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  1. 原著論文

「共同IRB」をめぐる日米欧州アジアの状況

https://repo.qst.go.jp/records/46505
https://repo.qst.go.jp/records/46505
78932936-0fb1-469c-a981-978a5ed1610c
Item type 学術雑誌論文 / Journal Article(1)
公開日 2013-03-19
タイトル
タイトル 「共同IRB」をめぐる日米欧州アジアの状況
言語
言語 jpn
資源タイプ
資源タイプ識別子 http://purl.org/coar/resource_type/c_6501
資源タイプ journal article
アクセス権
アクセス権 metadata only access
アクセス権URI http://purl.org/coar/access_right/c_14cb
著者 栗原, 千絵子

× 栗原, 千絵子

WEKO 463424

栗原, 千絵子

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景山, 茂

× 景山, 茂

WEKO 463425

景山, 茂

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栗原 千絵子

× 栗原 千絵子

WEKO 463426

en 栗原 千絵子

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抄録
内容記述タイプ Abstract
内容記述 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.
書誌情報 臨床評価

巻 40, 号 2, p. 419-434, 発行日 2013-03
ISSN
収録物識別子タイプ ISSN
収録物識別子 0300-3051
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