Chapter 9 of the National Health Act came into effect in March 2012. In this article, the Act’s statutory requirements relating to the informed
consent to participation in clinical research by mentally ill children and adolescents in South Africa are examined. The necessity of doing
clinical research in mentally ill children and adolescents is canvassed briefly and the requirements that chapter 9 sets out for lawful child and
adolescent consent to research participation are presented. Furthermore, the limitations of the newly enacted legislation is deliberated upon
and selective improvements are proposed.
Because of the likely erosion of the minor’s privacy, the requirement that a parent or legal guardian must consent to children’s and adolescents’
participation in research has the potential to obstruct much-needed mental health research. This requirement is likely to be found
unconstitutional. In certain circumstances, ethics committees tasked with the review of research should be allowed to dispense with parental
consent, and adolescents recognised as having the necessary capacity to consent independently to research participation. Furthermore, the
Act’s classification of research into therapeutic and non-therapeutic categories is considered problematic. It is recommended that research
permissible in minors be stated in terms of well-defined risk standards.
Finally, the requirement set in subsection 71(3) for ministerial consent in the case of non-therapeutic research in children and adolescents is
found to be overly protectionist, as it precludes the capacity of ethics committees to judge the ethics of the proposed research.