Western Australian Current Acts Western Australian Current Acts (1) The research
decision-maker for a research candidate may make a research decision in
relation to the candidate’s participation in medical research if —
(a) the
research has been approved by an HREC; and
(b) the
candidate is unable to make reasonable judgments in relation to participating
in the research; and
(c) an
independent medical practitioner determines in accordance with section 110ZV
that the candidate is not likely to be able to make reasonable judgments
within the timeframe for the research approved by the HREC.
(2) The research
decision-maker for a research candidate must not consent to the
candidate’s participation in medical research unless the research
decision-maker —
(a)
receives the determination of an independent medical practitioner under
subsection (3); and
(b)
determines, having regard to the independent medical practitioner’s
determination under subsection (3)(a), that the candidate’s
participation in the research is in the best interests of the candidate or is
not adverse to the interests of the candidate; and
(c)
determines, having regard to the independent medical practitioner’s
determination under subsection (3)(b), that the candidate’s
participation —
(i)
will only involve observing the candidate or carrying out
another non-invasive examination, treatment or procedure; or
(ii)
if subparagraph (i) does not apply — will not
involve any known substantial risks to the candidate; or
(iii)
if subparagraphs (i) and (ii) do not apply and there is
an existing treatment available to the candidate — will not involve any
known substantial risks to the candidate greater than the risks associated
with that treatment; or
(iv)
if subparagraphs (i) to (iii) do not apply — will
not involve substantial risks to the candidate greater than if the candidate
did not participate in the research.
(3) An independent
medical practitioner must determine —
(a)
whether the research candidate’s participation will be in the best
interests of the candidate or will not be adverse to the interests of the
candidate in accordance with section 110ZU; and
(b) the
matters stated in subsection (2)(c) in accordance with section 110ZW.
(4) A research
decision-maker for a research candidate cannot make a research decision under
this section to consent to the candidate’s participation in the medical
research if the participation is inconsistent with any advance health
directive in operation in respect of the candidate.
(5) A research
decision made under this section has effect as if —
(a) it
were made by the research candidate or with the candidate’s consent; and
(b) the
research candidate were of full legal capacity.
(6) If a research
decision-maker for a research candidate has made a research decision to
consent to the candidate’s participation in the medical research under
subsection (1), a research decision-maker for the candidate may decide that,
contrary to the research decision, the candidate will no longer participate in
the research.
(7) If a research
candidate regains the ability to make reasonable judgments in respect of
medical research while the candidate participates in the research or a
research decision-maker makes a decision under subsection (6) —
(a) the
research decision made under subsection (1) ceases to have further effect; and
(b) the
lead researcher in relation to the research must ensure that —
(i)
the research is discontinued as soon as is safely
practicable; and
(ii)
the research is not recommenced unless a research
decision is made by the candidate, or by the research decision-maker under
subsection (1), to consent to continue to participate in the research.
[Section 110ZR inserted: No. 14 of 2020 s. 12.]