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題名:生醫材料移轉之契約、法律與倫理議題--以美國經驗為借鑒
書刊名:臺北大學法學論叢
作者:林昀嫺 引用關係
作者(外文):Lin, Diana Yun-hsien
出版日期:2012
卷期:81
頁次:頁231-274
主題關鍵詞:材料移轉人體組織利益衝突產學合作模範契約Material transferHuman tissueConflict of interestsAcademia-industry cooperationModel agreement
原始連結:連回原系統網址new window
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  • 共同引用共同引用:25
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產學合作近年來成為我國科技政策之重心,尤其在生醫研究領域,用做基礎研究的材料可能潛藏龐大商業利益,因此在產學合作脈絡下出現了材料移轉契約 (Material Transfer Agreement)。本契約係指研究機構之間、及與私人企業之間移轉研究材料時,用以界定雙方法律上權利義務關係者。為了避免內容繁複、限制甚多的材料移轉契約阻礙材料的流通,美國國家衛生院 (National Institute of Health) 及重點大學因而擬定了模範契約。 本文首先對於產學合作與材料移轉契約的背景與定義加以說明,第 2 章則以美國大學使用材料移轉契約之經驗為基礎,分析並比較哈佛與史丹佛大學之各種類型材料移轉模範契約。鑑於我國生醫領域迭生產學合作的倫理爭議,也由於所移轉之研究材料可能為人體細胞組織,與其他材料相較,具有特殊性質與倫理影響,本文第 3 章將深入探討蒐集與移轉生物材料之過程中,可能涉及之倫理與法律爭議,例如產學合作之利益衝突、以及研究材料歸屬等。依據前兩章的討論,本文第 4 章將針對材料移轉契約在國內的應用加以評析,進而擬定模範契約的內容要點。第 5 章則總結本文的討論並做出建議。
Academia-industry cooperation has become the recent emphasis of national technology policies in Taiwan. In the field of biomedicine, materials of fundamental research potentially could generate immense interests in the commercial application. Material transfer agreements (MTA) are therefore used to allocate rights and obligations of both parties. In order to lower the cost and to expedite the transfer of research materials, U.S. National Institute of Health provides “Uniform Biological Material Transfer Agreement” and “Simple Letter Agreement for the Transfer of Materials”. The first chapter of this article introduces the development of MTA, its importance, definition and content. The next chapter examines the model agreements provided by Harvard University and Stanford University, whose statutes are to be analyzed and compared. The third chapter emphasizes legal and ethical issues concerning collecting and transferring materials involving human tissue. Judging from the recurrent breach of ethical guidelines in Taiwan’s academia-industry cooperation, issues pertaining to conflict of interests and other ethical requirements are to be addressed. Chapter four will comment on the MTA of Academia Sinica in Taiwan before proposing a modified version of model agreement. The fifth chapter concludes with suggestions.
期刊論文
1.王偉霖(20090100)。簡介生物材料移轉契約。全國律師,13(1),5-16。  延伸查詢new window
2.李宗棠(20080100)。美國Washington University v. Catalona 判決評析--學術機構與研究人員對人體組織所有權之爭。法律與生命科學,4,18-30。new window  延伸查詢new window
3.李崇僖、劉源祥(20070900)。以原住民族為對象之基因研究成果利益分享問題。臺灣科技法律與政策論叢,4(3),91-137。new window  延伸查詢new window
4.蔡篤堅(2003)。專題:醫療倫理委員引言。應用倫理研究通訊,25。  延伸查詢new window
5.Kassirer, Jerome P.(2001)。Financial Conflict of Interests: An Unresolved Ethical Frontier。AM. J. L. & MED.,27,149-152。  new window
6.Lemmens, Trudo、Freedman, Benjamin(2000)。Ethics Review for Sale? Conflict of Interests and Commercial Research Review Boards。MILBANK QUARTERLY,78,547-554。  new window
7.Rodriguez, Victor(2005)。Material transfer agreements: open science vs. proprietary claims。NATURE BIOTECHNOLOGY,23(4),489-491。  new window
8.Shaffer, Anthony D.、Ball, David T.(2008)。Washington University v. Catalona: What Questions Remain for The Tissue Ownership Case to Come。J. HEALTH & LIFE SCI. L.,1,101-120。  new window
9.Streitz, Wendy D.、Bennett, Alan B.(2003)。Material Transfer Agreements: A University Perspective。PLANT PHYSIOLOGY,133,10。  new window
10.Thompson, Dennis F.(1993)。Understanding Financial Conflicts of Interest,。THE NEW ENGLAND JOURNAL OF MEDICINE,329,573。  new window
11.Bennett, Alan B.、Streitz, Wendy D.、Gacel, Rafael A.(2007)。Specific Issues with Material Transfer Agreem。INTELLECTUAL PROPERTY MANAGEMENT IN HEALTH AND AGRICULTURAL INNOVATION: A HANDBOOK OF BEST PRACTICES,1,697-698。  new window
12.O'Connor, Sean(2006)。Use of MTAs to Control Commercialization of Stem Cell Diagnostics and Therapeutics。BERKELEY TECHNOLOGY LAW JOURNAL,21(3),1017-1042。  new window
13.陳仲嶙(20080400)。「臺灣生物資料庫管理條例」草案評介。法律與生命科學,5,23-33。new window  延伸查詢new window
14.王偉霖(20060700)。美國產學合作制度利弊之檢討--臺灣科學技術基本法之借鏡。世新法學,3,1-42。new window  延伸查詢new window
15.Eisenberg, Rebecca S.(1996)。Public Research and Private Development: Patents and Technology Transfer in Government-sponsored Research。Virginia Law Review,82(8),1663-1727。  new window
16.劉宏恩(20060400)。論生物醫學研究中利益衝突(Conflict of Interest)問題之規範--以利益衝突之基本概念及其規範上之必要性為討論核心。律師雜誌,319,65-81。  延伸查詢new window
17.劉靜怡(20080900)。「以人為對象」的研究和研究倫理委員會--以美國法制下之「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,3,201-274。new window  延伸查詢new window
18.Harriton, Peter J.(2001)。Faculty Conflicts of Interest in an Age of Academic Entrepreneurialism: An Analysis of Problem。J.C. & U.L.,27,775。  new window
圖書
1.王偉霖、邱文聰(201005)。產學合作引發利益衝突及知識近用限制之研究。2009科技發展與法律規範雙年刊:科學管制、學術研究自由與多元民主價值。  延伸查詢new window
2.(2010)。研究倫理教學手冊。  延伸查詢new window
3.劉靜怡、邱文聰。產學合作關係、利益衝突與科學誠信。2009科技發展與法律規範雙年刊:科學管制、學術硏究自由與多元民主價值。臺北:新學林。  延伸查詢new window
其他
1.(199901)。「科學技術基本法」完成三讀。  延伸查詢new window
2.中央社。採購涉弊中研院生醫所長60萬交保,http://tw.news.yahoo.com/article/url/d/a/100623/5/27xvr.html/, 2010/06/30。  延伸查詢new window
3.中廣新聞網。陳垣崇挨告中研院:盼建置完整產學合作架構,http://tw.news.yahoo.com/article/url/d/a/100623/1/27zpu.html/, 2010/06/30。  延伸查詢new window
4.COGR。Approaches to Developing an Institutional Conflict of Interest Policy-Section One,http://www.cogr.edu/viewDoc.cfm?DocID=151625, 2010/04/26。  new window
5.Council on Governmental Relationship(2000)。A Tutorial on Technology Transfer in U.S. Colleges and Universities 28-30,http://tulane.edu/ott/upload/TT_Tutorial-2.pdf, 2010/07/20。  new window
6.Harvard Office of Technology Development: Guidelines, Policies and Forms: Material Transfer Agreements,http://www.otd.harvard.edu/resources/agreements/materialtransfer, 2010/06/11。  new window
7.Harvard University MTA Submittal Form-Incoming Materials,http://www.otd.harvard.edu/resources/agreements/materialtransfer//#Incoming, 2010/06/11。  new window
8.Harvard University Policy on Conflicts of Interest and Commitment for Senior Officers and Administrators,http://www.ogc.harvard.edu/documents/conflict_policy-senior_officials.doc, 2010/04/30。  new window
9.Incoming MTA from industry to Stanford University,http://www.stanford.edu/group/ICO/industry/ industryMTA.html, 2010/06/11。  new window
10.Office of the Vice Provost and Dean of Researcher, Research Policy Handbook: Chapter 4: Conflicts of Commitment and Interest,http://rph.stanford.edu/Chpt4.html, 2010/04/30。  new window
11.Outgoing MTA for Industry,http://www.stanford.edu/group/ICO/researcher/documents/Outgoing_MTA_Industry7-24-09_001.doc, 2010/06/11。  new window
12.Rules and Regulations,http://www.nih.gov/about/ethics/08252005supplementalfinancialdisclosure.pdf, 2010/06/30。  new window
13.Signatories to the March 8, 1995, Master UBMTA Agreement,http://www.autm.net/AM/Template.cfm?Section=Technology_Transfer_Resources&Template=/CM/ContentDisplay.cfm&ContentID=37800, 2010/11/26。  new window
14.Simple Letter Agreement for the Transfer of Materials,http://www.stanford.edu/group/ICO/researcher/documents/slaform_000.doc, 2010/06/11。  new window
15.SLA MTA,http://www.nhlbi.nih.gov/resources/tt/docum.htm, 2010/06/11。  new window
16.Sponsored Research Agreement Template,http://www.stanford.edu/group/ICO/industry/documents/SRAtemplate2-02-10.doc, 2010/06/11。  new window
17.Standard Human Tissue Transfer Agreements,http://www.stanford.edu/group/ICO/researcher/ reMTA.html#hta1, 2010/06/11。  new window
18.Stanford University Incoming MTA Routing Form,http://www.stanford.edu/group/ICO/researcher/reMTA.html, 2010/06/11。  new window
19.The information on Industry-Sponsored Research Agreements (ISRAs),http://www.otd.harvard.edu/about/sponsoredresearch, 2010/06/11。  new window
20.UBMTA & SLA MTA,http://www.nhlbi.nih.gov/resources/tt/docum.htm, 2010/06/11。  new window
21.Court Jurisdiction。United States Court of Appeals for the Federal Circuit,http://www.cafc.uscourts.gov/about.html, 2010/04/12。  new window
22.Denis, Kathleen A.(2001)。University Licensing and Technology Transfer(666 PLI/PAT 317)。  new window
圖書論文
1.Krattiger, A.、Mahoney, R. T.、Nelsen, L.、Thomson, J. A.、Bennett, A. B.、Satyanarayana, K.、Graff, G.D.(2007)。Contracts and Agreements to Support Partnerships。EXECUTIVE GUIDE TO INTELLECTUAL PROPERTY MANAGEMENT IN HEALTH AND AGRICULTURE INNOVATION: A HANDBOOK OF BEST PRACTICES。  new window
 
 
 
 
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