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)

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)

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)

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)

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)

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)

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)

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)

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)

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)