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. |
Statistics Act, 1999
