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)

The Body Multiple is an extraordinary ethnography of an ordinary disease. Drawing on fieldwork in a Dutch university hospital, Annemarie Mol looks at the day-to-day diagnosis and treatment of atherosclerosis. A patient information leaflet might describe atherosclerosis as the gradual obstruction of the arteries, but in hospital practice this one medical condition appears to be many other things. From one moment, place, apparatus, specialty, or treatment, to the next, a slightly different “atherosclerosis” is being discussed, measured, observed, or stripped away. (...) This multiplicity does not imply fragmentation; instead, the disease is made to cohere through a range of tactics including transporting forms and files, making images, holding case conferences, and conducting doctor-patient conversations. The Body Multiple juxtaposes two distinct texts. Alongside Mol’s analysis of her ethnographic material—interviews with doctors and patients and observations of medical examinations, consultations, and operations—runs a parallel text in which she reflects on the relevant literature. Mol draws on medical anthropology, sociology, feminist theory, philosophy, and science and technology studies to reframe such issues as the disease-illness distinction, subject-object relations, boundaries, difference, situatedness, and ontology. In dialogue with one another, Mol’s two texts meditate on the multiplicity of reality-in-practice. Presenting philosophical reflections on the body and medical practice through vivid storytelling, The Body Multiple will be important to those in medical anthropology, philosophy, and the social study of science, technology, and medicine. (shrink)

Criticism of ethical review of research continues and research ethics committees (RECs) need to demonstrate that they are “fit for purpose” by meeting acknowledged standards of process, debate and outcome. This paper reports a workshop in Warsaw in April 2008, organised by the European Forum for Good Clinical Practice, on the problems of setting standards for RECs in the European Union. Representatives from 27 countries were invited; 16 were represented. Problems identified were the limited and variable resources, difficulties of setting (...) standards for ethical debate and its outcomes and that REC members, as volunteers, may resent the imposition of standards. Other ways to set standards were discussed, including analysis of current multicentre review, collecting REC member reports for review, learning from appeals and feedback from applicants, and use of other regional and national meetings. The place of a central, national board or ethics committee was debated as was the need for collaborating with partners in other fields. (shrink)