從美國法看我國人體試驗未成年受試者保護

Abstract

由於國內目前針對未成年受試者之人體試驗相當缺乏，幼童往往無法接受如同成年人般之醫療照護品質，而常仰賴仿單外用藥，成為幼兒健康照護的一大難題，且除了生醫研究，尚有其他公共衛生領域的非治療性研究，可能帶來的風險不易預期。此外，我國關於未成年受試者保護之法規範並不充足，名詞定義上亦不甚明確，相關條文分散於各個法律與法規命令當中，對臨床試驗研究者於適用上有所不便，有必要加以分析與整理。 本文藉由介紹美國涉及人體試驗未成年受試者保護之重要判決，以現實中曾經發生的真實案例，點出保護未成年受試者的重要性與迫切性，並針對未成年人是否適宜參與人體試驗、參與試驗之風險和利益應如何取得平衡、家長和法定監護人應如何保障子女的自主決定權、人體試驗委員會應如何扮演把關者的角色、法院是否及如何以國家公權力於事前介入審查、及有無需要採用其他額外的保護機制的必要，來確保未成年人不致淪為不當人體試驗底下的犧牲品等議題。本文主要乃比較及分析美國與我國關於未成年受試者保護之規範，希冀能藉以作為我國未來立法與行政上之參考，而在醫療發展與特定未成年受試者保護間取得良善的平衡點。

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.