研究倫理審査委員会の現状と改善策の提案 ―ある施設における臨床研究を対象とした平成18年度の審査過程の調査及び委員，申請者の意識調査より―

A research ethics committee (REC) is an appropriately constituted group that reviews and monitors biomedical research in order to protect the rights and welfare of human subjects. Although a number of studies have reported that Japanese institutions conducting biomedical research have established RECs, little is known about the quality of research protocols and the review process in these institutions. Using a checklist of 67 items, we reviewed 75 protocols that had been evaluated by the REC of an institution. Forty-six of 75 protocols did not clearly state the background of the study. In 25 of the 46 protocols, no committee members identified the absence of a stated background. Interviews with 18 investigators and 27 REC members revealed that some investigators and committee members did not understand the role of the REC. The results of this study suggest that about one-third of REC-approved protocols may contain shortcomings. The study implies that REC does not always function effectively to ensure that the research to be conducted is ethically sound. We suggest the following improvements: 1) education and training of investigators and committee members on how to conduct clinical research, 2) establishment of a research center to support and manage the conduct of clinical research, 3) improvement of relationship and communication between committee members, 4) introduction of a procedure whereby all committee members discuss each protocol until a consensus is reached, and 5) establishment of an organization to support efficient and effective operations of the RECs.