Regulatory Focus™ > News Articles > India’s CDSCO Issues Guidance on Recording Informed Consent

India’s CDSCO Issues Guidance on Recording Informed Consent

Posted 10 January 2014 | By Louise Zornoza

India's Central Drugs Standard Control Organization (CDSCO) issued guidance on 9 January 2014 on how to conduct audio-visual recordings of the informed consent process conducted with prospective  clinical trial subjects.

The guidance implements an order issued by the CDSCO on 19 November 2013 requiring the audio-visual recording of informed consent for subjects of all domestic and global clinical trials.  

The guidance specifies that information about the research and the nature of the prospective subject's participation must be provided both verbally and in writing, and must be in non-technical, understandable language.

The document also sets out requirements for the process, quality, storage and archiving of the audio-visual recording, and specifies that all documents must be preserved in compliance with principles of confidentiality. The guidance also requires that oral consent be obtained from the subject for the informed consent recording process itself, and states that there should not be any restriction on the trial subject's right to ask any questions related to the study because any such restriction would undermine the validity of informed consent.   

The audiovisual recording requirement follows the recent tightening of the regulation of clinical trials following a 2012 parliamentary report that found that 33 new drugs were approved by the CDSCO between January 2008 and October 2010 without any clinical studies at all.

CDSCO Guidance

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