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.

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.

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.

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.

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.

Evaluating the effects of an integrated medical ethics curriculum on first-year students.

INTRODUCTION: An integrated biomedical ethics track was implemented as part of the new medical undergraduate curriculum at the National University of Singapore Yong Loo Lin School of Medicine in academic year (AY) 2008/2009. This study analyses the effects of the new curriculum on fi rst-year students' knowledge, confidence and opinions in relation to the subject. MATERIALS AND METHODS: In a cohort-based quasi-experimental study, we administered a pre-course and post-course questionnaire to a group of fi rst-year students in AY2008/2009 who underwent the new biomedical ethics curriculum. The same questionnaire was carried out with the fi rst-year cohort of AY2007/2008, who had received only ad hoc teaching in biomedical ethics. The questionnaire focused on the students' opinions on selected taught topics in biomedical ethics and law, and formal ethics education; their confidence in relation to specific clinical ethical competencies; and their knowledge of selected taught topics in the fi rst-year syllabus. RESULTS: The experimental cohort acquired more knowledge and confidence. They rated more positively formal ethics teaching and assessment as a requirement of medical education. Attitudes were found to have been 'professionalised' within the experimental group, with significantly greater receptiveness towards ethical codes of the profession and the regulatory role of the Singapore Medical Council. They were found to be more conservative with respect to legislative changes in healthcare. CONCLUSION: The pioneer biomedical ethics curriculum had significant effects on the ethical development of fi rst-year medical students. Longitudinal research through further phases of the integrated curriculum is needed to identify learning issues that affect the consolidation of knowledge, confidence and attitudes in medical ethics, law and professionalism.

Live or let die: ethical issues in a psychiatric patient with end-stage renal failure.

Medical co-morbidities are very common in patients with psychiatric conditions. Although respecting one's autonomy to make treatment decisions is the ethical default position, the capacity to make such decisions may need to be assessed, especially when patients are in relapse of their psychiatric condition, and/or when the decisions made are high-risk and possibly fatal. This case report highlights the ethical issues of refusing potential life-saving treatment in a patient who is in relapse of her schizoaffective disorder. In particular, the assessment of decisional capacity and the role of the doctors (if the patient lacks capacity) are discussed. Recommendations are also made on how to better manage such situations.

How can we know that ethics education produces ethical doctors?

This article examines the challenges that medical ethics education faces, given its aim of producing ethical doctors. Starting with an account of the ethical doctor, it then inquires into the key areas of medical students' ethical development, viz. knowledge, habituation and action, and describes more specific outcomes in these areas. Methods of teaching aimed at achieving specific outcomes are also discussed. The authors then turn to some difficulties that stand in the way of achieving the desired outcomes of medical ethics education, and survey what has been achieved so far, by considering a number of studies that have evaluated the efficacy of a range of medical ethics courses. The article concludes by suggesting that medical ethics education should give attention to the problems of evaluation of ethics curricula as the discipline comes of age.