A medical research practitioner must not administer a medical research procedure to a person who does not have decision-making capacity to make a medical treatment decision in respect of that procedure unless—
(a) the relevant research project has been approved by the relevant human research ethics committee; and
(b) subject to section 53—
(i) the person has consented to the procedure being administered under an instructional directive; or
(ii) if there is no relevant instructional directive, the person's medical treatment decision maker has consented to the procedure being administered; or
(iii) if the person does not have a medical treatment decision maker, the procedure is authorised under Division 3.