人體生物資料庫通知基因研究「偶然發現」（incidental findings）之倫理及法律問題──兼論臺灣生物資料庫面臨之挑戰與建議

Ethical and Legal Challenges to Returning Incidental Findings from Genomic Research, and Some Suggestions for Biobanks in Taiwan

基因研究普遍改採「次世代定序」技術後，一般預料，基因研究計畫的研究者與提供研究檢體的生物資料庫，遭遇「偶然發現」（incidental finding, IF）的機率將會大幅增加。近年來，包括《台北宣言》及美國法的修正，都要求生物資料庫必須在告知同意程序中說明資料庫處理偶然發現之方式，顯見此一問題逐漸從零星的討論形成全球生物倫理治理的規範課題。但臺灣相關法制與基因研究之實務上，對相關問題尚未有系統性的規劃。本文將介紹偶然發現之情狀與通知義務的核心問題，進一步討論實行面的挑戰，藉以檢討我國現行法制與實務面的不足之處，並提出因應的具體建議。由於各資料庫有其屬性、資源、特色，制度上須保留相當的運作彈性；但修法與主管機關的「行政指導」等措施，能為各資料庫釐清適法風險，並整合有關的資訊及資源，使各資料庫面對「偶然發現」時的措施能合於倫理要求。

Since the wide adoption of Next-Generation Sequencing (NGS) technology in genomic and genetic research, research projects and biobanks are expected to encounter incidental finding (IF) more frequently. The World Medical Association Declaration of Taipei (2016) and U.S.’s revision of the Common Rule both acknowledge and indicate the necessity of addressing this expectation. Nevertheless, law and practice in Taiwan have not planned on responding this issue in a systematic way, and individual research results are returned in very few, if any, situations. This essay first briefly illustrates the essence of IF and the obligation of returning such findings. This essay then discusses the difficulties, ethical challenges, and the corresponding measures when returning IFs is put into practice. Reflections upon Taiwanese current regulations and practice are also included to provide further analysis according to Taiwanese local context. A workable and ethical framework on the return of IFs needs to be built according to each research project and biobank’s own features (e.g. size, research scope, resources and funding, etc.) Still, governmental (i.e. legislative and administrative) actions are needed for biobanks in order to lower the risks of breaching legal requirements and to make the best practice for biobanks governance when dealing with incidental findings according to ethical guidelines and obligations.