A Study on the Regulation of Biomedical Researchers' Relationships with Industry: Focusing on the Disclosure of Conflict of Interest by the Researchers

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