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

Regulations

Regulations relating to Research with Human Participants

2. Principles guiding research with human participants

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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.