Program

PO1-13-5

A Comparison of Clinical Research Ethics Committee between Japan and Foreign Countries

[Speaker] Yuka Onaka:1,2
[Co-author] Naoko Kitada:1,2, Hiromi Umezome:1, Shoko Tanaka:1, Akiko Okumura:1, Yoichi Yamamoto:1
1:Office for the Protection of Research Subjects, Department of Medical Innovation, Osaka University Hospital, Japan, 2:Research Support Section, Educational Research Support Division, Administration Department, Osaka University Hospital, Japan

In our country, "Ethical Guidelines for Medical and Health Research Involving Human Subjects" was promulgated in December 2014 and subsequently amended in February 2017, to address diversification of research and the occurrence of research misconduct. In addition, "Clinical Research Act" will be enforced in 2018 with the aim of ensuring the reliability of Clinical Research as well as contributing to improvement of public health in Japan. Under this Act, Clinical trial implementation standards for conducting specific clinical researches, review process by accredited clinical research review committee, and the disclosure of the sponsorship information to Clinical Research are established. In this manner, regulations concerning Clinical Research in Japan are changing fast in recent years.

As to the operation for Ethics Committee, "Certification of Ethical Review Committees" was introduced in 2014, to improve the quality of judgement in Ethical Review Committee. Following the enforcement of Clinical Research Act in 2018, judgement by Accredited Clinical Research Review Committee will be introduced, and is expected to lead to centralization of Ethical Review Committees.

Osaka University Hospital was chosen as "Project for Development of Central Institutional Review Board for Fiscal Year 2016", and conducted site investigation. In such activities, we visited some overseas institutions conducting ethical review to understand the current situation including centralization of IRBs/RECs in each country as well as exchanging opinions.

We summarized the characteristic features of Ethics Committee in each country by comparing the regulations as well as the administrative work, financial support to IRBs/RECs, composition of committee member, structure of IRBs/RECs office, educational training, reviewing fees, promoting centralization of IRBs/RECs. We will report the current issues resulting from our study, and challenge that needs to be tackled.

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