Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (intranasal insulin for the management of delirium) [2017] NSWCATGD 39

Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (intranasal insulin for the management of delirium) [2017] NSWCATGD 39

The Tribunal approved the clinical trial because each criterion in s 45AA(2) was satisfied: intranasal insulin was intended to cure or alleviate delirium; the material did not disclose known substantial risks and existing treatments were neither risk-free nor particularly effective; the development of intranasal insulin had reached a stage at which safety and ethical considerations made it appropriate to be available to patients with delirium unable to consent; the potential benefits outweighed the likely risks so participation was in the best interests of patients with delirium; and the trial had approval from a relevant ethics committee. The Tribunal determined that consent should be...

Jurisdiction
Australia
Judgment Date
07 July 2017
Procedural Posture
Application Under S 45 AA of the Guardianship Act 1987 (nsw) for Approval of a Clinical Trial Involving Adults Unable to Consent to Their Own Treatment / Final Decision and Orders
Outcome
The clinical trial was approved as one in which adults unable to consent to their own treatment may participate at Prince of Wales Hospital, subject to conditions including that persons responsible may give or withhold consent.
Legal Topics
['approval of Clinical Trial' 'adults Unable to Consent to Medical Treatment' 'consent by Person Responsible' 'intranasal Insulin for Management of Delirium' 'guardianship Act 1987 (nsw) Pt 5']
['guardianship' 'health Law' 'administrative Law'] ['approval of Clinical Trial' 'adults Unable to Consent to Medical Treatment' 'consent by Person Responsible' 'intranasal Insulin for Management of Delirium' 'guardianship Act 1987 (nsw) Pt 5']

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Procedural Posture

Application Under S 45 AA of the Guardianship Act 1987 (nsw) for Approval of a Clinical Trial Involving Adults Unable to Consent to Their Own Treatment / Final Decision and Orders

Legal Issues

  1. 1 ['Whether the clinical trial satisfied the requirements of s 45AA(2) of the Guardianship Act 1987 (NSW).' 'Whether the Tribunal should approve the clinical trial as one in which adults unable to consent to their own treatment may participate.' 'Whether the function of giving or withholding consent for medical treatment in the course of the trial should be exercised by the Tribunal or by the persons responsible for patients.' 'Whether the proposed consent form and information sheet provided sufficient information to enable persons responsible to decide whether patients should take part in the trial.']

Ratio Decidendi

The Tribunal approved the clinical trial because each criterion in s 45AA(2) was satisfied: intranasal insulin was intended to cure or alleviate delirium; the material did not disclose known substantial risks and existing treatments were neither risk-free nor particularly effective; the development of intranasal insulin had reached a stage at which safety and ethical considerations made it appropriate to be available to patients with delirium unable to consent; the potential benefits outweighed the likely risks so participation was in the best interests of patients with delirium; and the trial had approval from a relevant ethics committee. The Tribunal determined that consent should be...

Court Disposition

The clinical trial was approved as one in which adults unable to consent to their own treatment may participate at Prince of Wales Hospital, subject to conditions including that persons responsible may give or withhold consent.

Orders

  • ['The Tribunal has considered the clinical trial known as "A phase 3, double blind placebo randomized placebo controlled trial of intranasal insulin for the management of delirium".' 'The Tribunal is satisfied that in relation to the above-named clinical trial, all the requirements of section 45AA(2) of the...