(1) An independent
medical practitioner must take into account the following in making a
determination under section 110ZR(3)(b) or 110ZS(1)(i) —
(a)
whether the research candidate’s participation in medical research will
involve any known substantial risks to the candidate;
(b)
whether there is an existing treatment available to the research candidate;
(c) if
there is an existing treatment available to the research candidate —
(i)
whether there are substantial risks to the candidate
involved in the existing treatment available to the candidate; and
(ii)
if there are substantial risks involved in the existing
treatment — whether those risks are greater than the risks involved in
participating in the medical research;
(d) if
there is no existing treatment available — whether the risks involved in
participating in the medical research are greater than not participating in
the research.
(2) The independent
medical practitioner must inform the 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 110ZW inserted: No. 14 of 2020 s. 12.]
[Heading inserted: No. 14 of 2020 s. 12.]