81Medical research practitioner's certificate

81 Medical research practitioner's certificate

(1) Before, or as soon as practicable after, administering a medical research procedure under this Division (and in the case of a procedure lasting longer than 30 days, at intervals of no longer than 30 days), a medical research practitioner a must sign a certificate—

(a) certifying—

(i) that the person to whom the medical research procedure is being administered does not have decision‑making capacity to make a medical treatment decision in respect of that procedure; and

(ii) that the person's medical treatment decision maker cannot be identified or contacted (as the case may be); and

(iii) as to each of the matters set out in section 80; and

(b) stating that—

(i) the person's medical treatment decision maker (if one is subsequently identified) will be informed of the procedure; or

(ii) if the person recovers decision-making capacity, the person will be informed of the procedure.

(2) The medical research practitioner must inform the person's medical treatment decision maker (if one is subsequently identified) or, if the person recovers decision-making capacity, the person, as soon as reasonably practicable of—

(a) the person's inclusion in the relevant research project; and

(b) the option to refuse the continuation of the procedure and withdraw the person from future participation in the project without compromising the person's ability to receive any available alternative medical treatment or care.

(3) The medical research practitioner must—

(a) forward a copy of each certificate referred to in subsection (1) to the Public Advocate and the relevant human research ethics committee—

(i) in the case of the first certificate, as soon as practicable (and in any event within 2 business days) after administering the procedure; or

(ii) in any other case, at intervals of no more than 30 days; and

(b) ensure that each certificate is kept in the person's clinical records.

(4) A medical research practitioner must not sign a certificate under this section that the practitioner knows to be false.

1. 120 penalty units.

Division 4—Applications to VCAT