Clinical trial approval where incapacity

Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (AMOUNT Rehabilitation Trial) [2015] NSWCATGD 1, unsurprisingly given the title of the decision, concerned an application for approval for adults (unable to consent to their own treatment) to participate in a clinical trial.

The trial in question, previously approved by an ethics committee, was a 300 person randomised trial of the effect of affordable technology on physical activity levels and mobility outcomes in rehabilitation. More precisely, the hypothesis being tested is whether rehabilitation outcomes could be improved if a higher dose of repetitive exercise was provided to patients in hospital and after discharge through low-cost video and computer-based technologies such as Nintendo Wii, Xbox Kinect and mobile phone applications.

The Tribunal:

  • was satisfied that the proposed trial was a clinical trial within the meaning of the Guardianship Act and that the trial meets the criteria established in Section 45AA;
  • noted that the risks of participation were minimal;
  • approved the trial as a trial in which it is appropriate for patients who cannot give their own consent to be able to participate; and
  • determined that the function of giving or withholding consent for the carrying out of medical treatment on patients in the course of the proposed trial should be exercised by the ‘persons responsible’ for the patients sought to be recruited to the trial.


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