研究倫理審査の質の向上と効率化について一台湾の取り組みから学ぶ一

摘要

In Japan, the centralization of institutional review boards (ERBs) has been considered with the objectives to standardize the quality of the review process for multicenter studies and to facilitate efficient and speedy implementation of clinical trials and research. Therefore, we visited some core facilities in Taiwan to observe the IRB meetings for clinical studies, and to exchange ideas with staff of the IRB secretariats. Furthermore, we researched the pioneering review mechanisms for multicenter, sponsor-initiated clinical trials in Taiwan. In Taiwan, the Joint IRB (J-IRB ： a type of centralized review system) was established in 1997. This review system contributed to improve the quality of ethical reviews in the country. However, because the J-IRB was not fully government-initiated, many co-operating sites gradually started to conduct their own reviews, and this tendency caused a decline in the efficacy of the J-IRB. Following this, the Taiwanese government enacted alaw called the Human Subjects Research Act in 2011. Moreover, the government also started the Central IRB (C-IRB) system in 2013, which is a central-local hybrid type of ethical review system for multicenter clinical trials. The establishment of the C-IRB system increased the number of sponsor-initiated clinical trials. The new Human Subjects Research Act allowed each site to develop appropriate organizational structures, and thus maintained the high quality of clinical studies, regardless of whether they were sponsor-initiated or investigator-initiated studies. Considering the future Japanese goals to conduct ethical reviews and to organize the operational structures of medical facilities, we identified many constructive ideas based on the Taiwanese challenges in past decades.