生物資料庫之倫理治理機制與倫理審查機制的交錯

The Intertwining of Ethics Governance Mechanisms and Ethics Review Mechanisms in the Context of Biobanks

生物資料庫之研究型態涉及了二個層次的倫理議題：一是圍繞著利用生物資料庫資源之個別研究計畫的倫理審查應如何建置；二是關切生物資料庫整體的倫理治理應如何設計。這二個層次的議題是相互交錯關聯的。本文的目的，即在探索生物資料庫脈絡下，倫理審查機制與倫理治理機制在整合上的可能模式，並進行初步的分析比較。從倫理審查機制與倫理治理機制是否由同一組織體負責，以及係以生物資料庫為中心或以外於生物資料庫之研究倫理委員會為中心建置等角度切入，可以觀察到四種不同的整合模式。我國人體生物資料庫管理條例及人體研究法所建構起來的制度模式，具有精細的雙層分工組織與嚴密的雙軌審查程序之優點，足為其他國家仿效之標的。惟另一方面，部分其他國家或個案所採之模式，亦有其相對優勢，或亦值得作為我國未來法制思考之參考借鏡。

Biobank research involves two aspects of ethical issues. One concerns how to construct an ethics review mechanism for individual research projects that exploit biobank resources. The other concerns how to design an ethics governance mechanism for the management of a biobank. These two aspects of issues are intertwined. The purpose of this paper is to explore the potential integrated patterns of ethics review mechanisms and ethics governance mechanisms and provide comparative analysis. Through two perspectives of distinction, this paper identifies four models of the integration of ethics review mechanisms and ethics governance mechanisms. In Taiwan, the Human Biobank Management Act and Human Subjects Research Act construct a model that has sophisticated two levels of organizations and cautious two tracks of review processes. For other countries considering their biobank research regulation, this model is insightful. On the other hand, other models that has been adopted by certain countries or biobanks also have their own advantages, which may be worth to be taken into account when rethinking our regulation in the future.