2026-11-092026-11-09https://scholars.csmu.edu.tw/handle/123456789/38812The researches in the fields of human, social and behavioral sciences (HSB) are now required to have IRB’s approval before the research begins when the nature of research has something to do with human information such as the life style, social interactions, behavioral patterns…etc. Many scholars in these fields ask why such a procedure is needed since their research will not involve any invasive procedures such as tissue taken or drug in-taking. A review mechanism in Taiwan becomes indispensable but our IRBs that have been established within all medical centers or teaching hospitals are targeting on biomedical research projects not the research in the fields of human, social and behavioral sciences. When this demand becomes necessary, we must design a system for this purpose. This research proposal therefore is presented. According to PRIMER of USA, the need of ethical review of the research projects in human, social and behavioral sciences is due to the protection of human privacy and autonomy. The methods usually used by these sciences to gather data and information are through questionnaire survey and qualitative approach that interviews the prospective human subjects. In the process, the interview or survey may violate the confidentiality of each individual, for instance, when phone survey is sued, the person who answers the phone may not be the person who the study project intends to talk to thus creating some doubt and suspension damaging to the dignity of the original target. When questionnaire approach is taken, the questions sometime may have some personal nature that makes the subjects uncomfortable. Therefore, ethical consideration must not be neglected and review needed. This proposal will carry through these steps: 1. to gather regulations and rules of this review process used in the developed countries that have this HSB reviewing function established as a guide for Taiwan’s reference. 2. to survey how Taiwan’s existing IRB looks at this new demand and how they respond to it when such a protocol is presented for ethical approval. A questionnaire will also be sent to random scholars to see what they think about this new procedure and how they expect it to serve them. 3. to design a system that is workable in Taiwan that sticks to the principle of the ethicality of research projects for the HSB protocols. In short, this study will collect the data from developed countries to see how they respond to the demands of a reviewing requirement of the research focused on human, social and behavioral sciences. Then, a survey will be done domestically to find out how researchers in Taiwan see this new trend and also investigate how many cases/protocols in these related fields were reviewed in the last few years. A design will be attempted to set up an appropriate IRB for the human, social and behavioral sciences.人體試驗之審查機制已不再限於生物醫學有侵入性(invasive)的新醫療科技或藥物的 研究。近幾年來人體試驗之倫理性審查, 已擴展至人文社會及行為科學。不過人文社會 及行為科學之研究其實並沒有實行侵入人體之試驗,如抽血、吃藥物或未曾被認定的新 醫療嘗試,為什麼還要倫理審查?而要審查的又是什麼?這是人文社會及行為科學學者 對研究案件首先須通過倫理審查才能著手研究的疑惑。因之本研究首先要收集國際上已 有人文社會及行為科學倫理審查機制之國家的規範與理由,再而調查本國學者對此之需 求之看法,並以問卷方式調查目前台灣已成立40個IRB一年中有關這方面之案件之情況 及審查內容與方法,最後本研究將提出一個適合本地之機制,同時並提出對人文社會及 行為科學之研究也需要倫理審查之學理探討。 基本上,由美國PRIMER 之解說觀之,這方面之研究需要倫理審查是因人身保護不 應只是生理的,也應是心理的及社會的,因為人文社會及行為科學之研究常須用田野調 查方式來取得資訊,但在過程中就會使參與者的隱私受到公開化的危險,例如電話問卷 時可能接電話的不是受試者本人,很有可能使受試者過去的行為曝光。如以親自訪談方 式則有可能某些問題涉及隱私及家庭內幕造成傷害,因之問卷調查之內容必須合乎有倫 理性, 又訪談者必須受訓練,才能達到受試者之保護。特別在台灣比較傳統之社會裡, 這方面的考慮就必須慎重以對。台灣已開始建立全民之生命資料庫(biobank),這個資料 庫將不只是DNA 之研究,生活習慣、社會交往、個人性向⋯,都需要資訊,人文社會 及行為科學方面之調查將因而增加,本計劃將針對上述議題提出可行的方案。1研究倫理2IRB 3人體保護4行為社會人文研究IRBHuman subject experiment and protectionResearch in behavioralsocial and human sciences人文社會及行為科學之人体試驗研究的倫理審查機制Project