Cap. 525 Art. 35Clinical trials or other medical or scientific research. S.L. 458.43 S.L. 458.43

(1) No person with a mental disorder may be subjected to clinical trials or other medical or scientific research unless:

(a) free and informed consent is given by the said person; and

(b) an independent specialist appointed by the Commissioner examines the person and certifies in the clinical records that in his opinion the person is capable to give free and informed consent and that the expected benefits of the trials or research are likely to outweigh any potential harm to that person; and

(c) there is the approval of the ethics committee appointed by the Minister under the Clinical Trials Regulations.

(2) No person who lacks the mental capacity to give free and informed consent may be subjected to clinical trials or other medical or scientific research unless:

(a) the Commissioner is satisfied after assessment by two independent experts, one of whom shall be a specialist in mental health, that the expected benefits of the trials appointed by the Minister under the Clinical Trials Regulations.

(3) The person or, in the case of a person lacking mental capacity to give free and informed consent, the responsible carer, has the right to withdraw his consent for participation in any clinical trials or medical or scientific research at any time.

(4) Notwithstanding the provisions of this article, article 31(3) shall apply in the case of minors.