醫學研究中利益衝突之倫理反思與處置

Ethical Reflection and Management of Conflict of Interest in Medical Research

本文介紹醫學研究中「利益衝突」之定義與類型、管理利益衝突之重要性與處置原則、國際與美國之利益衝突規範與政策、我國利益衝突規範發展現況，最後以台大醫院為例，介紹醫療機構利益衝突管理之作業程序。作者指出利益衝突存在於人類日常事務的各種層面中，研究者與研究機構必需瞭解他們可能到次要利益的影響，也須瞭解受試者或病患若察覺研究者可能受到次要利益影響時，可能對他們或對進行中的醫療或研究產生疑慮或失去信心。能揭露利益衝突的存在，公開地去檢視、討論它，建立規範、透過審議方式來管理庫，便能開始把問題與傷害減少，進維護醫師與病人、研究者與受試者間的信賴與和諧。

This paper introduces the definition, types, importance, and managing principles of conflict of interest. Relevant international and national guidelines are explored, and the US models and recent Taiwanese development are adopted to illustrate the progress in regulations and policies. The author argues that through disclosure, review and authorization, and prohibition, the problem and negative impact of conflict of interest can be managed and reduced so as to help maintain trust and harmony between research participants and researchers. It is also advised that Taiwan should continue to develop more comprehensive and practical legal regulation concerning conflict of interest governance.