Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (SPICE III Trial) [2014] NSWCATGD 44

Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (SPICE III Trial) [2014] NSWCATGD 44

The Tribunal found the SPICE III trial constitutes a clinical trial within the Guardianship Act 1987 (NSW), as it tests a hypothesis by randomising patients between two sedation strategies, including use of dexmedetomidine beyond its TGA licence, and necessarily involves medical treatment. The trial satisfies all statutory criteria in section 45AA(2), including evidence of ethical approval, safety, and best interests. As consent forms relied on 'delayed consent', which the Guardianship Act does not permit, the Tribunal determined it must exercise the function of giving or withholding consent for individual patients.

Jurisdiction
Australia
Judgment Date
23 December 2014
Procedural Posture
Application for Approval for Adults Unable to Consent to Their Own Treatment to Participate in a Clinical Trial / Final Determination and Orders
Outcome
Approved
Legal Topics
['clinical Trials' 'consent for Medical Treatment' 'guardianship Act Criteria' 'therapeutic Goods Administration' 'ethics Approval']
['health Law' 'guardianship Law' 'administrative Law'] ['clinical Trials' 'consent for Medical Treatment' 'guardianship Act Criteria' 'therapeutic Goods Administration' 'ethics Approval']

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Procedural Posture

Application for Approval for Adults Unable to Consent to Their Own Treatment to Participate in a Clinical Trial / Final Determination and Orders

Legal Issues

  1. 1 ["Is the SPICE III clinical trial a 'clinical trial' within the meaning of the Guardianship Act 1987 (NSW)?" 'Does the trial meet statutory criteria for Tribunal approval under section 45AA(2) of the Guardianship Act?' 'Should consent to participation for adults lacking capacity be provided by the Tribunal or a person responsible?']

Ratio Decidendi

The Tribunal found the SPICE III trial constitutes a clinical trial within the Guardianship Act 1987 (NSW), as it tests a hypothesis by randomising patients between two sedation strategies, including use of dexmedetomidine beyond its TGA licence, and necessarily involves medical treatment. The trial satisfies all statutory criteria in section 45AA(2), including evidence of ethical approval, safety, and best interests. As consent forms relied on 'delayed consent', which the Guardianship Act does not permit, the Tribunal determined it must exercise the function of giving or withholding consent for individual patients.

Court Disposition

Approved

Orders

  • ['The SPICE III Trial is approved as a clinical trial in which adults who are unable to consent may participate.' 'The function of giving or withholding consent to participation for individual patients shall be exercised by the Tribunal.']