Author Topic: DCGI makes audio-visual documenting of informed consent compulsory for trials  (Read 2649 times)

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Offline santu

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Unsurprisingly browbeaten by the Supreme Court for not keeping the necessary level of visibility in clinical studies in the nation, the centarl health ministry has made compulsory the audio-visual recording of informed consent procedure of each subject who takes part in the clinical studies in the nation. This is in inclusion to the necessity of getting written informed consent from the contributing subjects.

The health ministry's instead belated action in this consideration comes after the Supreme Court's latest instruction to the government while providing its order in a writ case filed by the NGO Swasthya Adhikar Manch, Indore towards the ministry of health and family welfare concerning lack of visibility in clinical studies. As per the apex court order dated on 21.10.2013, in regard of 5 international clinical studies for which acceptance has been given by the DCGI office from January 1, 2013 to August 31, 2013, before the clinical studies are performed, proper preventative measure should be designed or administrative direction should be granted which makes sure that audio-visual documenting of the informed consent procedure of the participants is done and the documentation conserved, sticking to the principles of confidentially.

“In view of the above, it has been made the decision with the acceptance of the ministry of health and family welfare, that in all clinical studies, in addition to the necessity of acquiring written informed consent, audio-visual documenting of the informed consent method of each trial participent, which includes the process of offering information to the subject and his/her knowing on such consent is necessary to be done while sticking to the principles of confidentially. Such audio-visual documenting and related documentation would be maintained. This is appropriate to the new subjects to be registered in all clinical studies such as global clinical trials,” Drugs Controller General of India (DCGI) Dr GN Singh in his order said, and added additional that “All the sponsors/investigators/institutes/organisations and other stakeholders engaged in perform of clinical studies in the nation are hereby instructed to stick to the above necessity of audio-visual recording of informed consent procedure of trial subjects with instant effect.