| 摘要(英) |
Before 20th Century, there were few experiments on human being and mostly
were morally acceptable. There are more and more experiments employing human
subjects and cases of abuse abound. In United States, Germany and Japan there
were revealed many cases of inhuman treatment of subjects in experiments.
International associations set up a number of important rules such as the Nuremburg
Code, Helsinki Declaration, Belmont Report and others. These documents specified
the rules for human experiments. By the end of the 20th and the beginning of 21st
century, the Human Genome Project brought into view a new wave of different
experiments such as those concern genetic therapy, embryonic stem cell research,
pharmacogenomics and others. United Nation consequently issued a number of
declarations such as Declaration of Human Genome and Human Rights, International
Declarations on Bioethics, so as to provide a universal guideline for the field.
Using the four basic principles of respect for autonomy, benevolence and
non-maleficience and justice, this thesis examines the various code of ethics and
declarations on ethical conducts in human subject research and experiment and builds
up an evaluation framework , which is subsequently applied to the post genome era as
well as the situations in Taiwan. The basic elements of an ethical experiment
involving human subjects include the strict regulation and monitoring of such
research, with special emphasis on the safety and health of the subject. The selection
of subjects becomes very significant. It is also emphasis that risk and benefit
analysis and the benfit of the subjects should out-weight the harm to them. An
adequate insurance mechanism need be introduced. Applying to genetic research,
confidentiality needs be uphold, the dilemma of privacy and right to know and
sometimes not to know is very intrique. It is contended that when it involves life
and death, family members have the right to know. Furthermore, married couples
are responsible for their child and should respect each other’s the right to know.
Lastly, government must regulate the sharing of the benefit and burden of the
population according to rules set down by the United Nation in order to avoid the
monopoly of the wealthy in advance genetic technology. It is proper to consider the
employment of genetic therapy into the universal health insurance. The vulnerable
groups such as rare disease groups need be taken special care of.
|
| 參考文獻 |
一、中文專書
李瑞全，朱建民，葉保強，（合著），2005，《應用倫理與現代社會》，台北：國立
空中大學。
李瑞全，1999，《儒家生命倫理學》，台北：鵝湖出版社，初版。
李瑞全（編），2008，《後基因體世界之人體實驗教育暨國際學術研討會論文集》，
中壢：國立中央大學。
李瑞全（編），2008，《後基因體之健康照護與人體試驗國際研討會論文集》，中
壢：國立中央大學。
李瑞全，蔡篤堅（合編），2008，《醫療倫理告知--理論與實務》，台北：五南書局，
初版。
林火旺，1999，《倫理學》，台北：五南書局，初版。
林志六，2008，《新藥開發與臨床試驗》，台北：秀威資訊。
尉遲金，2007，《生命倫理》，台北：華都文化事業有限公司。
蔡甫昌，2007，《臨床倫理病案討論》，台北：橘井文化事業有限公司。
劉魏（譯），約瑟夫，波斯科(Joseph E.Persico)，民國85，《紐倫堡大審》（Nuremberg
Infamy on Trial），台北市：麥田出版社，初版。
二、中文期刊、論文
王湘齡，2001，＜從紐倫堡守則審查DDI 測試的醫學倫理問題＞，《應用倫理通
訊》第十九期，中壢：國立中央大學哲學研究所，頁39-45。
王心怡，1997，＜國內新醫療技術人體試驗制度＞，《衛生報導》第3期，台北：
行政院衛生署，頁32-35。
李瑞全，2003，＜基因疾病，基因治療與醫療保健＞，李瑞全、蔡篤堅合編，《基
因治療與倫理、法律、社會意涵論文選集》，台北：唐山出版社，頁29-52。
李瑞全，2001，＜人體實驗之倫理規範＞，《應用倫理通訊》第十九期，中壢：
國立中央大學哲學研究所，頁9-11。
李崇僖，2007，＜人體基因研究之倫理規範問題初探＞，《月旦法學雜誌》第141
期，台北：元照出版公司，頁47-61。
林志六，2000，《人體基因治療規範機制之研究-以機構內審查制度為中心》，台
北：國立台灣大學法律研究所碩士論文。
時國銘，2001，＜人體實驗之國際倫理規範：歷史的考察＞，《應用倫理通訊》
第十九期，中壢：國立中央大學哲學研究所應用倫理學研究室，頁12-21。
郭英調，2001，＜國內人體試驗委員會簡介＞，《應用倫理通訊》第十九期，中
壢：國立中央大學哲學研究所應用倫理學研究室，頁22-24。
劉宏恩，2007，＜試評日本基因資料庫之相關倫理規範與制度設計＞，《月旦法
學雜誌》第141期，台北：元照出版公司，頁25-30。
廖淑鈴，2001，＜談醫院中人體試驗委員會＞，《應用倫理通訊》第十九期，中
壢：國立中央大學哲學研究所應用倫理學研究室，頁25-30。
賴志銘，2001，＜以人類為受試者之生物醫學研究之國際倫理準則＞，《應用倫
理通訊》第十九期，中壢：國立中央大學哲學研究所應用倫理學研究室，頁
31-35。
高培桓，2001，《生物醫學人體試驗之國際法規範》，台北：國立東吳大學法律研
究所碩士論文。
三、英文專書
Annas, George J. and Michael A.Grodin, 1992, The Nazi Doctors and The Nuremberg
Code , New York: Oxford University Press.
Beauchamp, Tom L. and Childress, James F. 2001, Principles of Biomedical Ethics,
Fifth Edition, New York: Oxford University Press.
Brody, Baruch A. PH.D , 1998, The Ethics of Biomedical Research , New York:
Oxford University Press.
Epstein, Steven, 2007, Inclusion The Politics of Difference in Medical Research ,
London: The University of Chicago press.
Gevers, J. K. M. and E.H.Hondius and J.H.Hubben, 2005, Health Law,Human Rights
and the Biomedicine Convention , Boston: Martinus Nijhoff Publishers.
Harris, Sheldon H, 1994, Factories of Death , New York: Routledge.
Harold Y. Vanderpool,1996,The Ethics of Research Involving Human Subjects：
Facing the 21st Century,Frederick：University Publishing Group.
Klockars, Carl B ,1979, Deviance and Decency The Ethics of Research with Human
Subjects , London: Sage Publications.
King ,Nancy M.P. and Gail E.Henderson, 1999, Beyond Regulations Ethics in Human
Subjects Research , Chapel Hill&London: The University of North Carolina Press.
Lifton ,Robert Jay,1986,The Nazi Doctors Medical Killing and the Psychology of
Genocide, New York：BasicBooks.
Levine ,Robert J, 1986, Ethics and Regulation of Clinical Research , New Haven :
Yale University Press.
Shamoo, Adil E, 2002,Ethics of the Use of Human Subjects in Research, New York：
Garland Science Publishing.
Veatch, Robert M, 1997 , Medical Ethics ,Second Edition, London：Jones and Bartlett
Publishers.
Veatch ,Robert M , 1989 , Medical Ethics ,Boston：Jones and Bartlett Publishers.
四、英文期刊、論文
Brody, Baruch A, 1999, “ ResearchEthics:InternationalPerspectives” in Tom L.
Beauchamp & LeRoy Walters Contemporary Issues in Bioethics, Belmont,
CA:Wadsworth Publishing Company, Sixth edition, pp. 365-370.
Benatar, Solomon R, 1999, “Justice and Medical Research:A Global Perspective”inTom L. Beauchamp & LeRoy Walters（Eds.） Contemporary Issues in Bioethics,
Belmont, CA: Wadsworth Publishing Company, Sixth edition, pp. 390-393.
Clinton, William J,1999, “In Apology for the Study Done in Tuskegee”in Tom L.
Beauchamp & LeRoy Walters（Eds.） Contemporary Issues in Bioethics, Belmont,
CA: Wadsworth Publishing Company, Sixth edition, pp. 402-411.
Emanuel , Ezekiel J. and Franklin G.Miller, 1999, “The Ethics of Placebo-Controlled
Trial-A Middle Ground”in Tom L. Beauchamp & LeRoy Walters（Eds.）
Contemporary Issues in Bioethics, Belmont, CA:Wadsworth Publishing Company,
sixth edition, pp. 379-384.
Gregory E.Pence , 1999, “The Tuskegee Study”in Tom L.Beauchamp & LeRoy
Walters（Eds.） Contemporary Issues in Bioethics, Belmont, CA:Wadsworth
Publishing Company, sixth edition, pp. 394-401.
Harold T.Shapirp Eric M.Meslin, 1999, “Ethical Issues in the Design and Conduct of
Clinical Trial in Developing Countries” in Tom L.Beauchamp & LeRoy Walters
（Eds.） Contemporary Issues in Bioethics, Belmont, CA:Wadsworth Publishing
Company, Sixth edition, pp. 385-388.
Macklin, Ruth, 2008, “How Independent Are IRB?” in . IRB:Ethics & Human
Research. v.30 no.3:p15-20.
Resnik, David B, 2007, “Questionable Research Practices Compel Subjects to join
sendes ”in .IRB:Ethics & Human Research. v.29 no.6: p7-10
Rector, Thomas S, 2008, “How should we Communicate the Likelihood of Risks to
inform Decisions about Consent”in .IRB:Ethics & Human Research. v.30
no.4:p15-19.
|
[Endnote RIS 格式]
[相關文章]
[文章引用]
[完整記錄]
[館藏目錄]
[檢視]
plurk
funp
live
udn
HD
myshare
netvibes
friend
youpush
delicious
baidu
Google bookmarks
del.icio.us
hemidemi
facebook
twitter
google
reddit