How should the 'privilege' in therapeutic privilege be conceived when considering the decision-making process for patients with borderline capacity?

Therapeutic privilege (TP) is a defence that may be available to doctors who fail to disclose to the patient relevant information when seeking informed consent for treatment if they have a reasonable belief that providing that information would likely cause the patient concerned serious physical or mental harm. In a landmark judgement, the Singapore Court of Appeal introduced a novel interpretation of TP, identifying circumstances in which it might be used with patients who did not strictly lack capacity but might be inclined to refuse recommended treatments. In this paper, we explore the conceptual and practical challenges of this novel interpretation of TP. We propose that more emphasis should be placed on forms of shared and supported decision-making that foster the autonomy of patients with compromised mental capacity while being mindful of the need to safeguard their well-being. The kind of privilege that doctors might need to invoke is one of time and supportive expertise to ensure a flexible, responsive approach calibrated to the individual patients' needs. The provision of such service would extinguish the need for the novel TP proposed by the Singapore Court of Appeal.

Clarifying how to deploy the public interest criterion in consent waivers for health data and tissue research.

BACKGROUND: Several jurisdictions, including Singapore, Australia, New Zealand and most recently Ireland, have a public interest or public good criterion for granting waivers of consent in biomedical research using secondary health data or tissue. However, the concept of the public interest is not well defined in this context, which creates difficulties for institutions, institutional review boards (IRBs) and regulators trying to implement the criterion. MAIN TEXT: This paper clarifies how the public interest criterion can be defensibly deployed. We first explain the ethical basis for requiring waivers to only be granted to studies meeting the public interest criterion, then explore how further criteria may be set to determine the extent to which a given study can legitimately claim to be in the public interest. We propose an approach that does not attempt to measure magnitude of benefit directly, but rather takes into account metrics that are more straightforward to apply. To ensure consistent and justifiable interpretation, research institutions and IRBs should also incorporate procedural features such as transparency and public engagement in determining which studies satisfy the public interest requirement. CONCLUSION: The requirement of public interest for consent waivers in secondary biomedical research should be guided by well-defined criteria for systematic evaluation. Such a criteria and its application need to be periodically subject to intra-committee and intra-institution review, reflection, deliberation and amendment.

Some Unresolved Ethical Challenges in Healthcare Decision-Making: Navigating Family Involvement.

Family involvement in healthcare decision-making for competent patients occurs to varying degrees in many communities around the world. There are different attitudes about who should make treatment decisions, how and why. Legal and professional ethics codes in most jurisdictions reflect and support the idea that competent patients should be enabled to make their own treatment decisions, even if others, including their healthcare professionals, disagree with them. This way of thinking contrasts with some cultural norms that put more emphasis on the family as a decision-making entity, in some circumstances to the exclusion of a competent patient. Possible tensions may arise between various combinations of patient, family members and healthcare professionals, and healthcare professionals must tread a careful path in navigating family involvement in the decision-making process. These tensions may be about differences of opinion about which treatment option is best and/or on who should have a say or influence in the decision-making process. While some relevant cultural, legal and policy considerations vary from community to community, there are ethical issues that healthcare professionals need to grapple with in balancing the laws and professional codes on decision-making and the ethical principle of respecting patients and their autonomy. This paper will highlight and propose that a partial resolution to these issues may lie in relational understandings of autonomy, which in principle justify interventions by healthcare professionals and family that support patients in decision-making.

Sport Preparticipation Screening for Asymptomatic Atlantoaxial Instability in Patients With Down Syndrome.

Down syndrome (DS) is a clinical syndrome comprising typical facial features and various physical and intellectual disabilities due to extra genetic material on chromosome 21, with one in every 1000 babies born in the United Kingdom affected. Patients with Down syndrome are at risk of atlantoaxial instability (AAI). Although AAI can occur in other conditions, such as rheumatoid arthritis, this position statement deals specifically with patients with DS and asymptomatic AAI. Atlantoaxial instability, also referred to as atlantoaxial subluxation, is defined as increased movement between the first (atlas) and second (axial) cervical vertebra joint articulation, the atlantoaxial joint. Atlantoaxial instability is reported to occur in 6.8% to 27% of the DS population, although this varies depending on the age of the patients whom you are screening. Less than 1% to 2% of these patients are then thought to later develop symptomatic AAI, although the natural history and progression of AAI is not well understood. The risks associated with AAI are neurological injury from excessive movement of the cervical vertebra impinging on and then damaging the spinal cord, although the risk of this during sporting activities is extremely rare. Clearly, physical activity and sports participation for patients with DS has many biological, psychological, and social benefits, and the Faculty of Sport and Exercise Medicine (FSEM), United Kingdom, wishes to promote safe physical activity and sport for all. The FSEM, United Kingdom, has therefore produced a statement regarding sport preparticipation screening for asymptomatic AAI in patients with DS.

The 14th World Congress of Bioethics: Some personal reflections.

These reflections on the 14th World Congress of Bioethics in Bangalore stem from the author's personal and family connections with India and from his participation in all fourteen of the world congresses since the foundation of the International Association of Bioethics in 1992. The very wide scope of the meeting could be seen in two ways, as confusing and chaotic, or as richly diverse and enlightening. Emphasising the latter aspect, this paper argues that the powerful emphasis on health for all and on care for the marginalised in society has a crucial lesson for the bioethics community worldwide.

Advance Care Planning in a Multicultural Family Centric Community: A Qualitative Study of Health Care Professionals', Patients', and Caregivers' Perspectives.

CONTEXT: Advance care planning (ACP) has been shown to improve end-of-life care, but it was developed in the U.S., and most research has been conducted in western communities. OBJECTIVES: We aimed to study the attitudes and perceptions of patients with life-limiting illnesses, informal caregivers, doctors, nurses, and medical social workers regarding ACP in a multicultural family centric community. METHODS: We conducted an explorative qualitative study, using focus groups and individual in-depth interviews. We used purposive sampling techniques to recruit 61 adults (15 doctors, 13 nurses, 5 medical social workers, 15 patients, and 13 caregivers) from multiple health care settings across the country. RESULTS: The participants are genuinely anxious about the implementation of ACP. They had positive and negative expectations of ACP. Many were confused about the legal framework for health care decision-making and expected ACP to be of limited value because family members, rather than the patient, were usually the key decision makers. CONCLUSION: A nuanced approach to ACP that considers the family network is required in multicultural family centric communities. Policies should be reconciled to create a more consistent message that respects patients, the family, and is legally coherent. Further research could focus on adaptations of ACP to promote its acceptance in such communities.

Has the biobank bubble burst? Withstanding the challenges for sustainable biobanking in the digital era.

Biobanks have been heralded as essential tools for translating biomedical research into practice, driving precision medicine to improve pathways for global healthcare treatment and services. Many nations have established specific governance systems to facilitate research and to address the complex ethical, legal and social challenges that they present, but this has not lead to uniformity across the world. Despite significant progress in responding to the ethical, legal and social implications of biobanking, operational, sustainability and funding challenges continue to emerge. No coherent strategy has yet been identified for addressing them. This has brought into question the overall viability and usefulness of biobanks in light of the significant resources required to keep them running. This review sets out the challenges that the biobanking community has had to overcome since their inception in the early 2000s. The first section provides a brief outline of the diversity in biobank and regulatory architecture in seven countries: Australia, Germany, Japan, Singapore, Taiwan, the UK, and the USA. The article then discusses four waves of responses to biobanking challenges. This article had its genesis in a discussion on biobanks during the Centre for Health, Law and Emerging Technologies (HeLEX) conference in Oxford UK, co-sponsored by the Centre for Law and Genetics (University of Tasmania). This article aims to provide a review of the issues associated with biobank practices and governance, with a view to informing the future course of both large-scale and smaller scale biobanks.

The formative years: medical ethics comes of age.

When the Journal of Medical Ethics first appeared in April 1975, the prospects of success seemed uncertain. There were no scholars specialising in the field, the readership could not be guaranteed, and the medical profession itself seemed, at the very least, ambivalent about a subject thought by many to be the province of doctors alone, to be acquired through an apprenticeship model, and certainly not taught or examined in any formal sense. However, change was afoot, fresh scandals created an awareness that outside help was needed to think through the new challenges facing the profession, and the success of the medical groups revealed a clear way forward through multidisciplinary and critically reflective discussion of the host of emerging ethical and legal issues. In this article the formative years of the journal are recaptured, with a claim that the core principles on which it was founded must endure if it is to continue to 'do good medical ethics' over the next 40 years.

Governance of biomedical research in Singapore and the challenge of conflicts of interest.

This article discusses the establishment of a governance framework for biomedical research in Singapore. It focuses on the work of the Bioethics Advisory Committee (BAC), which has been instrumental in institutionalizing a governance framework, through the provision of recommendations to the government, and through the coordination of efforts among government agencies. However, developing capabilities in biomedical sciences presents challenges that are qualitatively different from those of past technologies. The state has a greater role to play in balancing conflicting and potentially irreconcilable economic, social, and political goals. This article analyzes the various ways by which the BAC has facilitated this.

Time for training in psychiatric ethics.

Psychiatry is often fraught with uncertainties and complex situations which give rise to particular ethical issues. However, there is still a dearth in formal training in psychiatric ethics. In this perspective by a clinician, researcher and bioethicist, a case is made for a special status in medical ethics and the need for the incorporation of a structured educational programme in psychiatric ethics during residency training. This educational process should also include the acquiring of certain virtues and competencies.

Shoulder impingement.

This update examines recent articles and evidence for the role of ultrasound in the diagnosis and management of shoulder impingement syndromes and emphasizes its principal application in evaluation for external impingement. Shoulder ultrasound is commonly used as the initial investigation for patients with shoulder pain and suspected impingement. This is due to the high resolution of current ultrasound machines, wide availability, good patient tolerance, cost effectiveness, and, most importantly, its dynamic and interventional role.

Broadening the scope of debates around stem cell research.

Over the last decade, stem cell research has generated an enormous amount of public, political and bioethical debate. These debates have overwhelmingly tended to focus on two moral issues: the moral status of human embryos and the duty to care for the sick and vulnerable. This preoccupation, especially on the question of moral status, has not only dichotomized the debate around two fundamentally incommensurable positions, it has come at the cost of other important issues largely being ignored. In highlighting some of the bioethical and regulatory deficiencies of this fixation, we draw on recent developments in the experimental use of autologous adult stem cells to argue for a more inclusive approach to the ethical issues surrounding stem cell research.

Hepatic portal venous gas--three non-fatal cases and review of the literature.

BACKGROUND: Hepatic portal venous gas is a rare imaging finding most commonly associated with intestinal ischaemia and high mortality. Increased use of advanced imaging techniques has resulted in increased reporting and recognition of hepatic portal venous gas. Advanced imaging can also recognise the many associated pathologies which have variable management strategies and prognoses. METHODS: We report 3 non-fatal cases and review the pathogenesis, aetiology, diagnosis, management and prognosis of hepatic portal venous gas. CONCLUSION: Once considered an indication for urgent surgery, hepatic portal venous gas is a rare imaging finding. More recently, HPVG has been recognised to be associated with various benign causes many of which may be treated non-operatively. However, intestinal ischaemia remains the most common cause and the most important to exclude. CT is the diagnostic modality of choice. The underlying cause determines the treatment strategy and outcome.

The ethics of blood donation: does altruism suffice?

Is the recommendation of the WHO, endorsed by all member states, that all blood donations should be voluntary and non-compensated ethically coherent and realizable in practice? In a recent paper, Farrugia et al have argued for a plurality of both compensated and non-compensated systems, claiming that, from both an ethical and practical perspective, the classical concept of the 'the gift relationship', advocated over 40 years ago by Richard Titmuss, is unnecessary and inadequate. This paper focuses on the ethical aspects of this debate, considering the concepts of altruism, reciprocity and social solidarity as they apply to the procurement of blood and blood products, as well as evidence regarding safety of different sources of blood and the motivations of regular donors. It concludes with a discussion of the view summarized in a recent publication by Campbell (2009), that, although the body may be monetized, doing so would result in a loss of human value.

Intervening in clinical research to prevent the onset of psychoses: conflicts and obligations.

A prevailing issue in clinical research is the duty clinicians have to treat or prevent the progression of disease during a study that they are conducting. While all clinical researchers have a duty of care for the patients who participate in clinical research, intervening at the onset or progression of disease may skew results and have a negative impact on the scientific validity of a study. Extreme examples of failures to intervene can be found in the Tuskegee syphilis study and in an attempt to determine if cervical smears were an accurate predictor of cancer, which was uncovered by the Cartwright Inquiry. However, the issue arises in all research where delay in intervention can cause harm. A current study in Singapore is investigating the significance of an 'ultra-high risk' state that may constitute the prodromal phase of psychosis. This project called 'The Longitudinal Youth at Risk Study' is potentially contentious because it is recruiting young people who are identified as being 'at risk' of developing psychosis. In this paper, the decision to offer treatment to all participants as well as a fast track for those who are assessed to have developed serious mental illness into treatment is discussed. It is argued that this approach is ethically justified because of the duty of care that is owed to research participants, and suggests that the principle of equipoise may be used to guide intervention decisions in other clinical research protocols.

Regulating autologous adult stem cells: the FDA steps up.

The Food and Drug Administration (FDA) has sought an injunction to prevent a US-based company from offering an autologous adult stem cell treatment for musculoskeletal and spinal injuries. Given the alarming number of clinics promoting stem-cell-based interventions, the outcome of this case could have wide-ranging implications.

The Singapore flagship programme in translational and clinical research in psychosis.

AIM: This paper describes the rationale, aims and development of the Singapore Translational and Clinical Research in Psychosis, which is a 5-year programme. METHODS: The authors provide a selective review of the pertinent findings from the clinical, neuropsychological, genetics and neuroimaging studies on high-risk population and how they were factored in the hypotheses and design of this translational clinical research programme. RESULTS: This programme, which draws upon the previous work of various groups and the experience of the investigators of this consortium, comprises three interlinked studies. The first is a genome-wide association and copy number variation analysis using the diagnostic phenotype of schizophrenia and cognitive phenotypes, and a joint genome-wide analysis performed by combining our data with other datasets to increase the power to detect genetic risk factors. The second is a prospective study of a large group of individuals who are assessed to be at ultra-high risk of psychosis, and the third is a randomized controlled trial to improve neurocognition in patients with schizophrenia. CONCLUSION: The convergence of various factors including the unique structured characteristics of the Singaporean society, the presence of political will with availability of funding and the established research infrastructure make it possible to accrue the sample size for adequate power to elucidate biomarkers of disease risk and resilience.