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題名:從美國生醫研究利益衝突新規範檢視我國相關法制
書刊名:醫事法學
作者:李毓華
作者(外文):Lee, Yu-hua
出版日期:2012
卷期:19:2
頁次:頁22-63
主題關鍵詞:利益衝突公眾信賴機構內利益衝突研究倫理Conflict of interestPublic trustInstitutional conflict of interestResearch ethics42 C.F.R. Part 50, Subpart F45 C.F.R. Part 94
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(3) 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:25
  • 點閱點閱:5
利益衝突會腐蝕、侵蝕人們對於生技(生醫)研究活動的信賴,破壞民眾對於科學家及其從事之生技研究活動之信賴,且會削弱科學家彼此間之信賴感。以往揭露利益衝突被視為是管理利益衝突之主要方法,但此種管理利益衝突之措施應該加以改進,且必須建立處理機構內利益衝突之新思維。為了健全生技產業之發展,政府有必要率先提出更新、更有效率之利益衝突管理方式。本文認為,政府可先透過管理政府資金資助之生技研究方式著手,政府應確保其資助之生技研究之客觀性,亦即確保政府資助之生技研究不會因利益衝突而喪失研究客觀性、損及民眾生命、健康,而美國國家衛生主管機關(即HHS及其下屬機構)基於上開理由,於2011年8月修正公布有關「公共衛生經費贊助之研究案申請人有義務促進科學研究之客觀性」(42 C.F.R. Part 50, Subpart F)及「應負責的潛在契約主體」(45 C.F.R. Part 94)此二部分之相關規定,上開規定要求那些接受國家衛生主管機關贊助款項或與國家衛生主管機關合作之機構必須符合上開二部分之監管規定。綜觀規定內容,本文認為此套規範乃將管理學(即專案管理:project management)中有關風險管理(risk management)概念加以法制化,將利益衝突可能造成之研究不客觀之負面效應當成「風險」,藉由系統化之控管措施,監控機構內利益衝突之狀況(風險),透過嚴密的事前、事中、事後風險管制方式,即制訂風險管理政策、辨識風險、制訂風險應對規劃、監督執行風險應對規劃直至風險狀況被控制或消除,以求達到全面監控、管理利益衝突之效果,達到消除或減少利益衝突對於研究客觀性造成負面效益之目的。本文認為這套法制化之風險管理措施兼具原則性以及彈性運用空間,用於處理生技領域中之利益衝突可有效達到預防、監督、控管之效果;藉由介紹上開新規定,並提出對於本國法制之建議以作為未來立法政策之參考。
期刊論文
1.Lemmens, Trudo、Freedman, Benjamin(2000)。Ethics Review for Sale? Conflict of Interests and Commercial Research Review Boards。MILBANK QUARTERLY,78,547-554。  new window
2.湯德宗(20061100)。政府資訊公開法比較評析。國立臺灣大學法學論叢,35(6),37-105+107-115。new window  延伸查詢new window
3.劉宏恩(20101200)。生物醫學產學合作中的利益衝突及其規範。生物醫學,3(4),488-495。  延伸查詢new window
4.(2002)。Scientific Fraud: Outside the Bell Curve. A Major Scientific Fraud Has Just Been Confirmed。Economist。  new window
5.Armstrong, D.(20060711)。Financial Ties to Industry Cloud Major Depression Study; At Issue: Whether It's Safe for Pregnant Women to Stay on Medication. JAMA Asks Authors to Explain。Wall Street Journal,A1。  new window
6.Brown, J. R.(2000)。Privatizing the University: The New Tragedy of the Commons。Science,290,1701-1702。  new window
7.Chalmers, L.(2006)。From Optimism to Disillusion About Commitment to Transparency in The Medico-Industrial Complex。J. R. Soc. Med.,99,337-341。  new window
8.Chan, An-Wen、Altman, D. G.(2005)。Identifying Outcome Reporting Bias in Randomized Trials on Pub Med: Review of Publications and Survey of Authors。BMJ,330,753-758。  new window
9.Couzin, J.、Unger, K.(2006)。Scientific Misconduct, Cleaning Up the Paper Trial。Science,312,38-43。  new window
10.Cyranoski, D.(2006)。Veredict: Hwang's Human Stem Cells Were All Fakes。Nature,439,122-123。  new window
11.Eisenberg, R. S.(2003)。The Robert L Levine Distinguished Lecture Series. Patents, Product Exclusivity and Information Dissemination: How Law Directs Biopharmaceutical Research and Development。Fordham L. Rev.,72(3),477。  new window
12.Emanuel, E. J.、Steiner, D.(1995)。Institutional Conflict of Interest。N. Engl. J, Med.,332,262-267。  new window
13.Healy, David I.(2002)。Conflicting Interests in Toronto: Anatomy of a Controversy at the Interface of Academia and Medicine。Persp. Biol. Med.,45(2),250-263。  new window
14.Holden, C.(2005)。Stem Cell Research. Korean Cloner Admits Lying About Oocyte Donations。Science,310,1402-1403。  new window
15.Kalb, P. E.、Koehler, K. G.(2002)。Legal Issues in Scientific Research。JAMA,287,85。  new window
16.Kassirer, Jerome P.(2001)。Financial Conflicts of Interest。Am, J. L. & Med.,27,149-162。  new window
17.Lemmens, T.、Millers, P. B.(2003)。The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives。J. Law Med. & Ethics,31,398-418。  new window
18.Lemmens, Trudo(2004)。Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene。J. Law Med. & Ethics,32,641-657。  new window
19.Lexchin, J.(2006)。Bigger and Better: How Pfizer Redefined Erectile Dysfunction。Plos. Med.,3,429-432。  new window
20.Moore, Nancy J.(2001)。What Doctors Can Learn from Lawyers About Conflicts of Interest。B. U. L. Rev.,81,445-456。  new window
21.Moynihan, R.、Henry, D.(2006)。The Fight Against Disease Mongering: Generating Knowledge for Action。Plos. Med.,3,425-428。  new window
22.(2011)。Rules and Regulations。Federal Register,76,165。  new window
23.US Department of Health and Human Services(2004)。Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection。Federal Register,69,26393-26397。  new window
24.(20080630)。Suit Alleges Financial Conflict in Clinical Trial。Wall Street Journal。  new window
25.Tiefer, L.(2006)。Female Sexual Disfunction: A Case Study of Disease Mongering and Activist Resistance。Plos. Med.,3,426-440。  new window
研究報告
1.Silberner, J.(2000)。A Gene Therapy Death。  new window
學位論文
1.王凱玲(1999)。生物技術發明之專利保護(碩士論文)。國立臺灣大學。  延伸查詢new window
2.方尚文(2004)。人體試驗對既有醫療法制衝擊之研究--以當事人利益衝突為中心(碩士論文)。中原大學。  延伸查詢new window
3.李毓華(2003)。生物技術授權契約之研究(碩士論文)。東吳大學。  延伸查詢new window
圖書
1.Lo, Bernard、Field, Marilyn J.(2009)。Conflict of Interest in Medical Research, Education, and Practice。Washington, DC:National Academies Press。  new window
2.王偉霖、劉江彬(2010)。國際技術授權移轉制度理論與實務:兼論臺灣例立法與產學因應之策略。臺北市:華泰文化。new window  延伸查詢new window
3.周龍鴻(2007)。風險管理:國際專案管理師培訓教材。高雄市:長宏專案管理顧問有限公司。  延伸查詢new window
4.美國項目管理協會、盧有杰、王勇(2007)。項目管理知識體系指南。北京:電子工業出版社。  延伸查詢new window
5.American Association of Medical Colleges(2001)。Task Force on Financial Conflicts of Interest in Clinical Research. Protecting Subjects, Preserving Trust, Promoting Progress: Policy and Guidelines for the Oversight of Individual Financial Conflict of Interest in Human Subjects Research。Washington, DC:American Association of Medical Colleges。  new window
6.American Association of Medical Colleges(2002)。Task Force on Financial Conflicts of Interest in Clinical Research, Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of Individual Financial Conflict of Interest in Human Subjects Research。Washington, DC:American Association of Medical Colleges。  new window
7.Kurtz, D. L.(1999)。How to Manage Conflicts of Interest--A Guide for Nonprofit Boards。Washington, DC:National Center for Nonprofit Boards Press。  new window
8.Office of Inspector General(2000)。Recruiting Human Subjects: Pressures in Industry-Sponsored Research。Washington, DC:Department of Health and Human Services。  new window
9.Rodwin, Marc A.(2011)。Conflicts of Interest and the Future of Medicine。Oxford University Press。  new window
單篇論文
1.Denis, K. A.(2001)。University Licensing and Technology Transfer(666 PLI/PAT 317-328)。  new window
其他
1.After Hip Replacements。A Lawsuit: Implant Company Paid Penn Surgeon Consulting Fees,http://www.duffyfirm.com/news/afterhip-replacements-a-lawsuit-implant-company-paid-penn-surgeon-consulti/。  new window
2.Nelson, D.,Weiss, R.(20000919)。Penn Researchers Sued in Gene Therapy Death。  new window
3.(20080702)。Patient Sues Surgeon, U Penn Health System Over Undisclosed Consulting Payments, Lauren Uzdienski,http://www.healthpointcapital.com/research/2008/07/02/patient_sues_surgeo_n_u_penn_health_system_over_undis_closed_consulting_payments/。  new window
圖書論文
1.劉靜怡(2009)。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。臺北市:中央研究院法學研究所。  延伸查詢new window
2.Brown, J. R.(2006)。Self-Censorship。Law and Ethics in Biomedical Research: Regulation, Conflict of Interest, and Liability。Toronto:University of Toronto Press。  new window
3.Downie, J.(2006)。Grasping the Nettle: Confronting the Issue of Competing Interests and Obligation in Health Research Policy。Just Medicare: What's In, What's Out, How We Decide。Toronto:University of Toronto Press。  new window
4.Gelsinger, P. L.(2006)。Uninformed Consent: The Case of Jesse Gelsinger。Law and Ethics in Biomedical Research: Regulation, Conflict of Interest, and Liability。Toronto:University of Toronto Press。  new window
5.Kassirer, Jerome P.(2005)。Physicians' Financial Ties with the Pharmaceutical Industry: A Critical Element of a Formidable Marketing Network in Conflicts of Interest: Challenges and Solutions。Business, Law, Medicine, and Public Policy。Cambridge University Press。  new window
6.Hazard, Geoffrey C.(1996)。Conflicts of Interest in the Classic Professions, in Conflicts of Interest。Clinical Practice and Research。Oxford University Press。  new window
7.Krimsky, S.(2006)。The Ethical and Legal Foundations of Scientific "Conflict of Interest"。Law and Ethics in Biomedical Research: Regulation, Conflict of Interest, and Liability。Toronto:University of Toronto Press。  new window
8.Lemmens, T.、Luther, L.(2008)。Financial Conflict of Interest in Medical Research。The Cambridge Textbook of Bioethics。Cambridge University Press。  new window
9.Lemmens, T.(2006)。Commercialized Medical Research and the Need for Regulatory Reform。Just Medicare: What's In, What's Out, How We Decide。Toronto:University of Toronto Press。  new window
10.Perlman, David(2010)。Current Regulations, Comparison of Guidelines, and Considerations for Policy Development。Trust and Integrity in Biomedical Research。The Johns Hopkins University Press。  new window
 
 
 
 
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