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


Regulations relating to Research with Human Participants

3. Obligations of researchers who conduct research with human particpants


A researcher who conducts health research involving human participants must—

(a) submit the research proposal for ethics review and approval to a registered health research ethics committee and, where applicable, to the Medicines Control Council or any other body required by law, before commencing with the research;
(b) consult with representatives from the participating community or other relevant research stakeholders, where appropriate;
(c) consult with and notify the affected institutional or governmental authorities where necessary;
(d) assess the ongoing welfare of participants and take appropriate steps in the event that participants experience harms;
(e) disseminate research results, whether negative or positive, to research stakeholders, in a timely and competent manner including to participants and participating communities as far as possible; and
(f) register the research in the South African National Clinical Trials Register, if classified as a clinical trial.