ABSTRACT
The protocols for all randomised controlled trials carried out in Europe must be submitted to appropriate local or regional research ethics committees (RECs) for ethical approval. This chapter analyses the work of RECs. It reports on the structure, composition, and operation of RECs in the eleven sample European countries. The legal framework within which RECs operate has an obvious bearing on the degree of uniformity of operation. Euricon found that the greater the degree of uniformity in the constitution of RECs determined by law, the more uniform the responses on ethical questions from the RECs within that country. As might be expected, given the variation both in the area of authority and in the composition of RECs, there was some variety in the method of appointment of committee members. Where RECs are predominantly or wholly made up of doctors or those with medically related expertise, they are usually appointed by a medical body, or a representative of such a body.
