Consent to research by mentally ill children and adolescents: The implications of Chapter 9 of the National Health Act

ABSTRACT

Chapter 9 of the National Health Act came into effect in March 2012. In this article examines, the Act's statutory requirements relating to the informed consent to participation in clinical research by mentally ill children and adolescents in South Africa. 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. The article deliberates upon the limitations of the newly enacted legislation and proposes selective improvements. Because of the likely erosion of the minor's privacy, the article finds that 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. The article recommends that research permissible in minors be stated in terms of well-defined risk standards. Finally, the article finds the requirement set in subsection 71(3) for ministerial consent in the case of non-therapeutic research in children and adolescents to be overly protectionist, as it precludes the capacity of ethics committees to judge the ethics of the proposed research