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.
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