透過您的圖書館登入
IP:13.59.218.147
  • 期刊

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

Joint Ethics Review Mechanism for Multi-Center Clinical Trials: The International Trend and Taiwan Progress

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。

並列摘要


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.

參考文獻


林志六:提昇研究倫理審查效率-衛生福利部C-IRB機制之現況與未來。醫療品質雜誌 2013;7:35-7。[Enhancing the Efficiency of Ethics Review for Multi-center Clinical Trials – The current status and future of the c-IRB mechanism of Ministry of Health and Welfare in Taiwan.]
Menikoff J: The paradoxical problem with multiple-IRB review. N Engl J Med 2010;363: 1591-93
U.S. Department of Health and Human Services: Protection of Human Subjects. Code of Federal Regulation Title45, Part46. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. Accessed December 29, 2015.
U.S. Food and Drug Administration: Food and Drug Chapter. Code of Federal Regulation Title21, Part56. http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56. Accessed December 29, 2015.
U.S. Department of Health and Human Services: Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators. Fed Regist 2011; 76: 44512-31. http://www.gpo.gov/fdsys/pkg/FR- 2011-07-26/html/2011-18792.htm. Accessed December 29, 2015.

被引用紀錄


吳倚晴、戴君芳、蔡甫昌、陳建煒(2022)。我國臨床試驗倫理審查效率精進機制台灣醫學26(2),228-236。https://doi.org/10.6320/FJM.202203_26(2).0012
袁愷榕、莊宇真、趙祥、陳聰富、蔡甫昌(2017)。概括同意與單一研究倫理審查委員會於美國通用規則(Common Rule)修法中之進展台灣醫學21(3),302-309。https://doi.org/10.6320/FJM.2017.21(3).9

延伸閱讀