Audio-visual consent for clinical research participants in

India

Making a participant understand the purpose of a clinical research and

obtaining his/her consent for participation in the clinical trial is a rule that has
been set to bring in more transparency to the informed consent process and
protect the safety, wellbeing, and rights of the participants. Under schedule Y of
the approved protocols and Good Clinical Practice (GCP) guidelines published by
Central Drugs Standard Control Organization (CDSCO), Directorate General of
Health Services, Government of India, it is a must to obtain informed, written
consent from each study subject included in a clinical trial.

The Indian Government, as per the order of Supreme Court of India, made
audio-video (AV) recording of the informed consent mandatory for all clinical
trials in 2013. The recording also included the procedure of providing information
to the subject and his/her understanding on such consent. The identity and
records of the trial subjects were to be kept confidential. The immediate effect of
this regulation was a decline in the number of clinical trials conducted in India.

Highlights of the AV recording mandated in 2013

Obtain prior consent of the subject for AV recording of informed consent
process.
Document the consent, which can be oral, for AV recording.
Involve only those subjects in the trial who give consent for AV recording.

Although implementing this rule could have improved reliability, transparency

and quality of a clinical trial, there were many concerns that affected the overall
research process.

Merits to implementing AV recording of informed consent

Ensures legal safety to the investigators as well as participants, particularly
vulnerable subjects
Improves transparency in the trial process
Simple process of obtaining informed consent when compared to the
documentation process that existed

Demerits to the guidelines

Infrastructure involved in making arrangements for AV consent at study
sites. This overall increases the cost of conducting clinical trials in India.
Increase in time required to set up and conduct the consent process
Culture and preferences of the participants preventing recording as per the
guidelines, for example, necessity for women to remove the burqa or
ghunghat for video recording
 Willingness of a patient to discuss the aliment over camera, such as in cases
of sexually transmitted disorders and immunodeficiency syndromes
Feelings of uneasiness and discomfort in participants for being on camera,
which could result in refusal to participate
Language barrier, particularly for external monitors, makes it necessary for
careful choice of personnel for the recordings
Re-consenting, in case of any amendments, means additional task for the
personnel
Fear, in participants, of the video being used for illegal purposes
Misinterpretation of body language, both of and by the
patients/representatives, and the investigator/study staff
Ensure complete protection of confidentiality and integrity of patients identity
and data, as these are accessed by various staff members at different levels
Risk of tampering with the recorded data

These factors, overall, affected the participation of patients and experienced

staff in clinical trials. The existing trials also progressed at a slower pace.

With concerns rising among global clinical research organizations (CROs) in the
feasibility of conducting trials in India, in July 2015, the Indian Government
modified the AV recording norms. The AV consent was made mandatory only
for trials involving vulnerable population, or is done for a new chemical or
molecular entity. Instead of the audiovisual recording, audio recording of the
consent was made mandatory for clinical trials of anti-HIV and anti-leprosy
drugs.

These amendments to the clinical regulatory guidelines have been a welcome

relaxation for the industry. The result is evident with the number of clinical
trials seeing a surge in India.