Belmont in Europe: A Mostly Indirect Influence

Abstract

This paper traces the reception of the Belmont Report in Europe and its influence on the development of European research ethics thinking and European research ethics systems. It is very difficult to trace a clear, linear reception history because it is difficult to disentangle the influence of the Report from the influence of concurrent developments, such as the 1975 revision of the World Medical Association Declaration of Helsinki and the requirement for research ethics review in the Vancouver Group’s 1978 “Uniform Requirements for Manuscript Submission.” The Report’s insistence that the focus of research ethics should be the rights and interests of the individual research subject, and the use of an ethical framework and not ethical theory as the basis of analysis and justification of recommendations, were nevertheless very important for the development of research ethics. The divergence between Europe and the US in the governance of non-biomedical research can at least partly be explained by the absence of strong drivers for the introduction of research ethics committees outside of biomedicine in Europe, and by the ability of non-biomedical researchers to mobilize effectively against the introduction of such committees.