Application for approval to conduct clinical trial and for approval for patients unable to consent to their own treatment to participate (GWP42003-P Trial) [2017] NSWCATGD 30

NSW Civil and Administrative Tribunal New South Wales Medium Neutral Citation: Application for approval to conduct clinical trial and for approval for patients unable to consent to their own treatment to participate (GWP42003-P Trial) [2017] NSWCATGD 30 Hearing dates: Monday 23 January 2017 at Sydney Date of orders: 03 March 2017 Decision date: 03 March 2017 Jurisdiction: Guardianship Division Before: A Britton, Principal Member Dr J M Hollis, Senior Member (Professional) L Porter, General Member (Community) Decision: 1. The GWP42003-P Trial is approved as a clinical trial in which patients unable to consent may participate. 2. The function of giving or withholding consent is to be exercised by the 'person responsible'. 3. The proposed form for granting consent and the information available about the Trial provide sufficient information to enable persons responsible to make an informed decision about whether consent to participate in the Trial should be given. Catchwords: CLINICAL TRIAL – double-blind, randomised, placebo controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) as add-on therapy in the treatment of tuberous sclerosis complex – inadequately-controlled seizures – cannabidiol not approved by the Therapeutic Goods Administration – Phase III trial – consideration of s 45AA and 45AB of the Guardianship Act – trial approved – appropriate for approval by 'person responsible' – proposed form and information available about the trial capable of being understood by "persons responsible" Legislation Cited: Guardianship Act 1987 (NSW), Pt 5, ss 4, 33(1), 33(2), 33A, 34(1), 45AA, 45AA(2), 45AB Cases Cited: Shehabi v Attorney General (NSW) [2016] NSWCATAP 137 Texts Cited: National Statement on Ethical Conduct in Human Research, 2007 Category: Principal judgment Parties: Amy Boland (applicant) Representation: Applicant (in person) File Number(s): 14/2016 Publication restriction: It is an offence under s 65 of the Civil and Administrative Tribunal Act 2013 to publish or broadcast the name of any person who appears as a witness before the Tribunal in these proceedings or to whom these proceedings relate or who is mentioned or otherwise involved in these proceedings except with the consent of the Tribunal. A reference to the name of a person includes a reference to any information, picture or other material that identifies the person or is likely to lead to the identification of the person.