Ethics Committee This section shall document that the clinical investigation was conducted in accordance with the ethical principles of Declaration of Helsinki. A detailed description of the Ethics Committee constitution and date(s) of approvals of investigation documents for each of the participating sites should be provided. A declaration shall state that EC notifications as per Good Clinical Practice Guidelines issued by Central Drugs Standard Control Organization and Ethical Guidelines for Biomedical Research on Human Subjects, issued by Indian Council of Medical Research have been followed. The ethics report shall include the following points:— (a) a confirmation that the CIP and any amendments to it were reviewed by the EC; (b) a list of all ECs consulted.