Research ethics committees are charged with providing an opinion on whether research proposals are ethical. These committees are overseen by a central office that acts for the Department of Health and hence the State. An advisory group has recently reported back to the Department of Health, recommending that it should deal with inconsistency in the decisions made by different RECs. This article questions the desirability and feasibility of questing for consistent ethical decisions.

Citizens' juries are commended as a new technique for democratising health service reviews. Their usefulness is said to derive from a reliance on citizens' rational deliberation rather than on the immediate preferences of the consumer. The author questions the assertion of critical detachment and asks whether juries do in fact employ reason as a means of resolving fundamental disagreements about service provision. He shows that juries promote not so much a critically detached point of view as a particular evaluative framework (...) suited to the bureaucratic idiom of social welfare maximisation. Reports of jury practice reveal a tendency among juries to suppress by non-rational means the everyday moral language of health care evaluation and substitute for it a system of thought in which it can be deemed permissible to deny treatment to sick people. The author concludes that juries are chiefly concerned with non-rational persuasion and because of this they are morally and democratically irrelevant. Juries are no substitute for voting when it comes to protecting the public from zealous minorities. (shrink)

Presently, there is a movement in the UK research governance framework towards what is referred to as proportional ethical review. Proportional ethical review is the notion that the level of ethical review and scrutiny given to a research project ought to reflect the level of ethical risk represented by that project. Relatively innocuous research should receive relatively minimal review and relatively risky research should receive intense scrutiny. Although conceptually attractive, the notion of proportional review depends on the possibility of effectively (...) identifying the risks and ethical issues posed by an application with some process other than a full review by a properly constituted research ethics committee. In this paper, it is argued that this cannot be achieved and that the only appropriate means of identifying risks and ethical issues is consideration by a full committee. This implies that the suggested changes to the National Health Service research ethics system presently being consulted on should be strenuously resisted. (shrink)

Embryo research, cloning, assisted conception, neonatal care, savior siblings, organ transplants, drug trials – modern developments have transformed the field of medicine almost beyond recognition in recent decades and the law struggles to keep up. At the same time legal claims against doctors and the NHS has grown and doctors feel under siege. In this highly acclaimed and very accessible book, Margaret Brazier and Emma Cave provide an incisive survey of the legal situation in areas as diverse as fertility treatment, (...) surrogacy, patient consent, euthanasia and the definition of death, malpractice and medical privacy. (shrink)

The first part of this article sets out two possible models of proceduralization. This second part of this article begins to develop one of those forms, «thick» proceduralization, building on but modifying Habermas's model of deliberative democracy in two important respects. First, it is argued that it is not sufficient simply to call for deliberation for there is a real likelihood that even if all deliberants can be brought together true communication will be blocked by difference; difference in the modes (...) of discourse, the techniques of argument, language, and validity claims. Discourse may therefore have to be mediated through the adoption of strategies of translation, mapping, and dispute resolution. Whether regulators can or should perform such a mediating role remains however an open question. Second, it is argued that deliberative modes of policy formation and regulation are compatible with more pluralist and polyarchical arrangements than Habermas allows, and indeed that such arrangements may need to be adopted for thick proceduralization to become operative. (shrink)

Recent policy in relation to clinical research proposals in the UK has distinguished between two types of review: scientific and ethical. This distinction has been formally enshrined in the recent changes to research ethics committee structure and operating procedures, introduced as the UK response to the EU Directive on clinical trials. Recent reviews and recommendations have confirmed the place of the distinction and the separate review processes. However, serious reservations can be mounted about the science/ethics distinction and the policy of (...) separate review that has been built upon it. We argue here that, first, the science/ethics distinction is incoherent, and, second, that RECs should not only be permitted to consider a study’s science, but that they have anobligation do so. (shrink)

With the recent Clinical Trials Directive, a degree of harmonisation into research ethics committees across Europe, including the time taken to assess a trial proposal and the kinds of issues a committee should take into account, has been introduced by the European Union . How four different member states—Hungary, Portugal, Sweden and the UK—have chosen to implement the directive is shown. Although this has resulted in four very different ways of structuring RECs, similar themes are present in all four cases, (...) such as centralisation of control over RECs within member states, harmonisation of REC procedures across the EU and increased role of political decision making with regard to such committees. (shrink)