Guardianship and Administration Act 1990

An independent medical practitioner must take into account the following in making a determination under section 110ZR(3)(a) or 110ZS(1)(h) —

the wishes of the research candidate (to the extent they can be ascertained) as the paramount consideration;

the likely effects of the research candidate’s participation, including —

the existence, likelihood and severity of any potential risks to the candidate; and

whether those risks are justified by any likely benefits of the research to the candidate or to the broader community;

any consequences for the research candidate if they are not involved in the research;

any alternative treatments available to the research candidate;

any other prescribed matters.

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.

The independent medical practitioner must inform a research decision‑maker or researcher of the practitioner’s determination, and the reasons for the determination —

if practicable before the medical research commences — in writing; or

if paragraph (a) does not apply —

orally before the medical research commences; and

in writing after the research candidate commences participation in the medical research.