Korean Journal of Medical Ethics

The Korean Society for Medical Ethics

Korean J Med Ethics 2009; 12(2):165-176

pISSN: 2005-8284, eISSN: 2234-3598

DOI: https://doi.org/10.35301/ksme.2009.12.2.165

Article

임상시험 법률관계에서 미성년자 동의능력의 문제*

류화신¹^,^*

Legal Issues Concerning the Competence of Minors in Clinical Investigation

Hwa-Shin Ryoo¹^,^*

¹충북대학교 법학전문대학원

¹School of Law, Chungbuk National University

^*충북대학교 법학전문대학원. 043-261-3589. lawdeo@cbnu.ac.kr

ⓒ Copyright 2009 The Korean Society for Medical Ethics. This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Published Online: Jun 30, 2009

ABSTRACT

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.

Keywords: 동의능력; 미성년자 동의능력; 임상시험; 피험자; 충분한 설명에 의한 동의

Keywords: Competence; Competence of minors; Clinical investigation; Human subject; Informed consent