ABSTRACT
The protocols for all randomised controlled trials (RCTs) carried out in Europe must now, in practice, be submitted to appropriate local or regional research ethics committees (RECs) for ethical approval. The structure and role of RECs has developed in different ways in different European countries. This chapter examines the degree of uniformity of approach both within countries and across countries; identifies good practice; and considers to what extent RECs shared a common view of the purposes of ethical regulation. It explores what extent they were equipped to carry out such purposes. The chapter analyses the work and effectiveness of RECs. It reports on the structure, composition, and operation of RECs in the eleven sample European countries. This report has shown that in the eleven countries surveyed within Euricon there is significant divergence on three central issues relevant to the structure and operation of RECs, namely their area of responsibility, their composition and the method of selection of their members.
