Legal imperatives for consent for children participating in research.
|Article Type:||Letter to the editor|
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)
|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|
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.
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.
|Gale Copyright:||Copyright 2012 Gale, Cengage Learning. All rights reserved.|