80Administering a medical research procedure if person has no medical treatment decision maker

80 Administering a medical research procedure if person has no medical treatment decision maker

(1) A medical research practitioner may administer a medical research procedure under this Division without consent to a person who does not have a medical treatment decision maker if—

(a) the medical research practitioner believes on reasonable grounds that inclusion of the person in the relevant research project, and being the subject of the proposed procedure, would not be contrary to the following—

(i) the person's values, whether—

(A) expressed by way of a values directive or otherwise; or

(B) inferred from the person's life;

(ii) any other relevant preferences that the person has expressed, having regard to the circumstances in which those preferences were expressed;

(iii) the personal and social wellbeing of the person, having regard to the need to respect the person's individuality; and

(b) the medical research practitioner believes on reasonable grounds that the relevant human research ethics committee has approved the relevant research project in the knowledge that a person may participate in the project without the prior consent of—

(i) the person; or

(ii) a medical treatment decision maker; and

(c) the medical research practitioner believes on reasonable grounds that—

(i) one of the purposes of the relevant research project is to assess the effectiveness of the procedure being researched; and

(ii) the medical research procedure poses no more of a risk to the person than the risk that is inherent in the person's condition and alternative medical treatment; and

(d) the medical research practitioner believes on reasonable grounds that the relevant research project is based on valid scientific hypotheses that support a reasonable possibility of benefit for the person as compared with standard medical treatment.

(2) A medical research practitioner must continue to take reasonable steps to identify and contact the person's medical treatment decision maker to seek consent to the continuation of the procedure on the person.