原住民基因研究之倫理課題與規範初探

The Ethical and Regulatory Framework for Genetic Research on Indigenous Peoples: A Preliminary Analysis

10.6199/NTULJ.2007.36.03.06

李崇僖(Chung-Hsi Lee)

人類基因多樣性計畫 ； 貝蒙特報告 ； 社區諮商 ； 集體同意 ； 概括同意 ； Human Genome Diversity Project ； Belmont Report ； community consultation ； group consent ； general consent

臺大法學論叢

36卷3期（2007 / 09 / 01）

465 - 518

繁體中文

近年來隨著基因科技之發展，生物醫學界致力於探討疾病與基因之關係，因此在國際上以及許多國家內部都有進行基因檢體採集與儲存之計畫。有鑑於基因研究典範與過去醫學研究有所不同，而原住民族群又是特別容易受到基因研究影響的群體，因此本文乃針對原住民基因研究之倫理規範加以探討。本文採取自由主義多元文化論之立場，強調對原住民族特別保護之必要性，但同時應兼顧多元族群社會之相互尊重與利益協調，並保持個人應有的自主決定空間。 本文以「貝蒙特報告」所揭示之三項醫學倫理原則爲基礎，檢討其在基因研究上之適用性，並探討原住民應受到何種權利保障才符合醫學倫理之基本精神。本文認爲對原住民進行基因研究時，必須尊重原住民族作爲一個整體之利益，因此在集體協商方式上需要建立更詳細的規範架構。

In the past few years, biomedical researchers have focused their works on understanding underlying genetic links to complex diseases. These efforts have started several genetic sampling and databases projects, both on international level and individual countries. Since genetic research has very different impacts to participants than traditional medical research and indigenous peoples are always the most vulnerable to this research, this article tries to analyze the ethical framework for those genetic researches concerning indigenous peoples. For the basic presumption of this analysis, this article stands on the principles of liberal multiculturalism. Starting from the famous biomedical research ethical statement named Belmont Report, this article reviews the principles and adapts them to genetic research. In conclusion, the recommendations stress the importance of acknowledging the obligations that sample collectors should be responsible to indigenous peoples.

1. Anaya, James(1996).Indigenous Peoples in International Law.Oxford University Press.
2. Andrews, Lori B.,Maxwell J. Mehlman,Mark A. Rothstein(2002).Genetics: Ethics, Law and Policy.St. Paul:West Group.
3. Austin, A. Melissa(2005).Applying International Guidelines on Ethical, Legal, and Social Issues to New International Geneabnks.Jurimetrics Journal,45,115-134.
4. Barsh, Russel L.(2003).Pharmacogenomics and Indigenous Peoples: Real Issues and Actors.Cardozo Journal of International and Comparative Law,11,365-388.
5. Benatar, R. Solomon(2004).Towards Progress in Resolving Dilemmas in International Research Ethics.Journal of Medicine& Ethics,32,574-582.
6. Collins, S. Francis(2004).The Case for a U. S. Prospective Cohort Study of Genes and Environment.Nature,429,475.
7. Gostin, Lawrence O.(2000).Public Health Law: Power, Duty, Restraint.New York:The Milbank Memorial Fund.
8. Greely, Henry T.(1999).Breaking the Stalemate: A Prospective Regulatory Framework for Unforeseen Research Uses of Human Tissue Samples and Health Information.Wake Forest L. Rev.,34,737-766.
9. Greely, Henry T.(2001).Genotype Discrimination: The Complex Case for Some Legislative Protection.University of Pennsylvania Law Review,149,1483-1505.
10. Greely, Henry T.,Mark A. Rothstein (ed.)(2003).Pharmacogenomics: Social, Ethical, and Clinical Dimensions.New Jersey:John Wiley& Sons.
11. Halewood, Michael(1999).Indigenous and Local Knowledge in International Law: A Preface to sui generis Intellectual Property Protection.McGill Law Journal,44,953-996.
12. Hamilton, Cindy(2001).The Human Genome Diversity Project and the New Biological Imperialism.Santa Clara Law Review,41,619-641.
13. Hsieh, Alice(2004).A Nation`s Genes for a Cure to Cancer: Evolving Ethical, Social and Legal Issues Regarding Population Genetic Databases.Columbia Journal of Law and Social Problems,37,359-411.
14. HUGO Ethical Committee(2000).Statement on Benefit-Sharing.
15. Keal, Paul(2003).European Conquest and the Rights of Indigenous Peoples: The Moral Backwardness of International Society.Cambridge University Press.
16. Kleiner, K.(2000).Blood Feud.New Scientist,7
17. L. L. Cavalli-Sforza,P. Menozzi,A. Piazza(1994).The History and Geography of Human Genes.Princeton University Press.
18. Lekovic, Gregory P.(2004).Genetic Diagnosis and Intellectual Property Rights: A Proposal to Amend The Physician Immunity Statute.Yale Journal of Health Policy Law and Ethics,4,275-304.
19. Leng, Chee Heng(1995).Bioethics and Human Population Genetics Research 1.UNESCO International Bioethics Committee.
20. Lerner, Natan(2003).Group Rights and Discrimination in International Law.Martinus Nijhoff.
21. Lewinski, von Silke(2003).Indigenous Heritage and Intellectual Property.Kluwer Law International.
22. Mappes, Thomas A.,David Degrazia(2001).Biomedical Ethics.Boston:McGraw Hill.
23. Marchant, E. Gary(2005).Property Rights and Benefit-Sharing for DNA Donors?.Jurimetrics Journal,45,153-178.
24. Murphy, Timothy(2004).Case Studies in Biomedical Research Ethics.MIT Press.
25. Background on Ethical and Sampling Issues Raised by the International HapMap Project
26. National Research Council(1997).Evaluating Genetic Diversity.Washington, DC:National Academy Press.
27. North American Regional Committee of Proposed Human Genome Diversity Project(1997).Model Protocol: Proposed Model Ethical Protocol for Collecting DNA Samples.Houston Law Review,333,1431-1473.
28. Shamoo, Adil,David Resnik(2003).Responsible Conduct of Research.New York:Oxford.
29. Sharp, Richard,Morris Foster(2002).An Analysis of Research Guidelines on the Collection and Use of Human Biological Materials from American Indian and Alaskan Native Communities.Jurimetrics Journal,42,165-182.
30. Smaglik, Paul(2000).Tissue Donors Use Their Influence in Deal Over Gene Patent Terms.Nature,407,821.
31. Stevens, Jacqueline(2003).Racial Meanings and Scientific Methods: Changing Policies for NIH-Sponsored Publications Reporting Human Variation.Journal of Health Politics, Policy and Law,28,1033-1079.
32. Thornberry, Patrick(2002).Indigenous Peoples and Human Rights.Juris.
33. Weijer, Charles(1999).Another Tuskegee?.Am. J. Trop. Med.,61,1-25.
34. Weir, Robert F.,Robert S. Olick(2004).The Stored Tissue Issue.New York:Oxford University Press.
35. WHO Advisory Committee on Health Research(2002).Genomics and World Health.Report of the Advisory Committee on Health Research.
36. 王嵩山(2001)。台灣原住民的社會與文化。台北:聯經。
37. 史帝夫·奧森著、霍達文譯(2004)。人類基因的歷史地圖。台北:聯經。
38. 李崇僖(2005)。原住民文化遺產保護之國際現況與展望。輔仁法學，29，1-52。
39. 李崇僖(2007)。基因資訊隱私保護法理與規範。台灣本土法學雜誌，91，71-85。
40. 林子儀、蔡明誠編(2003)。基因技術挑戰與法律回應。台北:學林。
41. 林淑雅(2000)。第一民族：台灣原住民族運動的憲法意義。台北:前衛。
42. 威爾·金里卡著、劉莘譯(2003)。當代政治哲學導論。台北:聯經。
43. 威爾‧金里卡著、鄧紅風譯(2004)。少數群體的權利。台北:左岸。
44. 施正鋒(2005)。台灣原住民族政治與政策。台中:新新台灣文化教育基金會。
45. 科塔克著、徐雨村譯(2005)。文化人類學：文化多樣性的探索。台北:麥格羅希爾。
46. 浦忠成(1999)。原住民的神話與文學。台北:台原。
47. 陳叔倬(2000)。原住民人體基因研究之倫理爭議與立法保護。生物科技與法律研究通訊，6，7。
48. 劉宏恩(2004)。冰島設立全民醫療及基因資料庫之法律政策評析。臺北大學法學論叢，54，41-99。
49. 顏瑞鴻譯(1995)。生物技術暨遺傳工程辭典。台北:貓頭鷹。

1. 陳仲嶙(2009)。從研究自由之觀點論基因研究的社群參與。臺北大學法學論叢，71，1-40。
2. 許育典、林修睿(2015)。研究倫理作為研究自由的內在界限─以生物資料庫的原住民族基因研究為核心。東海大學法學研究，47，75-129。
3. (2009)。論研究對象選取之正義原則─後基因體時代的新課題。應用倫理評論，46，147-154。