Clinical trials
Why is approval of a clinical trial required?
If it is proposed to conduct a clinical trial in NSW which may include adults unable to provide informed consent to treatment, the Guardianship Tribunal must approve the clinical trial. The Tribunal can only approve a clinical trial if it is satisfied as to certain criteria, which are provided in the brochures listed below.
The Tribunal will not deal with an application for approval of a clinical trial until:
- it receives proof that the relevant ethics committees have approved the clinical trial; and
- all the centres conducting the clinical trial have provided the Tribunal with the patient information sheets and consent forms for the clinical trial.
Making the application
Applications should be made to the Tribunal only by a representative of the pharmaceutical company proposing the trial or by the principal investigator of a centre proposing to conduct the trial.
You can make an application:
More information
For more information about applying for approval of a clinical trial, read the information brochures Application for Approval of a Clinical Trial and Access to New Treatments through Clinical Trials.