Please use this identifier to cite or link to this item: http://hdl.handle.net/11455/21160
標題: 台灣產研臨床試驗契約書之探討
The Study of the Clinical Trial Agreement between Industry and Research Institution in Taiwan
作者: 陳舜芳
Chen, Sung-Fang
關鍵字: 臨床試驗契約
clinical trial agreement
受試者保護
跨國合作廠商
智慧財產
文章發表
損害賠償
保密
保險
反賄賂原則
protection of human subjects
transnational partners
intellectual property
publication
indemnity
confidentiality
insurance
and anti-corruption principles.
出版社: 科技法律研究所
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Altsman,M.D.著,誰先來?在自己身上作實驗的醫生,導讀(Who Goes First?-The Story of Self-Experimentation in Medicine,) ,第一版,台北:天下文化,(原書於1998年出版)。 7. 郭英調(2000),臨床研究手冊,初版,台北:合慶。 8. 中村敏昭、齊藤靜敬、蔡篤俊、謝瑞智合著(2004),醫療紛爭與法律,增定版,台北:文笙。 9. 王澤鑑著(1998),侵權行為法第一冊,初版,台北:三民。 10. 王澤鑑著(2001),債法原理第一冊,增定版,台北:三民。 11. 羅宜爾編著(2007),國際私法,初版,台北:考用。 12. 陳春山編著(2004),醫師病人醫療糾紛,第三版,台北:書泉。 13. 柯澤東著(2006),國際私法新境界─國際私法專論,初版,台北:元照。 14. 徐昌錦著(2002),契約簽訂與履行,第八版,台北:書泉。 15. 杜怡靜著(2006)契約之成立與效力,修定二版,台北:三民。 16. 汪紹銘著(2006)醫療糾紛與損害賠償-如何跟醫師打官司,初版,台北:三民。 17. 鄭玉波,保險法論(2006),修訂六版一刷,台北:三民。 18. 劉承愚(2001),如何閱讀英文合約,基礎篇,再版二刷,智勝。 19. 陳聰富(2008),侵權歸責原則與損害賠償,台北:元照。 20. 陳聰富(2004),因果關係與損害賠償,台北:元照。 21. 許高山(1998),如何有效簽章─契約、支票、訴訟狀、存證信函,台北:永然。 22. 趙秀文、楊智傑譯(2006),Vincent R.Johnson 著英美侵權法,五南。 23. 施啟揚(1996),民法總則,台北:氏者自版。 24. 施啟揚(1979),契約的訂定與履行,正中書局。. 25. 蔡甫昌譯(2004),Peter A. Singer 著,臨床生命倫理學,台北:財團法人醫院評鑑暨醫療品質策進會。 26. 嚴久元(1980),當代醫事倫理學,台北:橘井。 27. 黃錦堂(2006),行政組織法之基本問題,翁岳生編,行政法(上),元照。 28. 施啟揚(1979),契約的訂定與履行,正中書局。. 三、期刊論文、研究計畫報告 1. 劉靜怡(2008)「以人為對象」的研究和研究倫理委員會─以美國法治下之「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,第3期,頁201-274。 2. 邱永仁(2001),人體試驗「除罪化」之探討,台灣醫界,第44 卷第9 期。 3. 楊秀儀(1999),誰來同意?誰作決定?——從「告知後同意法則」談病人自主權的理論與實際:美國經驗之考察,台灣法學會「紀念世界人權宣言五十週年」學術研討會論文報告,台灣法學會學報,第20 期。 4. 楊秀儀(2002),溫暖的父權vs.空虛的自主——到底法律要建立什麼樣的醫病關係?,應用倫理研究通訊,第21 期。 5. 楊秀儀、林欣柔(2004),告別馬偕肩難產事件?,月旦法學雜誌,第112 期。 6. 楊秀儀(2005),美國「告知後同意」法則之考察分析,月旦法學雜誌,第121 期,2005 年6月。 7. 侯英泠(2001),醫療行為的民事賠償責任(上)月旦法學雜誌,第72 期,2001年6月。 8. 郭英調(2001),國內「人體試驗委員會」簡介,應用倫理研究通訊,第19 期,2001 年7 月。 9. 薛瑞元(2004),醫療契約與告知義務,月旦法學雜誌,第112 期,2004 年9 月。 10. 牛惠之(2007),跨國人體試驗相關倫理與法律問題─成熟伙伴關係、利益分享與雙重醫療標準之省思,月旦法學雜誌(No.141)2007.2 11. 楊秀儀(2005),美國「告知後同意」法則之考察分析,月旦法學雜誌,121期,2005年6月,頁138-152。 12. 侯英泠(2004),醫療契約上之告知義務:從德國法論醫師之契約上說明義務,月旦法學雜誌(No.112) 2004年9月,頁9-23 13. 郭正典(1999),醫療風險應由整個社會共同承擔,88 年9 月13 日,自由時報,自由廣場 14. 王培東(2002),臨床試驗:任何醫療模式,皆需臨床試驗作最後的驗證,台灣醫界,第45 卷第11 期,頁10,2002 年11 月。 15. 陳維昭(2009),生技產業如何起飛,中國時報98年4月29日,時論廣場A16 四、網路資料 (一)文章 1. 巫文玲(2008),生物技術開發中心:全球新藥研發欣欣向榮http://www.itis.org.tw 2. 張惇雯、林裕閔,美國藥物專利權之探討與剖析,1.1.4 http://eminent.yuntech.edu.tw/creation/paper/upload/1231426108.pdf 專利過期,仍享有原廠開發的優勢,利用優先權延長專利藥物的保護期 3. 宋華琳(1997),美國藥品加速審批程式研究,美國會於1997年11月9日通過了「食品和藥品管理局現代化法案」。 http://big5.china.com.cn/gate/big5/law.china.cn/thesis/t xt/2007-11/27/content_1904308.htm 4. 陳祖裕,參加聯合人體試驗委員會舉辦西雅圖參訪行程紀實http://www.jirb.org.tw/seattle_chen.asp 5. 林志六,人體試驗受試者保護規範措施,財團法人醫藥品查驗中心 www.cde.org.tw/03center/write/book02_a/人體試驗受試者保護規範措施.pdf 6. 郭英調,http://www.jirb.org.tw/first_introduction.asp 郭英調(2004),人體試驗委員會之最新動態,論文發表於行政院衛生署主辦之「人體試驗委員會查核」研討會,台北。 7. 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Edward Jenner英國醫生琴納注意了中國人痘接種醫術的免疫功效,但又嘗試尋找一種避免重症天花的更好接種痘苗。1798年撰寫和出版了《對天花牛痘疫苗的成因及其效果的研究》專著http://tourtw.org/crn-webapp/cbspub/secDetail.jsp?bookid=14601&secid=14639 (二)官方資料 1. 2007年 & 2008年衛生署人體試驗委員會委員及主持人之考試認證試辦計畫公告名單2009/2/2 http://www.jirb.org.tw/News/Content.aspx?intNewsID=206 2. 藥品查驗登記審查準則 http://www.doh.gov.tw/ufile/doc/200502_藥品查驗登記審查準則.doc 3. 查驗登記案臨床審查重點 http://www.cde.org.tw/08faq/NDA_Clinical.html 4. 臺灣藥物法規資訊網,http://regulation.cde.org.tw 5. 廠商得依據89.12.12衛署藥字第0890035812號(雙十二公告)、90.12.25公告、91.01.07 公告、92.06.10公告與95.03.29公告. http://www.cde.org.tw/bse_website/report33.html 6. 生技製藥國家型科技計畫http://npbp.m-w.com.tw/tw/index.php 7. 【世界衛生組織赫爾辛基宣言2000年版】譯自” World Medical Association Declaration of Helsinki” 52nd WMA General Assembly, Edinburgh, Scotland, October 2000。http://www.jirb.org.tw/document/歷史文件/赫爾辛基宣言%20%202000中文版.doc 8. 醫療機構人體試驗委員會組織及作業基準http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDAT01.asp?lsid=FL027593 9. 第101條試驗主持人及試驗機構應盡善良管理人之注意http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDAT01.asp?lsid=FL033502 10. 涂劍詒、陳淑儀,試驗中新藥 (Investigational New Drug) 簡介,財團法人醫藥品查驗中心http://www.cde.org.tw/03center/write/book02_a/%E8%A9%A6%E9%A9%97%E4%B8%AD%E6%96%B0%E8%97%A5%E7%B0%A1%E4%BB%8B.pdf http://www.fda.gov/cder/guidance/959fnl.pdf 11. 醫療機構人體試驗委員會組織及作業基準 http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDAT01.asp?lsid=FL027593 12. 醫療機構及醫事人員發布醫學新知或研究報告倫理守則http://www.csh.org.tw/各類委員會/人體試驗委員會/相關法規/IRB作業基準/醫 療機構及醫事人員發布醫學新知或研究報告倫理守則.doc 13. 醫療機構接受媒體採訪注意事項http://homepage.vghtpe.gov.tw/~ged/top2/top2_b3.htm 14. 衛生署受試者同意書範本,http://www.jirb.org.tw/document/衛生署受試者同意書範本.pdf 15. 臨床試驗受試者招募原則,http://www.jirb.org.tw/document/臨床試驗受試者招募原則.pdf 16. 行政院衛生署公告執行國內藥品臨床試驗主持人資格-即日起施行(2007/5/23) http://www.jirb.org.tw/%BD%C3%A5%CD%B8p%A4%BD%A4%E5-1.pdf 17. 法學資料檢索系統,http://jirs.judicial.gov.tw/Index.htm 18. 98年5月20日醫療法修訂公佈實施http://www.6law.idv.tw/6law/law/%E9%86%AB%E7%99%82%E6%B3%95.htm 19. 98年5月20日醫療法於醫療法衛生法規資料檢索系統 http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDAT0201.asp 20. 陳恆德,亞太地區臨床試驗現況 http://www.cde.org.tw/03center/write/book04/%E4%BA%9E%E5%A4%AA%E5%9C%B0%E5%8D%80%E8%87%A8%E5%BA%8A%E8%A9%A6%E9%A9%97%E7%8F%BE%E6%B3%81.pdf 21. 朱夢麟、陳恆德,〈生技醫藥研發中心之法規評估與審查〉, 財團 法人醫藥品查驗中心http://www.cde.org.tw(2004 年12 月5 日)。http://www.fda.gov/cder/guidance/959fnl.pdf 22. 醫療機構人體試驗委員會組織及作業基準http://www.doh.gov.tw/ufile/Doc/IRB%E5%85%AC%E5%91%8A%E7%89%88921112.doc 23. 藥品優良臨床試驗準則,http://www.edah.org.tw/irb/docs/GCP%E8%A6%8F%E7%AF%84.doc 24. 造訪衛生署臨床試驗與研究推動小組http://science.doh.gov.tw/cectr/island.htm 25. 藥品臨床試驗一般基準www.vghks.gov.tw/erli/irb/法規/藥品臨床試驗一般基準.pdf 貳、英文文獻 一、英文書籍 1. Levine, R. J. (1986), Ethics and Regulation of Clinical Research (2nd ed.), Yale University Press, New Haven and London. 2. Bankert, E. A.and R. J. Amdur (2006), Institutional Review Board Management and Function (2nd ed.), Jones and Bartlett Publishers, Massachusetts. 二、期刊論文 1. Lo, B., L.E. Wolf, and A. Berkeley,(2000) Conflict-of-Interest Policies for Investigators in Clinical Trials. N Engl J Med, 343(22): p. 1616-1620. 2. Bodenheimer T., ( 2000) Uneasy alliance: clinical investigators and the pharmaceutical industry. N Engl J Med;342:1539-1544. 3. Davidoff, F., et al.,(2001), Sponsorship, Authorship, and Accountability. N Engl J Med, 345(11): p. 825-827. 4. Drazen, J.M.(2002),, Institutions, Contracts, and Academic Freedom. N Engl J Med, 347(17): p. 1362-1363. 5. Schulman KA, Seil DM, Timbie JW, et al., (2002) A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N Engl J Med ;347:1335-1341. 6. Nathan DG, Weatherall DJ., (2002), Academic freedom in clinical research. N Engl J Med;347:1368-1371. 7. Schulman KA, Seils DM, Timbie JW, et al., (2002), A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N Engl J Med;347:1335-1341. 8. Drazen JM.,(2002), Institutions, contracts, and academic freedom. N Engl J Med;347:1362-1363. 9. Steinbrook, R.,( 2002), rotecting Research Subjects -- The Crisis at Johns Hopkins.The New England Journal of Medicine, 346(9): 716-720. 10. Bernstein, A. (2003). Toward effective Canadian public-private partnerships in health research. CMAJ 168: 288-289 11. Tobin, M.J.,(2003), Conflicts of Interest and AJRCCM: Restating Policy and a New Form to Upload. Am. J. Respir. Crit. Care Med., 167(9): p. 1161-1164. 12. Constantinou, G., et al., (2003) The Olivieri Case. N Engl J Med, 348(9): p. 860-863. 13. Nathan, D. G., Wilson, J. D. (2003). Clinical Research and the NIH -- A Report Card. NEJM 349: 1860-1865 14. Novak, J. W., Barnes, M., Gallin, K. E., Meyer, R. E., Korn, D., Schulman, K. A., Seils, D. M., Califf, R. M. (2003). Clinical-Trial Agreements between Medical Schools and Industry. NEJM 348: 476-478 15. Meier B.(2004) Contracts keep drug research out of reach. New York Times. November 29, A1. 16. Topol EJ., ( 2004). Failing the public health -- rofecoxib, Merck, and the FDA. N Engl J Med;351:1707-1709. 17. DuVal, G (2004). Institutional ethics review of clinical study agreements. J. Med. Ethics 30: 30-34 18. Baer I, Feiler ME, Regulski A, Switzer SS.(2004) Clinical trial contracts: a discussion of four selected provisions. Washington, D.C.: Association of American Medical Colleges. https://services.aamc.org/publications/showfile.cfm?file=version6.pdf&prd_id=76&prv_id=75&pdf_id=6 19. Steinbrook, R.,( 2005) Gag Clauses in Clinical-Trial Agreements. The New England Journal of Medicine, 352: 2160-2162. 20. Sierles, F. S., Brodkey, A. C., Cleary, L. M., McCurdy, F. A., Mintz, M., Frank, J., Lynn, D. J., Chao, J., Morgenstern, B. Z., Shore, W., Woodard, J. L. (2005). Medical Students'' Exposure to and Attitudes About Drug Company Interactions: A National Survey. JAMA 294: 1034-1042 21. Mello, M.M., B.R. Clarridge, and D.M. Studdert, ( 2005), Academic Medical Centers'' Standards for Clinical-Trial Agreements with Industry. N Engl J Med, 2005. 352(21): p. 2202-2210. 22. Gotzsche, P. C., Hrobjartsson, A., Johansen, H. K., Haahr, M. T., Altman, D. G., Chan, A.-W. (2006). Constraints on Publication Rights in Industry-Initiated Clinical Trials. JAMA 295: 1645-1646 23. Shuchman, Miriam,(2007),Commercializing Clinical Trials -- Risks and Benefits of the CRO Boom,N Engl J Med 357: 1365-1368 24. Getz KA.,(2007), Global clinical trials activity in the details. Applied Clinical Trials. September 1, (Accessed January 30, 2009, at http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=453243.) 25. Kimmelman, J.,( 2007) Inventors as investigators: The ethics of patents in clinical trials. Academic Medicine, 82(1): p. 24-31. 26. Mello, M. M., Joffe, S. (2007). Compact versus Contract -- Industry Sponsors'' Obligations to Their Research Subjects. NEJM 356: 2737-2743 27. Angell, M. (2008). Industry-Sponsored Clinical Research: A Broken System. JAMA 300: 1069-1071 28. Kirby Lee, Peter Bacchetti, and Ida Sim, ( 2008) Publication of Clinical Trials Supporting Successful New Drug Applications: A Literature Analysis. PLoS Med.September; 5(9): e191. 29. Eisenstein, E.L., et al., (2008) Sensible approaches for reducing clinical trial costs. Clinical Trials, 5(1): p. 75-84. 30. Glickman SW et al.( 2009), Ethical and Scientific Implications of the Globalization of Clinical Research. N Engl J Med;360:816-23. 31. Goodyear, M. D E, Lemmens, T., Sprumont, D., Tangwa, G. (2009). Does the FDA have the authority to trump the Declaration of Helsinki?. BMJ 338: b1559-b1559 http://www.ahrp.org/cms/index2.php?option=com_content&do_pdf=1&id=579 三、網路資料 (一)文章 1. Investigator Non-Compliance with IRB Approved Human Subjects Research Approved 6/6/03http://irb.jhmi.edu/Guidelines/, http://www.firstclinical.com/resources/articles/LegalConflict.pdf 2. Adam Chasse, "Overcoming Contracting Challenges in Clinical Research", Drug Information Association Annual Meeting, 2003., www.quintiles.com/Performance/Presentations.htm 3. Oliver Wendell Holmes, Jr. , http://en.wikipedia.org/wiki/Oliver_Wendell_Holmes,_Jr. 4. Planning a Clinical Trial Checklist http://www.cardiff.ac.uk/racdv/resgov/clintrials/checklist/index.html http://fhs.mcmaster.ca/csd/docs/chklst-guidelines-jun15-07.doc http://research.unc.edu/oct/study_startup_checklist.pdf 5. Link to firstclinical.com, http://www.firstclinical.com 6. First Clinical Research - #1 source of clinical research information http://www.firstclinical.com/journal/ 7. Journal of Clinical Research Best Practices - Hundreds of free articles http://firstclinical.com/regdocs/search/ 8. First Clinical Research Laws, Regulations and Guidances - Hundreds of searchable documents , http://www.firstclinical.com/directories/ 9. Adam Chasse,"Overcoming Contracting Challenges in Clinical Research", Drug Information Association Annual Meeting,2003. First Clinical Research Directories - Thousands of clinical research resources. http://www.firstclinical.com/resources/articles/LegalConflict.pdf 10. Model Clinical Trial Agreement Version 1.22-September 2007 http://www.firstclinical.com/magi/documents/MAGI_Model_CTA.doc 11. Standardizing CTAs: International Efforts A model clinical trial agreement will save both site and sponsor time, money, and resources. Feb 1, 2005 By: Norman M. Goldfarb Applied Clinical Trialshttp://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=145641&sk=&date=&pageID=2 12. A checklist for clinical trial agreement http://www.rgp.ufl.edu/research/pdf/clinical_trial_checklist.pdf 13. Roger Meyer, M.D. and Evangeline Loh, Ph.D.,et,al,. Clinical Trial Contracts:A Discussion of Four Selected Provisions, 2004, Association of American Medical Colleges(AAMC) https://services.aamc.org/publications/showfile.cfm?file=version6.pdf&prd_id=76&prv_id=75&pdf_id=6 14. The Committee on the Safety of Medicines (CSM) (2005)was an independent advisory committee that for 40 years advised the UK Licensing Authority on the quality, efficacy and safety of medicines. It was replaced on 30 October 2005 by the Commission on Human Medicines which combines the functions of both the former committee and the Medicines Commission. http://en.wikipedia.org/wiki/Committee_on_the_Safety_of_Medicines 15. Truelove C. 21st Annual report: belt tightens on big pharma.Med Ad News 2007;26:4-7. http://www.pharmalive.com/magazines/medad/view.cfm?articleID=5067 16. Rai S. Drug companies cut costs with foreign clinical trials. New York Times. February 24, 2005:C4. http://www.nytimes.com/2005/02/24/business/24clinic.html 17. Angell, M. (2008). Industry-Sponsored Clinical Research: A Broken System. JAMA 300: 1069-1071 http://www.nytimes.com/2005/04/24/business/24drug.html?pagewanted=print&position 18. Bio-Science Law Review By Sangeeta Puran, Mayer, Brown, Rowe & Maw LLP 19. Intellectual property rights in clinical data http://pharmalicensing.com/public/articles/view/1182867769_46812139d71b7 20. Planning for Challenges of Global Clinical Trials , Epstein Becker & Green P.C., Washington D.C. by Leah R. Kendall Article from INTERNATIONAL LEGAL NEWS http://www.imakenews.com/iln/e_article001156026.cfm?x=b11,0,w 21. http://www.imakenews.com/eletra/mod_print_view.cfm?this_id=1156026&u=iln&show_issue_date=F&issue_id=000279255&lid=b11&uid=0 22. Streamlining Clinical Trial Agreement Negotiations http://firstclinical.com/resources/articles/Streamlining.pdf 23. Norman M Goldfarb(2005), Legal conflict on a global scale:Clinical trial agreements in the international context http://www.firstclinical.com/resources/articles/LegalConflict.pdf 24. World Medical Association. Declaration of Helsinki. 2008. www.wma.net/e/policy/pdf/17c.pdf. (二)官方資料 1. [No author listed(2006)] Content and format of an application. Code of Federal Regulations (CFR) Title 21, Pt. 314.50. 2. [No author listed(2006)] Availability for public disclosure of data and information in an application or abbreviated application. CFR Title 21, Pt. 314.430. 3. [No author listed(2006)] Freedom of Information Act. Title 5 US Code 552(b)(4). 4. The original Food and Drugs Act(1906)is passed by Congress on June 30 and signed by President Theodore Roosevelt. 5. The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 is passed by Congress, containing new provisions. http://www.fda.gov/oc/history/historyoffda/section2.html 6. The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 is passed by Congress, containing new provisions. http://www.fda.gov/oc/history/historyoffda/section2.html 7. 維基百科1968年藥品法http://en.wikipedia.org/wiki/Medicines_Act_1968 The Medicines Act 1968 is an Act of Parliament of the United Kingdom. committee and the Medicines Commission. 8. 維基百科衛生與人類服務部The United States Department of Health and Human Services (HHS)(1979) http://en.wikipedia.org/wiki/United_States_Department_of_Health_and_Human_Services The United States Department of Health and Human Services (HHS), is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America". 9. 美國總統雷根(1983)率先簽署全世界第一個孤兒藥法案(The Orphan Drug Act, ODA)。http://en.wikipedia.org/wiki/Orphan_drug ;http://ntuh.mc.ntu.edu.tw/neur/4_educate_148.htm 10. 維基百科The Belmont Report http://en.wikipedia.org/wiki/Belmont_Report 11. NIH Guide for Grants and Contracts. (1979)Vol. 8,. No. 8,. June. 5. Page.5 http://www.nih.gov/grants/guide/historical/1979_06_05_Vol_08_No_08.pdf 12. 維基百科1983年1月4日美國總統雷根率先簽署全世界第一個孤兒藥法案(The Orphan Drug Act, ODA)。http://en.wikipedia.org/wiki/Orphan_drug ;http://ntuh.mc.ntu.edu.tw/neur/4_educate_148.htm 13. Office of Inspector General. Recruiting human subjects: Pressures in industry-sponsored clinical research (OEI-01-97-00195), June 2000. Access date:12 April 2001. http://www.hhs.gov/oig/oei/reports/am 459.pdf 14. Organization Policy on Determination of “Human Subject Research” and Exempt Research (Policy No. 102.1) http://irb.jhmi.edu/Policies/102_1.html 15. Model Clinical Trial Agreement Version 1.22-September 2007 http://www.firstclinical.com/magi/documents/MAGI_Model_CTA.doc 16. Roger Meyer, M.D. and Evangeline Loh, Ph. D. , Clinical Trial Contracts: A Discussion of Four Selected Provisions, Association of American Medical Colleges. At http://www.aamc.org/publication 17. 臨床試驗註冊網址:http://prsinfo.clinicaltrials.gov/ 18. 學術研究論文發表所需臨床試驗線上註冊相關訊息。參見 http://www.icmje.org/clin_trialup.htm 19. 鼓勵國內臨床試驗計畫,為促進臨床試驗的公開性,受試者的安全保障及滿足大眾對臨床試驗資訊的需求,並彰顯台灣執行臨床試驗之能力及品質,請各試驗委託者於國內臨床試驗計畫獲准執行後,登錄美國國家圖書館建立之公開登記及查詢的臨床試驗登錄資料http://www.clinicaltrials.gov/ct2/home 20. NIH Guide for Grants and Contracts. (1979)Vol. 8,. No. 8,. June. 5,. Page. Five. Application should not be made without consulting these guidelines and grants1.nih.gov/grants/guide/historical/1979_06_05_Vol_08_No_08.pdf 21. NIH Guide: NIH Policy for DATA and Safety Monitoring http://grants.nih.gov/grants/guide/notice-files/not98-084.html 22. A Brief History of Early Drug Regulation in the United States(2009), Society of Toxicology http://www.toxexpo.com/gp/fda.asp 23. The U.S. Kefauver Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act., http://www.fda.gov/cder/about/history/Page32.htm 24. Consumer Bill of Rights is proclaimed by President John F. Kennedy(1962) in a message to Congress. Included are the right to safety, the right to be informed, the right to choose, and the right to be heard. http://www.hcqualitycommission.gov/cborr/ 25. 受試者保護規章(2005):概述在衛生與人類服務部( HHS )規章下 [ 美國聯邦法規( CFR )第 4章第 46 部分 ]使用物件:此檔主要旨在幫助倫理審查委員會管理員、倫理審查委員會主席及其它負責準備和支援倫理審查委員會書面程式的相關機構的工作人員。主旨在幫助倫理審查委員會管理員、倫理審查委員會主席及其它負責準備和支持倫理審查委員會書面程序的相關機構的工作人員。 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 26. Rehnquist J. The globalization of clinical trials: a growing challenge in protecting human subjects. Washington, DC: Department of Health and Human Services, 2001. (DHHS publication no. OEI-01-00-00190.)
摘要: In America, the institution where the clinical trial is carried out has the responsibility for creating an institutional culture of respect and trust in the protection of the rights and welfare of human research subjects. It outlines the separate responsibilities of the institution, as represented through the institutional official, investigators, and the IRB in promoting an ethical and safe research environment. The creation of a supportive institutional culture is based on the ability of all parties to apply the concepts of trust embraced by the Belmont Report and the federal regulations through successful working relationships with their colleagues. History has shown that a breakdown in any level of compliance will weaken the protection of human subjects, erode the public''s trust in scientific research, and result in a demand for broader and stronger regulation and oversight. Consequently, the study of the clinical trial agreement between industry and research institution will bring to light whether the two sides abide by the ethical principles. The development of a template can save time, money and resources. The present study investigates six special elements in the core of agreement, i.e. intellectual property, publication, indemnity, confidentiality, insurance, and anti-corruption principles, by making a comparison of the agreement between major hospitals in Taiwan and foreign pharmaceutical companies in clinical trials to develop one model agreement template. The objective of this thesis is to analyze the clinical trial research agreement and contractual liability. To explore the issue systematically, this thesis is organized as follows: the introduction, a shared responsibility for protecting human subjects through the institutional official, IRB, investigator, pharmaceutical companies and public responsibility and the protection of subjects, medical injuries caused to the subject by clinical trials, clinical trial contracts, clinical trial contract problems and solutions and the conclusions and suggestions. Chapter one contains the introduction. Chapter two analyzes the shared responsibility for protecting human subjects through the Belmont Report to guide research with human subjects and ensure the maintenance of a culture abiding by the following three ethical principles: respect, beneficence and justice. The institution, therefore, is uniquely situated to take responsibility for various aspects of human research. Chapter three is focusing on the protection of human subjects. An analysis of the transnational norms of ethics literature is introduced, and the mechanisms and difficulties in laws and regulations to protect Taiwan''s human subjects are examined. Chapter four analyses the causes in clinical trials which bring injuries to the subject. Clinical trials, like any form of medical procedures, may bring harm to the patient if there is defect in any aspect of the process. More importantly, there is the risk of harm to health that can not be completely eradicated ─ including the risk of psychological harm. In Chapter five, discussion about the “clinical trial agreement” is limited to that between the research institutions and the pharmaceutical companies. Although, unlike the "informed consent," there is no legal basis for it, the agreements are more important, complex and difficult than the "informed consent." Most agreement of transnational clinical trials are in English. But there is a lack of literature to study it, for example, the integrity of its structure, to help understand the legal documents in order to facilitate follow-up exploration of the responsibility of any side involved in the contract. The legal status and responsibilities of companies holding transnational trials, and the difficulties in implementation are also discussed. In Chapter six, an article published in The New England Journal of Medicine by Michelle M. M., is studied to explore problems and solutions related to clinical trial contracts, Also, a comparison of the agreement template of 14 hospitals in Taiwan is made focusing on the six elements of an agreement: intellectual property, publication, indemnity, confidentiality, insurance, and anti-corruption principles. One template is provided for reference. Chapter seven is the conclusions and suggestions. We encourage our colleagues, on behalf of the host institutions, to negotiate with the legal person in the transnational pharmaceutical companies. We wish to have the professional bargaining ability, adhering to the professional standard, but also insisting on justice. One should not think only of "profit" but should think more of "human value". One should learn from China''s ancient philosophy of "Do not do to others what you don''t want to be done to you. ", so that a win-win result which is mutually beneficial to both sides can be achieved.
美國對於保護受試者權益的責任,歸究於機構應負最大的責任。機構代表對所有參與的審查單位與贊助者有監督責任。機構代表,主持人和機構內倫理審查委員會(IRB;Institutional Review Board)(又稱人體試驗委員會)三個不同角色應負起提升醫學倫理及病人安全的研究環境。這三個角色,彼此相信賦予共同的目標:積極建立一個保護受試者,符合 Belmont Report:尊重、行善、及公義三個倫理原則與規範的機構文化。歷史明證,任何保護受試者的防線被破壞,就會瓦解大眾對科學研究的不信任。隨之,受試者招募失敗,立即阻礙了臨床試驗的進行。維護這道防線的重要性,雙方將遵守的倫理與規範都揭示在產業贊助者與試驗機構之間的協議書上。 制訂一份範本可以節省時間,金錢和資源。舉凡,機構與藥廠都分擔著減少花費及加速進行臨床試驗的共識。本論文學習「產研臨床試驗協議」中特殊條款之核心六要件,智慧財產、文章發表、損害賠償、保密、保險條款、與反賄賂原則,比較台灣各大醫院與國外藥廠制訂的臨床試驗契約書,提出一份範本。 本文主旨在論述臨床試驗契約以及契約責任,共區分為「緒論」、「臨床試驗之試驗機構、人體試驗委員會、試驗主持人、大藥廠與大眾的責任」、「試驗之受試者保護」、「臨床試驗造成醫療傷害之事由」、「臨床試驗契約」、「臨床試驗契約的問題與疏困」與「結論與建議」共七章。 第一章「緒論」,說明研究動機與目的,並簡述臨床試驗規範發展、產研協議書探討文獻回顧,及本文之研究方法並界定研究範圍。 第二章「臨床試驗之臨床試驗之試驗機構、人體試驗委員會、試驗主持人、大藥廠與大眾的責任」,首先論述當事人之責任關係。忠誠於三個Belmont倫理原則,尊重、行善、及公義。本章的重點是,臨床試驗機構是這個團隊中唯一要對臨床試驗研究負全責。 第三章「保護受試者」,從臨床試驗的必要性,引申到臨床試驗受試者保護的必要性。分析紐倫堡法典、赫爾辛基宣言、國際醫學組織委員會與世界衛生組織共同制訂的國際倫理準則、及國際醫藥法規協合會的優良臨床試驗規範,闡述現行受試者保護機制之規範依據與發展,次而,審視台灣本土之受試者保護法規、保護機制與施行困境。 第四章「臨床試驗造成醫療傷害之事由」,臨床試驗與一般的醫療作業是類似,係由醫療行為之實施、治療(試驗)藥品之使用與醫療器材之提供所構成。過程中任何一個環節出現瑕疵,就可能給病人帶來醫療損害。還有更重要的討論,是不能完全避免之醫療危險─包括心理傷害的風險。 第五章「臨床試驗契約」,只有討論研究機構與試驗委託者訂定契約書,雖然,不像有法源依據的「受試者同意書」。但是,重要、複雜、困難高於「受試者同意書」。跨國臨床試驗協議書,以英文合約書為主,學理上缺乏討論文獻,舉例其完整的結構來幫助瞭解這份法律文件,以利後續契約責任之探討。也提出有關跨國合作廠商的法律地位、責任與實施困難。 第六章 「臨床試驗契約的問題與疏困」特舉美國Michelle M. Mello, J.D., Ph.D.發表於新英格蘭醫學雜誌的一篇調查文獻 ,逐一詳加解析,是不可多得的文獻。再由協議書核心六要件,智慧財產、文章發表、損害賠償、保密、保險條款、與反賄賂原則比較之,提出一份範本以供參用。 第七章「結論與建議」,鼓勵同行們,肩負著機構的承辦責任,與跨國大藥廠的法規人員談判時,一定要深自期許具有專業的談判能力,要堅持專業,也堅持與生俱來的正義感,思維裡不應只有利益,更要多些人性價值。應該學習中國古老哲學「己所不欲,勿施於人」,讓雙方都能互利雙贏。
URI: http://hdl.handle.net/11455/21160
文章連結: http://www.airitilibrary.com/Publication/alDetailedMesh1?DocID=U0005-2208200901350500
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