Legal imperatives for consent for children participating in research

To the Editor: Concerning ‘consent for children participating in research’, I wish to make readers aware that my previous statement1 that s71 of the National Health Act of 20032 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 imperatives4 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

Johannesburg

shan.naidoo@wits.ac.za

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.