Where the Authority grants authorization for the conduct of a clinical trial of a drug, herbal medicinal product, cosmetic or medical device or procedure the trial shall not take place until

(a) in the case of the treatment of adult persons, the voluntary written informed consent of the person taking part in the clinical trial has been freely obtained by the person conducting the trial and for a person who cannot read and write in a language that must person under stands;

(b) in the case of the treatment of a child or persons under legal disability, the voluntary written informed consent of their parents or legal guardians has been freely obtained by the person conducting the trial;

(c) in the case of animals, the voluntary written informed consent of the owners of the animals taking part in the clinical trial has been freely obtained by the person conducting the trial; and

(d) insurance coverage is provided for prospective participants.