Informed consent process in India
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Informed consent is required for all clinical trials in India, including obtaining written consent from each subject or their legal representative and maintaining an impartial witness. For pediatric trials, consent from a parent or guardian is needed along with written child assent. Audio-video recordings must be made for vulnerable subjects in certain high-risk clinical trials to document that full information was provided and understood.
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Informed consent process in India
- 1. Informed Consent Process in India Presenter: Dr. Ashish Singh PariharPh.D.
- 2. As per New CT Rule 2019 a. In all trials, a freely given, informed, written consent is required to be obtained from each study subject. b. The subject's consent must be obtained in writing/Thumb impression c. Consenting from legally acceptable representative (LAR) d. Impartial witness provision e. In case of clinical trials on paediatrics, a. Consent should be obtained from the parent or legal guardian b. Written assent f. A checklist of essential elements
- 3. AV consenting g. An audio-video recording of the informed consent process in case of vulnerable subjects in clinical trials of New Chemical Entity or New Molecular Entity including procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record: • Note: in case of clinical trial of anti-HIV and anti-leprosy drugs, only audio recording of the informed consent process of individual subject including the procedure of providing information to the subject