Medical research - Victorian Law Reform Commission

Chapter 14
Medical research
4
303
CONTENTS
Introduction 304
Current law 304
Community responses 306
Other jurisdictions 308
The Commission’s views
and conclusions 309
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Chapter 14
Medical research
Introduction
14.1 In this chapter, the Commission makes recommendations for reform of the law
concerning authorisation of participation in medical research by people who are
unable to make their own decisions about the matter.
14.2 The Guardianship and Administration Act 1986 (Vic) (G&A Act) was amended in
2006 to establish a four-step process for authorising participation in a ‘medical
research procedure’ by a person who is unable to make a decision about their own
participation. 1 In all cases, a relevant human research ethics committee must approve
the research project. If the patient is unlikely to be capable of giving consent to the
procedure within a reasonable time, a ‘person responsible’ may give substitute consent
for participation in the research procedure. 2 If a person responsible is not available, the
registered practitioner may be able to proceed without any external authorisation.
14.3 Prior to the 2006 amendments, it was necessary to obtain approval from the Victorian
Civil and Administrative Tribunal (VCAT) for participation in a medical research
procedure by a person who was unable to consent. While the 2006 changes to the
G&A Act have streamlined the process of obtaining substitute consent for participation
in medical research, improvements can be made without compromising the interests
of vulnerable people.
14.4 Two important issues require reform. The first is that in some instances the G&A Act
processes for authorising medical treatment and medical research are both applied
to the same procedure when standard treatment is being researched. This need for
separate authorisation seems unnecessary, especially when the research procedure
must also have ethical approval.
14.5 The second issue is that in some instances the substitute decision maker of last resort
may be the medical researcher. A disinterested person should authorise participation
in any research when it might not be of any benefit to the participant and could be
intrusive or exploitative.
14.6 This chapter contains recommendations about the following:
• distinguishing between participation in medical research procedures that
require separate legal authorisation and those that do not require separate
legal authorisation because they form part of medical treatment that has been
authorised
• distinguishing between routine and significant medical research procedures for
the purpose of authorising participation when there is no personal guardian or
health decision maker to make the decision
• matters for substitute decision makers to consider when deciding whether to
authorise participation in a medical research procedure.
Current law
14.7 The G&A Act provides for substitute consent to medical research procedures in
Division 6 of Part 4A.
1 Guardianship and Administration (Further Amendment) Act 2006 (Vic). This Act inserted Division 6 of Part 4A into the Guardianship and
Administration Act 1986 (Vic).
2 In Chapter 5, the Commission recommends changing the term ‘person responsible’ to ‘health decision maker’.
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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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14.12 Different considerations guide the process of substitute decision making for
participation in medical research from those that apply when making decisions about
medical treatment. The person responsible, or the registered practitioner, must be
satisfied that participation in a medical research procedure ‘would not be contrary’ to
the best interests of the patient. The person responsible must act in the patient’s ‘best
interests’ when deciding whether to consent to any proposed medical treatment. 10
The reason for the difference appears to be that participation in a research procedure
could be an activity of no particular benefit to the person concerned in some instances,
such as receiving a placebo in a drug trial, or when the research involves a procedure
for which the benefits are still not clear.
14.13 The G&A Act provides additional guidance about the matters that must be taken into
account when deciding whether a proposed research procedure is not contrary to the
patient’s best interests. These are:
• the wishes of the patient, so far as they can be ascertained
• the wishes of any nearest relative or any other family members of the patient
• the nature and degree of any benefits, discomforts and risks for the patient in
having or not having the procedures
• any other consequences to the patient if the procedure is or is not carried out, and
• any other prescribed matters. 11
14.14 The first step in the process—ethics committee approval—is usually determined in
accordance with the National Statement on Ethical Conduct in Human Research (the
National Statement) which was jointly developed by the National Health and Medical
Research Council, the Australian Research Council and the Australian Vice-Chancellors’
Committee in 2007. The National Statement governs all human research funded by or
conducted under the auspices of these bodies.
Community responses
14.15 In response to the information paper, comments were made about the cumbersome
and confusing processes set out in the G&A Act for medical research. 12 It was also
suggested that the requirements for contacting the person responsible could be time
consuming and could, as a result, compromise medical research. 13
14.16 In the consultation paper, the Commission identified two options to address the issue
of substitute consent for participation in medical research. One of those options was
to retain the current provisions in the G&A Act, but simplify them in new guardianship
laws. The other was to allow the person responsible (or the new health decision
maker) to consent to medical research in the same way they could consent to medical
treatment.
14.17 The Commission consulted representatives from various hospital ethics committees
in order to consider means of improving the current provisions in the G&A Act. 14
The responses from those people have greatly assisted the Commission to refine its
recommendations.
10 Ibid s 42H(2).
11 Ibid s 42H(2).
12 Submission IP 40 (Australian & New Zealand Society for Geriatric Medicine).
13 Submission IP 57 (Alfred Hospital Ethics Committee and the General Ethical Issues Sub Committee).
14 Members comprised: Professor John McNeil, Chair, Alfred Hospital Ethics Committee & General Ethical Issues Sub-Committee; Mr Peter
Gallagher, HREC member, Alfred Medical Research & Education Precinct; Professor Peter Cameron, Director of Research, Alfred Hospital;
Associate Professor David Taylor, HREC Chair, Austin Health; Professor Rinaldo Bellomo, Senior Researcher, Austin Health; Dr Angela Watt,
Director Research Governance & Ethics, Office for Research, Royal Melbourne Hospital; The Hon. Allan McDonald, QC, HREC member,
Melbourne Health/Royal Melbourne Hospital; Mr Phil Grano, Principal Legal Officer, Office of the Public Advocate.
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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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Medical research
Ethics approval
14.24 Some people emphasised the important role played by human research ethics
committees in approving and monitoring research. 23 The Catholic Archdiocese of
Melbourne suggested that the process of substitute consent for participation could
be strengthened by requiring human research ethics committee approval to be in
accordance with the National Statement. 24
14.25 The Catholic Archdiocese said:
The National Statement limits research on a person who is unable to consent to
low or negligible research procedures and requires that such research be for the
benefit of the participant or at least a group to which the participant belongs. It
would be helpful if these requirements were included in the G&A Act. 25
UN Convention and Victorian Charter
14.26 Both the United Nations’ Convention on the Rights of Persons with Disabilities (the
Convention) 26 and the Charter of Human Rights and Responsibilities Act 2006 (Vic)
(the Charter) 27 deal with the issue of participation in medical research without consent.
14.27 The Convention provides that:
No one shall be subjected to torture or to cruel, inhuman or degrading treatment
or punishment. In particular, no one shall be subjected without his or her free
consent to medical or scientific experimentation. 28
14.28 Similarly, the Charter provides that:
A person must not be …. subjected to medical or scientific experimentation or
treatment without his or her full, free and informed consent. 29
14.29 The Charter also acknowledges that human rights may be limited in some
circumstances. Charter rights ‘may be subject under law only to such reasonable limits
as can be demonstrably justified in a free and democratic society’. 30
14.30 There are a number of Victorian laws which authorise medical treatment without
the full, free and informed consent of the person. 31 It is arguable, however, that they
impose reasonable and justifiable limits upon Charter rights. 32
Other jurisdictions
14.31 Queensland and New South Wales are the only other Australian jurisdictions that
have separate legislative provisions concerning substitute consent for participation
in medical research. Tribunal approval is required in both states for participation in
a medical research procedure by a person who is unable to consent. 33
23 Ibid.
24 Submission CP 27 (Catholic Archdiocese of Melbourne).
25 Ibid.
26 Convention on the Rights of Persons with Disabilities, opened for signature 30 March 2007, 999 UNTS 3 (entered into force 3 May 2008)
(‘Convention on the Rights of Persons with Disabilities’).
27 Charter of Human Rights and Responsibilities Act 2006 (Vic).
28 Convention on the Rights of Persons with Disabilities art 15(1).
29 Charter of Human Rights and Responsibilities Act 2006 (Vic) s 10(c).
30 Ibid s 7(2).
31 See, eg, Guardianship and Administration Act 1986 (Vic) pt 4A; Mental Health Act 1988 (Vic); Disability Act 2006 (Vic) pt 8; Severe Substance
Dependence Treatment Act 2010 (Vic).
32 For example, involuntary treatment under the Mental Health Act 1986 (Vic), has been found to be Charter compliant: see Kracke v Mental
Health Review Board [2009] VCAT 646 (23 April 2009) [775]–[785].
33 Guardianship and Administration Act 2000 (Qld) s 72; Guardianship Act 1987 (NSW) ss 45AA–45AB.
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14.32 In New South Wales, the Guardianship Tribunal may approve the involvement in a
clinical trial of patients who are unable to consent. 34 The Tribunal then determines if it
needs to provide individual consent for participation by each patient in the trial, or if
the person responsible for each patient can provide consent. 35
14.33 Queensland distinguishes between two categories of medical research: ‘approved
clinical research’ 36 and ‘special medical research or experimental health care’. 37 The
Queensland Civil and Administrative Tribunal (QCAT) may approve clinical research
generally. If this occurs, QCAT is no longer required to provide individual consent for
participation in this ‘approved clinical research’. 38 Queensland’s definition of ‘approved
clinical research’ specifically excludes ‘a comparative assessment of health care already
proven to be beneficial’. 39
14.34 By contrast, participation in ‘special medical research or experimental health care’
requires QCAT consent in each case. 40
14.35 Both the New South Wales and Queensland legislation contain matters for the
tribunals to consider when deciding whether to approve the proposed research
procedure. 41
The Commission’s views and conclusions
14.36 The 2006 amendments to the G&A Act, which streamlined the process for obtaining
substitute consent for participation in a medical research procedure, were important
developments in seeking to provide a balance between advancing medical knowledge
and protecting vulnerable people from exploitation or unnecessary intrusion. The
experience of dealing with these provisions over the past six years demonstrates that
the process can be refined and improved.
14.37 As noted above, the consultation paper put forward two reform options in relation
to medical research. The first was to retain the existing medical research consent
procedures, but simplify them. The second was to apply the same procedures to
obtaining consent for medical research as those that apply for obtaining consent for
medical treatment. The Commission’s final reform recommendations amalgamate
aspects of these options with the aim of simplifying the current procedures and
making them more consistent with those used when seeking substitute consent for
medical treatment.
14.38 The Commission believes that the current four-step process for authorising
participation by a person in a medical research procedure, when that person is
unable to consent to the procedure, is unnecessarily cumbersome and inappropriately
delegates decision-making authority to researchers in some instances.
14.39 The existing process can be streamlined by distinguishing those medical research
procedures that require legal authorisation from those that require authorisation
in order to comply with the relevant human research ethical requirements. When a
person with appropriate powers has authorised medical treatment for a person who
is unable to consent to their own treatment 42 and research is being conducted about
34 Guardianship Act 1987 (NSW) s 45AA.
35 Ibid s 45AB.
36 Guardianship and Administration Act 2000 (Qld) sch 2 pt 2 cl 13.
37 Ibid sch 2 pt 2 cl 12.
38 This is because, once approved, ‘approved clinical research’ is treated like other health matters, which do not require QCAT consent:
Guardianship and Administration Act 2000 (Qld) s 72.
39 Guardianship and Administration Act 2000 (Qld) sch 2 pt 2 cl 13(1A).
40 Ibid s 72.
41 See Guardianship Act 1987 (NSW) s 45AA; Guardianship and Administration Act 2000 (Qld) s 72, sch 2 pt 2 cls 13(3)–(5).
42 Under current law, this would include a guardian or an enduring guardian with appropriate powers as well as a registered practitioner relying
upon the emergency treatment powers in section 42A of the Guardianship and Administration Act 1986 (Vic).
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Medical research
the efficacy of that treatment, it is legally unnecessary to also seek substitute consent
to participation in research that is an adjunct to the treatment. This is because consent
has already been given to conduct that would otherwise constitute an assault. In these
circumstances, participation in any medical research should be governed by relevant
ethical obligations imposed by the National Statement or any subsequent document
that regulates research concerning humans.
14.40 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 Commission proposes that, as with
substitute consent to medical treatment, new guardianship legislation should
distinguish between significant and routine procedures for the purposes of authorising
participation by a person who is unable to make their own decision about the matter.
Similar steps have been taken in Queensland to differentiate routine research from
‘special medical research or experimental health care’. 43
Ethics committee approval
14.41 The Commission believes that ethics committee approval should continue to be a
mandatory prerequisite to using the statutory process for authorising participation
in a medical research procedure by a person who is unable to consent to their own
participation.
14.42 The National Statement is justifiably concerned with a much broader range of
considerations than those of the law governing substitute consent to conduct that
would otherwise constitute the crime and the tort of assault.
14.43 When the law has ensured that a substitute decision maker has authorised conduct
that would otherwise be unlawful, the more detailed ethical prescriptions of the
National Statement should govern the manner in which medical researchers interact
with people who are unable to consent to their own participation in a medical
research procedure.
14.44 This approach provides two layers of protection for vulnerable people and ensures that
a broad array of sanctions is available when researchers fail to comply with their legal
or ethical obligations. In many instances, professional sanctions will be more effective
than those available to the criminal and civil courts when a researcher engages in
research practices which are harmful to or disrespectful of a person who is unable to
make their own decision about participation in a medical research procedure.
14.45 Whether Victorian law continues to refer to ethics committee approval in general
terms, or whether it requires approval in accordance with the National Statement, is a
matter for the Victorian Government when introducing new legislation, having regard
to the status of the National Statement and the extent to which it binds all relevant
ethics committees in Victoria.
Legal authorisation
Researching medical treatment
14.46 As explained earlier, the current process of requiring substitute consent to both
medical treatment and medical research procedures when the efficacy of a particular
mode of treatment is being researched is legally unnecessary, because in most
instances only one procedure or interference with the body of another person is
involved. While it would be unethical to allow research to be performed on a person
without appropriate authorisation, no useful end is served by requiring dual legal
authorisation for the one procedure.
43 Guardianship and Administration Act 2000 (Qld) s 72.
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14.47 The medical treatment provisions of the legislation should govern legal consent
in these circumstances, while the National Statement or some other similar set of
ethical considerations should govern ethical consent to participation in the research
procedure.
14.48 The Commission acknowledges that, in some circumstances, the boundary between
treatment and research will not be clear. For example, in some instances it might be
appropriate to take a small quantity of blood from a person for testing associated
with medical treatment. The clinical staff involved in this process might also consider
it desirable to take a small additional quantity of blood for use in some allied research
procedure.
14.49 In this example, the substitute consent for the extraction of blood for treatment
purposes would not extend to the extraction for research purposes because the act
that has been authorised is only the taking of an amount of blood that is required
for medical treatment purposes. Researchers would also need to follow the legal
authorisation processes in order to take the additional quantity of blood. If, however,
research was conducted on blood that had been taken solely for treatment purposes,
the ethical requirements of the National Statement would apply.
14.50 The Public Advocate should be encouraged to publish guidelines prepared in
consultation with relevant professional and consumer groups.
Recommendations
Medical research that is an adjunct to medical treatment
220. New guardianship legislation should clearly distinguish between a ‘medical
research procedure’ that is an adjunct to ‘medical treatment’ and a ‘medical
research procedure’ that is undertaken for the purposes of medical research
and not primarily for the purpose of providing a medical intervention to treat a
person’s current condition.
221. When a ‘medical research procedure’ is carried out as an adjunct to ‘medical
treatment’, the procedures dealing with substitute consent to ‘medical treatment’
should govern legal authorisation for the treatment and the requirements of the
relevant ethics committee should govern ethical authorisation for the ‘medical
research procedure’.
New definitions
222. New guardianship legislation should indicate that:
(a) Research that is carried out as an adjunct to ‘medical treatment’ is not a
‘medical research procedure’ for the purposes of requiring authorisation
when a person is unable to consent to that research.
(b) A procedure is not a ‘medical research procedure’ unless it is approved by an
ethics committee.
Substitute consent
14.51 The existing provisions of the G&A Act dealing with substitute consent for
participation in a medical research procedure do not distinguish between the role of a
guardian and that of a person responsible. The two roles are blended in Step 3 of the
process, as a guardian with health care powers simply becomes someone who can be
the person responsible for authorising participation.
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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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14.59 The Public Advocate should develop and publish guidelines, in consultation with
relevant professional bodies and other interested organisations, to assist registered
practitioners when determining whether a particular medical research procedure is
‘significant’ or ‘routine’.
Recommendations
Substituted consent for participation in a medical research procedure
223. It should be possible for a person to appoint an enduring personal guardian to
make decisions about their participation in a ‘medical research procedure’ when
they do not have the capacity to make their own decisions about participation.
224. It should be possible for the tribunal to appoint a personal guardian with the
power to make decisions about participation in a ‘medical research procedure’
for a person who does not have the capacity to make their own decisions about
participation.
225. New guardianship legislation should permit a health decision maker to make
decisions about participation in a ‘medical research procedure’ for a person
who lacks the capacity to make their own decisions and who does not have an
enduring personal guardian or a personal guardian with the power to make those
decisions for them.
226. A personal guardian or an enduring personal guardian with ‘medical research
procedure’ powers or a health decision maker should be permitted to authorise
participation in a ‘medical research procedure’ for the principal when the principal
lacks the capacity to make their own decision about the matter.
227. The Public Advocate should be permitted to authorise participation in a ‘medical
research procedure’ which is a ‘significant procedure’ for a person who does not
have the capacity to authorise their own participation and who does not have a
personal guardian, an enduring personal guardian or a health decision maker to
make that decision for them.
228. The ‘procedural authorisation’ process in the Guardianship and Administration
Act 1986 (Vic) should be reproduced in new guardianship legislation for the
purpose of authorising participation in a ‘medical research procedure’ which is
a ‘routine procedure’ for a person who does not have the capacity to authorise
their own participation and who does not have a personal guardian, an enduring
personal guardian or a health decision maker to make that decision for them.
229. The Public Advocate should develop and publish guidelines in consultation with
relevant professional bodies and other interested organisations to assist registered
practitioners when determining whether a particular medical research procedure
is ‘significant’ or ‘routine’.
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Recovery within a reasonable period
14.60 The Commission recommends retaining the existing requirement that a medical
research procedure should not be carried out on a person who cannot consent, if it
would be reasonable to wait for the person concerned to make this decision. This is
Step 2 in the current four-step G&A Act process discussed earlier in this chapter. 47
14.61 This step does not deny a person access to the best available treatment. If new
treatment that is still in research trials to determine its efficacy were the best available
option for a person who was unable to consent to that procedure, the substitute
decision maker for medical treatment would have the power to decide whether to
authorise that treatment.
14.62 If researchers seek participation in a medical research procedure by a person who is
likely to regain capacity within a reasonable period to make their own decision, it is
appropriate to delay any participation until that time.
Recommendation
Recovery within a reasonable period
230. Step 2 of the current four-step process for authorising the performance of a
medical research procedure upon a person who is unable to make their own
decisions about the matter should be reproduced in new guardianship legislation.
Considerations that govern decisions about participation
14.63 As noted earlier, different considerations currently govern the process of substitute
decision making for participation in medical research compared to those that apply
when making decisions about medical treatment. A substitute decision maker for
medical treatment must be satisfied that the proposed treatment is in the person’s
‘best interests’, 48 whereas a substitute decision maker for participation in a medical
research procedure must be satisfied that the proposed research procedure ‘would not
be contrary’ to the person’s best interests. 49
14.64 The Commission believes that this different guiding consideration should remain,
subject to some modifications and additions. In Chapter 17, the Commission proposes
that the concept of ‘best interests’ be replaced by ‘promoting the personal and social
wellbeing’ of the person concerned. Consequently, substitute decision makers for
participation in a medical research procedure should authorise participation only
when they believe that it would not be contrary to the patient’s personal and social
wellbeing to participate.
14.65 Two additional considerations should guide the substitute decision maker. Throughout
the report, the Commission has emphasised the growing significance of the principle
of substituted judgment—that is, seeking to make the decision that the represented
person would have made in the circumstances. Many members of the community
hold strong views about their willingness, or unwillingness, to participate in medical
research. The likely response of the represented person, if known, is clearly a matter
that should guide any decision by a substitute decision maker.
47 Guardianship and Administration Act 1986 (Vic) s 42R.
48 Ibid s 42H(2).
49 Ibid ss 42S(3), 42T(2)(c), 42U.
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14.66 The National Statement refers to the likely benefit to the patient, or to a class of
people to which the patient belongs, as a relevant ethical consideration. This matter
should also be a relevant legal consideration when a substitute decision maker is
deciding whether to authorise participation in a medical research procedure by a
person who is unable to make their own decision about the matter.
Recommendation
Criteria for consenting to a medical research procedure
231. A substitute decision maker should only be permitted to authorise participation
in a medical research procedure if they believe that it would not be contrary
to the patient’s personal and social wellbeing to participate in that procedure.
When determining whether the procedure would not be contrary to the patient’s
personal and social wellbeing, the following are relevant considerations:
(a) the decision that the person might have made in the circumstances
(b) the extent to which the procedure is likely to benefit the patient, or a class of
people to which the patient belongs
(c) the matters set out in section 42U(1) of the Guardianship and Administration
Act 1986 (Vic).
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