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Please use this identifier to cite or link to this item: http://ntour.ntou.edu.tw:8080/ir/handle/987654321/35275

Title: 人體試驗受試者之個人資料保護問題研究
The Study of Personal Data Protection of Subjects Participating Human Trial
Contributors: NTOU:Institute of the Law of the Sea
Keywords: nil
Date: 2013
Issue Date: 2013-10-07T02:52:57Z
Abstract: 摘要 醫學持續進步,乃是基於資訊之發達與不斷創新,與醫療設備及藥物材料等相關研究。而要達到改善醫療診治及預防的目的,也需要「人體試驗」與其他性之研究。本論文旨在探討「人體試驗」相關的法律問題,與受試者安全及相關議題。 個人資料保護係建立於《憲法》對個人之保護基礎,我國在2011年10月通過《個人資料保護法》,對於醫療基因、健康檢查、性生活和犯罪前科等個人資料明確規定屬「敏感性個人資料」,並闡明敏感性個人資料概念、如何使用個人資料、處理模式與保護爭議問題。 此外,「人體試驗」定義及其相關倫理規範,被視為具有強制性的法律,我國也遵循國際法規範研訂「人體試驗」需符合生物醫學及符合倫理及準則,本研究亦從國際法觀點、判例及代表性之宣言及法典說明。 本研究進一步就「人體試驗」受試者醫療資訊之隱私權保護,以及醫療資訊意義及受試者個人資料保護問題,保護個人醫療資訊及措施,以四個國家為例說明國際間「人體試驗」研究個人醫療資訊保護革新。 本研究總結改善「人體試驗」的管理,是刻不容緩的事。唯有藉著獨立專法的設定、專責管理機構、有效評鑑制度、加強專業與生命教育倫理訓練與相關法律修正,以真正達到保障受試者權益的理想目標。
Abstract The progress of medicine is enhanced by the development of medical technology, continuous innovation, and the relevant researches in medical and pharmaceutical science. In order to meet the goal of improving medical treatment and disease prevention, human trial researches and many types of clinical researches are extermely necessary. This thesis is aimed to explore the important issues regarding legal, safety and related terms of trial subjects involved in human trials. The Personal Information Protection Act, based on the foundation of the Constitution of the Republic of China, was promulgated on October 2012 in Taiwan. The purpose of this Act is to regulate proper use of personal sensitive data such as medical record, medical treatment, genetic information, sexual life, health examination and criminal records. Besides, principle, collection, processing and the use of personal information are also clearly defined within the Act. Nowadays, the definition and relevant ethic regulation of human trial are well-recognized and seen as mandatory regulation. The requirements of meeting the biomedical and ethic principle while conducting human trial are also applied In Taiwan. In this thesis, international perspectives, case reports and typical declaration and law are also well discussed. Representative cases from four countries were compared to identify the innovation of personal medical information in the field of human trial research. The protection of personal medical privacy for the participants in human trial are further explored, and the meaning of medical information, related policies, implementation are as well.
URI: http://ethesys.lib.ntou.edu.tw/cdrfb3/record/#G0040046002
Appears in Collections:[海洋法律研究所] 博碩士論文

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