Survey of institutional review boards in Japan

Yuka Narumoto, Shigeki Nishihara, Madoka Saito, Kumiko Ueda, Satoshi Kuroda, Akihito Higashikage, Sakae Hongo-Aoe, Yasuhiro Kawakami, Yoshihisa Kitamura, Toshiaki Sendo

Research output: Contribution to journalReview article

Abstract

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.

Original languageEnglish
Pages (from-to)105-113
Number of pages9
JournalJapanese Journal of Clinical Pharmacology and Therapeutics
Volume47
Issue number3
DOIs
Publication statusPublished - 2016

Keywords

  • Central institutional review board
  • GCP
  • Institutional review board
  • Questionnaire survey

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Fingerprint Dive into the research topics of 'Survey of institutional review boards in Japan'. Together they form a unique fingerprint.

Cite this