Form 16 - Application process - Clinical research

1. What you need to know

The Guardianship and Administration Act 2000 provides that the Tribunal may approve clinical research.

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 the giving of placebos to some of the participants in the trial.

NOTE: A comparative assessment of health care already proven to be beneficial to participants is not medical research as defined by the Act, and does not need approval by the Tribunal.

Approved clinical research is clinical research approved by the Tribunal. The Tribunal may approve clinical research, which seeks to include persons with impaired decision making capacity, only if the Tribunal is satisfied about the following:

• the clinical research is approved by an ethics committee,
• any drugs, devices, biologicals or techniques on trial in the clinical research are intended to diagnose, maintain or treat a condition affecting the participants in the research,
• the 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 on trial has reached a stage at which safety and ethical considerations make it appropriate for the drugs or techniques to be made available to the participants despite the participants being unable to consent to participation,
• having regard to the potential benefits and risks of participation, on balance, it is not adverse to the interests of the participants to participate.

Once the proposed clinical research has been approved by the Tribunal, then it is considered a health matter, and section 66 of the Act determines who may consent to the Adult’s participation in the approved clinical research. Participation in approved clinical research without consent may only occur in accordance with section 63 of the Act, which involves urgent health care; and section 64 which involves minor and uncontroversial health care. All trials are subject to the National Health Medical Research (NHMRC) Guidelines.

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2. Complete and lodge this form:

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