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臺灣醫學

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篇名 多中心臨床試驗聯合倫理審查機制之國際趨勢及台灣進展
卷期 20:1
並列篇名 Joint Ethics Review Mechanism for Multi-Center Clinical Trials: The International Trend and Taiwan Progress
作者 蔡甫昌姚智中林志六陳聰富楊泮池
頁次 059-074
關鍵字 臨床試驗研究倫理倫理審查聯合倫理審查機制clinical trialresearch ethicsethics reviewjoint review mechanismTSCI
出刊日期 201601
DOI 10.6320/FJM.2016.20(1).9

中文摘要

傳統模式之多中心臨床試驗研究倫理審查常有重複審查而造成資源浪費及效率低落,甚至造成受 試者權益受損之虞,世界各國多針對此狀況而倡議聯合倫理審查機制,以提昇審查效率並兼顧審查品質, 落實人體研究受試者保護之理念。本文分析各國政府主管機關對於多中心臨床試驗聯合倫理審查之法規 與報告,及美、英、南韓及新加坡聯合倫理審查機制之運作現況及審查模式,並探討我國多中心臨床試 驗聯合倫理審查機制之發展與現況。作者指出,我國發展聯合倫理審查機制有其必要性,其運作已有具 體成效,能兼顧審查效率與審查品質之提升,並落實受試者權益之保障與促進生醫產業之發展。

英文摘要

Traditional model of ethics review for multi-center clinical trials is often criticized to be lack of efficiency and wasting of resource due to repetitive reviews, which also lead to insufficient human subject protection. Joint review mechanisms were hence developed and promoted by many countries for the purposes of enhancing quality and efficiency in ethics review as well as achieving better human subject protection. In this paper, the authors reviewed and analyzed the legislation and practice of joint ethics review mechanisms which were developed in US, UK, South Korea and Singapore, and explored the progress of JIRB, NRPB-IRB, and c-IRB in Taiwan. The author maintained that the development of joint ethics review mechanism is necessary and beneficial, and has proved to be effective in Taiwan. While improving efficiency and quality for ethics review, human subject protection can be actualized and biomedical research can be promoted.

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