Queensland Numbered Acts

GUARDIANSHIP AND ADMINISTRATION AND OTHER LEGISLATION AMENDMENT ACT 2019 - SECT 29

29 Insertion of new ch 5, pt 3A

Chapter 5 —
insert —

Part 3A - Clinical research

74A What is clinical research

(1)
"Clinical research" is—

(a) medical research intended to diagnose, maintain or treat a condition affecting the participants in the research; or

(b) 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.

(2) However, a comparative assessment of health care already proven to be beneficial is not medical research.

Examples—

• a comparative assessment of the effects of different forms of administration of a drug proven to be beneficial in the treatment of a condition, for example, a continuous infusion, as opposed to a once-a-day administration of the drug

• a comparative assessment of the angle at which to set a tilt-bed to best assist an adult’s breathing

74B What is approved clinical research
"Approved clinical research" is clinical research approved by the tribunal.

74C Approval of clinical research

(1) The tribunal may approve clinical research only if the tribunal is satisfied—

(a) the clinical research is approved by an ethics committee; and

(b) 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; and

(c) the clinical research will not involve any known substantial risk to 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; and

(d) the development of any drugs, devices, biologicals or techniques to be trialled in the clinical research has reached a stage at which safety and ethical considerations make it appropriate for the drugs, devices, biologicals or techniques to be made available to participants in the research despite the participants being unable to consent to participation; and

(e) having regard to the potential benefits and risks of participation in the clinical research, on balance it is not adverse to the interests of participants in the research to participate.

(2) The fact the drugs, devices, biologicals or techniques to be trialled in the clinical research will or may involve giving placebos to some of the participants in the research does not prevent the tribunal being satisfied it is, on balance, not adverse to the interests of the participants to participate.

(3) The tribunal’s approval of clinical research does not operate as a consent to the participation in the clinical research of any particular person.