The Guardianship Amendment Act 1998 came into force on 1 June 1998. That Act amends the Guardianship Act 1987.
The primary purpose of the amendments is to ensure that people who cannot consent to their own treatment can get access to treatments for conditions when those treatments are available only through a clinical trial.
To ensure that this purpose is achieved, the amendments require the Guardianship Tribunal to give its approval before people who are unable to provide their own valid consent can take part in a particular clinical trial.
The Guardianship Tribunal may not give approval to people unable to provide their own valid consent taking part in a particular clinical trial, unless the following criteria are satisfied:
These safeguards mean that only a person who has suffered a stroke can be enrolled in a trial of medication that, for example, seeks to reduce the level of disability resulting from a stroke. Similarly, only people who have dementia can be enrolled in a trial that seeks to test medication designed to delay the progress of memory loss resulting from dementia.
It should be noted that in some clinical trials some of the participants will be given a placebo and not the treatment itself.
The 1998 amendments empower the Guardianship Tribunal to give 'persons responsible' for people who cannot consent to their own treatment the function of giving or withholding consent to those persons gaining access to the treatment available through a clinical trial. Before these amendments, the Tribunal was the only body that could consent to a person being enrolled in a clinical trial if the person was unable to consent to their own treatment.
When the Guardianship Tribunal gives its approval to people unable to provide their own valid consent to taking part in a particular clinical trial, it will be able to give the function of acting as substitute decision maker about whether a person should be included in a particular clinical trial to 'persons responsible'.
It is anticipated that the Tribunal will give this function to 'persons responsible' in relation to most clinical trials it gives approval to.
Another information sheet about 'person responsible' is available from the Guardianship Tribunal.
In those few cases when the Tribunal does not empower 'persons responsible' to give consent, the Tribunal will be the body to consider whether or not to give consent to individuals being enrolled in clinical trials.
The amendments provide a further safeguard. Before giving 'persons responsible' the function of giving or withholding consent for people they are 'persons responsible' for gaining access to treatment available through a clinical trial, the Tribunal must be satisfied that:
both provide sufficient information to enable 'persons responsible' to decide whether or not it is appropriate that the patient should take part in the trial.
Before a 'person responsible' makes the decision as to whether the person they are 'person responsible' for should be included in a clinical trial, they should:
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