Medical research - Victorian Law Reform Commission

Chapter 14
Medical research
14.52 As the Commission pointed out in Chapter 13, it is not appropriate to regard
a guardian with health care powers and a person responsible in the same way.
Guardians have been specifically chosen by the person concerned or VCAT to make
medical decisions for a person. A person responsible is automatically appointed
because of their relationship to the person concerned, rather than following an
individual determination of their suitability to make medical treatment decisions.
14.53 New guardianship legislation should continue to require substitute consent for
participation in any medical research procedure by a person who is unable to make
their own decisions about the matter. It should be possible for a person with capacity
to appoint an enduring personal guardian to make decisions about this matter, or for
VCAT to appoint an enduring guardian with these powers. In the event that there is
no personal guardian with these powers, the automatically appointed health decision
maker 44 should be able to make these decisions.
Significant procedures
14.54 The existing process can be improved by making the Public Advocate rather than
medical researchers the substitute decision maker of last resort when the proposed
medical research procedure is significant. The Public Advocate should be permitted
to make decisions about participation in a significant medical research procedure
for a person who is unable to make their own decisions and who does not have
a personal guardian or health decision maker to make the decision for them. At
present, researchers themselves make these decisions using the ‘Step 4 – Procedural
authorisation’ process in the G&A Act. 45
14.55 Decisions about participation by vulnerable people in research procedures should
be made by a public official, who is at arms-length from the research, when the
procedures involved are significant because they are potentially harmful, intrusive or
exploitative. In some instances, it could be very difficult for committed researchers to
be sufficiently dispassionate and attuned to the interests of people who are unable to
make their own decisions about participation in a research trial that might produce
considerable benefits for the researchers.
14.56 Although the 2006 reforms simplified the unnecessarily cumbersome process of
seeking VCAT approval for all participation in research procedures by people who
are unable to consent, a public body should be involved in those cases where there is
no substitute decision maker and the research procedure is significant because of its
possible impact on people who are unable to protect their own interests.
14.57 While medical research should be encouraged, vulnerable people should be protected.
As the United Kingdom Parliament said in its equivalent legislation: ‘the interests of
the person must be assumed to outweigh those of science and society’ 46 in these
circumstances.
14.58 The Commission recommends that new guardianship legislation should distinguish
between ‘significant’ and ‘routine’ medical research procedures in the same way and
for the same reasons as in substitute consent for medical treatment, discussed in
Chapter 13. While the Public Advocate should be the substitute decision maker of last
resort when dealing with participation in a significant medical research procedure, the
registered practitioners involved in a medical research procedure should continue to be
able to rely upon the procedural authorisation process when the procedure is routine.
44 See Chapter 13 for a discussion of this proposed title and role.
45 Guardianship and Administration Act 1986 (Vic) s 42T.
46 Mental Capacity Act 2005 (UK) s 33(3).
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Victorian Law Reform Commission – Guardianship: Final Report 24