Perspectives on non-financial conflicts of interest in health-related journals: A scoping review.

The objective of this scoping review was to systematically review the literature on how non-financial conflicts of interest (nfCOI) are defined and evaluated, and the strategies suggested for their management in health-related and biomedical journals. PubMed, Embase, Scopus and Web of Science were searched for peer reviewed studies published in English between 1970 and December 2023 that addressed at least one of the following: the definition, evaluation, or management of non-financial conflicts of interest. From 658 studies, 190 studies were included in the review. nfCOI were discussed most commonly in empirical (22%; 42/190), theoretical (15%; 29/190) and "other" studies (18%; 34/190) - including commentary, perspective, and opinion articles. nfCOI were addressed frequently in the research domain (36%; 68/190), publication domain (29%; 55/190) and clinical practice domain (17%; 32/190). Attitudes toward nfCOI and their management were divided into two distinct groups. The first larger group claimed that nfCOI were problematic and required some form of management, whereas the second group argued that nfCOI were not problematic, and therefore, did not require management. Despite ongoing debates about the nature, definition, and management of nfCOI, many articles included in this review agreed that serious consideration needs to be given to the prevalence, impact and optimal mitigation of non-financial COI.

Ethical and Regulatory Challenges with Autologous Adult Stem Cells: A Comparative Review of International Regulations.

Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the aim of identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies.

How shortcomings in the mental health system affect the use of involuntary community treatment orders.

Objective The aim of the present study was to examine stakeholder perspectives on how the operation of the mental health system affects the use of involuntary community treatment orders (CTOs). Methods A qualitative study was performed, consisting of semi-structured interviews about CTO experiences with 38 purposively selected participants in New South Wales (NSW), Australia. Participants included mental health consumers (n=5), carers (n=6), clinicians (n=15) and members of the Mental Health Review Tribunal of NSW (n=12). Data were analysed using established qualitative methodologies. Results Analysis of participant accounts about CTOs and their role within the mental health system identified two key themes, namely that: (1) CTOs are used to increase access to services; and (2) CTOs cannot remedy non-existent or inadequate services. Conclusion The findings of the present study indicate that deficiencies in health service structures and resourcing are a significant factor in CTO use. This raises questions about policy accountability for mental health services (both voluntary and involuntary), as well as about the usefulness of CTOs, justifications for CTO use and the legal criteria regulating CTO implementation. What is known about this topic? Following the deinstitutionalisation of psychiatric services over recent decades, community settings are increasingly the focus for the delivery of mental health services to people living with severe and persistent mental illnesses. The rates of use of involuntary treatment in Australian community settings (under CTOs) vary between state and territory jurisdictions and are high by world standards; however, the reasons for variation in rates of CTO use are not well understood. What does this paper add? This paper provides an empirical basis for a link between the politics of mental health and the uptake and usefulness of CTOs. What are the implications for practitioners? This paper makes explicit the real-world demands on the mental health system and how service deficiencies are a significant determinant in the use of CTOs. Practitioners and policy makers need to be candid about system limitations and how they factor in clinical and legal justifications for using involuntary treatment. The results of the present study provide data to support advocacy to improve policy accountability and resourcing of community mental health services.

Religious Perspectives on Human Suffering: Implications for Medicine and Bioethics.

The prevention and relief of suffering has long been a core medical concern. But while this is a laudable goal, some question whether medicine can, or should, aim for a world without pain, sadness, anxiety, despair or uncertainty. To explore these issues, we invited experts from six of the world's major faith traditions to address the following question. Is there value in suffering? And is something lost in the prevention and/or relief of suffering? While each of the perspectives provided maintains that suffering should be alleviated and that medicine's proper role is to prevent and relieve suffering by ethical means, it is also apparent that questions regarding the meaning and value of suffering are beyond the realm of medicine. These perspectives suggest that medicine and bioethics have much to gain from respectful consideration of religious discourse surrounding suffering.

Ethical considerations in the management of Ebola virus disease.

Is it ethically appropriate in some circumstances for HCWs to decline to care for patients with EVD? How should treatment decisions be made regarding limitation of therapy for patients with EVD? There are two main ethical questions regarding the critical care of patients with EVD in an Australian setting: Is it ethically appropriate in some circumstances for HCWs to decline to care for patients with EVD? How should treatment decisions be made regarding limitation of therapy for patients with EVD? The key concern is ensuring that no patient is denied therapy that should be provided, while preventing unnecessary risk to HCWs. It is imperative to develop an approach that facilitates rigorous, evidence-based and ethically justifiable decision making, which should include a predetermined, institutionally endorsed process for assessing difficult clinical scenarios as they arise.

Part of the fabric and mostly right: an ethnography of ethics in clinical practice.

OBJECTIVES: To describe how ethics is practised in a health care setting, and to ascertain whether there was interest in establishing clinical ethics support services. DESIGN AND SETTING: Observations and interviews undertaken between April and November 2012 in a large NSW urban hospital with newborn care, maternity and oncology departments and analysed by coding and categorising the data. MAIN OUTCOME MEASURES: Key themes in the participants' attitudes to professional ethics were identified. RESULTS: Ethics is not typically an explicit feature of clinical deliberations, and clinicians tend to apply basic ethical principles when ethical problems are identified. They also discuss difficult decisions with colleagues, and try to resolve ethical differences by discussion. Participants judged the ethics of clinical practice to be "mostly right", primarily because ethics is "part of the fabric" of everyday clinical work that aspires to "optimising care". Nevertheless, most clinicians would welcome ethics support because ethics is integral to health care practice, is not always "done well", and may be the source of conflict. CONCLUSIONS: Ethics is very much a part of the fabric of clinical practice, and the ethical challenges that arise in patient care in this particular setting are generally managed adequately. However, many clinicians have concerns about the ethical aspects of some practices and decisions, and believe that access to expert ethics support would be useful. Helping clinicians to provide ethically sound patient care should be a priority for health care providers across Australia.

Managing ethical issues in patient care and the need for clinical ethics support.

OBJECTIVE: To investigate the range, frequency and management of ethical issues encountered by clinicians working in hospitals in New South Wales (NSW), Australia. METHODS: A cross-sectional survey was conducted of a convenience sample of 104 medical, nursing and allied health professionals in two NSW hospitals. RESULTS: Some respondents did not provide data for some questions, therefore the denominator is less than 105 for some items. Sixty-two (62/104; 60%) respondents reported occasionally to often having ethical concerns. Forty-six (46/105; 44%) reported often to occasionally having legal concerns. The three most common responses to concerns were: talking to colleagues (96/105; 91%); raising the issue in a group forum (68/105; 65%); and consulting a relevant guideline (64/105; 61%). Most respondents were highly (65/99; 66%) or moderately (33/99; 33%) satisfied with the ethical environment of the hospital. Twenty-two (22/98; 22%) were highly satisfied with the ethical environment of their department and 74 (74/98; 76%) were moderately satisfied. Most (72/105; 69%) respondents indicated that additional support in dealing with ethical issues would be helpful. CONCLUSION: Clinicians reported frequently experiencing ethical and legal uncertainty and concern. They usually managed this by talking with colleagues. Although this approach was considered adequate, and the ethics of their hospital was reported to be satisfactory, most respondents indicated that additional assistance with ethical and legal concerns would be helpful. Clinical ethics support should be a priority of public hospitals in NSW and elsewhere in Australia.

Don't be scared, be angry: the politics and ethics of Ebola.

The current outbreak of Ebola virus disease in West Africa is the worst so far. The unprecedented extent of mortality and morbidity in this outbreak has followed more from imposition of neoliberal economic policies on the countries affected than from the biological virulence of Ebola virus. The lack of vaccines and medications for Ebola virus disease is evidence that markets cannot reliably supply treatments for epidemic diseases. We attribute the current difficulties in containment chiefly to the erosion or non-development of the health and medical infrastructure needed to respond effectively, as a direct result of market-privileging policies imposed in the interests of wealthy nations. These events and responses hold lessons for public health priorities in Australia.

Knowledge, beliefs, and decisions of pregnant Australian women concerning donation and storage of umbilical cord blood: a population-based survey.

BACKGROUND: Many women giving birth in Australian hospitals can choose to donate their child's umbilical cord blood to a public cord blood bank or pay to store it privately. We conducted a survey to determine the proportion and characteristics of pregnant women who are aware of umbilical cord blood (UCB) banking and who have considered and decided about this option. The survey also sought to ascertain information sources, knowledge, and beliefs about UCB banking, and the effect of basic information about UCB on decisions. METHODS: Researchers and hospital maternity staff distributed a survey with basic information about UCB banking to 1,873 women of at least 24 weeks' gestation who were attending antenatal classes and hospital clinics in 14 public and private maternity hospitals in New South Wales. RESULTS: Most respondents (70.7%) were aware of UCB banking. Their main information sources were leaflets from hospital clinics, print media, antenatal classes, TV, radio, friends, and relatives. Knowledge about UCB banking was patchy, and respondents overestimated the likelihood their child would need or benefit from UCB. Women who were undecided about UCB banking were younger, less educated, or from ethnic or rural backgrounds. After providing basic information about UCB banking, the proportion of respondents who indicated they had decided whether or not to donate or store UCB more than doubled from 30.0 to 67.7 percent. CONCLUSIONS: Basic information for parents about UCB banking can affect planned decisions about UCB banking. Information should be accurate and balanced, should counter misconceptions, and should target specific groups.

The lived experience of involuntary community treatment: a qualitative study of mental health consumers and carers.

OBJECTIVE: To describe the lived experiences of people subject to community treatment orders (CTOs) and their carers. METHOD: We recruited 11 participants (five mental health consumers and six carers) through consumer and carer networks in NSW, Australia, to take part in interviews about their experiences. We analysed the interview data set using established qualitative methodologies. RESULTS: The lived experiences were characterised by 'access' concerns, 'isolation', 'loss and trauma', 'resistance and resignation' and 'vulnerability and distress'. The extent and impact of these experiences related to the severity of mental illness, the support available for people with mental illnesses and their carers, the social compromises associated with living with mental illness, and the challenges of managing the relationships necessitated by these processes. CONCLUSIONS: The lived experience of CTOs is complex: it is one of distress and profound ambivalence. The distress is an intrinsic aspect of the experience of severe mental illness, but it also emerges from communication gaps, difficulty obtaining optimal care and accessing mental health services. The ambivalence arises from an acknowledgement that while CTOs are coercive and constrain autonomy, they may also be beneficial. These findings can inform improvements to the implementation of CTOs and the consequent experiences.

Double meanings will not save the principle of double effect.

In an article somewhat ironically entitled "Disambiguating Clinical Intentions," Lynn Jansen promotes an idea that should be bewildering to anyone familiar with the literature on the intention/foresight distinction. According to Jansen, "intention" has two commonsense meanings, one of which is equivalent to "foresight." Consequently, questions about intention are "infected" with ambiguity-people cannot tell what they mean and do not know how to answer them. This hypothesis is unsupported by evidence, but Jansen states it as if it were accepted fact. In this reply, we make explicit the multiple misrepresentations she has employed to make her hypothesis seem plausible. We also point out the ways in which it defies common sense. In particular, Jansen applies her thesis only to recent empirical research on the intentions of doctors, totally ignoring the widespread confusion that her assertion would imply in everyday life, in law, and indeed in religious and philosophical writings concerning the intention/foresight distinction and the Principle of Double Effect.

Religious perspectives on the use of psychopharmaceuticals as an enhancement technology.

The use of psychopharmaceuticals as an enhancement technology has been the focus of attention in the bioethics literature. However, there has been little examination of the challenges that this practice creates for religious traditions that place importance on questions of being, authenticity, and identity. We asked expert commentators from six major world religions to consider the issues raised by psychopharmaceuticals as an enhancement technology. These commentaries reveal that in assessing the appropriate place of medical therapies, religious traditions, like secular perspectives, rely upon ideas about health and disease and about normal human behavior. But unlike secular perspectives, faith traditions explicitly concern themselves with ways in which medicine should or should not be used to live a "good life".

The economic evaluation of personalised oncology medicines: ethical challenges.

Insights into the molecular drivers of cancer are providing opportunities for the development of new targeted treatments and more personalised approaches to cancer management. Drugs targeting mutant epidermal growth factor receptors, such as erlotinib and gefitinib, may provide more effective, safer and better tolerated treatment options compared with chemotherapy among appropriately selected patients with advanced non-small cell lung cancer (NSCLC). First-line access to these newer treatments remains unfunded after several considerations by the Pharmaceutical Benefits Advisory Committee and their assessment that these are not cost-effective treatments. We suggest that there may be evidentiary and ethical challenges associated with the assessment of the cost-effectiveness of personalised oncology medicines in Australia, and that a new approach is needed to determine the value and cost-effectiveness of personalised medicine.