Informed consent: (i) In all investigations, a freely given, informed, written consent is required to be obtained from each study subject. The investigator shall provide information about the study verbally and through the patient information sheet, in a language that is non-technical and is understandable by the study subject. The subject's consent must be obtained in writing using an 'Informed Consent Form'. The patient information sheet as well as the Informed Consent Form shall be approved by the Ethics Committee and furnished to the Central Licensing Authority. Any change in the informed consent documents should be approved by the Ethics Committee and submitted to the Central Licensing Authority before such changes are implemented. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 168 of 248 (ii) Where a subject is not able to give informed consent (e.g. an unconscious person or a minor or those suffering from severe mental illness or disability), the same may be obtained from a legally acceptable representative. If the subject or his legally acceptable representative is unable to read or write, an impartial witness should be present during the entire informed consent process who must append his signatures to the consent form. Explanation : A legally acceptable representative means a person who is able to give consent or authorise an intervention in the patient as provided by the law in India. (iii) A checklist of essential elements to be included in the study subject's informed consent document as well as a format for the Informed Consent Form for study Subjects is given in Table 8 of this Schedule. (iv) The informed consent process, in case of vulnerable subjects in clinical investigations of an innovative medical device which is not approved anywhere in the world, shall be audio-video recorded.