Application for additional orders relating to a clinical trial previously approved by the Tribunal and known as the SPICE III Trial [2015] NSWCATGD 24

Application for additional orders relating to a clinical trial previously approved by the Tribunal and known as the SPICE III Trial [2015] NSWCATGD 24

The Tribunal determined that the amended protocol and consent forms provide sufficient information for persons responsible to make an informed decision, and the Ethics Committee has approved the trial at additional sites. Therefore, persons responsible may exercise the function of giving or withholding consent, and the trial is approved at new sites.

Jurisdiction
Australia
Judgment Date
19 June 2015
Procedural Posture
Application for Additional Orders Relating to a Previously Approved Clinical Trial / Final Orders After Urgent Hearing
Outcome
Application granted
Legal Topics
['clinical Trial Approval' 'consent for Medical Treatment' 'substitute Decision Making']
['health Law' 'guardianship Law'] ['clinical Trial Approval' 'consent for Medical Treatment' 'substitute Decision Making']

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Procedural Posture

Application for Additional Orders Relating to a Previously Approved Clinical Trial / Final Orders After Urgent Hearing

Legal Issues

  1. 1 ['Whether persons responsible may give or withhold consent for trial participation for adults unable to consent' 'Whether approval should be extended to additional trial sites']

Ratio Decidendi

The Tribunal determined that the amended protocol and consent forms provide sufficient information for persons responsible to make an informed decision, and the Ethics Committee has approved the trial at additional sites. Therefore, persons responsible may exercise the function of giving or withholding consent, and the trial is approved at new sites.

Court Disposition

Application granted

Orders

  • ["SPICE III Trial approved at Prince of Wales Hospital, Prince of Wales Private Hospital, Nepean Hospital, Hornsby Ku-Ring-Gai Hospital, St Vincent's Hospital, Lismore Base Hospital, Westmead Hospital, Royal North Shore Hospital, Gosford Hospital." 'Persons responsible may exercise the function of giving or...