| 摘要: | 人體生物資料庫帶動基因體醫學近二十年之蓬勃發展，促成國際相關倫理規範之訂定並健全各國人體研究與資訊保護相關法規之增修，於新冠病毒襲擊期間，成為突破和加速研發之關鍵所在。類似台灣生物資料庫自一開始持續追蹤二十年後探究因果關係的宏偉企圖，因應科學進步與技術發展，可作為即時解決問題的重要基礎，並能兼顧原始宏遠的初衷，而倫理治理架構的周延性成為生物資料庫因應環境趨勢的成敗關鍵。雖然世界上公眾參與醫學研究之呼籲與嘗試已然成形，但基因研究具特殊意義，所衍生之疑慮，不僅對參與的個人且對整個社會都產生影響。如何透過完善之公眾溝通，並制定新的治理框架來因應，以落實保障參與者之健康福祉，並產生符合公義之研究成果，成為重要課題。
本論文研究內容涵蓋：(1) 透過台灣生物資料庫為主的倫理社會議題之研究，反思生命倫理學面臨之挑戰，提出後基因體時代生命倫理學之發展方向；(2) 有系統整理各國生物資料庫涵蓋公眾參與之相關理論、研究論文與執行方案，檢討其侷限性與迷思；(3) 檢討專業主義由上而下的治理模式，提出專業分眾賦權之概念，分析與檢討台灣生物資料庫先期規劃ELSI 分項所研擬之公眾參與完整策略與群體同意方案完整策略；(4) 探討其他既存之認同社群、社區或共識團體促進生物資料庫公眾參與成功的作法。
本論文研究發現，人體生物資料庫與生物醫學之研究，必須有賴專業人員賦權，以協助參與者提升自主能力，透過不同層級與範圍之社群參與機制之建立，才能協助參與實質參與資料庫之監督與管理，進而對於研究議題能有想法、有意見，才有可能成為共同研究的主體，與研究者共同生產知識，也才有機會建立符合公義之惠益分享機制。而隨人體生物資料庫以及生醫研究與治療方案更密切地整合，並朝向個人化醫療與保健發展，個人研究結果回饋成為重要之倫理治理議題，更需仰賴公眾參與及做決策。在發展的過程中，如何想像更大規模的資訊收集、保存、治理、運用、反饋的通則，在充實其倫理治理架構的同時，並建全整體社會乃至國家生醫研究的倫理治理機制，成為新的世界趨勢。最重要的是具有參與者和研究者兩方面能相得益彰的公眾信賴，以此為基礎，才能支持真正對於民眾健康福祉有益之研究設計帶動生醫研究之成長。
;The flourishing development of genomic medicine over the past two decades has been driven by human biobanks, leading to the establishment of international ethical standards and the enhancement of regulations related to human research and information protection in various countries. During the COVID-19 pandemic, these biobanks became a key factor in breakthroughs and accelerated research and development. Similar to Taiwan′s biobank, which has the grand ambition of exploring causal relationships through continuous tracking over twenty years from its inception, the biobank can serve as a crucial foundation for promptly addressing problems in response to scientific advancements and technological developments while maintaining its original long-term vision. The comprehensiveness of the ethical governance framework becomes the key to the success or failure of the biobank in adapting to environmental trends. Although calls and attempts for public participation in medical research have already taken shape globally, genetic research holds special significance, and the concerns it raises impact not only the individuals involved but also society as a whole. How to address these concerns through effective public communication and the establishment of a new governance framework, in order to safeguard the health and well-being of participants and produce research outcomes that align with justice, has become a critical issue.
The research content of this thesis includes: (1) Reflecting on the challenges faced by bioethics through the study of ethical and social issues primarily based on Taiwan′s biobank, and proposing the direction for the development of bioethics in the post-genomic era; (2) Systematically organizing the relevant theories, research papers, and implementation plans covering public participation in biobanks from various countries, and reviewing their limitations and misconceptions; (3)Reviewing the top-down governance model of professionalism, proposing the concept of professional empowerment, and analyzing and reviewing the comprehensive public participation strategy and community consent plan formulated by the ELSI Project of Taiwan Biobank early planning; (4)Exploring the practices of other existing identity communities, neighborhoods, or consensus groups in promoting successful public participation in biobanks.
This thesis finds that human biobanks and biomedical research must rely on the empowerment of professionals to assist participants in enhancing their autonomy. By establishing community participation mechanisms at different levels and scopes, participants can be substantively involved in the supervision and management of the biobank, enabling them to have ideas and opinions on research topics. Only then can they become co-subjects of the research, jointly producing knowledge with researchers, and have the opportunity to establish a benefit-sharing mechanism that aligns with justice. As human biobanks become more closely integrated with biomedical research and treatment plans, moving towards personalized medicine and healthcare, the return of individual research results has become an important ethical governance issue, which increasingly requires public participation and decision-making. During the development process, how to envision general principles for the large-scale collection, preservation, governance, utilization, and feedback of information, while enriching its ethical governance framework and establishing a comprehensive ethical governance mechanism for biomedical research across society and even at the national level, has become a new global trend. Most importantly, public trust, which benefits both participants and researchers, is crucial. On this foundation, it is possible to support research designs that genuinely benefit public health and well-being, thereby driving the growth of biomedical research. |
