Legal imperatives for consent for children participating in research.
Article Type: Letter to the editor
Subject: Research ethics (Standards)
Human experimentation in medicine (Usage)
Human experimentation in medicine (Ethical aspects)
Human experimentation in medicine (Standards)
Self-experimentation in medicine (Usage)
Self-experimentation in medicine (Ethical aspects)
Self-experimentation in medicine (Standards)
Author: Naidoo, Shan
Pub Date: 06/01/2012
Publication: Name: South African Medical Journal Publisher: South African Medical Association Audience: Academic Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2012 South African Medical Association ISSN: 0256-9574
Issue: Date: June, 2012 Source Volume: 102 Source Issue: 6
Topic: Event Code: 350 Product standards, safety, & recalls; 290 Public affairs Advertising Code: 91 Ethics
Geographic: Geographic Scope: South Africa Geographic Code: 6SOUT South Africa
Legal: Statute: National Health Act of 2003
Accession Number: 293812436
Full Text: To the Editor: Concerning 'consent for children participating in research', I wish to make readers aware that my previous statement (1) that s71 of the National Health Act of 2003 (2) was not in force, is no longer the case. A statement from the National Health Research Ethics Council (NHREC) Chairperson Professor D du Toit informs all stakeholders that s71 of the National Health Act was proclaimed with effect from 1 March 2012. (3) Professor du Toit makes the point that s71 introduces new requirements for health research, 'including (1) written consent (2) consent from a parent or guardian for research with children (3) "therapeutic research" should be in a child's best interest and (4) consent from the Minister must be obtained for "non-therapeutic research" with children'. He further elaborates that 'regulations are yet to be issued providing greater detail and operational guidance to RECs, particularly for the latter requirement'. I deduce that the Minister will probably soon delegate the consent for non-therapeutic research on children to an appropriately defined body such as the NHREC. The ethical imperatives (4) that I raised in my previous letter are now legal imperatives in our country.

Shan Naidoo

Department: Community Health

Member of the HREC (Medical)

Faculty of Health Sciences

University of the Witwatersrand


(1.) Naidoo S. Consent for children participating in research. S Afr Med J 2012;102(3):110.

(2.) National Department of Health. The National Health Act 61 of 2003. Pretoria: Government Printer, 2003.

(3.) Statement from the Council on Proclamation of s71 of National Health Act. Pretoria: National Health Research Ethics Council, Department of Health, 2012.

(4.) National Department of Health. Ethics in Health Research: Principles, Structures and Processes. Pretoria: Government Printer, 2006.
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