The Law About Medical Research on Minors and Consent Requirements: Time to Harmonise the Law?

Abstract

The existing South African legal framework, especially the National Health Act 61 of 2003 (‘NHA’), governs the requirements for children to consent to participate in medical research. However, the NHA undermines the consent of a child to participate in medical research without parental consent, which will be explored. The Constitution of South Africa, the Children’s Act, and the Choice on Termination of Pregnancy Act must also be considered when determining consent requirements for children involved in medical research. The Children’s Act adopts a more flexible approach to consent requirements for medical treatment and acknowledges a child's evolving maturity. Should this be extended to the NHA? The NHA fails to address the evolving autonomy of children. Furthermore, it does not adequately consider sensitive research involving adolescents, such as issues related to sexual and reproductive health. The NHA definition of medical research is also too comprehensive and needs to be categorised to address when parental consent is required, if at all. It is crucial to compare various legislation to the NHA when exploring consent requirements for minors. The incongruencies in our legislation suggest an amendment to the NHA is necessary to align with the Children’s Act and other legislation involving minors and international law. Moreover, the applicability of the POPIA raises a debate among academics about consent requirements for medical research. The POPIA should clarify whether it applies to health research in light of other sectoral legislation that explicitly regulates medical research. Therefore, there is a need to harmonise the current legal framework to allow adolescents to consent to participate in medical research, without parental consent, especially considering their evolving autonomy. Harmonising our legislation is essential to advance medical research and improve healthcare for children in South Africa.