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

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

The Trial satisfied each criterion in s 45AA(2): CBD was intended to alleviate seizure activity associated with TSC; the evidence disclosed no known substantial risks from CBD; the Phase III status and absence of reported adverse consequences in controlled studies made it appropriate on safety and ethical grounds for CBD to be available to patients with TSC, including those unable to consent; the potential benefits outweighed the known risks and participation was in the best interests of persons with TSC; and the Trial had approval from the Hunter New England Human Research Ethics Committee and complied with relevant NHMRC guidelines. Because proposed participants were likely to have...

Jurisdiction
Australia
Judgment Date
03 March 2017
Procedural Posture
Application Under S 45 AA of the Guardianship Act 1987 (nsw) for Approval to Conduct a Clinical Trial in Which Patients Unable to Consent May Participate / Final Decision and Orders
Outcome
The GWP42003-P Trial was approved as a clinical trial in which patients unable to consent may participate, with consent to be given or withheld by the person responsible.
Legal Topics
['approval of Clinical Trial' 'consent to Medical Treatment for Patients Unable to Consent' 'person Responsible' 'cannabidiol Trial for Tuberous Sclerosis Complex']
['guardianship' 'health Law' 'medical Research'] ['approval of Clinical Trial' 'consent to Medical Treatment for Patients Unable to Consent' 'person Responsible' 'cannabidiol Trial for Tuberous Sclerosis Complex']

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Procedural Posture

Application Under S 45 AA of the Guardianship Act 1987 (nsw) for Approval to Conduct a Clinical Trial in Which Patients Unable to Consent May Participate / Final Decision and Orders

Legal Issues

  1. 1 ['Whether the GWP42003-P Trial met the criteria in s 45AA(2) of the Guardianship Act 1987 (NSW) for approval as a clinical trial in which patients unable to consent may participate.' 'Whether the function of giving or withholding consent for participation in the Trial should be exercised by the persons responsible or by the Tribunal under s 45AB of the Guardianship Act 1987 (NSW).' 'Whether the proposed consent form and information about the Trial provided sufficient information to enable persons responsible to decide whether patients should take part in the Trial.']

Ratio Decidendi

The Trial satisfied each criterion in s 45AA(2): CBD was intended to alleviate seizure activity associated with TSC; the evidence disclosed no known substantial risks from CBD; the Phase III status and absence of reported adverse consequences in controlled studies made it appropriate on safety and ethical grounds for CBD to be available to patients with TSC, including those unable to consent; the potential benefits outweighed the known risks and participation was in the best interests of persons with TSC; and the Trial had approval from the Hunter New England Human Research Ethics Committee and complied with relevant NHMRC guidelines. Because proposed participants were likely to have...

Court Disposition

The GWP42003-P Trial was approved as a clinical trial in which patients unable to consent may participate, with consent to be given or withheld by the person responsible.

Orders

  • ['The GWP42003-P Trial is approved as a clinical trial in which patients unable to consent may participate.' "The function of giving or withholding consent is to be exercised by the 'person responsible'." 'The proposed form for granting consent and the information available about the Trial provide sufficient...