45AB Consent for participation in clinical trials in
(1) If the Tribunal is satisfied as to the matters specified in
section 45AA (2) in relation to a clinical trial, it may, by order,
(a) that the function of giving or withholding consent for the
carrying out of medical or dental treatment on patients in the course of the
trial is to be exercised by the persons responsible for the patients (in which
case Division 3 applies), or
(b) that the Tribunal is to exercise that function itself (in which
case Division 4 applies).
(2) Before making a determination referred to in subsection (1) (a),
the Tribunal must be satisfied that the form for granting consent and the
information available about the trial provide sufficient information to enable
the persons responsible to decide whether or not it is appropriate that the
patients should take part in the trial.