Suchergebnisse

This paper explores how a particular form of regulation—prior ethical review of research—developed over time in a specific context, testing the claims of standard explanations for such change (which center on the role of exogenous shocks in the form of research scandals) against more recent theoretical approaches to institutional changes, which emphasize the role of gradual change. To makes its case, this paper draws on archival and interview material focusing on the research ethics review system in the UK National Health Service. Key insights center on the minimal role scandals play in shaping changes in this regulatory setting and how these depend upon the absence of a single coherent profession (and accompanying social contract) associated with biomedical research.

Drawing on scholarship around academic freedom and new public management, this article explores the way in which research ethics committees in UK universities (URECs) can come to exhibit behaviour – common in their US equivalents – that prioritises the reputational protection of their host institution over and above academic freedom and the protection of research subjects. Drawing on two case studies the article shows both how URECs can serve to restrict research that may be 'embarrassing' for a university and how, in high profile cases, university management come to use such committees as mechanisms for internal discipline.

Focusing on the high-profile drug disaster at London's Northwick Park Hospital in 2006, this article explores how such an event can be seen as an example of organizational deviance co-constructed between the company running the research and the research ethics committee which approved the trial. This deviance was the result of the normalization of a specific dosing practice in the broader regulatory field, allowing the researchers and regulators to take a risky dosing strategy for granted as best practice. Drawing on the work of Diane Vaughan, this article uses interview data with researchers and members of the research ethics committee concerned as well as documentary material, to show how work group cultures between regulators and those they are intended to oversee are maintained, and how the culturally embedded assumptions of such work groups can result in organizational and regulatory deviance.

For years, sociologists working in other countries or UK-based medical sociologists have complained about the effects of having to seek approval from a research ethics committee (REC) or its equivalent before starting work. With the arrival of the ESRC's Research Ethics Framework, concern about ethics review has expanded to sociologists working on a wider range of topics. This article uses ethnographic data from a study of UK RECs to examine how these bodies assess applications from social scientists, particularly those proposing qualitative research (which opponents claim is given an especially hard time by such committees). These data challenge the idea that RECs are somehow ideologically biased against qualitative research and that they cannot give an adequate assessment of applications from sociologists and other social scientists. The article concludes by suggesting sociologists' time would be better spent studying the institutional nature of the university RECs stimulated by the ESRC.

This article explores the way in which social explanations underpin the names of particular disciplines. Taking the example of pharmacogenomics (a spin-off from the Human Genome Project), it shows how this term has been constructed since it appeared in 1997, the differences and similarities between it and its precursor, pharmacogenetics, and the way in which commercial interests underpin this new term. Drawing on the idea of visions and the sociology of expectation, the article shows how different actors compete to have their preferred definitions of the term accepted by the world at large.

With the recent Clinical Trials Directive, a degree of harmonisation into research ethics committees (RECs) 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 (EU). 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.