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. |
