Where a clinical trial of a drug, herbal medicinal product, cosmetic or medical device is authorized under this Part, the person conducting the trial shall, before commencing the trial

(a) inform the persons taking part in the trial or persons whose animals will take part in the trial about

(i) the aims and objectives of the clinical trial and the way in which it will be conducted, and

(ii) the possible risks, discomforts and any other adverse effects that may result,

 (b) ensure that a person or an animal taking part in the trial does not sustain an injury during the trial from the amounts which are prescribed by the Authority; and

(c) sign an indemnity in the form determined by the Authority indemnifying the Authority from liability in respect of an injury or an adverse event which may be sustained by a person or an animal, directly or indirectly, as a result of the conduct of the trial and which occurs or reveals itself at the time of trial or subsequently.