In the context of medical research, children are especially vulnerable to exploitation. As a result several codes of research ethics emphasise the need for special protection. Prior to the implementation of the National Health Act children participating in medical research enjoyed limited legal protection. Instead, research and ethical committees relied on non-research law and ethical guidelines to identify protective measures for children.
The National Health Act establishes a platform for developing a wide range of legal norms for research on human subjects and supplements and strengthens the already existing principles related to informed consent.
The Act deals specifically with consent for child participation in research. Section 71 requires written consent from a parent or legal guardian for a child to participate in all research conducted with minors, irrespective of age. In addition, minors with sufficient understanding must consent alongside their parents or legal guardians.
While the purpose of the Act is to provide legal protection to participants, it fails to take into account the emerging autonomy of the adolescent sufficiently and ignores the fact that many children do not have parents or legal guardians and are cared for by alternative caregivers. These stricter controls are in contravention with other legislation such as the Children’s Act and Choice on Termination of Pregnancy Act, and may also undermine the constitutional rights of children.
The study critically evaluates the consent requirements of the National Health Act with reference to the evolving capabilities of children and the exercise of their parents’ or caregivers’ parental or similar responsibilities and rights, and relevant suggestions are made. The study discusses the conceptual framework related to medical research on children and the applicable international and national regulatory framework. The position before and after the Act came into operation is also assessed. An evaluation of the requirements for consent to be informed is made and a description of the current legal framework related to the acquisition and exercise of parental responsibilities and rights is considered. Specific reference is made to situations where children do not reside with parents or guardians but with alternative caregivers. In conclusion, a comparative study is undertaken and relevant suggestions are made.