Clinical trials

NCAT must approve a clinical trial before any adult who cannot consent to their own treatment can take part in that clinical trial. A person responsible must consent on behalf of the person with the disability for participation in the approved clinical trial.

Why is approval of a clinical trial required?

A clinical trial conducted in NSW, which may include persons who are 16 years of age or older who are unable to provide informed consent to treatment, must have the approval of the Tribunal under Part 5 of the Guardianship Act 1987​.

A clinical trial is a trial of a drug or intervention technique that involves giving medical treatment to the trial participant. Trials may relate to a new drug or the use of an existing drug in a way or for a purpose that has not yet been approved.

NCAT can only approve a clinical trial if it is satisfied that the trial meets certain criteria. Refer to the Clinical trials fact sheet [PDF, 56kB] for further information.

Making an application

Applications to NCAT for the approval of a clinical trial must only be made by a representative of the pharmaceutical company proposing the trial or by the principal investigator of a centre proposing to conduct the trial using the application form.