人體生物資料庫法制的變革建議──管制定位的觀點

The Reform of Human Biobank Research Laws: The Perspective of Regulatory Positioning

人體生物資料庫管理條例與人體研究法間具有特別法與普通法之關係，但前者立法在後者之前，使前者在制定時，無由藉思考和一般性規定情境的本質差異來制定契合的規範。影響所及，人體生物資料庫管理條例產生了系統性的偏航，除創造許多解釋適用上的疑難，也有許多規定面臨欠缺正當性之質疑。
本文的目的，即在發掘更具體系性的切入點，並參酌美國的立法例，全面性地檢討人體生物資料庫管理條例，並為未來法制改革提供具體方向。本文認為，供未來不特定研究之用的特徵乃是生物資料庫研究與一般研究區隔的關鍵之點，並據此提出以下二項立法架構上的修正建議，供未來法制改革之參考：從單獨立法到合併立法；從以資料庫現象為中心到以關鍵行為為中心。

The Human Biobank Management Act and the Human Subjects Research Act reflect a relationship between specialized laws and general laws. However, since the Human Biobank Management Act was enacted before the Human Subjects Research Act, it could not draw on the essential differences between biobank research and the general research for which the Human Subjects Research Act is designed to formulate adequate, coherent regulation. The impact of this background has resulted in a systematic deviation. The Act not only creates many questions and problems in interpretation and application, but also contains many provisions that conflict with the regulatory rationale of biobank research.
This article seeks to find a systematic entry point—drawing on the insights from the United States Common Rule—to comprehensively review the Human Biobank Management Act and provide specific directions for future legal reforms. This article argues that the critical point distinguishing biobank research from general research is the feature of providing materials for future unspecified research. Based on that, this article puts forward the following two suggestions regarding the legislative structure for future legislative reform:Transition from separate legislation to combined legislation;Shift focus from biobank phenomenon-centered to key behavior-centered.