合於倫理的審查機制：人體試驗委員會的利益衝突

Ethical Reviewing: Conflicts of Interest in Institutional Review Board

蕭雅純(Ya-Chun Hsiao) ； 陳鋕雄(Chih-Hsiung Chen)

《台灣醫學》 16卷5期 (2012/09) Pp. 510-517

https://doi.org/10.6320/FJM.2012.16(5).07

摘要

為避免生醫試驗因利益衝突而影響受試者安全，人體試驗委員會在審核過程中肩負把關重責。然而人體試驗委員也可能因為自身或機構的財務利益涉及利益衝突，對此台灣目前尚乏明確規範。本文介紹美國法規與國際學術界的見解，提出五項可能處置原則包括：公開揭露、增進人體試驗委員會的獨立性、迴避、持續性監督、成立國家級的損害救濟，以期作為建立台灣相關規範之參考。

關鍵字

生醫研究 ； 利益衝突 ； 人體試驗委員會 ； 公開揭露 ； 迴避

並列摘要

To prevent harms on human subjects in clinical trials, institutional review board (IRB) plays the essential gatekeeper role in the review process. However, members of IRB might face conflicts of interest by themselves because of personal or institutional financial interest, which have not been clearly regulated in Taiwan. This paper introduces relevant American rules and opinions from international academia, and lists five regulatory principles, including public disclosure, enhancing the independency of IRB, withdrawal, continuing monitor, and establishing national injuries compensation fund, and to be reference for making the relevant rules in Taiwan.

並列關鍵字

conflicts of interest ； biomedical research ； institutional review board ； public disclosure ； withdrawal