S.L. 458.43 ст. 4Protection of clinical trial subjects. Cap. 586.

(1) A clinical trial may be undertaken only if, in particular -

(a) the foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual trial subject and other present and future patients. A clinical trial may be initiated only if the Ethics Committee and, or the Licensing Authority comes to the conclusion that the anticipated therapeutic and public health benefits justify the risks and may be continued only if compliance with this requirement is permanently and continuously monitored;

(b) the trial subject or, when the person is not able to give informed consent, his legal representative, has had the opportunity, in a prior interview with the investigator or a member of the investigating team, to understand the objectives, risks and inconveniences of the trial, and the conditions under which it is to be conducted and has also been informed of his right to withdraw from the trial at any time by revoking his informed consent without suffering any detriment;

(c) the rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning him in accordance with the Data Protection

Act and any amendments thereto, are safeguarded;

(d) the trial subject or, when the person is not able to give informed consent, his legal representative has given his written consent after being informed of the nature, significance, implications and risks of the clinical trial. However if the individual is unable to write, oral consent may be given in the presence of at least one witness;

(e) provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor.

(2) It shall be the responsibility of an appropriately named qualified doctor or, where appropriate, of a named qualified dentist or other named person with appropriate qualifications as the case may be, to provide at all times the necessary medical care and make medical decisions on behalf of the subjects.

(3) The subject shall be provided with a contact point where he may obtain further information.