Informed consent is a primary precondition of legal and ethical clinical research and is regarded as the 'cardinal principle for judging the propriety of research with human beings'. (1) Based on the ethical principle of respect for personal autonomy, informed consent flows from the recognition that all persons have unconditional worth. (2) Having unconditional worth further implies that those unable or potentially unable to make autonomous decisions, such as the very young, the mentally ill and others, should be protected. (3)
Mentally ill persons are regarded as potentially vulnerable to exploitation in research because their mental illness may inhibit their ability to give fully informed consent to participation. (4) Many scholars have commented on whether mentally ill persons should be allowed to participate in research: in the past, some held that all research with mentally ill persons should be prohibited; others believed that research aimed at bettering the situation of the mentally ill had to be allowed under very circumscribed conditions; (5) today, the quest is to ensure that mentally ill persons are protected against potential exploitation in research, and that appropriate research is undertaken to develop new knowledge in the service of this vulnerable group.
This contribution examines the statutory requirements relating to the informed consent of mentally ill persons to participation in clinical research in South Africa. Ethical research can only be undertaken if these requirements are met and the legal issues that frame the debate are considered.
The article is structured as follows: the juridical basis of informed consent in South African law is outlined before presenting the requirements for lawful consent developed in South African common law and case law. 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.
Juridical foundations of informed consent to research participation
South African law regulates consent to participation in research as part of the wider concept of consent to medical intervention. Before the analysis of informed consent focuses on the Mental Health Care Act, the juridical foundation of informed consent in the South African common, case, statute and constitutional law is briefly established. Because common and case law do not deal with informed consent in a research setting, the general principles of informed consent to medical interventions need to be extrapolated to a research setting.
Under South African law, legal liability for wrongful (delictual) or unlawful (criminal) conduct during a medical intervention is based on one--or a combination of--the following: contractual liability, delictual liability, criminal liability, or professional censure for unprofessional or unethical conduct. (12) Any medical intervention--whether therapeutic or experimental--is considered lawful only in the presence of certain grounds of justification. These are consent, necessity and negotiorum gestio (13) (the list of justifications, however, is not closed). (14) The general criterion determining lawfulness is the boni mores or legal convictions of society. (15) The grounds of justification mentioned here are therefore merely crystallisations of the boni mores test for circumstances that frequently occur in practice. …