Clinical Research

Clinical research that includes persons with impaired decision-making capacity must be approved by QCAT.

QCAT may approve clinical research, which seeks to include persons with impaired decision making capacity.

Clinical research is:

  • medical research intended to diagnose, maintain or treat a condition affecting the participants in the research; or
  • a trial of drugs, devices, biologicals or techniques involving the carrying out of health care that may include  giving placebos to some of the participants in the trial.

However, a comparative assessment of health care already proven to be beneficial to participants is not medical research, and does not need approval by QCAT.

Approved clinical research is clinical research approved by QCAT.

QCAT may approve clinical research, only if the tribunal is satisfied about the following:

  • the clinical research is approved by an Ethics Committee
  • any drugs, devices, biologicals or techniques to be trialled in the clinical research are intended to diagnose, maintain or treat a condition affecting the participants in the research
  • the clinical research will not involve any known substantial risk to the participants or, if there is existing health care for the particular condition, the research will not involve known material risk to the participants greater than the risk associated with the existing health care
  • the development of any drugs, devices, biologicals or techniques to be  trialled has reached a stage at which safety and ethical considerations make it appropriate for the drugs, devices and biologicals or techniques to be made available to the participants despite the participants being unable to consent to participation; and
  • having regard to the potential benefits and risks of participation in the clinical research, on  balance it is not adverse to the interests of the participants to participate

What happens once the clinical research is approved?

Once the proposed clinical research has been approved by QCAT, then it is considered a health matter, and the Guardianship and Administration Act 2000 determines who may consent to the adult’s participation in the approved clinical research. All trials are subject to the National Health Medical Research (NHMRC) Guidelines.

Form 16 - Application for approval to conduct clinical research

PDF File (394.1 KB)

Apply for approval to conduct clinical research (Form 16)

Help and FAQs

As part of an independent tribunal, QCAT registry staff cannot provide legal advice.

Registry staff can explain and answer questions about how QCAT works and its processes.

Registry staff cannot help with:

  • whether or not you should submit an applicationwhether your application is under the correct jurisdiction
  • if you should lodge an appeal or a counter-application* recommending a specific lawyer to assist you
  • how to word your application, supporting documents or what to say at a proceeding* contacting a QCAT member or adjudicator directly
  • predicting likely outcomes of a case or appeal
  • helping you to prepare your case
  • advising what orders/decisions you should seek
  • explaining what you should do to follow QCAT directions
  • enforcing an order or decision of the tribunal
  • advising exact timeframes for resolution of a matter – this depends on your individual matter.

QCAT staff cannot provide legal advice (see right hand side bar for more information).

All parties involved in a matter before QCAT must represent themselves. Whether you are represented or not you can still seek legal advice about your rights.

In some cases, a party is automatically able to be represented. QCAT will always agree to representation:

  • for a child or a person with impaired capacity, or
  • if the matter relates to disciplinary proceedings including a review of a disciplinary decision
  • if the enabling Act related to the matter allows it.

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