Performance of research ethics committees in Spain. A prospective study of100 applications for clinical trial protocols on medicines

Objectives-To review thr characteristics and performances of research ethic s committees in Spain in the evaluation of multicentre clinical trial drug protocols. Design-A prospective study of 100 applications. Setting-Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. Main measures-Protocol-related features, characteristics of research ethics committees and evaluation dynamics. Results-The 100 applications involved 15 Protocols (of which 12 were multin ational) with 12 drugs. Committes met monthly (except one). They had a mean number of 12 members requested a mean of six complete dossiers and nine ad ditional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committees), which were approved by the other committees involved The mean time from submissi on to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raise d queries for 38 of the 97 finally approved applications. Impact of evaluat ion fee, number of members, queries raised and experience of committees on timings were riot statistically significant. Conclusion-Obtaining ethical approval is time-consuming. There is much dive rsity in the,research ethics committees' performance. A remarkable delay (> 20 days) exists between the at decision and the arrival of the written app roval, suggesting administrative or organisational problems.