45AATribunal may approve clinical trials

#### 45AA Tribunal may approve clinical trials 45AA Tribunal may approve clinical trials > > (1) The Tribunal may approve, in accordance with this section, a clinical trial as a trial in which patients to whom this Part applies may participate. > > > (2) The Tribunal may give an approval under this section only if it is satisfied that— > > > > > (a) the drugs or techniques being tested in the clinical trial are intended to cure or alleviate a particular condition from which the patients suffer, and > > > > > (b) the trial will not involve any known substantial risk to the patients (or, if there are existing treatments for the condition concerned, will not involve material risks greater than the risks associated with those treatments), and > > > > > (c) the development of the drugs or techniques has reached a stage at which safety and ethical considerations make it appropriate that the drugs or techniques be available to patients who suffer from that condition even if those patients are not able to consent to taking part in the trial, and > > > > > (d) having regard to the potential benefits (as well as the potential risks) of participation in the trial, it is in the best interests of patients who suffer from that condition that they take part in the trial, and > > > > > (e) the trial has been approved by a relevant ethics committee and complies with any relevant guidelines issued by the National Health and Medical Research Council. > > > (3) The fact that a clinical trial will or may involve the giving of placebos to some of the participants in the trial does not prevent the Tribunal from being satisfied that it is in the best interests of patients that they take part in the trial. > > > (4) The Tribunal’s approval of a clinical trial under this section does not operate as a consent to the participation in the trial of any particular patient to whom this Part applies. The appropriate consent must be obtained under Division 3 or 4 before any medical or dental treatment in the course of the trial is carried out on the patient. > > > (5) In this section— > > > > ethics committee means— > > > > > (a) for so long as there is any relevant Institutional Ethics Committee registered by the Australian Health Ethics Committee established under the [National Health and Medical Research Council Act 1992](http://www.legislation.gov.au/) of the Commonwealth—an Institutional Ethics Committee so registered, or > > > > > (b) in the absence of such a committee, an ethics committee established by— > > > > > > > (i) a local health district or a public hospital, or > > > > > > > (ii) a university, being an ethics committee concerned, wholly or partly, with medical research, or > > > > > > > (iii) the National Health and Medical Research Council. > > **s 45AA:** Ins 1998 No 7, Sch 1 \[9\]. Am 2010 No 97, Sch 2.9 \[2\]; 2011 No 4, Sch 2.11 \[2\].