Section 20: Protection of subjects

20. Protection of subjects (1) No sponsor or investigator shall use a human being as a subject unless— (a) where the subject is of the age of 18 or over, he gives his written consent thereto; (b) where the subject is of the age of 18 or over but incapable of giving his consent— (i) his spouse, parent or guardian gives written consent thereto; (ii) his participation in the clinical trial is essential; and (iii) the clinical trial relates directly to the condition from which he is suffering; (c) where the subject is under the age of 18— (i) his responsible party gives written consent thereto; and (ii) in case he is capable of forming an opinion, the sponsor and investigator are satisfied of his willingness to participate in the clinical trial. (2) For the purposes of subsection (1), an investigator shall, before a clinical trial is conducted, give a full and reasonable explanation of the nature and object of the clinical trial and the risks involved, if any— (a) where the subject is of the age of 18 or over, to the subject; (b) where the subject is of the age of 18 or over but incapable of giving his consent, to his spouse, parent or guardian; C25A – 15 [Issue 3] Clinical Trials Act (c) where the subject is under the age of 18— (i) to his responsible party; and (ii) to the subject himself according to his capacity of understanding. (3) A subject may, at any time, withdraw from a clinical trial without incurring any liability. (4) No medical practitioner shall induce— (a) a patient whom he is treating to consent to be a subject; or (b) the responsible party of a patient whom he is treating to consent to the patient being a subject. (5) Subject to subsection (6), no person shall, by means of any threat, coercion or reward, compel or induce another person to be a subject. (6) Subsection (5) shall not apply to a sponsor who compensates a subject for his participation in a clinical trial. (7) The Council shall publish guidelines on informed consent requirements which every sponsor and investigator shall comply with. (8) In this section— “responsible party” means the person who exercises parental authority over a subject under the Code Civil Mauricien.