查詢結果分析
來源資料
頁籤選單縮合
題名 | 受試者保護與人體試驗委員會=The Protection of the Human Research Subject and Institutional Review Board |
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作者 | 唐淑美; 顏上詠; 陳祖裕; 林正介; | 書刊名 | 醫事法學 |
卷期 | 17:2 2010.12[民99.12] |
頁次 | 頁1-12 |
分類號 | 412.12 |
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 subject; Institutional review board; Human Subject Division of University of Washington; FHCRC; WIRB; |
語文 | 中文(Chinese) |
中文摘要 | 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。 |
英文摘要 | 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. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。