Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (ADRENAL Trial) [2015] NSWCATGD 23

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 (ADRENAL Trial) [2015] NSWCATGD 23 Hearing dates: 2 and 22 May 2015 Date of orders: 19 June 2015 Decision date: 19 June 2015 Jurisdiction: Guardianship Division Before: C Fougere, Principal Member H Creasey, Senior Member (Professional) J Koussa, General Member Community Decision: The ADRENAL Trial does not fall within the definition of clinical trial in section 33(1) of the Guardianship Act 1987 (NSW).

Application dismissed. Catchwords: CLINICAL TRIAL – Randomised blinded placebo controlled trial of hydrocortisone in critically ill patients with septic shock – both arms reflect existing, accepted treatment for septic shock – use of hydrocortisone within its TGA registration – consent under Part 5 of the Guardianship Act Legislation Cited: Therapeutic Goods Act 1989 (Cth) Civil and Administrative Tribunal Act 2013 (NSW) Guardianship Act 1987 (NSW) Cases Cited: Alcan (NT) Alumina Pty Ltd v Commissioner of Territory Revenue [2009] HCA 41 Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (AMOUNT Rehabilitation Trial) [2015] NSWCATGD 1 Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (SPICE III Trial) [2014] NSWCATGD 44 P v NSW Trustee and Guardian [2015] NSWSC 579 Project Blue Sky Inc v Australian Broadcasting Authority [1998] HCA 28 Scott v Commercial Hotel Merbein Pty Ltd [1930] VLR 25 Texts Cited: Macquarie Dictionary (online edition) Oxford English Dictionary (online edition) Pearce DC and Geddes RS, Statutory Interpretation in Australia (2011, 7th ed), [2.26] Category: Principal judgment Parties: Professor Bala Venkatesh Representation: Dr Ashley Tsacalos, Legal Representative File Number(s): 4/2015 Publication restriction: Nil