Abstract
摘要:任何涉及人類研究參與者的研究,都可能為她/他們帶來風險或產生違背其利益的結果,因此在現今人類知識發展不論生物醫學領域或行為社科領域都確實需仰賴研究參與者來參與研究的情況下,如何設有完善保護研究參與者的機制並確實執行,將是學術永續經營與發展的重要關鍵;而研究倫理治理架構正是其運作關鍵。但由於研究法的不同,生物醫學領域與行為社會科學領域對於研究參與者所可能造成的潛在風險,在生理、心理、社會、經濟…等各層面上也有所不同,經營、管理、維運一個具行為與社會科學特色的研究倫理治理架構,在本校附設醫院早已建置有生物醫學研究倫理審查體制的情況下,就更顯重要。
本校發展具行為與社會科學特色的研究倫理治理架構已有10年,在各期計畫的執行下已漸趨完備,本計畫除了將持續推廣研究人員須盡妥善保護研究參與者之責,且研究設計應符合國際倫理要求的基本觀念之外,在下一年度執行第五期時的研究目的有五:
1、經營、管理、維運行為社科研究倫理治理架構,並朝體制化邁進,準備將此一組織提升為本校的正式單位,以盡大學的社會責任,使本校的研究過程與結果更得社會與學界的認同與信賴。
2、發展本校特色的行為社科研究倫理教育訓練。將設計針對外籍教師與研究人員、國際生等,以母語非中文對象者,符合其需求的研究倫理課程與內容,並以英文授課。
3、持續依據執行經驗,修訂、檢視各項標準作業程序書;並隨國內法規與國際現勢的發展,研擬研究倫理治理架構之相關辦法,保障行為與社會科學研究倫理審查制度確實行。
4、目前已完成審查端的電子化線上審查系統,在此基礎上,將架構行政人員端的行政處理與計畫主持人端的線上填寫審案資料等,第二階段電子化線上系統的研發與測試,以增加行政效率並提升行政人力的專業程度。
5、仍持續協助「北區保護研究參與者聯盟行政管理中心」在處理區盟審查、教育訓練、諮詢服務等相關行政事務等任務上的功能,並擴大招攬服務對象。
Abstract: Any research involving human research participants may bring risks on them or produce a result which is contrary to their interests. Therefore, while the current development of knowledge in the field of bio-medical or behavioral and social sciences really relies on the research participants to participate in studies, how to protect research participants with a sound mechanism and how to run it well, will be an important key to the development and sustainable management of research in academic. All this is called research ethics governance framework.
Over ten years Intensity of effort, the validity of promoting the concept and implementation when do research principal investigators should also take the responsibility to protect research participants at the same time can be seen in National Taiwan University(NTU). In order to make research ethics governance framework more perfect in National Taiwan University and to develop a review organization with social and behavior sciences specificity, we plan to enhance institutional capacity, efficiency and characteristics to be in line with international standards and norms.
The specific objectives of this project include:
(1)to maintain the continuity of research ethics governance framework of NTU, and cumulative reviewing experience in the field of social behavior research ethics committee. We hope to create an ethic review system with distinguishing feature for social/behavior sciences in Taiwan. In the long run, we expect the social and behavioral sciences research ethics governance framework in NTU can get trust from all people in society.
(2)to develop the social- behavioral science research ethics education and training programs with English in NTU for Foreigner teachers and international students whose native language is not Chinese.
(3) to adjust and promote the review system and SOP.
(4)to establish the online review system to simplify the review process and increase review efficiency.
(5) to sustain the function such as reviewing protocols, conducting educational training courses and consultation of “the administrative center of the League of Universities in Northern Taiwan”, and help the league universities to deal with administrative affairs. We believe that making ourselves better is the best way to expand and attract more League partners under our service.
Keyword(s)
研究參與者
研究倫理治理架構
行為與社會科學特色的研究倫理審查制度
標準作業程序書
北區聯盟
Research Participants
the research ethics governance framework
the research ethics committee with behavior and social science specificity
the SOPs
the League of Universities in Northern Taiwan for Human Research Protection Program