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


Regulations relating to Research with Human Participants

2. Principles guiding research with human participants


Health research that involves human participants must—

(a) comply with the Department of Health national ethical guidelines for research with human participants at a minimum;
(b) be responsive to health needs or priorities of the population, participating community or proposed participants;
(c) have a valid scientific methodology and be likely to provide answers for the specific research questions that are posed;
(d) include a favourable risk-benefit analysis;
(e) ensure that the recruitment and selection process is just and fair;
(f ) be undertaken with appropriate consent processes;
(g) undergo independent review by a registered health research ethics committee;
(h) respect participants' rights, including but not limited to rights to dignity, privacy, bodily integrity and equality;
(i) make provision for compensation for research-related injury, for more than minimal risk research; and
(j) be managed by a lead researcher, or person with similar standing or title, with suitable experience and qualifications.