後基因體年代之生醫研究倫理及法制---利益衝突問題之類型、影響及其應有規範(III)

Abstract

生物醫學發展至今日，產業界與學術界的關係越來越密切，甚至兩者之間的界限有逐漸模糊的趨勢。過去二十多年來，各國政府皆積極鼓勵生物醫學領域的產學合作，越來越高比例的研究是由藥廠或生技公司提供經費、或是與藥廠或生技公司合作進行。在財務利益的關係上，一方面，產學彼此合作原本就往往包括財務利益回饋做為條件；另一方面，越來越多學術機構人員(或學術機構本身)同時身兼生技公司的發起人或投資人；而且，即使是單純任職學術究機構的研究者，也往往透過專利的取得而可能享有商業利益。針對上述經驗，歐美許多國家近年來發現：產學合作或研發成果商業化固然可能促進科技相關產業及經濟發展，但也可能明顯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誠實正確性。尤其值得注意的是：在生醫研究的領域中，因為往往是以「人」為研究或試驗對象，所以特別還有「是否會因研究機構或研究者自身的利益，而不慎犧牲參與民眾或受試者權益」的顧慮存在。同時，當研究是在醫療機構中進行時，即使不牽涉產學合作或商業利益，只要醫師同時身兼病人的照顧者與研究者的雙重角色，也會有潛在的角色衝突與 (非財務上的)利益衝突存在。針對上述問題，目前許多國際專業組織與學會都已訂定避免「利益衝突」的倫理守則，部份國家(例如美國)並以法令予以明文規範，但我國則處於泰半空白的狀態，對於生醫研究機構、研究人員及受研究民眾而言，皆欠缺足可依循的準則或保護。此等規範或準則欠缺之狀態，不但可能影響相對弱勢的病人及民眾之權益，也可能造成研究機構、研究人員及產業界之困擾，增添其研發時之不確定性與交易成本。因此，本計畫認為：我國推動生醫科技發展之整體政策，需要設法提出能夠同時兼顧「促進科技及產業發展」、「保護受研究對像(病人及一般民眾)」、「保護研究機構及研究人員」、「避免科學之誠實正確性因利益衝突受影響」之多元利益平衡政策。而此一多元利益平衡之目標，不宜僅訴諸於研發機構及人員之個別自省自律，而是可能必須透過一套較具確定性的規範性機制來確保其實現。搭配本計畫所屬之整合型計畫之整體目標，本計畫希望最終能在利益衝突問題之處理上，提出一個研究機構及人員應有之負責任架構(structure of accountability)，並強調此等架構對於生物醫學繼續獲得社會信任與支持之重要性。本計畫將分三年進行。第一年將分析「利益衝突」問題之緣起、性質、類型，以及世界上幾個主要國家對該問題的討論與規範現況。第二年則探討「利益衝突」問題的之現實影響及實證資料，希望能把問題放在事實脈絡當中，做具體探討，而非僅做抽像性的概念探討；必要時本計畫希望能針對台灣現況做實證調查及訪談。第三年將以前兩年的研究成果為基礎，嘗試提出具體可行的倫理守則與法令規範方向，供我國政府部門、學術研究機構及研究人員參考。

In the past two or three decades, one of the features of biomedical research has been the dramatic increase of industry support. As collaboration between industry and academia has been increasing, and the distinction between private and public sectors seems to be blurred in the area of biomedical research, conflict of interest situations will be seen more often. Recently they have raised growing concerns from the policy makers, professional groups, and general public in many countries. 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 will focus 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. The overall goal of this project is to propose a structure of accountability that can ensure the protection of research participants, the performance of researchers』 professional responsibilities, and the objectivity and integrity of science. To accomplish that, this project needs to explore the nature and causes of conflicts of interest, examine their different types and possible different implications, analyze the existing policies/regulations that respond to these implications, and finally propose a policy and a workable mechanism if the foregoing analyses find the existing ones insufficient. Instead of studying only 「law in books,」 this project will attempt to study the 「law in action」 and put issues in actual contexts. In order to achieve so, it mainly adopts three research methods: case study method, interview method (in-depth and focus group interviews with biomedical researchers and IRB members), and comparative socio-legal studies. Moreover, this project will work closely with the other component projects in investigating the protection of human subjects and sample donors, the limitations of the existing mechanisms of informed consent and IRB, and how to manage the risks of and build trust for biomedical research in the post-genomic era.