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    Title: 生醫科技產學合作之公眾信賴及其課責(accountability):研究倫理與國家規範(II)
    Other Titles: Public Trust and Accountability in Academia-Industry Collaboration in Biomedical Science: Research Ethics and State-Regulation
    Authors: 劉宏恩
    Contributors: 國立政治大學法律科際整合研究所
    行政院國家科學委員會
    Keywords: 生醫科技產學合作;公眾信賴;課責(accountability);倫理;國家規範
    Date: 2012
    Issue Date: 2012-11-27 13:55:15 (UTC+8)
    Abstract: 近年來,各國政府皆積極鼓勵生醫科技領域的產學合作,越來越高比例的研究是由藥廠或生技公司提供經費、或是由學術機構與藥廠或生技公司合作進行。在台灣,立法院還特別制定「生技新藥產業發展條例」,大幅開放政府研究機構之研究人員擔任營利性之生技新藥公司的創辦人、董事或諮詢顧問,政府的政策也積極鼓勵將政府出資的研究成果予以商業化。雖然,產學合作或研發成果商業化可能可以促進科技相關產業及經濟發展,但是這樣的作法也可能改變大學等學術機構的運作及生態,影響部份學術研究者的研究方向和研究態度,在比較極端的情形甚至可能損及科學研究的客觀正確性,或是傷害研究受試者的權益。相關的「利益衝突」問題若未能妥善處理,也可能引發社會大眾對於生醫研究的疑慮與不信任,影響民眾參與研究的意願,生醫科技發展可能因為社會大眾的不支持而遭遇阻礙。 2010 年6 月,中研院生醫所所長陳垣崇因為其產學合作的作法疑似涉及圖利而遭檢調搜索,震驚國內各界。這個事件的發生,顯示我國政府當年從國外引進產學合作模式時,過於偏重經濟面、技術面與商業面的誘因與發展,忽略了制度面的遊戲規則與倫理界限。此事件發生後,各界評論似乎仍然沒有就學術倫理、社會信賴、機構管理責任,或是更廣泛的公益與私益的調和等問題做進一步討論,以致於國內各界仍然停留在各說各話、莫衷一是的停滯狀態。因此,本計畫希望針對生醫科技產學合作的「公眾信賴」及「課責機制」的議題做深入探討,並且將其放在台灣社會的具體脈絡與社會意向中做討論。研究方法上將會調查社會大眾對於生物醫學研究的利益衝突的認知與態度,並設法瞭解此等利益衝突是否會影響民眾對於生醫研究的信賴。此外,本計畫也將訪談生物醫學研究人員,以瞭解國內相關產學合作與利益衝突的實際狀況。更進一步,本計畫將針對國際上對於類似問題的管理制度與論述,以及背後的典範轉移趨勢,做跨國性的比較與分析。最後,本計畫預期將提出一套兼顧研究倫理/學術任務、產業利益/經濟誘因、生醫科技發展、公眾信賴的合理課責機制。
    Conflicts of interest are situations where financial and/or other personal considerations have the potential to compromise or bias professional judgment and objectivity. The “interest” does not necessarily mean “financial interest,” and a conflict of interest can happen at both individual and institutional levels. Conflict of interest issues are important not only because they may lead to harm to particular research participants, but also because they may damage scientific integrity and the pursuit of the truth. On a social level, they may reduce the trust and confidence that people generally have in research. This project focuses on the conflict of interest situations that happen in human subjects research in biomedicine and health science, and it will pay special attention to the proper roles, responsibilities, and professional conduct of researchers. This project has first explored the nature and causes of conflicts of interest and examined their different types and possible different implications. The project has also analyzed the existing policies/regulations that respond to these implications in Taiwan, and unfortunately the foregoing analyses find the existing ones totally insufficient and even ignorant of the conflict of interest issues. This project plans to cooperate with the Center for Survey Research (CSR), Academia Sinica to conduct empirical studies on Taiwanese people’s attitude and understanding of conflict of interest (COI) in biomedical research. Special focus is on whether and how the COI undermines the public’s trust in the research enterprise and medical researchers. The survey result may shed some light on the policy and management of COI that we should develop to ensure public’s trust in biomedical research, and the applicant intends to compare the findings with the findings of similar surveys in other countries to see whether there is any cultural or social difference, and if there is what the policy implications may be.
    Relation: 基礎研究
    學術補助
    研究期間:10108~ 10207
    研究經費:1007仟元
    Data Type: report
    Appears in Collections:[法律與科技整合研究所] 國科會研究計畫

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