Western Australian Current Acts Western Australian Current Acts (1) A researcher may
conduct medical research in relation to a research candidate if —
(a) the
research has been approved by an HREC; and
(b) the
candidate requires urgent treatment as defined in section 110ZH; and
(c) the
candidate is unable to make reasonable judgments in respect of their
participation in the research; and
(d)
there is no research decision in relation to the candidate in respect of their
participation in the research; and
(e) it
is not practicable for the researcher to obtain a research decision in
relation to the candidate from the research decision-maker for the candidate;
and
(f) it
is unlikely that it will be practicable for the researcher to obtain a
research decision in relation to the candidate from the research
decision-maker for the candidate within the timeframe for the research
approved by the HREC; and
(g) the
researcher receives an independent medical practitioner’s determination
in accordance with section 110ZV that the candidate is not likely to be able
to make reasonable judgments in respect of their participation in the research
within the timeframe for the research approved by the HREC; and
(h) the
researcher receives an independent medical practitioner’s determination
in accordance with section 110ZU that the candidate’s participation is
in the best interests of the candidate or is not adverse to the interests of
the candidate; and
(i)
the researcher receives an independent medical
practitioner’s determination in accordance with section 110ZW that the
candidate’s participation in the research —
(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.
(2) A researcher must
not conduct medical research in relation to a research candidate in accordance
with an urgent medical research decision if the researcher is aware, or ought
reasonably to be aware, the research is inconsistent with any advance health
directive in operation in respect of the candidate.
(3) While a researcher
conducts medical research in relation to a research candidate in accordance
with an urgent medical research decision, the lead researcher in relation to
the research must continue to take reasonable steps to obtain a research
decision under section 110ZR in relation to the research candidate from the
research decision-maker for the candidate.
(4) Subsection (5)
applies if —
(a) a
researcher conducts medical research in relation to a research candidate in
accordance with an urgent medical research decision; and
(b)
either —
(i)
the research candidate regains the ability to make
reasonable judgments in respect of the medical research; or
(ii)
a research decision-maker makes a research decision under
section 110ZR to refuse consent to the candidate’s participation in the
research.
(5) The lead
researcher in relation to the medical research must ensure that —
(a) the
research is discontinued as soon as is safely practicable; and
(b) the
research is not recommenced unless the research candidate or research
decision-maker consents to continue to participate in the research.
[Section 110ZS inserted: No. 14 of 2020 s. 12.]