The Union Health Ministry has made audio-visual
recording of the informed consent of each subject mandatory in a
clinical trial. This is in addition to obtaining his/her written
consent.
This decision comes in the wake of the
Supreme Court pulling up the Ministry for lack of transparency in
clinical trials.In its October 21, 2013, order on a writ petition filed
by an NGO, the Swasthya Adhikar Manch, Indore, the court said with
respect to five global clinical trials, which was approved by the Drugs
Controller-General of India (DCGI) office from January 1, 2013, to
August 31, 2013, an appropriate provision should be made or
administrative direction issued, ensuring that audio-visual recording of
the informed consent process was done and the documentation preserved,
adhering to confidentiality principles.
In his order,
DCGI G.N. Singh said all
sponsors/investigators/institutes/organisations and other stakeholders
involved in clinical trials should adhere to this requirement with
immediate effect.
Reacting to this, the Indian
Society for Clinical Research — an association of professionals involved
in clinical trials — said lack of guidance and direction on operational
and logistical issues of managing the audio-visual recording process
like the kind of equipment to be used, and where and how information
should be stored could leave room for ambiguity and inconsistencies in
execution.
More clarity was required on how
confidentiality of patients should be protected and maintained in an
‘audio-visual’ context and what processes needed to be followed in
instances where, for religious and socio-cultural reasons, patients
might not want to be videographed, the association said.
Source: The Hindu
