Original Research

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

A Nienaber
South African Journal of Psychiatry | Vol 16, No 4 | a262 | DOI: https://doi.org/10.4102/sajpsychiatry.v16i4.262 | © 2010 A Nienaber | This work is licensed under CC Attribution 4.0
Submitted: 14 June 2010 | Published: 01 December 2010

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A Nienaber, Faculty of Law, University of Pretoria, South Africa

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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.


Research law; Clinical research


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