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臺北大學法學論叢 TSSCI

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篇名 生醫材料移轉之契約、法律與倫理議題—以美國經驗為借鑒
卷期 81
並列篇名 Biomedical Material Transfer-The U.S. Experiences on Model Agreement, Legal and Ethical Issues
作者 林昀嫺
頁次 231-274
關鍵字 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 agreementTSSCI
出刊日期 201203

中文摘要

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。

英文摘要

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.

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