Present status of Japanese ethics committees: a survey in Tokushima Prefecture.

Abstract

Clinical research is important to improve medical quality, and ethics review is essential to conduct clinical research. Since the establishment of the first Japanese ethics committee at the University of Tokushima in 1982, Japanese ethics committees have increased. In this study, we surveyed the status of clinical studies and ethics committees in one Japanese region. The survey was conducted in collaboration with the Tokushima Medical Association. A questionnaire was established and mailed to all medical institutions (n=737) registered to the Tokushima Medical Association in 2012. Among 737, 223 (30.3%) questionnaires were returned and 221 were completed and are included in this analysis (respondents). Among respondents, 51 (23.1%) had performed clinical research, and of these, 17 had established ethics committees (though one was omitted from the following analysis due to an unsatisfactory response). Among 16 ethics committees, review of protocol amendments, review of serious adverse events, annual follow-up of approved protocols, and education for committee members were active in 10 (62.5%), 9 (56.3%), 6 (37.5%) and 4 (25.0%), respectively. Research ethics education was active in 4 (25.0%). Based on the results, we attempt to establish an appropriate system for ethical conduct of health-related research in Tokushima Prefecture.