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題名 論生物醫學研究者與廠商間關係之應有規範：以研究者利益衝突之揭露制度為中心
A Study on the Regulation of Biomedical Researchers` Relationships with Industry: Focusing on the Disclosure of Conflict of Interest by the Researchers
作者 李銘杰
Li, Ming Chieh
貢獻者 劉宏恩
Liu, Hung En
李銘杰
Li, Ming Chieh
關鍵詞 利益衝突
揭露
公眾信賴
人體研究法
科學技術基本法
Conflict of Interest
Disclosure
Public Trust
Human Subjects Research Act
Fundamental Science and Technology Act
日期 2015
上傳時間 3-Aug-2015 13:32:11 (UTC+8)
摘要 2010年6月，中央研究院院士陳垣崇接受臺灣士林地方法院檢察署偵查，被指涉嫌違反「貪污治罪條例」及「政府採購法」。事件的起源於，陳垣崇找到一個使用特定藥物會產生嚴重副作用的基因記號，並由中研院申請專利權。而後陳垣崇與親朋好友合資設立「世基公司」，並取得取得中研院專屬授權。此外陳垣崇研究所使用的「核酸分子檢測試劑」、「預測基因檢測試劑」，也僅向這家受專利保護的公司採購。此事件發生後，許多生醫學界的學者站出來力挺陳垣崇，並認為檢調的動作打壓我國生技產業發展，且可能讓有意回國奉獻的海外學者感到卻步。陳垣崇亦於公開信中指出，國內的研發能量越來越充沛，但法令卻未能與時俱進，限制了研究發展。事實上，此事件的背後所隱含的是「利益衝突」（conflict of interests, COI）規範之議題，綜觀陳垣崇事件發生時國內之法律規範，確實如部份生物醫學學者所提，法律未能與時俱進，然而，未能與時俱進的不僅是產學合作之相關法規，亦包含管制研究人員利益衝突之相關規範。陳垣崇事件發生後，我國於2011年11月25日通過「科學技術基本法」部分條文修正案，以及2011年12 月 28 日通過「人體研究法」，皆包含研究人員利益衝突迴避及資訊揭露之規範。然而，這些規範是否能達到其設立之目標，亦即避免利益衝突不當影響了研究之進行與成果之發表，仍需要進一步檢視。利益衝突管制中最重要且必要的手段之一是資訊揭露（disclosure），因此本文分析國內外生物醫學利益衝突規範中與揭露制度有關的內容，並以實證調查資料佐證揭露制度對於研究參與者的重要性，藉此對我國現有的生物醫學利益衝突管制規範提出建議與修正方向。
In June, 2010, Yuan-Tsong Chen, an academician at the Academia Sinica, was investigated by the Taiwan Shi-Lin District Prosecutors Office due to suspected violations of the Anti-Corruption Act and Government Procurement Act. To be brief, Yuan-Tsong Chen had patented his findings through the Academia Sinica, and then a company which was established by Yuan-Tsong Chen, his relatives and his friends obtained the exclusive patent right from the Academia Sinica. In fact, the case mentioned above is one kind of conflict of interest (COI), and it indicated that the regulations on COI was insufficient during that time. After the event, the Taiwan government amended the Fundamental Science and Technology Act” and passed the “Human Subjects Research Act” in 2011, and both Acts included the regulations of COI of researchers. However, it is not clear whether these Acts are effective.
Disclosure of COI by researchers is a necessary part of COI policies. Therefore, this study will examine the current regulations in Taiwan, focusing on the disclosure of biomedical researchers’ COI, and analyze the foreign laws and empirical survey data to summarize the suggestions on amending the Acts.
參考文獻 英文部分
專書
LO, BERNARD & MARILYN FIELD, CONFLICT OF INTEREST IN MEDICAL RESEARCH, EDUCATION, AND PRACTICE (2009).
NEWTON, ISAAC, RULES FOR THE STUDY OF NATURAL PHILOSOPHY (1726).
SWANN, JOHN, ACADEMIC SCIENTISTS AND THE PHARMACEUTICAL INDUSTRY: COOPERATIVE RESEARCH IN TWENTIETH-CENTURY AMERICA (1988).

期刊論文
Agrawal, Shantanu et al., The Sunshine Act — Effects on Physicians, 368 N. ENGL. J. MED. 2054-2057 (2013).
Brennan, Troyen et al., Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers, 295 J. AM. MED. ASSOC. 429-433 (2006).
Camp, Mark et al., Patients’ Views on Surgeons’ Financial Conflicts of Interest, 95 THE JOURNAL OF BONE & JOINT SURGERY 1-8 (2013).
Campbell, Eric, Doctors and Drug Companies — Scrutinizing Influential Relationships, 357 J. AM. MED. ASSOC. 1796-1797 (2007).
Chren, Mary-Margaret & Seth Landefeld, Physicians` Behavior and Their Interactions with Drug Companies, 271 J. AM. MED. ASSOC. 684-689 (1994).
DeAngelis, Catherine, Conflict of Interest and the Public Trust, 284 J. AM. MED. ASSOC. 2237-2238 (2000).
Etain, Bruno et al., Attitudes of Medical Students towards Conflict of Interest: A National Survey in France, 26 PLOS ONE 1-4 (2014).
Gatter, Robert, Walking the Talk of Trust in Human Subjects Research: The Challenge of Regulating Financial Conflicts of Interest, 52 EMORY LAW J. 327- 401 (2003).
Huss, Anke et al., Source of Funding and Results of Studies of Health Effects of Mobile Phone Use: Systematic Review of Experimental Studies, 115 ENVIRON. HEALTH PERSPECT. 1-4 (2007).
Lane, Keryn & Robert Berkow, The Merck Manual: A Century of Medical Publishing and Practice, 22 CBE. VIEWS 112-113 (1999).

網路資源
Institute of Medicine, Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research - Workshop Summary, March 21, 2014, http://www.iom.edu/Reports/2014/Conflict-of-Interest-and-Medical-Innovation-Ensuring-Integrity-While-Facilitating-Innovation-in-Medical-Research.aspx, Last Visited: April 25, 2015.
National Institutes of Health, Frequently Asked Questions, July 29, 2009, http://grants.nih.gov/grants/policy/coifaq.htm#331, Last Visited: March 9, 2015.
National Institutes of Health, Financial Conflict of Interest, September 29, 2014, http://grants.nih.gov/grants/policy/coi/, Last Visited: March 9, 2015.
Association of American Medical Colleges, Implementing the Regulations on Financial Conflicts of Interest: Results from the AAMC Conflict of Interest Metrics Project, April, 2015, https://www.aamc.org/download/429214/data/april2015implementingtheregulationsonfinancialconflictsofintere.pdf, Last Visited: April 24, 2015.
Baker & Mckenzie, Interactions between Life Sciences Companies and Health Care Professionals: Can the French Sunshine Act Push Transparency So Far, 13 April, 2012, http://www.bakermckenzie.com/files/Publication/976c4652-1c6d-4fa6-adb8-f85705a23f05/Presentation/PublicationAttachment/d4893957-c26b-403c-97b5-0a6f93019cc9/al_paris_frenchsunshineact_apr12.pdf, Last Visited: May 28, 2015.
Potomac River Partners, Let the Sun Shine in France: A Summary of the French Sunshine Act & Comparison to the US Law, n.d., http://potomacriverpartners.com/wp-content/uploads/2014/05/French-Sunshine-Act-Quickcard_05.06.14.pdf, Last Visited: May 31, 2015.
Medical Research: Can We Trust It, Hartford Courant, April 09, 2000, http://articles.courant.com/2000-04-09/news/0004080005_1_researchers-academic-science-rezulin, Last Visited: May 20, 2015.
Physician Payment Sunshine Act Final Rule: Research, Policy and Medicine, February 05, 2013, http://www.policymed.com/2013/02/physician-payment-sunshine-act-final-rule-research.html, Last Visited: May 26, 2015.
National Institutes of Health, Summary of Major Changes, September 22, 2011, http://grants.nih.gov/grants/policy/coi/summary_of_major_changes.doc, Last Visited: May 26, 2015.
Taylor Wessing, French Health Industry, Agreements & Gifts, July, 2013, http://www.taylorwessing.com/synapse/ti_frenchhealthindustry.html, Last Visited: May 28, 2015.
描述 碩士
國立政治大學
法律科際整合研究所
101652006
資料來源 http://thesis.lib.nccu.edu.tw/record/#G0101652006
資料類型 thesis
dc.contributor.advisor 劉宏恩zh_TW
dc.contributor.advisor Liu, Hung Enen_US
dc.contributor.author (Authors) 李銘杰zh_TW
dc.contributor.author (Authors) Li, Ming Chiehen_US
dc.creator (作者) 李銘杰zh_TW
dc.creator (作者) Li, Ming Chiehen_US
dc.date (日期) 2015en_US
dc.date.accessioned 3-Aug-2015 13:32:11 (UTC+8)-
dc.date.available 3-Aug-2015 13:32:11 (UTC+8)-
dc.date.issued (上傳時間) 3-Aug-2015 13:32:11 (UTC+8)-
dc.identifier (Other Identifiers) G0101652006en_US
dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/77250-
dc.description (描述) 碩士zh_TW
dc.description (描述) 國立政治大學zh_TW
dc.description (描述) 法律科際整合研究所zh_TW
dc.description (描述) 101652006zh_TW
dc.description.abstract (摘要) 2010年6月，中央研究院院士陳垣崇接受臺灣士林地方法院檢察署偵查，被指涉嫌違反「貪污治罪條例」及「政府採購法」。事件的起源於，陳垣崇找到一個使用特定藥物會產生嚴重副作用的基因記號，並由中研院申請專利權。而後陳垣崇與親朋好友合資設立「世基公司」，並取得取得中研院專屬授權。此外陳垣崇研究所使用的「核酸分子檢測試劑」、「預測基因檢測試劑」，也僅向這家受專利保護的公司採購。此事件發生後，許多生醫學界的學者站出來力挺陳垣崇，並認為檢調的動作打壓我國生技產業發展，且可能讓有意回國奉獻的海外學者感到卻步。陳垣崇亦於公開信中指出，國內的研發能量越來越充沛，但法令卻未能與時俱進，限制了研究發展。事實上，此事件的背後所隱含的是「利益衝突」（conflict of interests, COI）規範之議題，綜觀陳垣崇事件發生時國內之法律規範，確實如部份生物醫學學者所提，法律未能與時俱進，然而，未能與時俱進的不僅是產學合作之相關法規，亦包含管制研究人員利益衝突之相關規範。陳垣崇事件發生後，我國於2011年11月25日通過「科學技術基本法」部分條文修正案，以及2011年12 月 28 日通過「人體研究法」，皆包含研究人員利益衝突迴避及資訊揭露之規範。然而，這些規範是否能達到其設立之目標，亦即避免利益衝突不當影響了研究之進行與成果之發表，仍需要進一步檢視。利益衝突管制中最重要且必要的手段之一是資訊揭露（disclosure），因此本文分析國內外生物醫學利益衝突規範中與揭露制度有關的內容，並以實證調查資料佐證揭露制度對於研究參與者的重要性，藉此對我國現有的生物醫學利益衝突管制規範提出建議與修正方向。zh_TW
dc.description.abstract (摘要) In June, 2010, Yuan-Tsong Chen, an academician at the Academia Sinica, was investigated by the Taiwan Shi-Lin District Prosecutors Office due to suspected violations of the Anti-Corruption Act and Government Procurement Act. To be brief, Yuan-Tsong Chen had patented his findings through the Academia Sinica, and then a company which was established by Yuan-Tsong Chen, his relatives and his friends obtained the exclusive patent right from the Academia Sinica. In fact, the case mentioned above is one kind of conflict of interest (COI), and it indicated that the regulations on COI was insufficient during that time. After the event, the Taiwan government amended the Fundamental Science and Technology Act” and passed the “Human Subjects Research Act” in 2011, and both Acts included the regulations of COI of researchers. However, it is not clear whether these Acts are effective.
Disclosure of COI by researchers is a necessary part of COI policies. Therefore, this study will examine the current regulations in Taiwan, focusing on the disclosure of biomedical researchers’ COI, and analyze the foreign laws and empirical survey data to summarize the suggestions on amending the Acts.		en_US
dc.description.tableofcontents 第一章 緒論 1
第一節 問題意識 1
第二節 研究方法 4
第二章 生物醫學利益衝突問題之理解與管制 5
第一節 利益衝突之概念 5
第二節 利益衝突之類型 7
第三節 管制利益衝突之理由 11
第四節 利益衝突管制之手段 14
第三章 生物醫學研究者利益衝突管制之外國經驗 15
第一節 美國生物醫學研究利益衝突之管制規範 15
第一目 聯邦管制法規之利益衝突相關規定 15
第二目 病人保護及可負擔健保法之利益衝突相關規定 28
第三目 美國利益衝突管制之批評與意見 41
第二節 法國生物醫學研究者利益衝突之管制規範 43
第一目 背景簡介 43
第二目 法國陽光法內容 44
第三目 法國陽光法施行細則 48
第四目 小結 55
第五目 美國與法國陽光法比較 56
第四章 臺灣民眾對生物醫學利益衝突問題之社會意向調查資料 59
第一節 民眾信任度與生物醫學利益衝突問題之關聯性 59
第二節 民眾對於生物醫學研究及其研究者之信任問題 61
第一目 資料來源以及分析方法 61
第二目 民眾對於不同生物醫學資訊提供者之信任度比較 63
第三目 民眾社會意向在生物醫學利益衝突問題上之重要性 65
第三節 民眾對於生物醫學利益衝突之意向態度與其影響因素 75
第一目 資料分析方法 75
第二目 生物醫學利益衝突意向態度之影響因素分析結果 77
第五章 我國關於利益衝突管理之規範與現行法檢討 89
第一節 研究開始前及研究進行中之利益衝突管制規範 89
第一目 研究開始前及研究進行中之相關管制法規 89
第二目 人體研究法通過後執行單位之因應 90
第二節 研究結束後之利益衝突管制規範 97
第一目 研究結束後之相關管制法規 97
第二目 科學技術基本法相關規範通過後執行單位之因應 100
第三節 我國現行利益衝突管制規範之檢討 106
第六章 結論 112
參考文獻 115		zh_TW
dc.format.extent 2486696 bytes-
dc.format.mimetype application/pdf-
dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0101652006en_US
dc.subject (關鍵詞) 利益衝突zh_TW
dc.subject (關鍵詞) 揭露zh_TW
dc.subject (關鍵詞) 公眾信賴zh_TW
dc.subject (關鍵詞) 人體研究法zh_TW
dc.subject (關鍵詞) 科學技術基本法zh_TW
dc.subject (關鍵詞) Conflict of Interesten_US
dc.subject (關鍵詞) Disclosureen_US
dc.subject (關鍵詞) Public Trusten_US
dc.subject (關鍵詞) Human Subjects Research Acten_US
dc.subject (關鍵詞) Fundamental Science and Technology Acten_US
dc.title (題名) 論生物醫學研究者與廠商間關係之應有規範：以研究者利益衝突之揭露制度為中心zh_TW
dc.title (題名) A Study on the Regulation of Biomedical Researchers` Relationships with Industry: Focusing on the Disclosure of Conflict of Interest by the Researchersen_US
dc.type (資料類型) thesisen
dc.relation.reference (參考文獻) 英文部分
專書
LO, BERNARD & MARILYN FIELD, CONFLICT OF INTEREST IN MEDICAL RESEARCH, EDUCATION, AND PRACTICE (2009).
NEWTON, ISAAC, RULES FOR THE STUDY OF NATURAL PHILOSOPHY (1726).
SWANN, JOHN, ACADEMIC SCIENTISTS AND THE PHARMACEUTICAL INDUSTRY: COOPERATIVE RESEARCH IN TWENTIETH-CENTURY AMERICA (1988).

期刊論文
Agrawal, Shantanu et al., The Sunshine Act — Effects on Physicians, 368 N. ENGL. J. MED. 2054-2057 (2013).
Brennan, Troyen et al., Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers, 295 J. AM. MED. ASSOC. 429-433 (2006).
Camp, Mark et al., Patients’ Views on Surgeons’ Financial Conflicts of Interest, 95 THE JOURNAL OF BONE & JOINT SURGERY 1-8 (2013).
Campbell, Eric, Doctors and Drug Companies — Scrutinizing Influential Relationships, 357 J. AM. MED. ASSOC. 1796-1797 (2007).
Chren, Mary-Margaret & Seth Landefeld, Physicians` Behavior and Their Interactions with Drug Companies, 271 J. AM. MED. ASSOC. 684-689 (1994).
DeAngelis, Catherine, Conflict of Interest and the Public Trust, 284 J. AM. MED. ASSOC. 2237-2238 (2000).
Etain, Bruno et al., Attitudes of Medical Students towards Conflict of Interest: A National Survey in France, 26 PLOS ONE 1-4 (2014).
Gatter, Robert, Walking the Talk of Trust in Human Subjects Research: The Challenge of Regulating Financial Conflicts of Interest, 52 EMORY LAW J. 327- 401 (2003).
Huss, Anke et al., Source of Funding and Results of Studies of Health Effects of Mobile Phone Use: Systematic Review of Experimental Studies, 115 ENVIRON. HEALTH PERSPECT. 1-4 (2007).
Lane, Keryn & Robert Berkow, The Merck Manual: A Century of Medical Publishing and Practice, 22 CBE. VIEWS 112-113 (1999).

網路資源
Institute of Medicine, Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research - Workshop Summary, March 21, 2014, http://www.iom.edu/Reports/2014/Conflict-of-Interest-and-Medical-Innovation-Ensuring-Integrity-While-Facilitating-Innovation-in-Medical-Research.aspx, Last Visited: April 25, 2015.
National Institutes of Health, Frequently Asked Questions, July 29, 2009, http://grants.nih.gov/grants/policy/coifaq.htm#331, Last Visited: March 9, 2015.
National Institutes of Health, Financial Conflict of Interest, September 29, 2014, http://grants.nih.gov/grants/policy/coi/, Last Visited: March 9, 2015.
Association of American Medical Colleges, Implementing the Regulations on Financial Conflicts of Interest: Results from the AAMC Conflict of Interest Metrics Project, April, 2015, https://www.aamc.org/download/429214/data/april2015implementingtheregulationsonfinancialconflictsofintere.pdf, Last Visited: April 24, 2015.
Baker & Mckenzie, Interactions between Life Sciences Companies and Health Care Professionals: Can the French Sunshine Act Push Transparency So Far, 13 April, 2012, http://www.bakermckenzie.com/files/Publication/976c4652-1c6d-4fa6-adb8-f85705a23f05/Presentation/PublicationAttachment/d4893957-c26b-403c-97b5-0a6f93019cc9/al_paris_frenchsunshineact_apr12.pdf, Last Visited: May 28, 2015.
Potomac River Partners, Let the Sun Shine in France: A Summary of the French Sunshine Act & Comparison to the US Law, n.d., http://potomacriverpartners.com/wp-content/uploads/2014/05/French-Sunshine-Act-Quickcard_05.06.14.pdf, Last Visited: May 31, 2015.
Medical Research: Can We Trust It, Hartford Courant, April 09, 2000, http://articles.courant.com/2000-04-09/news/0004080005_1_researchers-academic-science-rezulin, Last Visited: May 20, 2015.
Physician Payment Sunshine Act Final Rule: Research, Policy and Medicine, February 05, 2013, http://www.policymed.com/2013/02/physician-payment-sunshine-act-final-rule-research.html, Last Visited: May 26, 2015.
National Institutes of Health, Summary of Major Changes, September 22, 2011, http://grants.nih.gov/grants/policy/coi/summary_of_major_changes.doc, Last Visited: May 26, 2015.
Taylor Wessing, French Health Industry, Agreements & Gifts, July, 2013, http://www.taylorwessing.com/synapse/ti_frenchhealthindustry.html, Last Visited: May 28, 2015.		zh_TW