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.
Highlights
The article examines the legal requirements relating to the informed consent of mentally ill persons to participation in clinical research in South Africa
This is followed by a deliberation on the requirements for the participation of mentally ill persons in research as laid down by the Mental Health Care Act[6] and its Regulations,[7] the National Health Act[8] and the Draft Regulations Relating to Research on Human Subjects,[9] and the Constitution.[10]
As the article has a very specific focus - informed consent to participation in clinical research by mentally ill persons – the discussion on informed consent in South African common, case and statute law is limited to the law as it pertains to mentally ill adult[11] persons; a discussion of the law on informed consent as it pertains to so-called pure 'therapeutic' research; and a discussion of the law as it pertains to controlled clinical trials and not to standard medical interventions or treatment
Summary
South African common law and case law on informed consent do not deal with informed consent in a research setting, and common law and case law do not deal with the informed consent of mentally ill persons to participation in research. With the exception of the Draft Regulations Relating to Research on Human Subjects published for comment in terms of the National Health Act, no statute provides and comprehensively for the informed consent of mentally ill persons to research participation. The achievement of this is a goal that needs to be worked towards.
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