Section 8: Functions of Ethics Committee

8. Functions of Ethics Committee (1) The functions of the Ethics Committee shall be to— (a) give its opinion on every application for a trial licence or an amendment to a trial licence, submitted to it by the Council; (b) advise the Council on the health, welfare, safety and protection of subjects in clinical trials; (c) ensure that ethical values and international scientific standards are complied with and that local community values and customs are respected; [Issue 4] C25A – 8 Revised Laws of Mauritius (d) prepare and adopt statements of general principles on which to base its evaluations; (e) keep records of all its proceedings in relation to a clinical trial for a period of at least 15 years following the completion of the clinical trial. (2) For the purpose of giving its opinion under subsection (1) (a), the Ethics Committee shall take such factors as it thinks fit into consideration, including— (a) the relevance of the clinical trial and its protocol; (b) the suitability of any investigator; (c) the anticipated benefits and risks of the clinical trial; (d) the adequacy of the measures to be taken for the health, welfare, safety and protection of subjects; (e) the adequacy of the insurance cover to be contracted for the protection of subjects. (3) The Ethics Committee shall establish and follow its own standard operating procedures. PART IV – PHARMACOVIGILANCE COMMITTEE (Part IV came into operation on 24 September 2011.)