Guardianship and Administration Act 1990

A researcher may conduct medical research in relation to a research candidate if —

the research has been approved by an HREC; and

the candidate requires urgent treatment as defined in section 110ZH; and

the candidate is unable to make reasonable judgments in respect of their participation in the research; and

there is no research decision in relation to the candidate in respect of their participation in the research; and

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

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

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

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

the researcher receives an independent medical practitioner’s determination in accordance with section 110ZW that the candidate’s participation in the research —

will only involve observing the candidate or carrying out another non‑invasive examination, treatment or procedure; or

if subparagraph (i) does not apply — will not involve any known substantial risks to the candidate; or

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

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.

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.

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.

Subsection (5) applies if —

a researcher conducts medical research in relation to a research candidate in accordance with an urgent medical research decision; and

either —

the research candidate regains the ability to make reasonable judgments in respect of the medical research; or

a research decision‑maker makes a research decision under section 110ZR to refuse consent to the candidate’s participation in the research.

The lead researcher in relation to the medical research must ensure that —

the research is discontinued as soon as is safely practicable; and

the research is not recommenced unless the research candidate or research decision-maker consents to continue to participate in the research.