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Qualitative studies on assisted reproductive technology commonly focus on the perspectives of participants living in major metropolises. In doing so, the experiences of those living outside major cities, and the unique way conditions of spatiality shape access to treatment, are elided. In this paper, we examine how location and regionality in Australia impact upon access and experience of reproductive services. We conducted twelve qualitative interviews with participants residing in regional areas across Australia. We asked participants to discuss their experience with assisted reproduction services and the impacts of location on access, service choice, and experience of care, and analysed the data using reflexive thematic analysis, as outlined by Braun and Clarke (2006, 2019). Participants in this study reported that their location impacted the services available to them, required considerable time in travel, and reduced continuity of care. We draw on these responses to examine the ethical implications of uneven distribution of reproductive services in commercial healthcare settings which rely on market-based mechanisms.

This section examines recent reforms to the regulatory framework for biologicals contained in the Therapeutic Goods Act 1989 (Cth) in the context of the "New Frontier" of reform envisioned in a report completed by the Commonwealth Government in 2021. It compares Australia's proposed reform of the approval processes for biologicals to similar reforms that have been made over the last three decades in the United States and the European Union. It places the Australian reforms in the context of the commercialisation of regenerative medicine and identifies several potential shortcomings of the proposed reforms and reports on the current lack of data on the processes of expedited approvals in Australia more generally.

PurposeIn this study, the authors aimed to explore consumer perspectives on accelerated access to medicines. The authors were particularly interested in how they balance competing considerations of safety, efficacy, equity and access; whether and how their views change when there are different levels of uncertainty surrounding the safety and efficacy of new medicines; and the procedures that they think should be used to make decisions about accelerated access to new medicines.Design/methodology/approachThis was an exploratory qualitative study. Thirteen semi-structured interviews with patient advocates and two focus groups with patients were conducted and analysed thematically. Interviews and focus groups were audio recorded and transcribed verbatim. Data were analysed through inductive thematic analysis.FindingsParticipants outlined a range of justifications for accelerated access, including addressing unmet medical needs and encouraging further research and development. However, they were also cognisant of the potential risks and viewed ongoing data collection, disinvestment and market withdrawal as ways to address these. They also emphasised the importance of transparent decisions being made by people with relevant expertise, based on a thorough consideration of scientific evidence and stakeholder perspectives.Originality/valueThis is the first study to comprehensively explore Australian consumers' views of accelerated access to medicines. The results suggest that consumers want timely access to new medicines, but not at the expense of safety, efficacy, equity and sustainability. While accelerated access programs are likely to be welcomed by consumers, they must be fully informed of their conditions and limitations, and robust post-market data surveillance must be implemented and enforced to protect the interests of both individual patients and the broader community.

BACKGROUND In many countries, ART service provision is a commercial enterprise. This has benefits, for example, creating efficiencies and economies of scale, but there are also concerns that financial imperatives can negatively impact patient care. The commercialization of ART is often conceptualized as being driven solely by the financial interests of companies and clinicians, but there are in fact many complex and intersecting socio-political demands for ART that have led to, sustain and shape the industry. OBJECTIVE AND RATIONALE To use the academic and policy discourse on the commercialization of ART to build a theoretical model of factors that influence demand for ART services in high-income countries in order to inform potential policy responses. SEARCH METHODS We searched electronic databases for journal articles (including Web of Science, Scopus, PubMed) and websites for grey literature, carried out reference chaining and searched key journals (including Human Reproduction, Fertility and Sterility). The terms used to guide these searches were ‘assisted reproductive technology’ OR ‘in vitro fertilization’ AND ‘commerce’ OR ‘commercialisation’ OR ‘industry’ OR ‘market’. The search was limited to the English language and included articles published between 2010 and 2020. We used an established method of critical interpretive synthesis (CIS) to build a theoretical model of factors that influence demand for ART services in high-income countries. We developed initial themes from a broad review of the literature followed by iterative theoretical sampling of academic and grey literatures to further refine these themes. OUTCOMES According to contemporary academic and broader socio-political discourse, the demand for ART has arisen, expanded and evolved in response to a number of intersecting forces. Economic imperatives to create sustainable national workforces, changing gender roles and concerns about the preservation of genetic, national/ethnic and role-related identities have all created demand for ART in both public and private sectors. The prominence given to reproductive autonomy and patient-centred care has created opportunities to (re)define what constitutes appropriate care and, therefore, what services should be offered. All of this is happening in the context of technological developments that provide an increasing range of reproductive choices and entrench the framing of infertility as a disease requiring medical intervention. These socio-political drivers of demand for ART can be broadly organized into four theoretical categories, namely security, identity, individualization and technocratization. LIMITATIONS, REASONS FOR CAUTION The primary limitation is that the interpretive process is ultimately subjective, and so alternative interpretations of the data are possible. WIDER IMPLICATIONS Development of policy related to commercial activity in ART needs to account for the broad range of factors influencing demand for ART, to which commercial ART clinics are responding and within which they are embedded. STUDY FUNDING/COMPETING INTEREST(S) This work was supported by a National Health and Medical Research Council Ideas Grant (APP1181401). All authors declare that they have no conflict of interest in relation to this work.

Corruption is a word used loosely to describe many kinds of action that people find distasteful. We prefer to reserve it for the intentional misuse of the good offices of an established social entity for private benefit, posing as fair trading. The currency of corruption is not always material or financial. Moral corruption is all too familiar within churches and other ostensibly beneficent institutions, and it happens within medicine and the pharmaceutical industries. Corrupt behavior reduces trust, costs money, causes injustice, and arouses anger. Yet it persists, despite all efforts since the beginnings of societies. People who act corruptly may lack conscience and empathy in the same way as those with some personality disorders. Finding ways to prevent corruption from contaminating beneficent organizations is therefore likely to be frustratingly difficult. Transparency and accountability may go some way, but the determined corruptor is unlikely to feel constrained by moral and reporting requirements of this kind. Punishment and redress are complicated issues, unlikely to satisfy victims and society at large. Both perhaps should deal in the same currency—material or social—in which the corrupt dealing took place.

Objective This study examined the practices and attitudes of Australian biobanks regarding access to samples and data, as well as local and global networking with other biobanks. Methods This was a mixed-methods study, including an online survey of Australian biobank administrators and qualitative interviews with survey participants. The survey examined the criteria applied when considering requests to share or network. The interviews explored attitudes and practices regarding sharing and networking. Results Most (90.9%; 30/33) biobanks offered access to their samples and data to others, principally for research (90.6%; 29/32). The most common criteria used to evaluate access requests included ethical oversight (84.8%; 28/33), scientific merit (84.8%; 28/33) and intended use (81.8%; 27/33). Just over two-thirds (69.7%; 23/33) of biobanks participated in Australian networks, and 39.1% (9/23) participated in global networks. Networking took the form of both sharing standardised operating procedures and policies (60.9%) and sharing samples and data (43.5%). Thirteen of the 16 interviewees participated in networks. Motivations for sharing included scientific necessity, sharing expertise and standardising operations and governance. Significant barriers to networking remain, including insufficient resources, inconsistent regulations and procedures, and cultural and political issues to do with the conduct of research. Conclusions Many Australian biobanks are already active participants in various types of global biobanking. If biobanks are to expand and make the most of their involvement in global networks, then important barriers need to be overcome. What is known about the topic? Biobanks that store human tissue and associated data are increasingly forming local, national and global networks. These networks create opportunities for enhancing the utility and sustainability of biobanks, but also raise considerable technical, legal and ethical challenges. What does this paper add? This paper reports findings from a mixed-methods study of Australian biobanks and reveals contemporary practices and perspectives concerning sample and data sharing, as well as local and global networking. It found most Australian biobanks currently take part in these activities. What are the implications for practitioners? Many Australian biobanks are networking in various ways across regional and national borders. A better understanding of current practices and views on significant and emerging issues is relevant to the diverse range of biobank stakeholders involved in any agenda to expand biobank networking, including patients, consumers, clinicians, scientists, policy makers and regulators.

Over the course of the twentieth century, numerous national and international ethics 'codes' have been developed. While such codes serve important substantive and symbolic functions, they can also pose challenges. In this article, we discuss these challenges, noting that they fall into four main categories relating to conceptual tensions, power imbalances, organisational barriers, and threats of exploitation. We illustrate these challenges using examples provided from the United Nations Educational Scientific and Cultural Organization (UNESCO) Universal Declaration on Bioethics and Human Rights. We emphasise the importance of accountability in the development and maintenance of national and international codes and argue that, despite all their challenges, codes provide an important common language among otherwise disparate and sometimes adversarial groups, and provide visible and explicit sets of standards that may be invoked by community members to criticise and hold powerful bodies to account. This is particularly important for practitioners and researchers who belong to organisations that are signatories to codes, who can use these codes to both guide and justify ethical behaviour in the face of competing organisational, professional and political imperatives.

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 (and adequately resourced), it should be quite possible to both speed up science and remain attentive to scientific quality and integrity.

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.

Conflicts of interests (COI) 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 recentBMJfeature 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.

Between 1933 and 1945, almost 300,000 people were murdered and 360,000 sterilized by the National Socialist (Nazi) regime under a group of crimes now collectively known as the Krankenmorde, the murder of the sick and disabled. Founded in narrow-minded and inconsistent accounts of a good and valuable life, the Nazi eugenic and “euthanasia” crimes were brutal and violent acts organized and executed by doctors, nurses and other professionals. Acknowledgement of this group of victims was delayed and obscured due to historical events as well as prevailing political and social attitudes toward mental illness and disability. As a result, the breadth of the Krankemorde crimes and its victims, its relationship to the Holocaust and its contemporary significance–to bioethics and society more broadly–is less recognized or understood than that of other Nazi medical crimes, such as the infamous experiments on prisoners. First presenting a history of the Krankenmorde and its aftermath in Germany and Nazi occupied territories, this chapter goes on to examine the value of bioethics having better knowledge of this part of its history and, in particular, engaging with its own epistemic constraints in relation to disability and ableism. These ideas are explored further in the context of contemporary bioethical issues related to the rights and treatment of people with disabilities, specifically the allocation of health resources. Throughout the chapter we seek to highlight the lives of Krankenmorde victims–those who survived and those who did not–all of whom have been historically overlooked and marginalized.

Waitzberg and colleagues’ participants articulate a wide range of strategies to manage tensions between clinical and economic obligations. There are, however, three notable absences in the data. First, all strategies described by participants are underpinned by the assumption that clinical (and associated administrative) practices need to either align with economic considerations or be made more compatible with them. Second, the dual agency dilemma was framed exclusively as existing at the level of the health care institution, with little attention paid to obligations to broader health systems. Third, there was no evidence of critical questioning of the priorities of the hospitals in which participants work. These absences do not render the strategies used by Weitzberg and colleagues’ participants morally "wrong," but they do suggest that people who are deeply embedded in a system might fail to recognise the full range of moral concerns and moral possibilities.

Aims Medicines regulators issue post-market safety warnings to advise of newly uncovered risks, but with mixed impacts. We aimed to identify factors influencing the use of regulatory warnings by primary care and specialist physicians in the US and Australia. Methods Semi-structured qualitative interviews were carried out with 40 primary care physicians, endocrinologists and other generalist specialists in Boston (USA) and Australia. Coding and analysis were performed inductively and iteratively to identify and examine key factors. Analysis centred around four areas: physicians' awareness of drug safety information, preferred information sources, opinion-forming and sharing of information with patients. Results Uncertainty, trust and clinical authority emerged as factors influencing use of advisories. Although regulators were trusted as authoritative institutions, they appeared to lack clinical authority, and physicians validated regulatory information against other trusted sources including evidence, expert opinion and experience. Specialists became aware of drug safety issues through specialised literature, using evidence and clinical consensus to form opinions. Primary care physicians, fielding high volumes of information, relied on convenient, accessible information sources including the media and the "clinical grapevine" for awareness, and on clinical colleagues, specialists and experience for interpretation. Communicating risk to patients was complicated by uncertainty; physicians tailored information to patients' health literacy and information needs. US physicians were more aware of their national regulator's post-market safety role than Australian physicians of theirs. Conclusion Drug safety warnings may not be optimally received or used. Regulators should consider strategies that increase trust, clinical relevance and accessibility, and address physicians' needs in communicating risk to patients.

In recent years, a variety of ‘accelerated access’ schemes have been introduced by pharmaceutical regulators and funders globally. These schemes aim to overcome perceived regulatory and reimbursement barriers to accessing medicines – particularly for patients with limited time or therapeutic options. However, patient access to approved medicines is mediated by a number of third parties including regulators and payers, and physicians who act both as gatekeepers and guides to prescribed medications. It is therefore essential to know how physicians think about accelerated access as they are responsible for advising patients on and prescribing medicines made available via these pathways. We conducted semi-structured interviews with 18 Australian physicians focusing on their attitudes towards accelerated access. We identified three ‘archetypes’ of physicians: ‘confident accelerators’, ‘cautious accelerators’, and ‘decelerators’. Although all acknowledged the potential risks and benefits of accelerated access, they disagreed on their magnitude and extent and how they should be balanced in both policy formation and clinical practice. Overall, our results illustrate the diversity of clinical opinions in this area and the importance of monitoring both the prescribing and clinical outcomes that result from accelerated access programmes to ensure that these are both clinically and morally acceptable.

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.

It is increasingly recognised that evidence generated using “real-world data” (RWD) is crucial for assessing the safety and effectiveness of health-related interventions. This, however, raises a number of issues, including those related to (1) the quality of RWD, and of the scientific methods used to generate evidence from it, and (2) 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 (Xafis et al. 2019). 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.

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.

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.

Background In the past decade many novel, and in some cases transformative, cancer medicines have entered the market. Their prices and the amount spent on them by governments have increased rapidly, bringing to the forefront trade-offs that must be made. In this paper we explore the Australian public’s attitude towards the funding of high cost cancer medicines (HCCM) to inform reimbursement and health technology assessment (HTA) policy. Methods A survey consisting of 49 questions about the funding of HCCMs was developed by the investigators. Recruitment was conducted via Qualtrics. 1039 Australian adults completed the survey. Results The Australian public overwhelmingly supports funding of HCCMs (95.5 %) to enhance equity of access (97.8 %), and to respond to patients’ needs (98 %). When respondents were challenged to balance equity versus access in different contexts inconsistencies emerged. Different demographic factors were important in predicting support for various strategies. Conclusion Our results suggest that the Australian public strongly supports government funding of HCCMs and values both equity and access. Equally, however, the public is uncertain about how equity and access are to be balanced and achieved, and such ambivalence needs to be both further explored and accommodated in policy processes. Our results may be used by policymakers in Australia, and countries with similar systems and values, to further develop policies and processes for funding HCCMs.

BACKGROUND: Biobanks are vital resources for genetics and genomics, and it is broadly recognised that for maximal benefit it is essential that they include samples and data from diverse ancestral groups. The inclusion of First Nations people, in particular, is important to prevent biobanking research from exacerbating existing health inequities, and to ensure that these communities share in the benefits arising from research. AIMS: To explore the perspectives of Australian Aboriginal people whose tissue - or that of their family members - has been stored in the biobank of the National Centre for Indigenous Genomics (NCIG). METHODS: Semi-structured interviews with 42 Aboriginal people from the Titjikala, Galiwinku, Tiwi Islands, Yarrabah, Fitzroy Crossing, Derby, One Arm Point and Mulan communities, as well as a formal discussion with A. Hermes, an Indigenous Community Engagement Coordinator at the NCIG who had conducted the interviews. The interviews and the structured discussion were double coded using a procedure informed by Charmaz's outline of grounded theory analysis and Morse's outline of the cognitive basis of qualitative research. RESULTS: In this article, we report on A. Hermes' interviews with members from the above Aboriginal communities, as well as on her personal views, experiences, and interpretations of the interviews she conducted with other community members. We found that participation in the NCIG biobank raised issues around broken trust, grief and loss, but also - somewhat unexpectedly - was perceived as a source of empowerment, hope and reconnection. CONCLUSIONS: This research reminds us (again) of the need to engage deeply with communities in order to respond appropriately with respect for their cultural values and norms, and to develop culturally relevant policies and processes that enhance the benefits of biobank participation and minimise potential harms.

To ensure their sustainability and scientific utility, human biobanks are networking internationally. Sharing biospecimens and associated data across jurisdictions raise a number of practical, ethical, legal and social challenges that could reduce the publics’ willingness to donate their much needed tissue for research purposes. This research aims to identify the impact of biobank location on willingness to donate through a national quantitative survey ( n = 750) and 16 in-depth interviews. A latent class analysis in combination with qualitative results suggests that a large proportion of Australians are willing to donate and/or allow their tissue to be stored offshore to help others, but others are reluctant due to uncertainty around foreign ethical and regulatory standards and the loss of potential local benefits. The results highlight for the first time the diversity of public views, and provide important guidance for policy makers and science communicators eager to tailor strategies for specific publics.

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)

The prevalence of businesses selling autologous stem cell-based interventions to patients in Australia has raised serious concerns about how weaknesses in regulation have enabled the emergence of an industry that engages in aggressive marketing of unproven treatments to patients. Little is known about how patients experience this marketing and their subsequent interactions with practitioners. This paper reports results from 15 semistructured interviews with patients and carers, and also draws upon discussion conducted with patients, carers and family members (22 participants) in a workshop setting. We explore how Australian patients and carers understand and experience these interventions, and how their presumptions about the ethics of medical practice, and the regulatory environment in Australia have conditioned their preparedness to undergo unproven treatments.

The “Australian Consensus Framework for Ethical Collaboration in the Healthcare Sector” (ACF) is an Australian initiative aimed at countering dysfunction and growing mistrust in the health sector through the development of a cross-sectoral consensus framework. The development of this framework arose from Australia’s involvement in the Asia Pacific Economic Cooperative (APEC) and has since become the largest of its kind internationally, with over 70 signatories representing professional bodies, industry organisations, hospital and health services associations, regulators, and patient and advocacy groups. In this article, we describe and critique the framework and outline its implementation.

We thank Goldstein and Peterson, Caplan, and Bramstedt for engaging with our paper on the ethics of publishing and using Chinese transplant research that involves organs procured from executed prisoners.1–4 In that paper, we examine consequentialist and deontological arguments for and against using data from unethical research. Goldstein and Peterson question the relationship between the social and scientific value of the research and the decision to publish the results. They argue that the failure to publish scientifically valid and socially valuable Chinese transplant research results in potential repetition of the research and subsequent exposure of new participants to research risks for data that already exists. This argument has intuitive appeal, in both its positive form (the data are already there so let’s use them) and negative form (by not using the data we subject future participants to avoidable research risks). Prima facie, failure to use the data does seem to breach a fundamental principle of research ethics, that of only exposing people to risks in research to produce novel and socially valuable knowledge. However, this point relies heavily on the assumption that data from unethical research are valid and valuable. This is a useful assumption to make in a theoretical argument as it clarifies the challenge of weighing up the potential utility of the …

When infectious disease outbreaks strike, health facilities acquire labels such as "war zones" and "battlefields" and healthcare professionals become "heroes" on the "front line." But unlike soldiers, healthcare professionals often take on these dangerous roles without any prior intention or explicit expectation that their work will place them in grave personal danger. This inevitably raises questions about their role-related obligations and whether they should be free to choose not to endanger themselves. In this article, I argue that it is helpful to view this situation not only through the lens of "professional duty" but also through the lens of "role-related conflicts." Doing so has the advantage of avoiding exceptionalism and allowing us to draw lessons not only from previous epidemics but also from a wide range of far more common role-related dilemmas in healthcare.

In recent years, there has been growing concern about the impact of conflicts of interest on the generation, interpretation, and dissemination of evidence in health and biomedicine. Particular attention has been paid to conflicts of interest in the development of evidence reviews and clinical practice guidelines for health professionals, because conflicts of interest in this context pose a threat to evidence-based medicine and may contribute to the use of unnecessary tests and treatments. However, little attention has been paid to the subject of conflicts of interest in the synthesis and dissemination of evidence for patients. As a first step in addressing this gap, we have conducted a conceptual analysis in which we have mapped the types of conflicts of interest that may be relevant to the synthesis and dissemination of evidence for patients. In this paper, we will describe our taxonomy, present a critical analysis of the possible effects, if any, of these conflicts of interest, and outline possible strategies for minimising harm. We anticipate that this conceptual analysis will facilitate a better understanding of conflicts of interest as they pertain to the synthesis and dissemination of evidence for patients and, in particular, their role as a driver of the problem of overdiagnosis and overtreatment.

Growth hormone (GH) replacement therapy was recently recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme for adults with severe GH deficiency and impaired quality of life. This approval was significant for two reasons. First, the application was initiated and coordinated by a health professional working group, who prepared a 'public interest' submission to PBAC. Second, it resulted in a recommendation to subsidise therapy for a rare disease after two prior rejections on the basis of uncertainty about efficacy and cost effectiveness. There are important lessons to learn about the power of professional groups to drive health policy and attain funding for rare diseases.

Despite accumulating evidence indicating that paracetamol is no more efficacious than placebo for acute uncomplicated low back pain and symptomatic osteoarthritis, it is still prescribed for these conditions. This is likely due to perceived clinical improvement in pain observed when the medicine is taken and the known harms associated with pharmacological alternatives. The benefits observed in the majority of patients are, however, likely to be placebo effects. This scenario poses an ethical dilemma between respecting patient autonomy by providing complete information while also promoting clinical benefit (beneficence). This article discusses this situation and considers a framework in which paracetamol might continue to be prescribed for these conditions in an ethical manner, namely through discussing the evidence and the benefit that some patients experience from it.

Neurocognitive health and mental wellbeing feature prominently in political, social, and media discourses and are accompanied by strong public interest in adopting emerging neurotechnologies. Kreit...

In their definition of serious ethical violations, DuBois and colleagues (2019) distinguish between such violations and “conflicts of interests,” on the grounds that the latter, while “also violati...

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.

Aim This paper reports on the findings from 6 focus groups conducted with Australian medical students. The focus groups sought students' perspectives on how the influence of commercial interests on medical practice and education could be managed. Method We conducted 6 focus groups with medical students in New South Wales, Australia. Participants were recruited via student-run medical society and faculty e-mail lists. Forty-nine students from 6 medical schools in New South Wales participated. The research team reflected on the extent to which students uncritically appealed to science in the abstract as a management solution for conflicts of interest. Data analysis was largely inductive, looking for uses of scientific terminology, EBM, and appeals to “science” in the management of COI and applied theoretical analyses of scientism. Results The students in our study suggested that science and evidence-based medicine, rather than ethics or professionalism, were the best tools to deal with undue influence and bias. This paper uses philosophy of science literature to critically examine these scientistic appeals to science and EBM as a means of managing the influence of pharmaceutical reps and commercial interests. We argue that a scientistic style of reasoning is reinforced through medical curricula and that students need to be made aware of the epistemological assumptions that underpin science, medicine, and EBM to address the ethical challenges associated with commercialised health care. Conclusion More work is needed to structure medical curricula to reflect the complexities of practice and realities of science. However, curricula change alone will not sufficiently address issues associated with commercial interests in medicine. For real change to occur, there needs to be a broader social and professional debate about the ways in which medicine and industry interact, and structural changes that restrict or mitigate commercial influences in educational, research, and policy settings.