|
KMID : 1172020190200010001
|
|
Journal of Korean Bioethics Association
2019 Volume.20 No. 1 p.1 ~ p.24
|
|
|
The need and legal Issues to approve exceptions to principles of obtaining informed consent from legally acceptable representative in research involving children
|
|
Choi Seul-Bi
Kim Eun-Ae
|
|
|
Abstract
|
|
|
|
In principle, in order to enroll children as research participants, informed consent(hereafter, IC) from their legally acceptable representatives(hereafter, LAR) should be in place. Children are deemed incapable of giving complete IC. 「Bioethics & Biosafety Act(hereafter, BioAct)」 stipulates that, for children under the age of 18 years old, researchers must obtain IC from their LAR. However, forcing researchers to obtain IC from children’s LAR(here after, LAR’s IC) can cause some problems both to protect children as research participants and to conduct research involving children. For example, it may not be appropriate to obtain LAR’s IC in research on violations of social norms or privacy, such as child’s deviation, domestic violence, or sexual experience. Despite differences in children’s understanding and maturity depending on age, prohibiting all children to participate in research unless LAR’s IC is too restrictive. Therefore, this article points out that there is a need to approve the exceptions to LAR’s IC in research involving children and analyses legal issues under the 「Bio Act」. Finally, this article suggests that the provisions including a basis for granting authority to the Institutional Review Board(hereafter, IRB) for approval of exceptions must be established in 「Bio Act」. And this article proposes that consideration to approve exceptions by IRB review should be made in that provisions such as research purpose and characteristics, research, procedures and method of the research, associated risks and benefit(especially to children as research participants), effect of obtaining LAR’s IC on children’s self-determination and privacy protection, ability to give IC or assent of children as research participant and preparation by researcher to obtain IC or assent of children, and special additional protections for children as research participants so that both the adequacy of the exercise of rights and the protection of children as research participants are possible.
|
|
|
KEYWORD
|
|
|
research involving children, obtaining informed consent, legally acceptable representative, exemption of obtaining informed consent, informed consent by legally acceptable representative, Institutional review board
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|