National Health Act, 2003 (Act No. 61 of 2003)

Chapter 9 : National Health Research and Information

71. Research on or experimentation with human subjects
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(1)Notwithstanding anything to the contrary in any other law, research or experimentation on a living person may only be conducted—
(a)in the prescribed manner; and
(b)with the written consent of the person after he or she has been informed of the objects of the research or experimentation and any possible positive or negative consequences of his or her health.

 

(2)Where research or experimentation is to be conducted on a minor for a therapeutic purpose, the research or experimentation may only be conducted—
(a)if it is in the best interests of the minor;
(b)in such manner and on such conditions as may be prescribed;
(c)with the consent of the parent or guardian of the child; and
(d)if the minor is capable of understanding, with the consent of the minor.

 

(3)
(a)Where research or experimentation is to be conducted on a minor for a non-therapeutic purpose, the research or experimentation may only be conducted—
(i)in such manner and on such conditions as may be prescribed;
(ii)with the consent of the Minister;
(iii)with the consent of the parent or guardian of the minor; and
(iv)if the minor is capable of understanding, the consent of the minor.
(b)The Minister may not give consent in circumstances where—
(i)the objects of the research or experimentation can also be achieved if it is conducted on an adult;
(ii)the research or experimentation is not likely to significantly improve scientific understanding of the minor’s condition, disease or disorder to such an extent that it will result in significant benefit to the minor or other minors;
(iii)the reasons for the consent to the research or experimentation by the parent or guardian and, if applicable, the minor are contrary to public policy;
(iv)the research or experimentation poses a significant risk to the health of the minor; or
(v)there is some risk to the health or wellbeing of the minor and the potential benefit of the research or experimentation does not significantly outweigh that risk.