(1) An independent
medical practitioner must take into account the following in making a
determination under section 110ZR(3)(a) or 110ZS(1)(h) —
(a) the
wishes of the research candidate (to the extent they can be ascertained) as
the paramount consideration;
(b) the
likely effects of the research candidate’s participation, including
—
(i)
the existence, likelihood and severity of any potential
risks to the candidate; and
(ii)
whether those risks are justified by any likely benefits
of the research to the candidate or to the broader community;
(c) any
consequences for the research candidate if they are not involved in the
research;
(d) any
alternative treatments available to the research candidate;
(e) any
other prescribed matters.
(2) The fact that
medical research may involve the giving of placebos does not prevent a
research decision-maker or an independent medical practitioner from being
satisfied that it is in the best interests of a research candidate or is not
adverse to the interests of the candidate that they participate in the
research.
(3) The independent
medical practitioner must inform a research decision-maker or researcher of
the practitioner’s determination, and the reasons for the determination
—
(a) if
practicable before the medical research commences — in writing; or
(b) if
paragraph (a) does not apply —
(i)
orally before the medical research commences; and
(ii)
in writing after the research candidate commences
participation in the medical research.
[Section 110ZU inserted: No. 14 of 2020 s. 12.]