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


Regulations relating to Research with Human Participants

5. Informed consent for research with human participants


Human participants, or their legally authorised representatives, must be informed of—

(a) the purpose of the research;
(b) the methods and procedures, including possible randomisation;
(c) alternatives to participation in the research;
(d) the potential harms and risks of harm posed by the research;
(e) the expected benefits of the research;
(f) the freedom to choose to participate or not, or to withdraw from the research without penalty or reason;
(g) the extent to which confidentiality and privacy will be maintained;
(h) details of the contact person in the event of a query or research-related injury;
(i) reimbursement and/or incentives given for participation;
(j) information about the sponsor;
(k) any potential conflict of interests;
(I) information about approval from the health research ethics committee or the Medicines Control Council, where relevant;
(m) insurance in the event of research-related injury, for more than minimal risk research; and
(n) the availability of beneficial products or interventions post-research.