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)

Biomedical research is so important that there is a positive moral obligation to pursue it and to participate in itScience is under attack. In Europe, America, and Australasia in particular, scientists are objects of suspicion and are on the defensive.i“Frankenstein science”5–8 is a phrase never far from the lips of those who take exception to some aspect of science or indeed some supposed abuse by scientists. We should not, however, forget the powerful obligation there is to undertake, support, and participate (...) in scientific research, particularly biomedical research, and the powerful moral imperative that underpins these obligations. Now it is more imperative than ever to articulate and explain these obligations and to do so is the subject and the object of this paper.Let me present the question in its starkest form: is there a moral obligation to undertake, support and even to participate in serious scientific research? If there is, does that obligation require not only that beneficial research be undertaken but also that “we”, as individuals and “we” as societies be willing to support and even participate in research where necessary?Thus far the overwhelming answer given to this question has been “no”, and research has almost universally been treated with suspicion and even hostility by the vast majority of all those concerned with the ethics and regulation of research. The so called “precautionary approach”9 sums up this attitude, requiring dangers to be considered more likely and more serious than benefits, and assuming that no sane person would or should participate in research unless they had a pressing personal reason for so doing, or unless they were motivated by a totally impersonal altruism. International agreements and protocols—for example, the Declaration of Helsinki10 and the CIOMS Guidelines11—have been directed principally at …. (shrink)

A social license to operate (SLO) is said to result from a complex and sometimes difficult set of negotiations between communities and organizations (NGOs, government, and industry). Each stakeholder group will hold different views about what is important, what is true, and who can or cannot be trusted. This article reviews the contributions made in this special issue on SLO. It also sketches the benefits of applying phronesis, or a practical wisdom-based theorization, of how SLOs can be co-produced.

The “social licence to operate” has been invoked in science policy discussions including the 2007 Universal Ethical Code for scientists issued by the UK Government Office for Science. Drawing from sociological research on social licence and STS interventions in science policy, the authors explore the relevance of expectations of a social licence for scientific research and scientific contributions to public decision-making, and what might be involved in seeking to create one. The process of seeking a social licence is not the (...) same as trying to create public or community acceptance for a project whose boundaries and aims have already been fully defined prior to engagement. Such attempts to “capture” the public might be successful from time to time but their legitimacy is open to question especially where their engagement with alternative research futures is “thin”. Contrasting a national dialogue on stem cells with the early history of research into bioenergy, we argue that social licence activities need t.. (shrink)