The proxy dilemma: Informed consent in paediatric clinical research - a case study of Thailand

Abstract

Informed consent is an essential requirement for the ethical conduct of research. It is also a necessary requirement for the lawful conduct of research. Informed consent provides a legal basis to enrol human subjects in clinical research. In paediatric research, where children do not generally enjoy a presumption of competence, a legal representative must authorise a child's enrolment. Determining who should act on behalf of the child is a matter of law, rather than ethical principle. But, if national laws are lacking or do not reflect socio-cultural realities, legal uncertainty can arise, which can have implications for children's enrolment in clinical research. Using Thailand as its case study, this paper contemplates how international legal frameworks, such as the UN Convention on the Rights of the Child, could be leveraged to navigate legal uncertainty in the informed consent process, enabling more children to access and participate in paediatric clinical research.