2011-05-012024-05-18https://scholars.lib.ntu.edu.tw/handle/123456789/705735摘要：科學研究，不論在社會行為科學領域或生物醫學領域，多以「人」之各種生理、心理、社會面向為其研究課題，而可泛稱為「人類研究」(human subject research)。「人類研究」既以人為對象，則做為研究對象之「人」，其權利福祉如何能獲得符合人性尊嚴之保障，使其得以從單純被操弄之研究客體(object)，轉而成為擁有基本人格之主體(subject)，如何使科學研究之進行，符合研究倫理的要求，即成為從事科學研究之科學社群無可迴避的重要議題。為此，國科會生物處與人文處乃依據「第八次全國科技會議」之決議，於 2009 年 6 月 22 日開始積極推動「人類行為研究倫理與人體研究倫理治理架構建置計畫」，鼓勵大學及研究機構成立相關『研究倫理委員會(REC)』(含行為科學研究)，並加強人員之培訓與輔導，確保審查品質。 為推動並協調各大學建立軟硬體兼備的校級人類研究倫理治理架構，有必要透過國科會進行「人類研究保護計畫辦」以為統籌。本計畫之具體目標為：：協助大學/研究機構建置機構內之人類研究倫理治理架構；此一架構主要由兩部分構成：一為制訂實施倫理治理架構所需之軟硬體設施的「人類研究保護計畫」，二為其他配套措施。本計畫將採行五個步驟以達成上述目標：1.標定利害相關者；2.由下而上形成 HRPP 之實體內涵；3.教育訓練；4.階段實施 HRPP；以及 5.資料蒐集與制度效益評估。此外，本計畫將五個步驟依照任務目標之不同，擬設置「規範與政策擬議」、「登錄、機構擔保與稽核管考」、「教育發展」以及「公眾溝聯」等四個任務分組，交由具特定專長之各 共同主持人執行，以求達到最大效益，具體落實計畫目標。<br> Abstract: Ever since the time when human and its various aspects first became the interests of modern sciences, research involving human subjects has been the common technique of both fields of biomedical sciences and social and behavioral sciences. Thus, how to conduct scientific research in a way that protects the welfare and the interest of the humans so that they are no longer the mere “object” of human sciences but the “subject” with dignity has also been an inevitable topic for academic communities. It is for this reason that both the department of Life Sciences and the department of Humanities and Social Sciences of National Science Council began to promote, according to the resolution of “the Eighth National Conference of Science and Technology,” the establishment of ethical governance framework of human subject research in universities and other academic institutions. Against the above background, the goal of this project is to assist universities/institutions to establish their own “Human Research Protection Programs”, that is, this project will coordinate the emerging issues under the new governance regime and provide other supporting measures. The following five steps will be adopted to achieve its goal: 1. Stakeholders identification; 2. A bottom-up approach to form the local research ethics involving human subjects; 3. Training and education; 4. A 4-phased strategy to implement the new HRPP regime; 5. Data collection and the evaluation of the system effectiveness. In addition, four subgroups, which are the division of regulation and policy, the division of registration, assurances and compliance, the division of education development, and the division of public engagement, will be formed under this project to ensure the above-mentioned steps implemented effectively.