Medical research - Victorian Law Reform Commission

14.8 A ‘medical research procedure’ is defined in the current Act as:
A procedure carried out for the purposes of medical research, including, as part
of a clinical trial, the administration of medication or the use of equipment or a
device… 3
14.9 The Act specifically excludes some procedures from its definition of a ‘medical research
procedure’, such as a non-intrusive examination (including a visual examination of the
mouth, throat, nasal cavity, eyes or ears or the measuring of a person’s height, weight
or vision), observing a person’s activities, undertaking a survey, or collecting or using
information including personal or health information. 4
14.10 The G&A Act establishes a four-step process for authorising a person’s participation
in a medical research procedure where they are unable to consent to that procedure.
Those steps are:
• Step 1: determine whether the research project is approved by the ‘relevant
human research ethics committee’. 5 Approval of the project is required before the
medical research procedure may be carried out and the procedure must be carried
out in accordance with any conditions of the approval.
• Step 2: determine whether the patient is likely to be able to consent to the
research procedure within a reasonable time. If this is likely, then the research
procedure should not go ahead until the patient is able to consent to it. 6 If the
patient is not likely to be able to consent within a reasonable time, Step 3 applies.
• Step 3: obtain the consent of the ‘person responsible’. 7 The person responsible
can consent to the procedure if they believe that it would not be contrary to the
patient’s best interests. 8 If it is not possible to comply with this step because the
person responsible is not available, Step 4 applies.
• Step 4: ‘procedural authorisation’ applies when the person responsible cannot be
identified or contacted. It allows a registered practitioner to carry out the research
procedure if the practitioner certifies that a number of things have been done and
that the practitioner holds a number of beliefs about the research project and the
person concerned. The practitioner must hold particular beliefs about:
– the best interests of the patient
– whether the ethics committee was aware that the research might involve
people who are unable to consent
– whether the procedure adds to risks the patient faces because of their
medical condition
– whether there is a reasonable scientific likelihood that the patient will benefit
from the research procedure. 9
14.11 The effect of Step 4 is that the person implementing the research procedure becomes
the substitute decision maker for a person who is unable to make a decision about
their own participation if there is no person responsible available to authorise
participation.
3 Guardianship and Administration Act 1986 (Vic) s 3(1). The definition also includes any procedures prescribed by regulations to be medical
research procedures. There are no additional procedures in regulations.
4 Guardianship and Administration Act 1986 (Vic) s 3(1).
5 Ibid s 42Q. The term ‘relevant human research ethics committee’ is defined in somewhat circular fashion in section 3 of the Act to mean ‘the
human research ethics committee responsible for approving the relevant research project’.
6 Guardianship and Administration Act 1986 (Vic) s 42R.
7 The appointment and role of the person responsible are discussed in Chapter 13.
8 Guardianship and Administration Act 1986 (Vic) s 42S.
9 Ibid s 42T.
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