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. |