Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (AMOUNT Rehabilitation Trial) [2015] NSWCATGD 1

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 (AMOUNT Rehabilitation Trial) [2015] NSWCATGD 1 Hearing dates: 10 November 2014 Date of orders: 06 January 2015 Decision date: 06 January 2015 Jurisdiction: Guardianship Division Before: Redfern J, Principal Member West C, Senior Member (Professional) Koussa J, General Member (Community) Decision: The Amount Rehabilitation Trial approved as a clinical trial in which adults unable to consent may participate. Function of giving or withholding consent to be exercised by 'person responsible'. Catchwords: CLINICAL TRIAL – trial of commercially available technologies for rehabilitation – randomisation of treatment –whether clinical trial – appropriate for approval by 'person responsible' Legislation Cited: Guardianship Act 1987 (NSW) Guardianship Regulation 2010 (NSW) Cases Cited: Alcan (NT) Alumnia Pty Ltd v Commissioner of Territory Revenue [2009] HCA 41; (2009) 239 CLR 27, [47] Texts Cited: Oxford English Dictionary (Online Edition) Category: Principal judgment Parties: Dr Leanne Hassett (Applicant) File Number(s): 8/2014 Publication restriction: Nil

REASONS FOR DECISION

BACKGROUND 1. On 29 September 2014, the applicant made an application for approval of a trial known as 'a randomised trial of the effect of affordable technology on physical activity levels and mobility outcomes in rehabilitation: The AMOUNT Rehabilitation Trial'. 2. The AMOUNT Rehabilitation Trial (the trial) was approved by the Southern Adelaide Clinical Human Research Ethics Committee on 29 May 2014, with an amended approval on 18 August 2014. It was authorised to be undertaken at Liverpool and Bankstown-Lidcombe Hospitals by the relevant Chief Executive on 4 July 2014. 3. The trial seeks to evaluate whether the use of affordable technology, being commonly used commercially available technologies, improves mobility outcomes for people admitted to hospital for aged care and neurological rehabilitation. The purpose of the trial is to compare mobility outcomes of those patients who are provided with affordable technology as part of their rehabilitation plan with the mobility outcomes of those who are not. The proposed trial is randomised between prospective patients who fall within the relevant criteria for participation. Because of concern that the trial may be a 'clinical trial' within the meaning of the Guardianship Act 1987 (NSW) (the Guardianship Act), and therefore requiring approval by this Tribunal, the applicant made this application before commencing the trial. 4. The critical issue for determination was whether this trial was a 'clinical trial' and, if so, whether the trial should be approved.