Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (AMOUNT Rehabilitation Trial) [2015] NSWCATGD 1

Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (AMOUNT Rehabilitation Trial) [2015] NSWCATGD 1

The AMOUNT Rehabilitation Trial was a clinical trial because it involved an evaluation of rehabilitative techniques, including randomised allocation between usual care and technology-assisted rehabilitation, and therefore involved medical treatment within the broad meaning of Part 5 of the Guardianship Act 1987 (NSW). The Tribunal was satisfied that the techniques were intended to alleviate limited mobility, the risks were minimal and not materially greater than existing treatments, the technologies were sufficiently developed and ethically appropriate, participation was in patients' best interests given potential mobility benefits and low risk, and the trial had relevant ethics approval...

Jurisdiction
Australia
Judgment Date
06 January 2015
Procedural Posture
Application for Approval of a Clinical Trial in Which Adults Unable to Consent to Their Own Treatment May Participate / Decision on Application
Outcome
The AMOUNT Rehabilitation Trial was approved as a clinical trial in which adults unable to consent may participate, with consent to be given or withheld by the persons responsible for the patients.
Legal Topics
['clinical Trials' 'adults Unable to Consent' 'person Responsible' 'rehabilitative Care' 'randomisation of Treatment']
['guardianship' 'health Law' 'medical Treatment Consent'] ['clinical Trials' 'adults Unable to Consent' 'person Responsible' 'rehabilitative Care' 'randomisation of Treatment']

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Procedural Posture

Application for Approval of a Clinical Trial in Which Adults Unable to Consent to Their Own Treatment May Participate / Decision on Application

Legal Issues

  1. 1 ['Whether the AMOUNT Rehabilitation Trial was a clinical trial within the meaning of Division 4A of Part 5 of the Guardianship Act 1987 (NSW).' 'Whether the trial satisfied the criteria for approval under s 45AA(2) of the Guardianship Act 1987 (NSW).' 'Whether the function of giving or withholding consent should be exercised by the persons responsible for patients under s 45AB(1)(a) of the Guardianship Act 1987 (NSW).' 'Whether the patient information and consent forms provided sufficient information for persons responsible to decide whether patients should participate.']

Ratio Decidendi

The AMOUNT Rehabilitation Trial was a clinical trial because it involved an evaluation of rehabilitative techniques, including randomised allocation between usual care and technology-assisted rehabilitation, and therefore involved medical treatment within the broad meaning of Part 5 of the Guardianship Act 1987 (NSW). The Tribunal was satisfied that the techniques were intended to alleviate limited mobility, the risks were minimal and not materially greater than existing treatments, the technologies were sufficiently developed and ethically appropriate, participation was in patients' best interests given potential mobility benefits and low risk, and the trial had relevant ethics approval...

Court Disposition

The AMOUNT Rehabilitation Trial was approved as a clinical trial in which adults unable to consent may participate, with consent to be given or withheld by the persons responsible for the patients.

Orders

  • ['The AMOUNT Rehabilitation Trial approved as a clinical trial in which adults unable to consent may participate.' 'The function of giving or withholding consent for the carrying out of medical treatment on patients in the course of the trial is to be exercised by the persons responsible for the patients pursuant to...