It is widely maintained that a clinical trial is ethical only if some form of equipoise between the treatments being compared obtains. To be in equipoise between two treatments A and B is to be cognitively indifferent between the statement ‘A is strictly more effective than B’ and its negation. It is natural to claim that equipoise regarding A and B is necessary for randomised assignment to treatments A and B to be beneficent and non‐maleficent and is sufficient for such (...) an assignment to be fair. Cashing this out precisely is difficult, and various forms of equipoise have been discussed which consider whose equipoise is relevant to the decision. This is to make judgement of equipoise something to be managed socially, while its prima facie significance is supposedly cognitive. Recent reconstructions of equipoise‐like concepts in epistemology give clues about how to understand equipoise cognitively. In this paper I examine some of this work and discuss how successful it has been. I suggest that while this work is promising, it still has far to go, and that while equipoise remains the best theory we have of the cognitive justification for clinical trials, it is nonetheless incoherent. (shrink)

Evidence based medicine has been a topic of considerable controversy in medical and health care circles over its short lifetime, because of the claims made by its exponents about the criteria used to assess the evidence for or against the effectiveness of medical interventions. The central epistemological debates underpinning the debates about evidence based medicine are reviewed by this paper, and some areas are suggested where further work remains to be done. In particular, further work is needed on the theory (...) of evidence and inference; causation and correlation; clinical judgment and collective knowledge; the structure of medical theory; and the nature of clinical effectiveness. (shrink)

Queen Mary, University of London, School of Law, Mile End Road, London E1 4NS, UK. Tel: +442078825126, Fax: +442089818733, Email: r.ashcroft{at}qmul.ac.uk ' + u + '@' + d + ' '//--> Abstract Recent doctrine in both national and international organisations concerned with public health planning and resource allocation has it that direct ethical justification of substantive decisions is so difficult as to be impossible. Instead, we should agree on criteria of procedural justice and reach decisions whose justification lies in how (...) they are arrived at, rather than any direct ethical justification on the ground of substantive moral principles. In this polemical article, I argue that this amounts to a serious dereliction of intellectual duty on the part of the bioethics community. Our role in these settings is to produce and defend the best substantive arguments we can. Failing to do this makes bioethicists at best redundant and at worst leads us to seriously defective conclusions. The argument is illustrated by analysis of the ethical frameworks for resource allocation under the UNAIDS ‘3 by 5’ programme and for pandemic influenza planning. CiteULike Connotea Del.icio.us What's this? (shrink)

In this review of Leon Kass’s Life, liberty and the defense of dignity and Deryck Beyleveld and Roger Brownsword’s Human dignity in bioethics and biolaw. I consider the prospects for a theory of dignity as a basis for bioethics research. I argue that dignity theories are worth exploring in more detail, but that research needs to consider both “antitheory” accounts of the language of bioethics, and to give more weight to accounts of dignity as an outcome of holding positive liberties (...) and as something that has a psychological dimension. (shrink)

ABSTRACT Many people argue that disagreements and inconsistencies between Research Ethics Committees are morally problematic and there has been much effort to ‘harmonise’ their judgements. Some inconsistencies are bad because they are due to irrationality, or carelessness, or the operation of conflicting interests, and so should be reduced or removed. Other inconsistencies, we argue, are not bad and should be left or even encouraged. In this paper we examine three arguments to reject the view that we should strive for complete (...) consistency between committees. The first argument is that differences in judgement are not necessarily incompatible with ideas of justice for patients who are potential participants of research reviewed by different committees. We call this ‘the justice argument.’ The second argument is that such committees do not have access to a single moral truth, to which their judgement is supposed to correspond. We call this the ‘moral pluralism argument.’ The third argument is that the process of ethics committee review is also morally relevant and not solely the outcome. We call this the ‘due process argument.’ While we fall short of establishing exactly how much variation and on what substantive issues would be ethically permissible, we show that it is largely inevitable and that a certain amount of variation could be seen as a desirable part of the institution of medical research. (shrink)

Regulation and governance of medical research is frequently criticised by researchers. In this paper, we draw on Everett Hughes’ concepts of professional licence and professional mandate, and on contemporary sociological theory on risk regulation, to explain the emergence of research governance and the kinds of criticism it receives. We offer explanations for researcher criticism of the rules and practices of research governance, suggesting that these are perceived as interference in their mandate. We argue that, in spite of their complaints, researchers (...) benefit from the institutions of governance and regulation, in particular by the ways in which regulation secures the social licence for research. While it is difficult to answer questions such as: “Is medical research over-regulated?” and “Does the regulation of medical research successfully protect patients or promote ethical conduct?”, a close analysis of the social functions of research governance and its relationship to risk, trust, and confidence permits us to pose these questions in a more illuminating way. (shrink)

Clinical trials and other forms of evaluation of medical treatment are held to give an objective assessment of the ‘clinical effectiveness’ of the medical treatments under evaluation. This kind of evaluation is central to the evidence-based medicine movement, as it provides a basis for the rational selection of treatment. The ethical status of randomised clinical trials is widely agreed to depend crucially upon the state of equipoise regarding which of two (or more) treatments is more (or most) effective in a (...) defined population. However, the meaning and nature of ‘clinical effectiveness’ are unclear. in this paper, I discuss the proposals to define clinical effectiveness as a relational property and as an intrinsic property, and the way effectiveness may supervene upon more fundamental physical properties of treatments. I discuss whether effectiveness is a single property or a family of properties; the types of outcome which can be explained by effectiveness properties; and the relationship between ‘objective’ and ‘preference’ outcomes. This paper suggests that while it may be possible to put clinical effectiveness on a proper metaphysical footing, in practice the language of clinical effectiveness is more properly a topic of the human sciences than of the natural sciences. (shrink)

Edited by four leading members of the new generation of medical and healthcare ethicists working in the UK, respected worldwide for their work in medical ethics, Principles of Health Care Ethics, Second Edition_is a standard resource for students, professionals, and academics wishing to understand current and future issues in healthcare ethics. With a distinguished international panel of contributors working at the leading edge of academia, this volume presents a comprehensive guide to the field, with state of the art introductions to (...) the wide range of topics in modern healthcare ethics, from consent to human rights, from utilitarianism to feminism, from the doctor-patient relationship to xenotransplantation. This volume is the Second Edition of the highly successful work edited by Professor Raanan Gillon, Emeritus Professor of Medical Ethics at Imperial College London and former editor of the Journal of Medical Ethics, the leading journal in this field. Developments from the First Edition include:_ The focus on ‘Four Principles Method’ is relaxed to cover more different methods in health care ethics. More material on new medical technologies is included, the coverage of issues on the doctor/patient relationship is expanded, and material on ethics and public health is brought together into a new section. (shrink)

Clinical trials and other forms of evaluation of medical treatment are held to give an objective assessment of the 'clinical effectiveness' of the medical treatments under evaluation. This kind of evaluation is central to the evidence-based medicine movement, as it provides a basis for the rational selection of treatment. The ethical status of randomised clinical trials is widely agreed to depend crucially upon the state of equipoise regarding which of two treatments is more effective in a defined population. However, the (...) meaning and nature of 'clinical effectiveness' are unclear. in this paper, I discuss the proposals to define clinical effectiveness as a relational property and as an intrinsic property, and the way effectiveness may supervene upon more fundamental physical properties of treatments. I discuss whether effectiveness is a single property or a family of properties; the types of outcome which can be explained by effectiveness properties; and the relationship between 'objective' and 'preference' outcomes. This paper suggests that while it may be possible to put clinical effectiveness on a proper metaphysical footing, in practice the language of clinical effectiveness is more properly a topic of the human sciences than of the natural sciences. (shrink)

(2003). The Ethics and Governance of Medical Research: What does regulation have to do with morality? New Review of Bioethics: Vol. 1, No. 1, pp. 41-58.

This target article considers the ethical implications of providing prenatal diagnosis (PND) and antenatal screening services to detect fetal abnormalities in jurisdictions that prohibit abortion for these conditions. This unusual health policy context is common in the Latin American region. Congenital conditions are often untreated or under-treated in developing countries due to limited health resources, leading many women/couples to prefer termination of affected pregnancies. Three potential harms derive from the provision of PND in the absence of legal and safe abortion (...) for these conditions: psychological distress, unjust distribution of burdens between socio-economic classes, and financial burdens for families and society. We present Iran as a comparative case study where recognition of these ethical issues has led to the liberalization of abortion laws for fetuses with thalassemia. We argue that physicians, geneticists and policymakers have an ethical and professional duty of care to advocate for change in order to ameliorate these harms. (shrink)

Bioethics has been subject to considerable social criticism in recent years. One criticism that has caused particular discomfort in the bioethics community is that bioethicists, because of the way their work is funded, are involved in profound conflicts of interest that undermine their title to be considered independent moral commentators on developments in biomedicine and biotechnology. This criticism draws its force from the assumption that bioethics is, or ought to be, a type of normative social criticism. Versions of this criticism (...) come from both the political left and right. For instance, such criticisms include allegations that bioethics is inherently socially conservative, that it is inherently “pro-technology”, that it lays spurious claims to moral and social authority and expertise, that its focus on autonomy links it to neoliberal theories of choice, and that it is an ideological mystification of real social relationships and political power. This commentary paper analyses the problem of bioethical conflict of interest, and argues that the types of conflict of interest facing bioethics are inherent to the role of “public intellectual” that bioethicists generally wish to assume. The paper defends this conception of the role of the bioethicist, arguing that bioethicists should be interested and openly so. (shrink)

Research Ethics Committees (RECs) are frequently a focus of complaints from researchers, but evidence about the operation and decisions of RECs tends to be anecdotal. We conducted a systematic study to identify and compare the ethical issues raised in 54 letters to researchers about the same 18 applications submitted to three RECs over one year. The most common type of ethical trouble identified in REC letters related to informed consent, followed by scientific design and conduct, care and protection of research (...) participants, confidentiality, recruitment and documentation. Community considerations were least frequently raised. There was evidence of variability in the ethical troubles identified and the remedies recommended. This analysis suggests that some principles may be more institutionalized than others, and offers some evidence of inconsistency between RECs. Inconsistency is often treated as evidence of incompetence and caprice, but a more sophisticated understanding of the role of RECs and their functioning is required. (shrink)

This article provides a critical overview of the most important issues pertaining to the ongoing debate on international research ethics. It critically describes three problems of continuing concern: 1) the question of whether the distinction between therapeutic and non‐therapeutic research should be upheld; 2) the questions of whether the currently demanded best proven diagnostic and therapeutic method of treatment for all research subjects is feasible both in developed and in developing countries, and whether it should be upheld; 3) the questions (...) of who owns international research ethics guidelines and regulatory frameworks and, how decisions about changes to such international guidelines can possibly be achieved, given that it seems to be the case that genuine disagreement about issues of content is possible and likely. (shrink)

Charles Foster and Jonathan Herring are to be congratulated on their useful presentation of the roles played by concepts of personhood and identity in English medical law.1 However, I fear that the project they have undertaken here is misconceived. It is an interesting and important misconception, which is widely shared in the literature on medical law and ethics; but a misconception it remains. The problem is this. What we call ‘the Law’ is in fact a complex assemblage of institutions, rules, (...) accredited persons, practices and systems. What it is not is a self-sufficient, integrated and self-interpreting system of doctrine. As such it does not have a clear structure which we can excavate and the idea that we can find concepts which explain and unify that structure at some deep level is thus quixotic. To approach ‘the Law’ in that way is to pursue a chimaera. We should instead think of ‘the Law’ as Wittgenstein taught us to approach a language.2 We can find concepts through investigation of language in practical use, but the …. (shrink)

The General Data Protection Regulation (GDPR) was introduced in 2018 to harmonize data privacy and security laws across the European Union (EU). It applies to any organization collecting personal data in the EU. To date, service-level consent has been used as a proportionate approach for clinical trials, which implement low-risk, routine, service-wide interventions for which individual consent is considered inappropriate. In the context of public health research, GDPR now requires that individuals have the option to choose whether their data may (...) be used for research, which presents a challenge when consent has been given by the clinical service and not by individual service users. We report here on development of a pragmatic opt-out solution to this consent paradox in the context of a partner notification intervention trial in sexual health clinics in the UK. Our approach supports the individual’s right to withhold their data from trial analysis while routinely offering the same care to all patients. (shrink)

Charles Foster and Jonathan Herring are to be congratulated on their useful presentation of the roles played by concepts of personhood and identity in English medical law. 1 However, I fear that the project they have undertaken here is misconceived. It is an interesting and important misconception, which is widely shared in the literature on medical law and ethics; but a misconception it remains. The problem is this. What we call ‘the Law’ is in fact a complex assemblage of institutions, (...) rules, accredited persons, practices and systems. What it is not is a self-sufficient, integrated and self-interpreting system of doctrine. As such it does not have a clear structure which we can excavate and the idea that we can find concepts which explain and unify that structure at some deep level is thus quixotic. To approach ‘the Law’ in that way is to pursue a chimaera. We should instead... (shrink)

This article provides a critical overview of the most important issues pertaining to the ongoing debate on international research ethics. It critically describes three problems of continuing concern: 1) the question of whether the distinction between therapeutic and non‐therapeutic research should be upheld; 2) the questions of whether the currently demanded best proven diagnostic and therapeutic method of treatment for all research subjects is feasible both in developed and in developing countries, and whether it should be upheld; 3) the questions (...) of who owns international research ethics guidelines and regulatory frameworks and, how decisions about changes to such international guidelines can possibly be achieved, given that it seems to be the case that genuine disagreement about issues of content is possible and likely. (shrink)

In ‘Salvaging the Concept of Nudge’ Yashar Saghai performs an important clarificatory task which certainly advances our philosophical and ethical understanding of nudges in public policy, and in healthcare ethics in particular.1 In this brief commentary I identify some issues which could usefully be taken forward in subsequent discussions.A central difficulty with ethical discussions of nudging is that insufficient care is taken to distinguish two morally important features of nudges. The first, which Saghai very properly concentrates upon, is the mechanism (...) of nudging. Nudges rely on psychological properties of human decision-makers as the way in which their intended effects are brought about. Much of the ethical concern with nudges focuses on just this. Whatever the motive of the nudger, or the objective of the nudge, or the ex ante or ex post ratification of the nudge by the nudge, operating through influence, impulse or non-rational features of the nudgee's decision-making is wrong. The nature of this wrongness can be spelled out in different ways, and which one of these we choose has important implications for the precise ethical argument …. (shrink)

Francis Fukuyama, in his Our Posthuman Future, and Gregory Stock, in his Redesigning Humans, present competing versions of the biomedical future of human beings, and debate the merits of more or less stringent regimes of regulation for biomedical innovation. In this article, these positions are shown to depend on a shared discourse of market liberalism, which limits both the range of ends for such innovation discussed by the authors, and the scope of their policy analyses and proposals. A proper evaluation (...) of the human significance and policy imperatives for biomedical innovation needs to be both more utopian in its imagination, and more sophisticated in its political economy. In essence, the Fukuyama/Stock debate tells us more about current US political ideology than it does about the morality of human genetic and biopsychological engineering. (shrink)

In this paper I argue that resource allocation in publicly funded medical systems cannot be done using a purely substantive theory of justice, but must also involve procedural justice. I argue further that procedural justice requires institutions and that these must be “local” in a specific sense which I define. The argument rests on the informational constraints on any non-market method for allocating scarce resources among competing claims of need. However, I resist the identification of this normative account of local (...) justice with the actual approach to local decision-making taken within the UK National Health Service. I illustrate my argument with reference to the case of provision of In Vitro Fertilisation within the UK NHS. (shrink)

When denial of medical treatment is being used as a lever to move people out of the country, ethicists and healthcare professionals should speak out.An ugly feature of political life throughout the Western world, and beyond, is the suspicion towards, and maltreatment of, migrants from poor to rich countries. People who would otherwise be horrified at being labelled racist nevertheless find it acceptable to support practices which can range from stigmatisation to confinement in brutalising conditions in “reception” and “removal” centres.1–5An (...) hour spent searching through government and NGO websites concerned with the treatment of asylum seekers and refugees in developed world countries is an hour well spent – but profoundly depressing. This is not only because of the frankly Orwellian language used by the governments of the UK and Australia , or because of the conditions and treatment meted out, but also because of the apparent support these practices have among the voting public. In the pointedly optimistic reports of Her Majesty’s Inspector of Prisons, for example, one can find praise for the fact …. (shrink)

Political argument and institutions in the UnitedKingdom have frequently been represented as the products of ablend of nationalistic conservatism, liberal individualism andsocialism, in which consensus has been prized over ideology. This situation changed, as the standard story has it, with therise of Thatcherism in the late 1970s, and again with the arrivalof Tony Blair's ``New Labour'' pragmatism in the late 1990s. Solidarity as an element of political discourse makes itsappearance in the UK late in the day. It has been most (...) stronglylinked to the Third Way debate, as framed most influentially inthe work of Prof. Anthony Giddens.In this paper we review the history and pre-history of the debateon solidarity in the UK, focussing mostly on its implications forwelfare state reform. In particular we discuss the proposals forthe long-term care of the Elderly issued by the Royal Commissionon long-term care in 1999. In this context we critically examinethe idea that solidarity is a new concept in British politicalculture, and that it is a concept which has real political ``bite''in the project of welfare reform. We examine this through aconsideration of Giddens's attempted synthesis of politicalargument and social theory. (shrink)

In this paper I examine the ways in which the concept of “public interest” is used in biomedical policymaking to justify the preemption or overruling of decisions made by individuals about their own, their family's, or group interests in the field of healthcare. I discuss six variants of public-interest justification, before going on to consider a concrete example, the use of personal health data in health services management and medical research. I distinguish between the global public interest and particular public (...) interests and consider critically how the global public interest can be said to arise from private interests. I show that there is always room for the private individual to defeat appeals to public interest on moral grounds, and hence that public interest cannot have overriding moral force. Hence, public-interest claims need to be considered as political appeals about competing claims and conceptions of justice, rather than as shortcuts to defining the universal solidary interest. (shrink)

Background Policies to use financial incentives to encourage healthy behaviour are controversial. Much of this controversy is played out in the mass media, both reflecting and shaping public opinion. Objective To describe UK mass media coverage of incentive schemes, comparing schemes targeted at different client groups and assessing the relative prominence of the views of different interest groups. Design Thematic content analysis. Subjects National and local news coverage in newspapers, news media targeted at health-care providers and popular websites between January (...) 2005 and February 2010. Setting UK mass media. Results The study included 210 articles. Fifteen separate arguments favourable towards schemes, and 19 unfavourable, were identified. Overall, coverage was more favourable than unfavourable, although most articles reported a mix of views. Arguments about the prevalence and seriousness of the health problems targeted by incentive schemes were uncontested. Moral and ethical objections to such schemes were common, focused in particular on recipients such as drug users or the overweight who were already stereotyped as morally deficient, and these arguments were largely uncontested. Arguments about the effectiveness of schemes and their potential for benefit or harm were areas of greater contestation. Government, public health and other health-care provider interests dominated favourable coverage; oppo- sition came from rival politicians, taxpayersÕ representatives, certain charities and from some journalists themselves. Conclusions Those promoting incentive schemes for people who might be regarded as ÔundeservingÕ should plan a media strategy that anticipates their public reception. (shrink)

The editors of the symposium hope it will provide a balanced appraisal of evidence based medicine.This symposium is devoted to evidence based medicine and the ethical issues it raises. Since Sir Archie Cochrane’s seminal Nuffield Provincial Hospitals Trust lectures in 1972 and their publication as the Rock Carling monograph for that year, Effectiveness and Efficiency: Random Reflections on Health Services, the idea that medical interventions and health services should be evaluated and selected on the basis of the most reliable evidence (...) available for their effectiveness and cost effectiveness has become very widely accepted.1,2 This widespread acceptance has not been complete, and it sometimes seems that there are as many critics of EBM as advocates. Whereas the importance of randomised trial evidence, critical appraisal, meta-analysis, and systematic review …. (shrink)

Evaluation of the potential of a cocaine vaccine requires a detailed understanding of the intended and unintended social consequences of its use. Prospective technology assessment is always difficult, but in the case of treatment and prevention of cocaine addiction we need to understand not only the neuroscience and pharmacology of cocaine addiction, but also social attitudes to drug use and addiction, the social context of drug use, and the factors which make drug use a rational strategy for an addict and (...) make treatment seeking or relapse more or less likely. By considering different scenarios related to differing levels of effectiveness of the vaccine, the authors argue that vaccination will be at best a useful adjunct to existing methods of treatment, rather than a substitute for them. (shrink)

Background Offering financial incentives to achieve medication adherence in patients with severe mental illness is controversial. Aims To explore the views of different stakeholders on the ethical acceptability of the practice. Method Focus group study consisting of 25 groups with different stakeholders. Results Eleven themes dominated the discussions and fell into four categories: (1) ‘wider concerns’, including the value of medication, source of funding, how patients would use the money, and a presumed government agenda behind the idea; (2) ‘problems requiring (...) clear policies’, comprising of practicalities and assurance that incentives are only one part of a tool kit; (3) ‘challenges for research and experience’, including effectiveness, the possibility of perverse incentives, and impact on the therapeutic relationship; (4) ‘inherent dilemmas’ around fairness and potential coercion. Conclusions The use of financial incentives is likely to raise similar concerns in most stakeholders, only some of which can be addressed by empirical research and clear policies. (shrink)

Consensus statement by UK teachers of medical ethics and law.

The ethical challenge is squarely focused on the question of what is owed to participants of vaccine trials who happen to become infected during the course of the trial. Not surprisingly, given the prominence of HIV/AIDS in many parts of the developing world, HIV vaccine trials have become the focal point of this debate. It is worth noting from the outset, however, that the same arguments that apply to HIV vaccines would apply to any number of microbicide trials aimed at (...) protecting women against a large variety of sexually transmitted illnesses.1 One of the controversial questions in this debate has been the issue of whether or not an infection acquired by vaccine trial participants during the course of the trial can reasonably be considered a trial related injury that ought to be subject to compensation (in the form of access to good quality AIDS treatments, including antiretrovirals). (shrink)

ABSTRACTMedicines that are vital for the saving and preserving of life in conditions of public health emergency or endemic serious disease are known as essential medicines. In many developing world settings such medicines may be unavailable, or unaffordably expensive for the majority of those in need of them. Furthermore, for many serious diseases these essential medicines are protected by patents that permit the patent‐holder to operate a monopoly on their manufacture and supply, and to price these medicines well above marginal (...) cost. Recent international legal doctrine has placed great stress on the need to globalise intellectual property rights protections, and on the rights of intellectual property rights holders to have their property rights enforced. Although international intellectual property rights law does permit compulsory licensing of protected inventions in the interests of public health, the use of this right by sovereign states has proved highly controversial. In this paper I give an argument in support of states’ sovereign right to expropriate private intellectual property in conditions of public health emergency. This argument turns on a social contract argument for the legitimacy of states. The argument shows, further, that under some circumstances states are not merely permitted compulsory to license inventions, but are actually obliged to do so, on pain of failure of their legitimacy as sovereign states. The argument draws freely on a loose interpretation of Thomas Hobbes's arguments in his Leviathan, and on an analogy between his state of War and the situation of public health disasters. (shrink)