The Queensland Civil and Administrative Tribunal (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.
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.