Children and adolescents experience a variety of psychiatric disturbances, including post-traumatic stress disorders, phobias, obsessive-compulsive disorders, depression, various developmental disorders, eating disorders, and psychotic disorders, as well as intellectual disability.  In a previous contribution, I commented that mentally ill adults are regarded as vulnerable to exploitation in research because there is the potential for their illness to compromise their judgment, reducing their ability to give fully informed consent to research participation.  Mentally ill children and adolescents are still more vulnerable due to their physical and developmental immaturity.
Codes of research ethics, such as the Declaration of Helsinki,  alert researchers to the potential for abuse in these research populations. For example, principle 9 of the Declaration of Helsinki emphasises that vulnerable populations need special protection, and principle 17 requires that health research in vulnerable populations be responsive to their health needs.
Glantz  gives some reasons why mentally ill children and adolescents should be regarded as vulnerable in a research setting. Firstly, because of their psychiatric disorder and youth, they may not be competent to volunteer to participate in a research project, and therefore will be participating either involuntarily or non-voluntarily. Secondly, the person providing proxy consent on their behalf may have various motives and, therefore, may not primarily be concerned with acting in the best interests of the child or adolescent (for example, parents and family who are overwhelmed by the physical and psychological burden of the child's or adolescent's illness). Thirdly, institutionalised mentally ill children and adolescents are removed from the 'ideal' protective parent. Finally, history indicates that mentally ill children and adolescents have been abused and exploited as research participants. [5,6]
Despite these potential pitfalls it is imperative that clinical research is conducted on children and adolescents in order to identify the pathogenesis of their mental illness, to develop effective treatment as well as preventive interventions, and, ultimately, to reduce the effect of mental illness on these children, their families, and the broader community.  It can even be asserted that there is an ethical duty on responsible healthcare professionals to conduct ethically sound research in mentally ill persons--children and adults--so as to alleviate their burden of disease (as part of the ethical duty of care or the ethical principle of beneficence).
This article examines the statutory requirements relating to the consent of mentally ill children and adolescents to participation in clinical research in South Africa, in light of chapter 9 of the National Health Act which came into operation on 1 March 2012.  It begins by summarising the legal context regarding consent in which the newly operational provisions of the National Health Act function. This section is followed by a critical examination of the changes in the legal requirements for children's and adolescents' lawful consent to participation in mental health research in terms of subsections 71(2) and 71(3) of the National Health Act.  Finally, the article suggests some tentative solutions to the problems arising from the provisions of the Act.
The article has a specific focus: the law on informed consent to participation in clinical research by mentally ill children and adolescents. Therefore, the emphasis is on the law as it pertains to clinical research and not to standard medical interventions or treatment.
The assessment of a mentally ill child's or adolescent's capacity to consent to research calls primarily for a clinical rather than a juridical judgment, and should be performed in terms of the existing laws and ethical guidelines on a case-by-case basis by the healthcare professional. …