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


Regulations relating to Research with Human Participants

1. Definitions


In these regulations "the Act" means the National Health Act (Act No. 61 of 2003), and any word or expression to which a meaning has been assigned in the Act, shall bear that meaning, unless the context indicates otherwise—


"best interests"

means significant decisions affecting a minor's life should aim to promote, amongst others, the minor's physical, mental, moral, emotional and social welfare;



means physical and psycho-social characteristics understood to affect health;



means the National Health Research Ethics Council established under Section 72 of the Act;

"health research ethics committee"

means any committee registered in terms of Section 73 of the Act;


"human participant"

means a living person about whom a researcher obtains data or specimens or identifiable private information through intervention or interaction with that person;


"Medicines Control Council"

means the Medicines Control Council established in terms of Section 2 of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) or its successor in title;


"minimal risk"

means the probability and magnitude of harm or discomfort anticipated in the research is not greater than that ordinarily encountered in daily life in a stable society or in routine medical, dental, educational or psychological tests or examinations;


"non-therapeutic research"

means research that does not hold out the prospect of direct benefit to the participant but holds out the prospect of generalizable knowledge;


"significant risk"

means substantial risk of serious harm;


"therapeutic research"

means research that holds out the prospect of direct benefit to the participant;


"vulnerable persons"

means those persons at increased risk of research-related harm, or who are limited in their freedom to make choices, or relatively incapable of protecting their own interests.