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;

"condition"

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

"Council"

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.