Analysis of 206 ethic reviews in a hospital within 3 years

Abstract

Objective To reveal the average pass rate of a general hospital's ethic review and common problems.Methods The records generated by the ethics committee of a hospital in 3 consecutive years were reviewed and analysed with ridit of CMH and Bootstrap statistical methods.Results The pass rate for drug clinical trial is 36.09%,medical instruments 18.42%,and subject evaluation 14.29%.Among the problems,those concerning informed consent take up 63.59%,of protocol 14.56%,of CRF 7.77% and of the others 22.820%.The domestic applicants had more problems than those abroad.Besides,the pass rate of drug trials decreased with year from 45.83% in 2006 to 19.44% in 2008,which was statistically significant (P=0.029).In terms of drug clinical trial,the pass rate of revised projects in foreign countries was significantly higher than the domestic ones (P=0.028).Conclusion Ethics Committee in a hospital plays a very important role in clinical researches.And informed consent and research protocol are very important in the ethic review. Key words: Medical Ethics; Drug trial; Clinical trials; Ethics Committees in hospital