48IConsent of person responsible

48I Consent of person responsible

(1)  The person responsible for a person to whom this Part applies may consent to the conduct of health and medical research in relation to that person if the person responsible reasonably believes that the person would have consented to the conduct of that health and medical research if the person had decision-making ability.

(2)  For the purposes of subsection (1) , in determining whether a person would have consented to the conduct of the health and medical research, the person responsible is to have regard to –

(a) any relevant directions, values or preferences outlined in an advance care directive given by the person in relation to whom the proposed health and medical research is to be conducted; and

(b) if the person has not given any relevant directions, values or preferences in an advance care directive, the views, wishes and preferences expressed by the person other than by way of an advance care directive; and

(c) if the person has not expressed any views, wishes or preferences, what the person responsible reasonably believes the views, wishes and preferences of the person are likely to be, based on all the information available including the values of the person inferred from the person's life; and

(d) whether consent to the conduct of the health and medical research will promote the person's personal and social well-being; and

(e) the likely effects and consequences of the health and medical research, including the likely effectiveness of the health and medical research, and whether these are consistent with the person's preferences and values; and

(f) the likely effects and consequences of the conduct of the health and medical research in relation to that person including –

(i) the known risks of the conduct of the health and medical research; and

(ii) any risks to the person that are greater than the risk that is inherent in the person's condition and in standard medical treatment or health care; and

(g) whether there are any alternatives, including refusing the conduct of the health and medical research.

(3)  For the purposes of , the lead health and medical researcher for a relevant research project is to provide, or cause to be provided, to the person responsible for a person under this Part –