Victorian Consolidated Legislation

Guardianship and Administration Act 1986 - SECT 42T

Step 4-Procedural authorisation

42T. Step 4-Procedural authorisation



(1) Step 4 is procedural authorisation for the carrying out of the medical
research procedure on the patient, which applies only if the person
responsible for the patient cannot be ascertained or contacted.

Note This section does not apply to a medical research procedure under section
42A-see section 42P(3).

(2) A registered practitioner may carry out, or supervise the carrying out of,
a medical research procedure on a patient without the consent under section
42S of the person responsible for the patient if-

   (a)  the patient is not likely to be capable, within a reasonable time as
        determined in accordance with section 42R(2), of giving consent to the
        carrying out of the procedure; and

   (b)  steps that are reasonable in the circumstances have been taken-

   (i)  to ascertain whether there is a person responsible and, if so, who
        that person is; and

   (ii) if the person responsible is ascertained, to contact that person to
        seek his or her consent to the proposed procedure under section 42S-
        but it has not been possible to ascertain whether there is a person
        responsible or who that person is or to contact that person; and

   (c)  the practitioner believes on reasonable grounds that inclusion of the
        patient in the relevant research project, and being the subject of the
        proposed procedure, would not be contrary to the best interests of the
        patient; and

   (d)  the practitioner does not have any reason to believe that the carrying
        out of the procedure would be against the patient's wishes; and

   (e)  the practitioner believes on reasonable grounds that the relevant
        human research ethics committee has approved the relevant research
        project in the knowledge that a patient may participate in the project
        without the prior consent of the patient or the person responsible;
        and

   (f)  the practitioner believes on reasonable grounds that-

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

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

   (g)  the 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 patient as compared with
        standard treatment.

(3) Before, or as soon as practicable after, the medical research procedure is
carried out, the practitioner supervising the carrying out of the procedure
(or, if there is no such person, the practitioner carrying out the procedure)
must sign a certificate-

   (a)  certifying as to each of the matters set out in subsection (2); and

   (b)  stating that the person responsible (if any) or the patient (if the
        patient gains or regains capacity) will be informed as required by
        subsection (4).

(4) A registered practitioner involved in the relevant research project must
inform the person responsible (if any) or the patient (if the patient gains or
regains capacity) as soon as reasonably practicable of-

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

   (b)  the option to refuse consent for the procedure to be continued and
        withdraw the patient from future participation in the project without
        compromising the patient's ability to receive any available
        alternative treatment or care.

(5) The registered practitioner supervising the carrying out of the procedure
(or, if there is no such person, the registered practitioner carrying out the
procedure) must-

   (a)  forward a copy of the certificate referred to in subsection (3) to the
        Public Advocate and the relevant human research ethics committee as
        soon as practicable (and in any event within 2 working days) after
        supervising the carrying out of, or carrying out, the procedure; and

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

(6) If-

   (a)  the medical research procedure is a procedure extending over a period
        exceeding one month after a copy of the certificate is forwarded to
        the Public Advocate and the relevant human research ethics committee
        under subsection (5); and

   (b)  the registered practitioner supervising the carrying out of the
        procedure (or, if there is no such person, the registered practitioner
        carrying out the procedure) believes on reasonable grounds that-

   (i)  the requirements of subsections (2)(b) and (8) (if applicable) have
        been met but the person responsible has not been able to be
        ascertained or contacted; and

   (ii) the patient has not gained or regained the capacity to consent- the
        practitioner must, at intervals of not more than one month while the
        procedure continues, sign a certificate, and forward a copy to the
        Public Advocate and the relevant human research ethics committee,
        certifying that each of the matters set out in subsection (2) continue
        to apply.

(7) The registered practitioner supervising the carrying out of the procedure
(or, if there is no such person, the registered practitioner carrying out the
procedure) must ensure that each certificate under subsection (6) is kept in
the patient's clinical records.

(8) If a medical research procedure is being carried out on a patient under
the authority of this section, steps that are reasonable in the circumstances
must continue to be taken (as the case requires)-

   (a)  to ascertain whether there is a person responsible and, if so, who
        that person is; and

   (b)  if the person responsible is ascertained, to contact that person to
        seek his or her consent to the proposed procedure.

Note If the person responsible is contacted and is willing and able to make a
decision (see section 37), section 42S applies. If the patient gains or
regains capacity to consent, his or her consent must be sought, as he or she
will no longer be a person to which this Division applies.