The empirical turn in bioethics has been widely discussed by philosophical medical ethicists and social scientists. The focus of this discussion has been almost exclusively on methodological issues in research, on the admissibility of empirical evidence in rational argument, and on the possible superiority of empirical methods for permitting democratic lay involvement in decision-making. In this paper I consider how the collection of qualitative and quantitative social research evidence plays its part in the construction of social order, and how this (...) creates certain paradoxes for the normative ideal of a public bioethics. The analysis in this paper is based on Foucauldian ideas, and on recent work in the history of the human sciences. The paper closes with some open questions for theoretical work in the sociology and philosophy of bioethics. (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)

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)

ABSTRACT Medicines 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 (such as HIV/aids and tuberculosis) 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)

Frances Kamm's characteristically subtle paper in response to Michael Sandel is an intriguing intervention in the long-standing and increasingly frustrating debate over the morality of enhancement...

Since the inception of the Human Genome Project, human genetics has frequently been conducted through big science projects, combining academic, state and industrial methods, interests and resources. The legitimacy of such projects has been linked to national prestige and images of the nation, the purity of scientific endeavour, the entrepreneurial spirit, medical progress and the public health. A key complication in these discourses is that large-scale genetic research has yet to show major results when considered in terms of the objectives (...) used to legitimate investment and social support for these projects. The main area showing promise at present is the developing field of pharmacogenetics, which is now attracting major industry and government investment. Sociological, ethical and philosophical study of human genetic sample-based research and pharmacogenetics has developed in parallel with inquiry in the biological and biomedical sciences. This paper introduces a symposium on the ethical and social aspects of this field of biomedical research. (shrink)

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)

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)

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.

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)

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)

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)

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)

A patient's informed consent is required by the Nuremberg code, and its successors, before she can be entered into a clinical trial. However, concern has been expressed by both patients and professionals about the beneficial or detrimental effect on the patient of asking for her consent. We examine advantages and drawbacks of popular variations on consent, which might reduce the stress on patients at the point of illness. Both informed and uninformed responses to particular trials, and trials in general, are (...) discussed. The selection by doctors of patients, to whom entry to trials will be offered, is explored. (shrink)

In this paper three models of teaching and learning medical ethics are discussed critically, the traditional and revised vocational models, and the patient-centred model. The autonomy-oriented patient-centred ethics of Beauchamp and Childress is rejected in favour of a hermeneutic practical ethics. A performative conception of ethics teaching is recommended as the most appropriate model for use in the theory and practice of ethics pedagogy.

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)

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)

Since the inception of the Human Genome Project, human genetics has frequently been conducted through big science projects, combining academic, state and industrial methods, interests and resources. The legitimacy of such projects has been linked to national prestige and images of the nation, the purity of scientific endeavour, the entrepreneurial spirit, medical progress and the public health. A key complication in these discourses is that large-scale genetic research has yet to show major results when considered in terms of the objectives (...) used to legitimate investment and social support for these projects. The main area showing promise at present is the developing field of pharmacogenetics, which is now attracting major industry and government investment. Sociological, ethical and philosophical study of human genetic sample-based research and pharmacogenetics has developed in parallel with inquiry in the biological and biomedical sciences. This paper introduces a symposium on the ethical and social aspects of this field of biomedical research. (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)

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)

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)

Consensus statement by UK teachers of medical ethics and law.

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)

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)

Steven Epstein, Inclusion: The politics of difference in medical research, Chicago: University of Chicago Press, 2007, reviewed by Richard E. Ashcroft.

People with learning disability sometimes display challenging behaviour. This can be managed by use of antipsychotic medication or behavioural therapy or both. There is no solid evidence, however, that these therapies are safe and effective. A randomised controlled trial of antipsychotic medication has been proposed to deliver such evidence. However, this presents difficult issues in the ethics of research with learning disabled people. In particular, is a trial the most efficient and fairest way to evaluate practice in this area? This (...) paper reviews the clinical situation, gives the rationale for the trial, and analyses the ethical arguments for and against such a trial. (shrink)