人體生物資料庫關於檢體採集的告知後同意研究－－從倫理、法制到實踐

Research on Informed Consent for Specimen Collection in Human Biobanks: From Ethics and Legal Frameworks to Practical Applications

在生物醫學研究領域，人體生物資料庫的建立與發展已成為推動生物醫學進步的重要基礎設施。生物資料庫不僅促進了疾病研究的加速發展與治療策略的制定，亦為基因體學與個人化醫療等新興科學領域提供了不可或缺的資源。然而，隨著資料庫規模的成長，其所涵蓋的檢體及資料涉及受試者隱私保護、檢體使用的法律依據及告知後同意的有效性等多重法律與倫理議題，亟待深入探討與完善。本文特別著重於以下三大核心議題之分析：第一，告知後同意制度的法律基礎與多階段告知後同意實施之適用性；第二，資料隱私保護措施之設計與規範；第三，檢體財產權歸屬及利益共享機制。本文透過剖析英國、日本及台灣三國之法規與管理架構，深入探討各國在保護受試者權益與促進科學研究進展間之法制平衡機制，並進一步檢視《紐倫堡守則》、《赫爾辛基宣言》、《貝爾蒙報告書》及《台北宣言》等國際倫理規範，評估該等規範對不同國家之生物資料庫法律實踐的影響，及建議台灣《人體生物資料庫管理條例》的改進方向。本文進一步比較近年來國際使用的告知後同意模式，包括「多階段告知後同意」與「動態同意」之具體實踐，並分析其對於提升受試者決策靈活性與資料使用之透明性的影響。最後，本文提出修法建議，包含引入「多階段告知後同意」機制，為台灣人體生物資料庫之告知後同意實務操作與法律規範提供具體參考。

The establishment and development of human biobanks have become essential infrastructure for advancing biomedical research. Biobanks not only accelerate the progression of disease studies and the formulation of treatment strategies but also provide indispensable resources for emerging fields such as genomics and personalized medicine. However, the expansion of biobank scales has introduced significant legal and ethical challenges, including privacy protection for participants, the legal basis for sample utilization, and the validity of informed consent, all of which require thorough analysis and reform. This study focuses on three core issues: (1) the legal foundations of informed consent systems and the applicability of phased informed consent; (2) the design and regulatory efficacy of data privacy protection measures; and (3) the ownership of biological samples and the fairness and transparency of benefit-sharing mechanisms. By analyzing the regulatory frameworks and management models of the United Kingdom, Japan, and Taiwan, the study evaluates how each jurisdiction balances the protection of participants’ rights with the advancement of scientific research. Additionally, the research critically examines the Nuremberg Code, Declaration of Helsinki, Belmont Report, and Taipei Declaration, assessing their influence on the legal practices of biobanks across different jurisdictions and identifying potential gaps within Taiwan’s《Human Biobank Management Act》. This study further explores international developments in informed consent models, specifically ’’Multi-stage Informed Consent’’ and ’’Dynamic Consent,’’ analyzing their practical applications and their roles in enhancing participant decision-making flexibility and ensuring data usage transparency. Based on these findings, the study proposes legislative recommendations, including the introduction of Multi-stage informed consent mechanisms, to provide comprehensive guidance for the practical implementation and legal regulation of informed consent in Taiwan’s human biobanks.