Need of AV recording of

informed consent in
clinical trial
In recent years, there has been considerable debate about the ethics
of clinical researchpractices in developing countries. One of the major issues
is the quality of informed consent process.
Indias clinical trials process has come under intense scrutiny after a series
of scandals involving alleged malpractices which have sparked huge public
protests. Owing to this concerns have been raised about the lack of ethical
outlook, and there have also been allegations that patients are recruited to
clinical trials without any proper informed consent.
In a survey questionnaire served to some investigators in India, very few
investigators (18%) felt that all their patients in studies were absolutely
autonomous.
With this background, it is not surprising that the Central Government in
consultation with Drugs Technical Advisory Board , Central Drug Standard
Control Organization proposed to make draft rule that audio-video recording of
the informed consent process of individual participant by an investigator
including process of providing information to the subject and his understanding
on such consent shall be maintained by the investigating person for record
while conducting clinical trials in India.
The Indian health ministry will soon make some amendments in the Schedule Y
of Drugs and Cosmetics (D&C) Rules to make a furnishing for AV (audio-video)
recording of the informed consent in clinical trial researches. Once the
necessary changes are done by the ministry the AV recording of informed
consent will become mandatory countrywide.
As per proposal the investigator should make audio / video recording of the
procedure of obtaining informed consent of the individual subject and maintain
it for record. This will make it a practice that at the time of enrollment proper
care would be taken to tell the subject about the pros and cons of the clinical
trial and that his participation was totally voluntary.

DCGI further mentioned that the clinical trial subject should also be made
aware during informed consent process, that there are chances of failure of the
trial product to give the intended therapeutic effect and in case of placebo
controlled trial, the placebo administered might not have the right effect.
Once the necessary amendments are made by the ministry in this regard, the
AV recording of informed consent will become mandatory in India. Besides, the
AV recording of the informed consent process of individual patient, including
procedure of giving information to the subject and his understood consent,
should be maintained by the investigator for record.
The reason behind this provision is that it will authenticate that at the time of
enlistment, proper care is taken to inform the trial subject about the pros and
cons of the clinical trial and to make sure that his participation is exclusively
voluntary.
The Drugs Technical Advisory Board (DTAB), the highest authority in the union
health ministry on technical matters, has given its approval to the proposal of
the CDSCO to make some amendments in Schedule Y of the D&C Act to insert a
clause that an AV recording of the informed consent process of individual
patient including procedure of giving information to the subject and his
understood consent shall be maintained by the investigator for record.
Even though it is compulsory under Schedule Y of the Drugs and Cosmetics
Rules to obtain a freely given informed, written consent from each trial subject
before he is enlisted in a clinical trial, in the absence of AV proof, there have
been complaints of exploitation of this provision by the companies who are
engaged in clinical research business. There were certain reports that many
times the informed consent was taken from the participating subjects without
telling about them the pros and cons of the trial.
The officials feel that the audio and video recording of this procedure of
individual subject will act as a proof of a well informed consent.

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