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. |
Statistics Act, 1999
