comes to precision medicines because trials are often small, deliver incomplete insights into outcomes of most interest to policymakers (eg, overall survival), and may fail to address other complex diagnostic and treatment-related questions. Additional methods, both experimental and observational, are increasingly being used to fill critical evidentiary gaps. A number of modified early- and late-phase trial designs have been proposed to better support earlier biomarker validation, patient identification, and selection for regulatory studies, but there is still a need for confirmatory evidence from real-world data sources. These data are usually provided through observational, postapproval, phase IIIB and IV studies, which rely heavily on registries and other electronic data sets—most notably data from electronic health records. It is, therefore, crucial to understand what ethical, practical, and scientific challenges are raised by the use of electronic health records to generate evidence about precision medicines.

“Sunshine” policy, aimed at making financial ties between health professionals and industry publicly transparent, has recently gone global. Given that transparency is not the sole means of managing conflict of interest, and is unlikely to be effective on its own, it is important to understand why disclosure has emerged as a predominant public policy solution, and what the effects of this focus on transparency might be. We used Carol Bacchi’s problem-questioning approach to policy analysis to compare the Sunshine policies in three different jurisdictions, the United States, France and Australia. We found that transparency had emerged as a solution to several different problems including misuse of tax dollars, patient safety and public trust. Despite these differences in the origins of disclosure policies, all were underpinned by the questionable assumption that informed consumers could address conflicts of interest. We conclude that, while transparency reports have provided an unprecedented opportunity to understand the reach of industry within healthcare, policymakers should build upon these insights and begin to develop policy solutions that address systemic commercial influence.

The process of globalization is commonly espoused as a means for promoting global health. Efforts to "go global" can, however, easily go awry as a result of lack of attention to local social, economic, and political contexts and/or as a result of commercial and political imperatives that allow local populations to be exploited. Critical analysis of the processes of globalization is necessary to better understand the local particularities of global projects and confront challenges more transparently. We illustrate the potential adverse impacts of globalization in the global health setting, through examination of international tuberculosis control, global mental health, and the establishment of transnational biobank networks.

Background Medication errors harm hospitalised patients and increase health care costs. Electronic Medication Management Systems (EMMS) have been shown to reduce medication errors. However, nurses do not always use EMMS as intended, largely because implementation of such patient safety strategies requires clinicians to change their existing practices, routines and behaviour. This study uses the Theoretical Domains Framework (TDF) to identify barriers and targeted interventions to enhance nurses’ appropriate use of EMMS in two Australian hospitals. Methods This qualitative study draws on in-depth interviews with 19 acute care nurses who used EMMS. A convenience sampling approach was used. Nurses working on the study units (N = 6) in two hospitals were invited to participate if available during the data collection period. Interviews inductively explored nurses’ experiences of using EMMS (step 1). Data were analysed using the TDF to identify theory-derived barriers to nurses’ appropriate use of EMMS (step 2). Relevant behaviour change techniques (BCTs) were identified to overcome key barriers to using EMMS (step 3) followed by the identification of potential literature-informed targeted intervention strategies to operationalise the identified BCTs (step 4). Results Barriers to nurses’ use of EMMS in acute care were represented by nine domains of the TDF. Two closely linked domains emerged as major barriers to EMMS use: Environmental Context and Resources (availability and properties of computers on wheels (COWs); technology characteristics; specific contexts; competing demands and time pressure) and Social/Professional Role and Identity (conflict between using EMMS appropriately and executing behaviours critical to nurses’ professional role and identity). The study identified three potential BCTs to address the Environmental Context and Resources domain barrier: adding objects to the environment; restructuring the physical environment; and prompts and cues. Seven BCTs to address Social/Professional Role and Identity were identified: social process of encouragement; pressure or support; information about others’ approval; incompatible beliefs; identification of self as role model; framing/reframing; social comparison; and demonstration of behaviour. It proposes several targeted interventions to deliver these BCTs. Conclusions The TDF provides a useful approach to identify barriers to nurses’ prescribed use of EMMS, and can inform the design of targeted theory-based interventions to improve EMMS implementation. Electronic supplementary material The online version of this article (doi:10.1186/s13012-017-0572-1) contains supplementary material, which is available to authorized users.

Context: Conflicts of interest (CoIs) are considered to be ubiquitous in health care and biomedicine. The disclosure of relevant interests is a first step in managing conflicts, although its usefulness is contested. Although several countries have mandated the public disclosure of doctors' financial relationships with the pharmaceutical industry, little is known about medical students' understanding of mandatory public disclosure. Methods: Six 90-minute focus groups were conducted with medical students in New South Wales, Australia. Participants ranged from first- to final-year students. Students were asked about their understanding and experiences of CoIs and, more specifically, for their views on and experiences of disclosure in medical education, mandatory disclosure and public registers. Qualitative data analysis was based on a framework approach. Results: Participants were generally not supportive of mandatory public disclosure of financial relationships with industry, principally because of concerns about privacy, control over disclosure, and others' (mis)interpretations of disclosures. Further, they did not know how to assess the disclosures presented to them as part of their medical education and described a wide range of reactions to disclosed information. Conclusions: This study suggests that students are currently not well prepared for mandatory public disclosure of CoIs. The subsequent discussion draws on Bourdieu's doxa to highlight assumptions of altruism in medicine, assumptions that are potentially in tension with recent events that have exposed doctors to moral scrutiny by the public. Medical students could be better prepared for future obligations by encouraging disclosures, and contextualising and helping students to interpret them. Disclosure as a box-ticking exercise is unlikely to achieve goals implied by transparency, but a more reflective approach may assist both scrutinisers and the scrutinised. Refereed/Peer-reviewed

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.

In Australia, the government is the primary payer for cancer medicines, and is supported by the Pharmaceutical Benefits Advisory Committee, which makes recommendations about which medicines should be funded on the Pharmaceutical Benefits Scheme. There is an increasing perception that too many Australians are being denied timely access to cancer medicines—an issue that was recently explored in a Senate Inquiry into the Availability of New, Innovative, and Specialist Cancer Drugs in Australia. This is seen as a problem because cancer is considered a major burden on populations and health systems internationally, and the development of innovative cancer medicines is seen as a significant part of the solution to this problem. However new cancer medicines are often very expensive, leading in many cases to limited or delayed access. In this article, we present an analysis of the Senate Report resulting from the Inquiry, which illustrates that – in the Australian context – there are four main ‘goods’ that are prioritised 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. Speculating that our Australian observations can be generalised more broadly, we conclude the paper by exploring some of the consequences of giving in to such pressure, and suggest that there is a need to deconstruct the implicit values in calls for ‘enhanced access’ to cancer medicines so that more nuanced solutions to the exceedingly difficult problem of providing access to these high cost medicines can be found.

Rationale: The pharmaceutical industry plays an increasingly dominant role in health care, raising concerns about “conflicts of interest” (COI) on the part of the medical professionals who interact with the industry. These concerns have led to widespread calls for the management of COI. 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 and dismissive of those who have opposing views, which is not only unproductive, but also likely to be deeply confusing for the vast majority of medical professionals who are simply trying to get their work done in an increasingly commercialized biomedical environment. One way of understanding and advancing debates of this kind is to analyse the social locations and belief systems of people with opposing views, and look for areas of similarity and difference that are not immediately evident in more superficial analyses. Method: Modified meta-narrative review of debates about COI in the academic and grey literature, using the analytical framework of Discourse Models. Results: Debates about COI can be characterised by two distinct Discourse Models. The Critical Discourse Model is espoused by those who see COI in health and biomedicine as a major problem that both can and should be addressed, while the Defensive Discourse Model is espoused by those who would conclude that current efforts to control COIs are at best unnecessary, and at worst harmful. The two Discourse Models are underpinned by profoundly differing views about how society should be organised—in particular whether market forces should be encouraged or curtailed—and how the dangers associated with market forces should be managed. Conclusion: While there is scope for progress in debates about COI, debates will never be completely resolved. in order to make any headway, both academics and policymakers must recognize that these debates are underpinned by profoundly differing views about security and flourishing.

Ideological biases influence medical research and practice and should be disclosed and managed, say Miriam Wiersma and colleagues. But Marc Rodwin argues that many of these interests are widespread and inherent to life and cannot be avoided or eliminated