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

NSW Civil and Administrative Tribunal New South Wales Medium Neutral Citation: 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 Hearing dates: 7 July 2017 Date of orders: 07 July 2017 Decision date: 07 July 2017 Jurisdiction: Guardianship Division Before: A Britton, Principal Member Dr H Creasey AM, Senior Member (Professional) J Koussa, General Member (Community) Decision: 1. 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".

2. The Tribunal is satisfied that in relation to the above-named clinical trial, all the requirements of section 45AA(2) of the Guardianship Act NSW (1987) have been met.

3. The Tribunal approves the clinical trial as one in which adults unable to consent to their own treatment may participate. Unless the Tribunal subsequently orders otherwise, this approval remains current until that trial has been concluded in New South Wales.

4. The Tribunal approves the clinical trial at the following site: Prince of Wales Hospital.

This approval is subject to the following condition(s): 5. The Tribunal orders that 'persons responsible' for those unable to consent to their own medical treatment may exercise the function of giving or withholding consent to the carrying out of medical treatment on the person they are 'person responsible' for in the course of the above-named clinical trial.