@article{oai:repo.qst.go.jp:00046505,
 author = {栗原, 千絵子 and 景山, 茂 and 栗原 千絵子},
 issue = {2},
 journal = {臨床評価},
 month = {Mar},
 note = {Background:In Japan, GCP Ordinance was revised in 2008 to make research institutes which have an
IRB (Institutional Review Board) possible to commit their review to an external IRB. The United States
(US) Food and Drug Administration (FDA) issued in 2006 a guidance to facilitate Central IRB review. The
European Union (EU) issued in 2001 a Clinical Trial Directive to mandate member states to establish
regulations by which multinational clinical trials can be initiated based on authorizations of one Ethics
Committee (EC) and one regulatory authority in one member state.
Objectives:To find information on regulatory reformation and the actual situation towards facilitating
utilization of cooperative or central IRB/EC after 2008.
Method:Literature survey and interview survey.
Findings:The US government has proposed regulatory reformation to mandate one IRB review for one
multi-central clinical research. The EU has proposed regulatory reformation to make possible one EC
review in EU for multi-national clinical trials. In Korea and Taiwan, a cooperative review system has been
facilitated and quality improvement of IRB review and human subject protection system has been
simultaneously facilitated. In Japan, there is a finding of a survey that shows the utilization rate of
cooperative IRB is approximately 30%. Actual utilization of cooperative/central IRB in the world has been
steadily increasing but not dramatically, and the above mentioned international situation is worth noting.},
 pages = {419--434},
 title = {「共同IRB」をめぐる日米欧州アジアの状況},
 volume = {40},
 year = {2013}
}