Medical research - Victorian Law Reform Commission

Medical treatment and medical research
14.18 The importance of maintaining different considerations to guide substitute decision
making about medical treatment and participation in medical research was
emphasised by medical researchers because participation in some research may be
of no immediate benefit to a person who takes part in it. 15 It is necessary, therefore,
to allow a substitute decision maker to authorise participation when satisfied that it
would not be contrary to the person’s best interests to participate rather than in the
person’s best interests to do so.
14.19 The Public Advocate argued that the process for obtaining substitute consent should
be essentially the same for a medical research procedure and a medical treatment
procedure. 16 Others argued that there should be even more stringent criteria for
obtaining consent to medical research than for medical treatment, given the human
rights issues at stake. 17
14.20 The Victorian Equal Opportunity and Human Rights Commission argued that only
VCAT should be empowered to consent to medical research procedures being
undertaken on a person who is unable to consent, despite the administrative hurdles
this would create for researchers:
Because of the potential grave human rights implications, the [Victorian Equal
Opportunity and Human Rights] Commission believes that only VCAT should be
authorised to consent to medical research procedures for persons with impaired
decision-making capacity. This will add an unwanted bureaucratic hurdle for
researchers, but a necessary one that forces them to consider in depth whether
there really is a need to carry out this research on vulnerable people who are
unable to consent. 18
Principles to guide decision makers
14.21 The value of the principle of substituted judgment was also raised in relation to
participation in medical research—that is, considering whether the person themselves
would have chosen to participate in the research. 19
Different procedures
14.22 Ethics committee members observed that some research procedures are part of
normal treatment, such research comparing the relative benefits of two routinely
used procedures. This research is qualitatively different from trialling an unknown
procedure, such as administering a new drug. 20
14.23 Some medical researchers also saw value in distinguishing between major and minor
procedures, allowing minor research procedures to be undertaken without substitute
consent. 21 It was also noted that, because asking families to consent to minor medical
research procedures at a time of stress and crisis can be distressing, it would be better
to be able to obtain consent to participation in research a few days later. 22
15 Consultation with Alfred Hospital Ethics Committee & General Ethical Issues Sub-committee (3 March 2011); Submission CP 76 (Professor
Rinaldo Bellomo).
16 Submission CP 19 (Office of the Public Advocate).
17 Submissions CP 23 (Dr Kristen Pearson) and CP 66 (Victorian Equal Opportunity and Human Rights Commission).
18 Submission CP 66 (Victorian Equal Opportunity and Human Rights Commission).
19 Submissions CP 23 (Dr Kristen Pearson) and CP 24 (Autism Victoria).
20 Roundtable with Ethics Committee representatives from the Alfred Hospital, Austin Health, Royal Melbourne Hospital and Office of the Public
Advocate (17 May 2011).
21 Ibid.
22 Ibid.
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