2005-01-142024-05-17https://scholars.lib.ntu.edu.tw/handle/123456789/681306摘要：人體試驗規範乃發展尖端生物醫學科技產業所必須建立之基礎法制建設。然而，我國現行由醫療法為中心所架構之人體試驗規範，係以「醫療產品」(包含醫療技術、藥品與醫療器材) 之管制為其範疇，未能涵蓋所有涉及人體試驗之科學活動。為保障受試者權益、建構一安全、合理且符合倫理要求之人體試驗環境，有必要獨立針對人體試驗及受試者保護研擬單一統合性之法規範，就受試者同意之落實程序、特殊族群之保護、機構內倫理審查之運作、權能、責任、控管、利益衝突、贊助者與試驗研究者及其所屬機構間之法律權利義務關係等問題，做較為詳盡之處理，同時嘗試與國際規範標準作調和取得一致，使之能具體落實於台灣，期能成為未來獨立立法之草案依據。<br> Abstract: Regulations on human subject research are the legal infrastructure that is quintessential for the advancement of the burgeoning biotechnology industry. The current regulatory scheme, however, centers only on the oversight of medical products, including medical techniques, drugs, and medical devices, and does not cover all other scientific activities that nonetheless involve human subjects. It is therefore critical to explore the possibility of constructing a single, comprehensive legal framework if the rights and the interests of the research subjects are to be protected and a safe and reasonable research environment that is at the same time most in compliance with all ethics demands is to be created. Issues such as how to bring into full play the function of informed consent, how to protect certain subject populations, how to conduct reviews in the institutional review boards, and how to harmonize international standards so as to put them into effect domestically will be addressed. This project is meant to lay a foundation for future legislation.人體試驗受試者保護人體試驗委員會受試者同意倫理審查human subject researchhuman experimentprotection of research subjectsinstitutional review boardIRBethics committeeinformed consentethical review