Review on Protection Mechanism of Institutional Review Board

• Main Authors: Shwu-Ling Liaw, 廖淑鈴
• Other Authors: Ing-Ling Hou
• Format: Others
• Language: zh-TW
• Published: 2007
• Online Access: http://ndltd.ncl.edu.tw/handle/44749504184303695870

碩士 === 國立成功大學 === 法律學研究所 === 95 === Human civilization and well-being are based on the continuous study and innovation. The development of modern medicine is, too. Medical study is the power to push the medical progress. In Chinese old times, the Sen-lung tasted various herbs to treat people; now, the researcher continuously study new drug to treat people from illness and pain. Any new drug development must go through a sound trial which needs some volunteers or human subjects to take risk of the clinical trial to prove that the treatment is effective. The process of human experimentation goes through lab, animal study and medical study. It is fine if the outcome of study is safe and effective. It will cause serious problem if the physician researcher conducted the study beyond his ability, without sound plan and the informed consent of subjects, especially children, patients with mental illness or having conscious problems, prisoners, or even more the researcher tried to hide the fact of harm from the subjects to violate the subjects’ benefit or result in injury on subjects. The objective of this thesis is to analyze the current protection mechanism of Institutional Review Board (IRB) in Taiwan after reviewing the related regulations. Based on the review of the related Taiwan and international regulations, the thesis provides some suggestions to create an integrated protection for the human subject.