Survey of institutional review boards in Japan

In Japan, more than 1000 institutional review boards (IRBs) were registered with the Pharmaceuticals and Medical Devices Agency (PMDA) as of April 2012. To improve efficiency, the Ministry of Health, Labour and Welfare calls for active utilization of cooperative or central IRBs. However, little progress has been made. The sponsors address this issue from the point of view of efficiency. Therefore, we performed a nationwide questionnaire survey on the status of IRB. Many medical institutions individually established IRBs, but the secretariats of IRBs felt that the duties were a burden. On the other hand, there was reluctance to request review from other IRBs. Such situation is similar to that in the Netherlands before accreditation was introduced. As the installation standard of IRB was set up by the government, an accreditation system should also be set up by the government or an independent agency and aggregation of local IRBs to one that meets the accreditation standard would be required to improve efficiency and quality of review on clinical trials.