Suchergebnisse

In this article, I try to provide a more balanced history of ethics governance of human-subjects research. By taking seriously the controversies about governance issues, it argues that, instead of resulting from inevitable historical logic, things could have been otherwise, and regulation was not the only possible solution to governance dilemmas. It describes changes in Dutch governance of ethics in research with human subjects by exploring three controversial issues in the development of research governance. First, it will focus on the debate about internal and external control regarding the medical profession to show that different stakeholders held different views on how to govern ethics of research with human subjects. Second, it will describe discussions about centralized versus decentralized governance. This topic was especially relevant in the constitution of formal ethical review practices in the late twentieth century. Third, it will investigate the homogeneity versus heterogeneity issue with respect to substantive and procedural criteria for the assessment of research. Exemplary for this issue is the multicenter drug trial, which has become a paragon in ethics review for other related fields of research. The article concludes with suggestions on what we can learn from this alternative account of history. Adapted from the source document.