임상시험 법률관계에서 미성년자 동의능력의 문제

This article examines some of the legal issues associated with consent and the competence of minors. A study was designed to evaluate the self-decisions of competent minors who are regarded as vulnerable subjects. The study begins with the Grimes Case (Grimes versus Kennedy Krieger Institute, Inc., 2001), which has established some special relationship between research institutes and human subjects. Since minors do not have the legal competence to complete a contract without the consent of their parents there is a conflict between the consent of parents as guardians and that of minors as self-decision makers. This article argues that the self-decisions of competent minors should take precedence over parental rights and that the authority of parents should be restricted. The article discusses the role of IRBs in protecting the consent of the competent minors.