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高大法學論叢

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篇名 腦組織研究與利用之倫理規範研析——以日本法經驗為借鑒
卷期 19:1
並列篇名 Researches and Analyses on Code of Ethics of the Research and Utilization of Brain Tissue -Examining the Experience of the Japan
作者 韓政道
頁次 137-182
關鍵字 腦組織腦銀行倫理指引說明同意包括同意brain tissuebrain bankethical guidelinesinformed consentblanket consent
出刊日期 202309

中文摘要

腦科學的研究十分重要,長期以來,世界各國無不投入大量的研究資源,並希望藉由腦組織的勸募、採集及腦組織檢體資料庫(以下簡稱腦庫)的設置,協助人類能對腦神經疾病及其原因等有更深入的理解與研究,藉此研製並開發有效治癒腦部疾病的醫療技術或藥品,廣泛造福社會人民。然而,腦庫雖被認為是近代腦科學研究與新藥研發不可或缺的拼圖,但在腦組織的勸募、採集到儲存與利用等運作過程中,也可能引發各種倫理上的爭端或是權利侵害等風險。相關的問題,我國現有法令是否有不足以因應的情況。本文希望能借鑒於曰本法制及其相關經驗,探討研究者對於存放於腦庫之腦組織或其檢體進行研究與利用時,如何確保腦組織之捐贈者及其相關人員的權益,以及避免倫理上的爭議,這將有助於我國未來腦庫的順暢運作與長期發展。換言之,如何建立一套值得我國社會信賴的腦組織研究與利用規範,應先釐清目前現有法令是否存在不足之處,以及進一步釐清腦組織本身,以及有關其研究與利用的法律性質與定位。同時,腦組織利用前,如何取得捐贈者生前或死後家屬的告知同意,以及超出同意與研究目的範圍外的利用行為又該如何處理,都有必要進行深入探討。總之,在目前我國對本議題尚未有豐富研究的情況下,本文希望能有拋磚引玉之效,為我國未來腦庫運作及相關倫理與權益之保障等有所貢獻。

英文摘要

Research on brain science is very important. For a long time, countries all over the world have invested a lot of research resources, hoping to help mankind to understand the brain through the recruitment and collection of brain tissue and the establishment of a brain tissue sample database (hereinafter referred to as the brain bank). With a deeper understanding and research on cranial nerve diseases and their causes, we can develop and develop medical technologies or drugs that can effectively cure brain diseases and widely benefit the people of society. However, although brain banks are an indispensable puzzle piece for modem brain science research and new drug development, they may also cause various ethical disputes or rights infringements during the recruitment, collection, storage and utilization of brain tissue, risk. A related question is whether there are situations in which our country's existing laws are not adequate. This article hopes to draw on Japan’s legal system and related experience to explore how researchers can ensure the rights and interests of brain tissue donors and related personnel and avoid ethical issues when conducting research and utilization of brain tissue or specimens stored in brain banks. This will contribute to the smooth operation and long-term development of our country’s future brain banks. In other words, in order to establish a set of regulations for the research and utilization of brain tissue that is worthy of the trust of our society, we should first clarify whether there are any shortcomings in existing laws and regulations, and further clarify the legal nature and positioning of brain tissue itself, as well as its research and utilization. At the same time, it is necessary to conduct in-depth discussions on how to obtain the informed consent of the donor’s family members during or after death before using brain tissue, and how to deal with utilization behaviors that exceed the scope of consent and research purposes. In short, as there is currently no extensive research on this topic in our country, this article hopes to serve as a starting point and contribute to the future operation of our country’s brain banks and the protection of related ethics and rights.

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