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)

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)

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)

Deputy Editor Richard Ashcroft introduces four papers on drugs and autonomyIn this symposium we bring together four papers which consider novel approaches to the use and response to what are popularly known as “drugs”. The language available here is not altogether helpful—the drugs discussed have very different pharmacological effects, social acceptability, long and short term psychological effects, medical uses, and legal status.1 Arguably, the way these three drugs are considered as constituting a unified medical field can only be understood (...) as a rather specific social and historical phenomenon, rather than being based on a coherent concept of “drugs”. Nevertheless a major part of international health and foreign policy turns on this social construction, and as doctors, ethicists, or policy makers we are obliged to work within this social reality, even as we criticise its basis.2A central consideration in all four papers is the role …. (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)

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.

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)

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)

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 ‘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)

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)

Bioethics should update its conception of the geneThe 25th of April marks the 50th anniversary of the publication in Nature of the letter by James Watson and Francis Crick announcing their solution to the structure of deoxyribose nucleic acid .1 By that time, much was known about the role of chromosomes in inheritance, the contribution of DNA to chromosome structure, and the chemistry of DNA.2 The gene concept itself was also well established by then; the principal scientific problem became to (...) specify what genes were in molecular terms and how they functioned in the cell during ordinary function and cell division.The importance of the solution of the structure of DNA was twofold. First, it gave insight into finding a mechanism for DNA replication, as the authors recognised in this famous sentence:"It has not escaped our notice that the specific pairing we have postulated immediately suggests a copying mechanism for the genetic material.3 … ". (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)

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 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)

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)

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)

Case Analysis in Clinical Ethics is an eclectic review from a team of leading ethicists covering the main methods for analysing ethical problems in modern medicine. Anneke Lucassen, a clinician, begins by presenting an ethically challenging genetics case drawn from her clinical experience. It is then analysed from different theoretical points of view. Each ethicist takes a particular approach, illustrating it in action and giving the reader a basic grounding in its central elements. Each chapter can be read on its (...) own, but comparison between them gives the reader a sense of how far methodology in medical ethics matters, and how different theoretical starting points can lead to different practical conclusions. At the end, Anneke Lucassen gives a clinician's response to the various ethical methods described. Practising clinical ethicists and students on upper level undergraduate and Master's degree courses in medical ethics and applied philosophy will find this invaluable. (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)

This open peer commentary examines the concept of authenticity in bioethics, specifically in the context of medical interventions for children with ADHD. The authors explore the philosophical foundations of authenticity, drawing from existentialist and perfectionist philosophical traditions. They argue that while the concept of authenticity can be complex and contextual, it remains a valuable tool for moral assessment in medical ethics. The commentary critically engages with the original article by Singh, agreeing that authenticity is inherently relational and context-dependent, while also (...) defending its potential theoretical usefulness. The authors suggest that bioethicists should continue to explore authenticity as a concept, balancing theoretical considerations with empirical studies of contextual decision-making, and recognizing the nuanced ways in which individuals understand and experience their own sense of self. (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)

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)

Medical, psychological, educational and social interventions to modify the behaviour of autistic people are only justified if they confer benefit on those people. However, it is not clear how ‘benefit’ should be understood. Most such interventions are justified by referring to the prospect that they will effect lasting improvements in the well-being and happiness of autistic people, so they can lead good lives. What does a good life for an autistic person consist in? Can we assume that his or her (...) well-being is substantively the same as the well-being of non-autistic individuals? In this paper, we argue that, as it stands, the current approach to the study of well-being is for the most part unable to answer these questions. In particular, much effort is needed in order to improve the epistemology of well-being, especially so if we wish this epistemology to be ‘autism-sensitive’. Towards the end of the paper, we sketch a new, autism-sensitive approach and apply it in order to begin answering our initial questions. (shrink)

Next SectionIn an online study conducted separately in the UK and the US, participants rated the acceptability and fairness of four interventions: two types of financial incentives and two types of medical interventions. These were stated to be equally effective in improving outcomes in five contexts: weight loss and smoking cessation programmes, and adherence in treatment programmes for drug addiction, serious mental illness and physiotherapy after surgery. Financial incentives were judged less acceptable and to be less fair than medical interventions (...) across all five contexts. Context moderated the relative preference between rewards and penalties: participants from both countries favoured rewards over penalties in weight loss and treatment for serious mental illness. Only among US participants was this relative preference moderated by perceived responsibility of the target group. Overall, participants supported funding more strongly for interventions when they judged members of the target group to be less responsible for their condition, and vice versa. These results reveal a striking similarity in negative attitudes towards the use of financial incentives, rewards as well as penalties, in improving outcomes across a range of contexts, in the UK and the USA. The basis for such negative attitudes awaits further study. (shrink)

The objects called cubes of opposition have been presented in the literature in discordant ways. The aim of the paper is to offer a survey of such various kinds of cubes and evaluate their relation with an object, here called “Aristotelian cube”, which consists of two Aristotelian squares and four squares which are semiaristotelian, i.e. are such that their vertices are linked by some so-called Aristotelian relation. Two paradigm cases of Aristotelian squares are provided by propositions written in the language (...) of the logic of consequential implication, whose distinctive feature is the validity of two formulas, A $$\rightarrow $$ → B $$\supset \lnot $$ ⊃ ¬ (A $$\rightarrow $$ → $$\lnot $$ ¬ B) and A $$\rightarrow $$ → B $$\supset \lnot $$ ⊃ ¬ ($$\lnot $$ ¬ A $$\rightarrow $$ → B), expressing two different forms of contrariety. Part of section 1 is devoted to define the notions of rotation and of r-Aristotelian square, i.e. a square resulting from some rotation of an Aristotelian square. In section 2 this notion is extended to the one of a r-Aristotelian cube, i.e. of a cube resulting from some rotation of some square of an Aristotelian cube. This notion is used in the sequel to analyze various cubes of oppositions which can be found in the literature: (1) the one used by W. Lenzen to reconstruct Caramuel’s Octagon; (2) the one used by D. Luzeaux to represent the implicative relation among S5-modalities; (3) the one introduced by D. Dubois to represent the relations between quantified propositions containing positive predicates and their negations; (4) the one called Moretti cube. None of such cubes is strictly speaking Aristotelian but each of them may be proved to be r-Aristotelian. Section 5 discusses the assertion that Dubois cube was anticipated in a paper published by Reichenbach in 1952. Actually Dubois’ construction was anticipated by the so-called Johnson–Keynes cube, while the Reichenbach cube, unlike Dubois cube, is an instance of an Aristotelian cube in the sense defined in this paper. The dominance of such notion is confirmed by J.F. Nilsson’s cube, representing relations between propositions with nested quantifiers, and also by a cube introduced by S. Read to treat quantifiers with existential import. A cube similar to Read’s cube, introduced by Chatti and Schang, is shown to be r-Aristotelian. In section 6 the author remarks that the logic of the formulas occurring in the cubes of Chatti–Schang and Read have the drawback of not satsfying the law of Identity. He then proposes a definition of non-standard quantifiers which satisfies Identity, are independent of existential assumptions and such that their interrelations are represented by an Aristotelian cube. (shrink)

В книге анализируются проблемы творчества с позиции новейших достижений когнитивной науки и неклассической эпистемологии. Предназначено специалистам по философии.

Cross-education is the phenomenon in which repeated practice of a unilateral motor task does not only result in performance improvement of the trained limb, but also in the untrained contralateral limb. The aim of this study was to test whether cross-education or positive transfer of learning is also achieved for tasks in which both limbs contribute in different ways by using modified equipment that switches the limbs’ role. To this end, a reverse field hockey stick was used that requires a (...) mirroring of arm and hand use and dominance. Two groups of young skilled female field hockey players participated in a crossover-design, in which participants received four training sessions with a reverse hockey stick followed by four training sessions with a regular hockey stick, or vice versa. In a pre-test, intermediate test, a post-test and a retention test, participants’ performance on a field hockey skill test with a regular hockey stick was measured. The results revealed that training with the reversed hockey stick led to significantly increased improvements compared to training with a regular hockey stick. We conclude that modified equipment can be used to exploit positive transfer of learning by switching the limbs’ roles. The findings are discussed by referring to the symmetry preservation principle in dynamic systems theory and have clear practical relevance for field hockey trainers and players seeking to further improve field hockey skills. (shrink)

The COVID-19 pandemic has undoubtedly become an era-defining challenge for the entire world. It has implications not only in the public health sector but also in the global economy and political landscape. The prevention strategy that has been followed in Sri Lanka is unique. Early action taken by the government and the ministry of health, being one of pre-emptive quarantining and isolation of suspected contacts even before they developed symptoms, was vital to contain the spread of the disease. During the (...) early phase, a nationwide lockdown in the form of a curfew was imposed which helped mitigate the spread of the virus. However, due to several lapses, there was a threat of community transmission; this was swiftly brought under control through ongoing government interventions. Thus, strict social/physical distancing measures enforced by the government, together with an increase in testing capacity, prevented widespread community transmission. Strictly containing the outbreaks as and when they were identified made it easier to bring the spread under control through contact tracing. In this article, we give an account of the strategy taken by Sri Lanka to mitigate the pandemic and comment on the lessons learned concerning the ethical responses to the COVID-19 crisis. (shrink)

Aggleton & Brown argue that a hippocampal-anterior thalamic system supports the “recollection” of contextual information about previous events, and that a separate perirhinal-medial dorsal thalamic system supports detection of stimulus “familiarity.” Although there is a growing body of human literature that is in agreement with these claims, when recollection and familiarity have been examined in amnesics using the process dissociation or the remember/know procedures, the results do not seem to provide consistent support. We reexamine these studies and describe the results (...) of an additional experiment using a receiver operating characteristic (ROC) technique. The results of the reanalysis and the ROC experiment are consistent with Aggleton & Brown's proposal. Patients with damage to both regions exhibit severe deficits in recollection and smaller, but consistent, deficits in familiarity. (shrink)