||研究者主導臨床研究における倫理・信頼性確保の試み（第一報）- 脳内タウイメージング用放射性薬剤[11C]PBB3の多施設連携研究での経験から -
栗原, 千絵子 ,
堀口, 隆司 ,
鈴木, 和子須原, 哲也
224 , 2015-07 , 株式会社三原学社
Ethical Guidelines for Medical Research Involving Human Subjects have been enforced since April of 2015 by the Ministry of Health, Labour and Welfare and the Ministry of Education, Science and Technology. According to the guidelines, a research project categorized as interventional or invasive clinical study that starts from October 2015 or later should implement monitoring and if necessary audit. Several study groups have issued guidelines on monitoring and audit, which seem to be appropriate for large-scale drug clinical trials, but a quality assurance system for other kinds of research is needed, especially for exploratory clinical research. We developed a scheme for exploratory clinical research, which we have been using before monitoring and audit become mandatory. This scheme is composed of: (1) a questionnaire-based check sheet; (2) letter for site-visit; (3) site-visit protocol; and (4) site-visit check sheet. We found that the scheme which we have implemented is useful for human subject protection and quality assurance of clinical research. This scheme can be applied flexibly according to the type and characteristics of other research projects.