Responsibilities of the Ethics Committee: (i) It is the responsibility of the Ethics Committee that reviews and accords its approval to a Clinical Investigation Plan to safeguard the rights, safety and well-being of all study subjects. The Ethics Committee should exercise particular care to protect the rights, safety and well-being of all vulnerable subjects participating in the study. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 167 of 248 Explanation : The vulnerable subject means the members of a group with hierarchical structure (e.g. prisoners, armed forces personnel, staff and students of medical, nursing and pharmacy institutions), patients with incurable diseases, unemployed or impoverished persons, patients in emergency situation, ethnic minority groups, homeless persons, nomads, refugees, minors or others incapable of personally giving consent. Ethics Committee(s) get documented 'standard operating procedures' and should maintain a record of its proceedings.