Medical research - Victorian Law Reform Commission

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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