The regulation of informed consent to participation in clinical research by mentally ill persons: An overview

Abstract

The article examines the legal requirements relating to the informed consent of mentally ill persons to participation in clinical research in South Africa. First, the juridical basis of informed consent in South African law is outlined; and second, the requirements for lawful consent developed in South African common law and case law are presented. Finally, the article deliberates upon the requirements for the participation of mentally ill persons in research as laid down by the Mental Health Care Act and its regulations, the National Health Act and its (draft) regulations, and the South African Constitution.

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

“…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. [2] Finally, the article suggests some tentative solutions to the problems arising from the provisions of the Act.…”

“…As subsection 71(1) of the National Health Act was the focus of a previous contribution, [2] only its salient points are highlighted here: consent to participation in research needs to be in writing (the previous common law position prescribed no formalities) and the research participant needs to be informed of the object of the research or experimentation as well as 'any possible positive or negative consequences to his or her health' . Although it seems that proxy consent is excluded from the operation of section 71(1) (the use of 'consent of the person'), it is unlikely that the section will be interpreted by the courts to exclude proxy consent.…”

“…[19] (I have previously discussed the Draft Regulations Relating to Research on Human Subjects that were published in 2007 but which are currently being re-drafted). [2] Consequently, one has to rely on the National Health Act to ascertain the requirements regarding participants' consent to such research.…”