Protecting Minor Subjects in Human Researches in Taiwan─ From the Perspective of American Law

• Main Authors: Liu, Wei-Ting, 劉瑋庭
• Other Authors: Chen, Chih-Hsiung
• Format: Others
• Language: zh-TW
• Published: 2012
• Online Access: http://ndltd.ncl.edu.tw/handle/99390527004421972455

碩士 === 國立交通大學 === 科技法律研究所 === 100 === Since there are few clinical trials targeting on minors, young children do not have sufficient choice of treatments as adults do. The problem that physicians often have to rely on off-label use to treat minors cannot be solved if scientists and pharmaceutical companies hesitate to conduct clinical trials on children. And besides biomedical research, there are still other non-therapeutic researches in public health areas, possible risks are not easy to be expected. In addition, our legislations and administrative regulations for protecting minor subjects are incomplete, and the languages and terms in some provisions are ambiguous. Furthermore, because relevant provisions are scattered in various laws and regulations, it is quite difficult for clinical researchers to apply. There is a great need to amend and reorganize those rules. This paper introduces several important cases in the United States involving minor subjects in clinical trials, particularly the case of Grimes v. Kennedy Krieger Institute. The relevant issues include whether and when minors could participate in clinical trials, how to strike a balance between risks and benefits, the roles of parents, legal guardian, and institutional review boards in the processes, and whether and when court should intervene or even implement prior reviews. In addition, if the double protection mechanism both failed, are there any additional appropriate mechanisms to protect minor subjects?　Furthermore, this paper reviews and compares the relevant regulations in the United States and Taiwan for the reference of future legislative amendments.