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OPINION
Year : 2014  |  Volume : 5  |  Issue : 1  |  Page : 6-10

Audio-video recording of informed consent process: Boon or bane


1 Clinical Operations, GlaxoSmithKline Pharmaceuticals Limited, Worli, Mumbai, Maharashtra, India
2 Institute of Medical Education Technology and Teachers' Training, MUHS Regional Centre, Civil Hospital, Aundh, Pune, Maharashtra, India

Correspondence Address:
Niranjan G Kulkarni
Clinical Team Leader, GlaxoSmithKline Pharmaceuticals Limited, Dr. Annie Besant Road, Worli, Mumbai 400 030, Maharashtra
India
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Source of Support: , Conflict of Interest: Tejashree N Kulkarni was working at Department of Infectious Diseases, Maharashtra University of Health Sciences, Seth Gordhandas Sunderdas Medical College and King Edward Memorial Hospital, Mumbai, Maharashtra, India when this article was submitted.


DOI: 10.4103/2229-3485.124547

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The Drugs Technical Advisory Board has recommended inclusion of audio-video (AV) recording of the informed consent process while conducting clinical trials in India. It is included as draft rule in the gazette of India notification dated 7 th June 2013. This will soon become a law. There are many anticipated advantages of AV recording like reliability, transparency, and improvement in quality of conduct of informed consent process. However, at the same time the industry will need to address challenges in infrastructure, maintaining confidentiality, cost implication, and so on. AV recording will help reassure the government and community about standards maintained by the industry/institute while conducting informed consent process, thereby increasing society's faith in clinical research.


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