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題名:人體生物資料庫之合理近用及其專利政策--以我國之商業運用利益回饋為核心
書刊名:智慧財產評論
作者:李崇僖 引用關係星友康
作者(外文):Lee, Chung-hsiHoshi, Tomoyasu
出版日期:2016
卷期:13:2
頁次:頁73-106
主題關鍵詞:人體生物資料庫人體檢體材料移轉契約介入權利益回饋BiobankHuman tissueMaterial transfer agreementMarch-in rightBenefit sharing
原始連結:連回原系統網址new window
相關次數:
  • 被引用次數被引用次數:期刊(2) 博士論文(0) 專書(0) 專書論文(0)
  • 排除自我引用排除自我引用:2
  • 共同引用共同引用:12
  • 點閱點閱:8
人體生物資料庫是當代生醫研究領域重要之公共資源,基於其所擔負之公益性與社會信任,各國皆強調人體生物資料庫之倫理治理重要性,我國甚至以特別立法詳細規範人體生物資料庫之管理與使用原則。本文特別關注其中生物資料應如何提供研究者之合理近用,以及提供研究者使用後,如何規範研究者將研究成果申請專利及行使專利權之問題,比較英國、日本與我國之制度模式後可發現,我國採行之制度模式與英、日兩國明顯不同,我國所創設之商業運用利益回饋制度,在運作上面臨許多實務問題,終究需要透過跨國制度原理比較,才可能找出適切之解決方法。本文最後對我國之制度運作提出具體建議。
Human tissue biobank has become an important resource for biomedical research. Because of the major public interest concerned, most countries have developed their own ethical governance frameworks. In this study, I focus on the norm of data release in different biobanks. How to adhere to fair access principle? What are the duties for researchers after they use the tissue and data from biobank? Can they apply patent of their research results? Whether the biobank has any power to limit the patent implementation? I compare the principles of UK. Biobank, Biobank Japan, and the law in Taiwan. My findings suggest that Taiwan should ponder the consequences of the benefit-sharing obligation, if Taiwan wants to keep in collaboration with international research community.
期刊論文
1.何建志(20130400)。對研究參與者提供利益回饋之法理與實務問題--人體生物資料庫管理條例之檢討。月旦法學,215,32-47。new window  延伸查詢new window
2.HUGO Ethics Committee(2000)。Statement on Benefit Sharing。Eubios Journal of Asian and International Bioethics,10,70-72。  new window
3.顏上詠(20090500)。臺灣人體生物資料庫管理條例草案評析。月旦法學,168,155-171。new window  延伸查詢new window
4.劉宏恩(20070200)。試評日本基因資料庫之相關倫理規範與制度設計--以其組織運作及告知後同意問題之處理為討論核心。月旦法學,141,25-46。new window  延伸查詢new window
其他
1.首相官邸健康‧醫療戰略推進會議2015年1月21日第九次會議資料,http://www.kantei.go.jp/jp/singi/kenkouiryou/suisinkaigi/dai9/siryou3.pdf.。  延伸查詢new window
2.ヒトゲノム・遺伝子解析研究に関する倫理指針(平成13年3月29日),http://www.mhlw.go.jp/file/06-Seisakujouhou-10600000-Daijinkanboukouseikagakuka/sisin1.pdf, 2015/10/10。  延伸查詢new window
3.National Institutes of Health(2003)。Final NIH Statement on Sharing Research Data,https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.。  new window
4.National Institutes of Health(2008)。Modifications to Genome-Wide Association Studies,https://gds.nih.gov/pdf/Data%20Sharing%20Policy%20Modifications.pdf.。  new window
5.UK Biobank(2011)。Access Procedures: application and review procedures for access to the UK biobank resource,http://www.ukbiobank.ac.uk/wp-content/uploads/2011/1 l/Access_Procedures_Nov_2011.pdf.。  new window
6.HUGO Ethics Committee(2000)。Statement on Benefit-Sharing,http://www.hugo-intemational.org/img/benefit_sharing_2000.pdf.。  new window
圖書論文
1.Elger, Bernice、Biller-Andorno, Nikola(2011)。Biobanks and Research: Scientific Potential and Regulatory Challenge。Biobanks And Tissue Research: The Public, The Patient And The Regulation。Springer。  new window
2.Gitter, Donna(2013)。The Challenges of Achieving Open Source Sharing of Biobank Data。Comparative Issues In The Governance Of Research Biobanks。  new window
3.Margoni, Thomas(2013)。The Roles of Material Transfer Agreements in Genetics Databases and Biobanks。Comparative Issues In The Governance Of Research Biobanks。  new window
4.Martin, Richards(2009)。Adrienne Hunt and Graeme Laurie, UK Biobanks Ethics and Governance Council: An Exercise in Added Value。Principles And Practice In Biobank Governance。  new window
 
 
 
 
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