Dixon-Woods Mary, Ashcroft Richard E
Department of Health Sciences, University of Leicester, 2nd Floor, Adrian Building, Leicester, LE1 7RH, UK.
Med Health Care Philos. 2008 Dec;11(4):381-91. doi: 10.1007/s11019-008-9152-0. Epub 2008 Jul 17.
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.
医学研究的监管与治理经常遭到研究人员的批评。在本文中，我们借鉴埃弗雷特·休斯的专业许可和专业使命概念，以及当代风险监管社会学理论，来解释研究治理的出现及其所受到的各类批评。我们对研究人员对研究治理规则和实践的批评给出了解释，表明这些被视为对其使命的干涉。我们认为，尽管研究人员有所抱怨，但他们从治理和监管制度中受益，特别是通过监管为研究获得社会许可的方式。虽然诸如“医学研究监管过度了吗？”以及“医学研究监管能否成功保护患者或促进道德行为？”等问题难以回答，但对研究治理的社会功能及其与风险、信任和信心的关系进行细致分析，能让我们以更具启发性的方式提出这些问题。
