아동인 연구대상자를 어떤 존재로 바라보고 어떻게 보호하여야 하는가? : <CIOMS 가이드라인 2016>상 아동대상연구 관련 주요내용의 분석을 중심으로

Abstract

Children are considered as those who have not reached the legal adult age, as well as those who need protection, because their physical and mental growth or maturity is not as developed as adults. ˹Bioethics and Safety Act˼ which includes legal provisions for research involving humans, stipulates that children as research participants should be protected by legal representatives, because they are incompetent and undeveloped. However, other than this, no further criteria are provided on how children should be perceived or how to protect them as research participants. In order for a child’s rights to be protected, studies involving children must be conducted, and children should not be maximally excluded or minimally included only because they are vulnerable. At the same time, they must be properly understood and protected on the grounds of being children. In this paper, we analyzed the contents of the study on the protection of children as research participants in the “International Ethics Guidelines for Health-Related Research Involving Humans Subjects,” which was revised and published in 2016 by the Council for International Organizations of Medical Science (hereafter, CIOMS). The study attempted to examine what kind of understanding researchers and Institutional Review Boards should have about children who are research participants, and what protections are appropriate. By comparing this study with the contents of the “International Ethical Guidelines for Biomedical Research Involving Human Subjects,” which was published by CIOMS in 2002, as well as the Declaration of Helsinki and the Belmont Report, this paper attempts to identify the differences and changes in the understanding of children as research participants, and their protection. This is intended to help determine the necessary considerations in preparing future legal and policy criteria for the protection of child research participants. Therefore, CIOMS Guidelines 2016 presents the following new perspectives on children as research participants. First, children are not the ones who should be excluded or minimized in research but the ones who need to be actively studied as participants because they are vulnerable. Second, children are not the ones who must be protected by adults because of their immaturity, but the ones who have various levels of maturity in the process of developing into mature human beings. Third, children are not the ones who has incidentally formal assent with the legal representative’s consent, but the ones who can express his or her true intention and must be respected in substance. Fourth, since the right to privacy and the right to self-determination of personal information should be respected, it may be unreasonable for children to assume the consent of the legal representative unconditionally.