人體試驗之倫理與法律

Ethics and Laws Related to Human Subject Research

醫療的進步有賴「人體試驗」的實施來成就，然人體試驗乃係於人體施行療效未經證實之新藥品、新醫療技術、新醫療器材，因其具高風險性，受試者雖一方面受益於人體試驗之醫療研究結果，但亦有可能成為失敗的人體試驗下之犧牲品。違法人體試驗之新聞，時有所聞，除了造成受試者健康受損、身心煎熬，亦可能演變出教人傷神的法律糾紛，因此瞭解人體試驗之倫理、法律對防止人體試驗糾紛或有助益。歷史是借鏡，本文嘗試翻開歷史淺談紐倫堡宣言、赫爾辛基宣言、貝爾蒙報告，故而將介紹人體試驗之倫理與法律，並輔以說明人體試驗之特色、定義、歷史發展與新聞事件。鑑於愈來愈多護理人員投入人體試驗市場，擔任研究助理的角色，希望本文可以增加研究護士的倫理觀與法律觀，進而保障受試者權益。

Advances in medical technology rely on human subject research to test the effects on real patients of unproven new drugs, equipment and techniques. Illegal human subject research happens occasionally and has led to subject injury and medical disputes. Familiarity with the laws and established ethics related to human subject research can minimize both injury and disputes. History is a mirror that permits reflection today on past experience. Discussing the Nuremberg Code, the Declaration of Helsinki and Belmont Report, this article describes the laws, ethics, history and news related to human subject research as well as the current definition and characteristics of human subject research. Increasing numbers of nurses serve as research nurses and participate in human subject research. The authors hope this article can increase research nurse knowledge regarding laws and ethics in order to protect human research subjects adequately.