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題名：論英國生物銀行之「告知後同意」
書刊名：清華科技法律與政策論叢
作者：顏上詠 引用關係／陳冠旭／唐淑美
作者(外文)：Yen, Shang-yung／Chen, Kuan-hsun／Tang, Shu-mei
出版日期：2005
卷期：2:2
頁次：頁189-224
主題關鍵詞：生物銀行；告知後同意；推定同意；告知後選擇；集體告知後同意；Biobank；Informed consent；Presumed consent；Informed choice；Group informed consent
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(9) 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:7
  • 共同引用共同引用:100
  • 點閱點閱:66
從醫病關係下之同意法理的發展來看，昔日父權模式（Paternalistic Model）下單純的「同意」模式已漸式微，另以尊重病患自主權的「告知後同意（Informed Consent）」取而代之。有鑒於「推定同意」在冰島「衛生部門資料庫法（Act on a Health Sector Database）」所引發全球各地之科學、社會、倫理學家以及隱私權運動者之嚴厲抨擊，英國生物銀行在參與同意上採取不同的蹊徑，要求經充分的說明程序後方取得潛在參與者的同意，來落實對參與者基因資訊自決權的保障。針對英國生物銀行之建置，本文提出四項觀點，（一）英國生物銀行以個人之「告知後同意」為手段，採集個別人體血液、組織等樣本，在未經由集體之告知後同意（Group Informed Consent）下，卻可能因個人基因資訊之蒐集而獲得特定族群之基因資訊。（二）釐清英國生物銀行與參與者間之關係。（三）參與者一旦應允加入生物銀行，對其捐贈之檢體所獲得之基因資訊應被視為貢獻給社會大眾（Dedicate to the Public），而此種貢獻有助於醫學之發展與進步，英國生物銀行應該將其研究之資訊分享給社會大眾。（四）生物銀行之參與同意不應僅僅規範於告知後同意這個階段，而宜嘗試更進一步引入「告知後選擇（Informed Choice）」，將之強調並適用於生物銀行之參與同意中。
In view of the development of jurisprudence on informed consent surrounding patient-doctor relationship, Paternalistic Model has become outdated and replaced by autonomy-based Informed Consent. However, the Act on a Health Sector Database enacted in Iceland still has evoked global criticisms from scientists, sociologists, philosophers and privacy-activists. UK Biobank has adopted a different approach. UK Biobank seeks to introduce a formal procedure, which provides a sufficient elaboration and subsequently acquires consent from potential participants so that participants' autonomy for their genetic information can be protected. As global attention has turned to the ethical, legal and social implications (ELSI) of biobank, informed consent has played a key role in these controversial issues. It is propounded in this paper: (1) sampling of individuals' biological samples, such as blood, tissue and urine based on individual informed consents in UK Biobank, group genetic information of particular races might be gathered without group informed consent, (2) the relationship among participans in UK Biobank should be clarified, (3) once participants agree to join UK Biobank, their biological samples and genetic information should be regarded as contributions to the public and be placed in public domain as shared information, and (4) adopting the concept of informed choice, providing additional choices to the participants.
期刊論文
1.Valerio Barrad, Catherine M.(1993)。Genetic Information And Property Theory。NW. U. L. REV.，87，1037。  new window
2.Annas, George J.(1999)。Genetic Privacy: There Ought to be A Law。TEX. REV. L. & POL.，4，9。  new window
3.Gertz, Renate(2004)。An analysis of The Icelandic Supreme Court Judgement on The Health Sector Database Act。SCRIPT-ED，1，290-306。  new window
4.McHale, J. V.(2004)。Regulating Genetic Databases: Some Legal And Ethical Issues。MED. L. REV.，12，70。  new window
5.Klotzko, Arlene Judith(2000)。SNPs of Disease: The U.K. Plans A National Genomic Database to Study Late-Onset Sickness。SCIENTIFIC AMERICAN，282，28。  new window
6.Richard, Tutton(2004)。Governing UK Biobank: The Importance of Ensuring Public Trust。TRENDS IN BIOTECHNOLOGY，22，284。  new window
7.Terrion, Halle Fine(1993)。Informed Choice: Physicians' Duty to Disclose Nonreadily Available Alternatives。CASE W. RES. L. REV.，43，491。  new window
8.Suter, Sonia M.(2004)。Disentangling Privacy from Property: Toward A Deeper Understanding of Genetic Privacy。GEO. WASH. L. REV.，72，737。  new window
9.Ridley, Donald T.(2001)。Informed RefUsaly Informed Choice: What Is It That Makes A Patient's Medical Treatment Decisums Informed?。Med. & L.，20，205。  new window
10.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
11.蔡明誠、林育廷、麥元馨(20030100)。基因檢測受試同意書相關研究與討論。生物科技與法律研究通訊，17/18，32-80。  延伸查詢new window
12.林萍章(20040200)。新版手術同意書與知情同意法則。萬國法律，133，33-44。  延伸查詢new window
13.陳子平(20000200)。醫療上「充分說明與同意（Informed Consent）」之法理。東吳法律學報，12(1)，47-84。new window  延伸查詢new window
14.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
15.Greely, Henry T.(2001)。Informed Consent and Other Ethical Issues in Human Population Genetics。Annu. Rev. Genet，35，785-800。  new window
16.楊秀儀(20050600)。美國「告知後同意」法則之考察之分析。月旦法學，121，138-152。new window  延伸查詢new window
會議論文
1.楊秀儀(2003)。病人，家屬，社會：論基因年代病患自主權可能之發展。基因技術挑戰與法律回應--基因科技與法律研討會。台北：學林文化事業。  延伸查詢new window
2.陳麗玲(2005)。生技時代人糖檢糖採集規範之調適--以Biobank之發展為例。生醫時代的醫藥議程與法律議題圖桌會議論文集。  延伸查詢new window
3.蔡明誠(2003)。基因研究人體檢糖採樣與原住民受試相關法律問題探討。基因技術挑戰與法律回應--基因科技與法律研討會。台北：學林文化事業。  延伸查詢new window
4.顏上詠、唐淑美(2004)。歐盟生物科技指令--以人性尊嚴為核心論生物科技發明之法律保護。歐洲人權學術研討會，(會議日期: 2004/10/13-2004/10/14)。  延伸查詢new window
圖書
1.Kerr, Anne(2004)。Genetics and Society: A Sociology of Disease。Psychology Press。  new window
2.秦慶瑤(200211)。基因興圖對生計醫藥產業發展之影響。財團法人生物技術開發中心。  延伸查詢new window
3.(2001)。House of Lords Select Committee on Science and Technology, Fourth Report, Report on Human Genetic Databases: Challenges And Opportunities。  new window
4.(1991)。Moore v. Regents of the University of California。  new window
5.Montgomery, Jonathan(2003)。HEALTH CARE LAW。Oxford。  new window
6.Nuffield Council on Bioethics(1995)。Human Tissue: Ethical And Legal Issues。  new window
7.Department of Health(20030903)。UK Biobank Ethics and Governance Framework Version 1.0。  new window
8.王澤鑑(1998)。侵權行為法。臺北：三民書局股份有限公司。  延伸查詢new window
其他
1.(2003)。Medical Research Council and The Wellcome Trust Department of Health, Setting Standards: UK Biobank Ethics And Governance Framework，http://www.ukbiobank.ac.uk/docs/egf-summary.doc， 2005/04/16。  new window
2.UK Biobank(2005)。Participant Information，http://www.ukbiobank.ac.uk/docs/20050317participantinfoleafletv2.pdf， 2005/04/16。  new window
圖書論文
1.范建得(2004)。我國推動Biobank所面臨之法律限制及其因應方向。迎向基因醫藥的新世紀：促進政策與法規的調和與監理機制的更新。  延伸查詢new window
2.陳桂苓(2004)。衛生署與台灣Biobank計畫相關倫理法規現況。迎向基因醫藥的新世紀：促進政策與法規的調和與監理機制的更新。  延伸查詢new window
3.陳文吟(1997)。探討美國 Moore v. Regents of the University of California 對生化科技之影響。智慧財產權與國際私法：曾陳明汝教授祝壽論文集。台北：臺灣大學法律學系。  延伸查詢new window
4.顏厥安(200409)。財產、人格，還是資訊？論人類基因的法律地位。鼠肝與蟲臂的管制。台北：元照出版有限公司。new window  延伸查詢new window
5.Minakshi Bhardwaj, Biobanks(2004)。Genomics And Databases: A Question of Attribution。CHALLENGES FOR BIOETHICS FROM ASIA。N.Z.：Eubios Ethics Institute。  new window
6.Twyman, Richard、Primrose, Sandy、Old, Bob、郭靜蓉(2004)。重組DNA技術的應用。遺傳工程入門。藝軒圖書。  延伸查詢new window
7.Kass, Nancy E.(2000)。Human Subjects Research, Ethics, Informed Consent in Research。ENCYCLOPEDIA OF ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY。John Wiley & Sons。  new window
8.Kopelman, Loretta M.(2000)。Human Subjects Research, Ethics, And Research on Children。ENCYCLOPEDIA OF ETHICAL, LEGAL, AND POLICY ISSUES IN BIOTECHNOLOGY。John Wiley & Sons。  new window
 
 
 
 
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