Video Recording of the informed consent processJune 20, 2015 2015-06-20 15:58
Video Recording of the informed consent process
The Supreme Court of India has acted upon the DCGI and has made it mandatory for all Multi National Companies and whoever wishes to conduct clinical trials in India to compulsorily video record the informed consent procedure in clinical trials.
This is in addition to obtain a written informed consent from the trial subject. This new rule is applicable to all global and indigenous trials enrolling new subjects. This move is aimed to protect the subject’s fundamental rights during a clinical trial and to ensure that the ethical code in conducting trial is not broken. The Drug Technical Advisory, ( DTAB) has opinioned that a video recording of the informed consent process will make sure that the patient has been informed about the pros and cons of the trial, and he /she is voluntarily participating in the trial without any influence or cohesion by a third party. This will also make sure that the subject has fully understood the implications of the trial and this understood concept of his / her shall be maintained by the investigator for record keeping of the process. The Drug Controller General of India, Dr. G N Singh says that it is the foremost duty of the Principal Investigator to adequately inform the trial subject about the essential components of the trial and the administration of the medicines.
The DTAB further opined that the subject must be aware of the fact that the drug which is being tested on him/her is new and its therapeutic efficacy and serious adverse events is not entirely established. In the recent past, there have been reports of violation of patients in the name of research and this move by the DGCI can certainly help to put an end to the same. India remains an attractive destination amongst pharmaceutical companies to conduct clinical trials owing to patient availability, regulatory infrastructure, efficient staff and its 14,000 plus hospitals. Also, India has a vast pool of diseases which are not yet being treated with medicines. India has also set up 12 new drug advisory committees to review the clinical trial procedure in the country.