Research involving human subjects is much more stringently regulated than many other nonresearch activities that appear to be at least as risky. A number of prominent figures now argue that research is overregulated. We argue that the reasons typically offered to justify the present system of research regulation fail to show that research should be subject to more stringent regulation than other equally risky activities. However, there are three often overlooked reasons for thinking that research should be treated as a (...) special case. First, research typically involves the imposition of risk on people who do not benefit from this risk imposition. Second, research depends on public trust. Third, the complexity of the moral decision making required favors ethics committees as a regulative solution for research. (shrink)

Courts are increasingly obliged to adjudicate upon challenges to allocative decisions in healthcare, but their involvement continues to be regarded with unease, imperilling the legitimacy of the judicial role in this context. A central reason for this is that judges are perceived to lack sufficient expertise to determine allocative questions. This article critically appraises the claim of lack of judicial expertise through an examination of the various components of a limit-setting decision. It is argued that the inexpertise argument is weak (...) when compared with other rationales for judicial restraint, such as the procedural unsuitability and lack of constitutional competence of courts. (shrink)

The effectiveness of antiretroviral regimes (ARVs) to reduce risk of HIV transmission from mother to child and as post-exposure prophylaxis has been known for almost two decades. Recent research indicates ARVs can also reduce the risk of HIV transmission via sexual intercourse in two other ways. With pre-exposure prophylaxis (PrEP), ARVs are used to reduce risk of HIV acquisition among persons who are HIV negative and significantly exposed to the virus. With treatment as prevention (TasP), ARVs are used to reduce (...) risk of HIV transmission from persons who are already HIV positive. The development of these new prevention strategies raises a rationing problem: given the chronic shortage of ARVs for HIV-infected persons in need of treatment, is it ethically justified to allocate ARVs for PrEP and/or TasP? This article examines the intuitively appealing view that allocation of ARVs for treatment should be the highest priority, the use of ARVs for TasP should be a secondary priority, and that utilizing ARVs for PrEP would be unethical. I will argue that selective, evidence-based allocation of ARVs for prevention in certain cases could be ethically justified even when there is insufficient anti-retroviral access for all those needing it for treatment. (shrink)

Bioethics is a diverse field that accommodates a broad range of perspectives and disciplines. The recent explosion of literature on methods in interdisciplinary and empirical ethics might appear, however, to overshadow the fact that ‘bioethics’ has long been an interdisciplinary field. The Interdisciplinary and Empirical Ethics Network (IEEN) was established, with funding from the Wellcome Trust, to facilitate critical and constructive discussion around the nature of this disciplinary diversity and shift focus away from the ‘empirical turn’, towards the ongoing development (...) of bioethics as an evolving field of interdisciplinary study. In April 2012 the IEEN organized a workshop at the Centre for Public Policy Research, King's College London, dedicated to discussing the relationship between aims and methods in interdisciplinary and empirical bioethics. This paper reports on that first meeting. (shrink)

In modern representative democracies, much healthcare is publicly funded or provided and so the question of what healthcare systems should do is a matter of public policy. Given that public resources are inevitably limited, what should be done and who should benefit from healthcare? It is a dilemma for policymakers and a subject of debate within several disciplines, but rarely across disciplines. In this paper, I draw on thinking from several disciplines and especially philosophy, economics, and systems theory. I conclude (...) that economist and philosopher John Broome’s writing provides the framework for an answer: a healthcare system in a democracy should do as much good as possible, although sometimes we should sacrifice some overall good for the sake of fairness. This leaves open some detailed questions about what in practice we consider to be good and fair, and about when some good should be traded off in order to be fair. The answers to these questions depend on our values, or as explained by systems theory, our weltanschauung. How policy decisions should be made when citizens’ values differ is a subject of extensive academic debate. However, it is a separate question. Representative democracies have mechanisms for resolving such debates. (shrink)

In modern representative democracies, much healthcare is publicly funded or provided and so the question of what healthcare systems should do is a matter of public policy. Given that public resources are inevitably limited, what should be done and who should benefit from healthcare? It is a dilemma for policymakers and a subject of debate within several disciplines, but rarely across disciplines. In this paper, I draw on thinking from several disciplines and especially philosophy, economics, and systems theory. I conclude (...) that economist and philosopher John Broome’s writing provides the framework for an answer: a healthcare system in a democracy should do as much good as possible, although sometimes we should sacrifice some overall good for the sake of fairness. This leaves open some detailed questions about what in practice we consider to be good and fair, and about when some good should be traded off in order to be fair. The answers to these questions depend on our values, or as explained by systems theory, our weltanschauung. How policy decisions should be made when citizens’ values differ is a subject of extensive academic debate. However, it is a separate question. Representative democracies have mechanisms for resolving such debates. (shrink)

Fair resource allocation in humanitarian medicine is gaining in importance and complexity, but remains insufficiently explored. It raises specific issues regarding non-ideal fairness, global solidarity, legitimacy in non-governmental institutions and conflicts of interest. All would benefit from further exploration. We propose that some headway could be made by adapting existing frameworks of procedural fairness for use in humanitarian organizations. Despite the difficulties in applying it to humanitarian medicine, it is possible to partly adapt Daniels and Sabin's ‘Accountability for reasonableness’ to (...) this context. This would require: (1) inclusion of internally explicit decisions and rationales; (2) publicity to donors, local staff, community leaders and governments, as well as frank answers to any beneficiary—or potential beneficiary—who asked for clarification of decisions and their rationale; (3) a consistent reasoning strategy to weigh conflicting views of equity in specific situations; (4) advocacy within the organization as a mechanism for revision and appeals; and (5) internal regulation according to publicly accessible mechanisms. Organizations could generate a common corpus of allocation decisions from which to draw in future similar cases. Importantly, the complexity of these challenges should encourage, rather than hinder, broader discussion on ethical aspects of resource allocation in humanitarian medicine. CiteULike Connotea Del.icio.us What's this? (shrink)

Artificial intelligence (AI) is a powerful tool for several healthcare tasks. AI tools are suited to optimize predictive models in medicine. Ethical debates about AI’s extension of the predictive power of medical models suggest a need to adapt core principles of medical ethics. This article demonstrates that a popular interpretation of the principle of justice in healthcare needs amendment given the effect of AI on decision-making. The procedural approach to justice, exemplified with Norman Daniels and James Sabin’saccountability for reasonablenessconception, needs (...) amendment because, as research into algorithmic fairness shows, it is insufficiently sensitive to differential effects of seemingly just principles on different groups of people. The same line of research generates methods to quantify differential effects and make them amenable for correction. Thus, what is needed to improve the principle of justice is a combination of procedures for selecting just criteria and principles and the use of algorithmic tools to measure the real impact these criteria and principles have. In this article, the author shows that algorithmic tools do not merely raise issues of justice but can also be used in their mitigation by informing us about the real effects certain distributional principles and criteria would create. (shrink)

This paper examines the role of bioethics in the successful control of COVID-19 in New Zealand. After the severe acute respiratory syndrome coronavirus episode in Toronto researchers developed a framework of values and principles to articulate values that were already commonly accepted “in the community of its intended users,” to be used to inform decision-making. New Zealand subsequently developed its own framework that was embedded in its Pandemic Influenza Plan. These formed the basis of the New Zealand response to COVID-19. (...) This paper illustrates the ways in which the bioethical framework was reflected in the decisions and actions made by the government. (shrink)

The UK’s Cancer Drugs Fund was introduced in 2010 following the Conservative Party’s promise to address the fact that numerous efficacious cancer drugs were not available because of their cost ineffectiveness, as deduced by the National Institute of Health and Care Excellence. While, at face value, this policy appears only to promote the UK’s public welfare, a deeper analysis reveals the ethically unjustifiable inconsistencies that the CDF introduces; where is the analogous fund for other equally severe diseases? Have the patients (...) without cancer been neglected simply due to the fear-inducing advertising and particularly ferocious speech which surrounds cancer? The CDF is unjustifiable when challenged by such questions. However, it is troubling to think that the CDF might be repealed in order to abolish these ethical concerns. Intuitively, one feels uncomfortable stripping the cancer patient of their benefits just so that they might be on an equally pessimistic footing with others. In the present essay, I argue that, although there are no ethically justifiable grounds for the CDF’s introduction, its removal would be inappropriate. Following this realisation, I investigate whether the procedural steps of the CDF itself—theoretically removed from the context of resource distribution for all disease types—represent an ethically justifiable system. I believe that the answer is yes, given the CDF’s conformity to accountability for reasonableness, a robust framework of procedural justice, which continuously improves the ethical and epistemological standards of the policies to which it is applied. (shrink)

Norman Daniels’s theory of ‘accountability for reasonableness’ is an influential conception of fairness in healthcare resource allocation. Although it is widely thought that this theory provides a consistent extension of John Rawls’s general conception of justice, this paper shows that accountability for reasonableness has important points of contact with both utilitarianism and intuitionism, the main targets of Rawls’s argument. My aim is to demonstrate that its overlap with utilitarianism and intuitionism leaves accountability for reasonableness open to damaging critiques. The important (...) role that utilitarian-like cost-effectiveness calculations are allowed to play in resource allocation processes disregards the separateness of persons and is seriously unfair towards individuals whose interests are sacrificed for the sake of groups. Furthermore, the function played by intuitions in settling frequent value conflicts opens the door for sheer custom and vested interests to steer decision-making. (shrink)

Biomedical research is increasingly carried out in low- and middle-income countries. International consensus has largely been achieved around the importance of valid consent and protecting research participants from harm. But what are the responsibilities of researchers and funders to share the benefits of their research with research participants and their communities? After setting out the legal, ethical and conceptual frameworks for benefit sharing, this collection analyses seven historical cases to identify the ethical and policy challenges that arise in relation to (...) benefit sharing. A series of recommendations address possible ways forward to achieve justice for research participants in low- and middle-income countries. (shrink)