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題名:受試者保護與人體試驗委員會
書刊名:醫事法學
作者:唐淑美顏上詠 引用關係陳祖裕林正介
作者(外文):Tang, Shu-meiYen, Shang-yungChan, Cho-yuLin, Cheng-chieh
出版日期:2010
卷期:17:2
頁次:頁1-12
主題關鍵詞:受試者人體試驗委員會華盛頓大學受試者保護部門Fred Hutchinson癌症研究中心西方人體試驗委員會Human research subjectInstitutional review boardHuman Subject Division of University of WashingtonFHCRCWIRB
原始連結:連回原系統網址new window
相關次數:
  • 被引用次數被引用次數:期刊(5) 博士論文(0) 專書(0) 專書論文(0)
  • 排除自我引用排除自我引用:5
  • 共同引用共同引用:44
  • 點閱點閱:4
有鑑於過去長期忽視人體研究受試者之權益,導致侵犯受試者之研究個案層出不窮,國際間掀起重視倫理議題之反省,紐倫堡綱領(Nuremburg Code)、赫爾辛基宣言(Helsinki Declaration)及貝爾蒙特報告(the Belmont Report)喚起學術界對研究倫理的共識與重視。各國紛紛設置相關研究倫理組織,如研究倫理委員會(Research Ethics Committee, REC)或人體試驗委員會(Institutional Review Board, IRB)來保護受試者的權利及福祉。我國國家科學委員會「人類行為研究倫理與人體研究倫理治理架構建置計畫」,強調為了因應人類行為與人體研究(行為與社會科學、生物醫學、工程、自然科學等)倫理之需求,應有建置「區域性研究倫理中心」或「校級研究倫理中心」之必要。本文擬從研究倫理爭議的個案為出發點,釐清科學家提出研究計畫面臨之倫理風險與爭議,復以作者們實地參訪見習之美國西雅圖人體試驗委員會,包括華盛頓大學受試者保護部門、Fred Hutchinson癌症研究中心以及西方人體試驗委員會之經驗,擬出人體試驗委員會審核時需要注意之相關倫理及法規議題,期望能借他方之石以攻錯。
The interests of human research subjects has long time been neglected and some notorious examples when investigators fail to respect the rights of subjects happened. The international community has declared the importance on the research ethical issues and stated that human subject research should be carried out in an ethical manner. The Nuremberg Code, the Declaration of Helsinki and the Belmont Report represent the evolving recognition of ethical principles in human research projects. An institutional review board (IRB) is an independent ethics committee or ethical review board that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects. The National Science Council in Taiwan recognized the role of IRB and sponsored the project of ”Human Behavior Research Ethics and Human Subject Research Ethics Governance” for establishing central regional program or research ethics center in order to enhance the research ethics and to maintain the rights and dignities of human subjects. This paper briefly assesses several projects associated with the ethical issues of human subjects. By the experience of visiting the IRBs in Seattle, including Human Subject Division of University of Washington, IRB of Fred Hutchinson Cancer Research Center (FHCRC) and Western Intuitional Review Board (WIRB), we found the staffing structure, examining procedures and adequately regulations are essential components for a well established IRB regime in Taiwan.
期刊論文
1.Beecher, Henry K.(1966)。Ethics and clinical research。The New England Journal of Medicine,274(24),1354-1360。  new window
2.Gertz, Renate(2004)。An analysis of The Icelandic Supreme Court Judgement on The Health Sector Database Act。SCRIPT-ED,1,290-306。  new window
3.Wieting, Stephen G.(2002)。Public And Private Priorities In Managing Time In Genetic Research: The Icelandic deCODE Case。Symbolic Interaction,25,271-287。  new window
4.顏上詠、陳冠旭、唐淑美(20050600)。論英國生物銀行之「告知後同意」。清華科技法律與政策論叢,2(2),189-224。new window  延伸查詢new window
5.劉宏恩(20060400)。論生物醫學研究中利益衝突(Conflict of Interest)問題之規範--以利益衝突之基本概念及其規範上之必要性為討論核心。律師雜誌,319,65-81。  延伸查詢new window
6.陳祖裕(2006)。參加聯合人體試驗委員會舉辦西雅圖參訪行程紀實。台北榮總學訊,115,13-20。  延伸查詢new window
7.Harkness, Jon、Lederer, Susan E.、Wikler, Daniel(2001)。Laying ethical foundations for clinical research。Bulletin of the World Health Organization: the International Journal of Public Health,79(4),365-366。  new window
8.劉宏恩(20040600)。冰島設立全民醫療及基因資料庫之法律政策評析--論其經驗及爭議對我國之啟示。臺北大學法學論叢,54,41-43+45-99。new window  延伸查詢new window
9.劉靜怡(20080900)。「以人為對象」的研究和研究倫理委員會--以美國法制下之「言論出版自由」與「思想研究自由」為論述核心。中研院法學期刊,3,201-274。new window  延伸查詢new window
圖書
1.Reverby, S. M.(2009)。Examining Tuskegee: The infamous syphilis study and its legacy。Chapel Hill, NC:University of North Carolina Press。  new window
2.National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research(1979)。The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research。Washington, DC:U. S. Department of Health, Education, and Welfare。  new window
3.Amdur, R. J.、Bankert, E. A.(2006)。Institutional Review Board: Management and function。Jones & Bartlett。  new window
4.Israel, M.、Hay, I.(2006)。Research ethics for social scientists。London:Sage。  new window
其他
1.(20100324)。原民基因風波,國衛院撤案。  延伸查詢new window
2.劉宏恩(20100708)。陳垣崇事件不可簡化成「法規鬆綁」的問題--產學合作的「利益衝突」亟待積極管理,http://markliu.org/COI_chen.htm。  延伸查詢new window
3.李宗祐(20070824)。研究葛瑪蘭唾液,林媽利遭糾正。  延伸查詢new window
4.Professional Testing Corporation(20101011)。Handbook for candidate: Certification examination IRB professional,http://www.ptcny.com/pdf/CCIP.pdf。  new window
5.王瑞伶,林秀美(20100322)。我的血液,你的專利,原民被犧牲?。  延伸查詢new window
圖書論文
1.劉靜怡(2009)。產學合作關係、利益衝突與科學誠信。2009科技發展與法律規範雙年刊。臺北:中央研究院。  延伸查詢new window
 
 
 
 
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