Please read this important information before making an application for approval of a clinical trial as one in which people unable to consent to their own medical or dental treatment may take part.
As a result of amendments to the Guardianship Act made in 1998, an application must be made to the Tribunal when a treatment - usually a new treatment - is only available in NSW if:
The purpose of the application is to gain the approval of the Tribunal for the clinical trial to be one in which adults 16 years old and over who cannot consent to their own treatment may take part.
The policy in the legislation, which sets out these requirements, is that people who cannot consent to their own treatment should not be denied necessary treatment because they cannot give a valid consent. They are also to be protected against receiving medical or dental treatment which will not promote their health and wellbeing.
In many clinical trials some of the participants will receive a placebo and not the treatment. The Tribunal will consider applications to approve clinical trials involving the administration of placebos when there is no existing treatment other than medical observation, treatment of symptoms and nursing care.
An application should be made if the clinical trial is to compare the effectiveness of a new treatment with an existing treatment. In these trials, a guarantee must be provided to ensure any person unable to give consent to their own treatment would get the existing treatment if they did not receive the new treatment. Also, Phase 1 and Phase 2 trials must have demonstrated that the new treatment is at least as safe and effective as the existing treatment.
The Tribunal cannot approve people who cannot give a valid consent taking part in a clinical trial if participants could miss out on either the existing or the new treatment and receive only a placebo.
If the clinical trial is to compare two existing treatments, people who cannot consent to their own treatment cannot participate unless it can be demonstrated that participants will receive one of the treatments - not a placebo - and that there are no known existing criteria indicating when one of the treatments will be preferred over the other.
If it is possible to differentiate between the treatments so that one is to be preferred when certain symptoms are exhibited, people who cannot consent to their own treatment cannot be included in the trial unless there is a guarantee that they will get the treatment indicated for them. If there is a possibility that they may get a treatment not indicated for them, they cannot take part in the trial. This is because the clinical trial would not meet the basic requirement in Part 5 of the Guardianship Act, which is that people who cannot consent to their own treatment must receive the most appropriate treatment to promote their health and wellbeing. They cannot be denied appropriate treatments for conditions they have to participate in a clinical trial when they may not get any, or any appropriate, treatment.
The application should be made by an appropriately qualified and experienced representative of the company proposing the clinical trial. This representative and the medical or dental practitioner who is the chief investigator responsible for the trial should attend the hearing.
If the clinical trial is proposed to be carried out at more than one site within NSW, the name of each site should be made known to the Tribunal. The applicant should advise those in charge at the other sites about the application and the time and date of the hearing so that they can attend to give evidence if they wish.
There is no application form for this kind of application. An application can be made by writing to the Tribunal requesting approval for people who cannot consent to their own treatment taking part in a particular clinical trial. The applicant must provide the Tribunal with the protocol for the proposed clinical trial and other available documentary material about the trial to satisfy the Tribunal that:
The information listed above can be provided with the application letter or separately before the application is listed for hearing.
The applicant should make sure that sufficient witnesses attend the hearing to provide verbal evidence in relation to all the criteria listed above.
The Tribunal must also approve the form for obtaining consent developed for the clinical trial and the information sheet about the clinical trial that will be available for people able to consent to their own treatment or substitute decision makers ('persons responsible') for people who cannot give a valid consent to their own treatment.
If you need more information about whether an application needs to be made or need to contact the Guardianship Tribunal about preparing an application, phone (02) 9555 8500 and ask to speak to the Legal Officer.
Guardianship Tribunal February 1998
Address: 2a Rowntree Street, Balmain, NSW, 2041
Postal Address: Locked Mailbag 9, Balmain NSW 2041
Phone: (02) 9555 8500
Fax: (02) 9555 9049
Tollfree: 1800 463 928
Email: gt@gt.nsw.gov.au
Website: www.gt.nsw.gov.au