Audiovisual Informed Consent Process in Vaccine Trials: Experience from North India

Although it is mandatory in India to obtain freely given, informed, written consent from a study subject before enrolment in a clinical trial, there have been several complaints about the misuse of this provision by research institutes, pharma companies, and clinical research organisations that are engaged in clinical trials. Audiovisual (AV) recording of the informed consent process in a clinical or vaccine trial has been used as a means to ensure preservation of the rights and well-being of participants, especially those from vulnerable populations. This paper describes the experience of the authors/investigators with obtaining AV consent from subjects' (healthy infants) parents in a phase III rotavirus vaccine trial so as to document the process involved in AV consenting, including the queries raised by the participants and how the queries were addressed.

Out of 155 parents/guardians of participating infants who were contacted to be a part of the study, 50 were reluctant to participate in the study trial (not necessarily in the AV consenting process). Among 105 parents/guardians of participating infants who expressed initial willingness to participate in the trial, all agreed to undergo the AV consenting process, and 100 finally consented to participate and were enrolled in the study. So, the participation rate was 64.5% (100/155) among those who were contacted, and 95.2% (100/105) among those who underwent AV consenting process. It was observed that only mothers most often did not decide by themselves whether or not to participate in the study and came back after a day or so to give their final response. When both the parents were present, they often took the decision on the spot. In one case, the parents consulted their family physician before deciding to participate in the study.

A portion of a room was dedicated for AV recording through artificially erected barriers to maintain participant confidentiality and eliminate outside noise in the recording. Recording was done using a webcam (C9210 Logitech HD Pro) mounted on a desktop computer. As the first step, consent to record audio and video for AV consent gathering was obtained from the parents/guardians. The written informed consent form was provided in English, Hindi, and Punjabi. A structured AV consent module was followed to ensure that all the components of informed consent were covered. Adequate time was given for the discussion and settling of queries. Information was given individually in the language that each participant was most conversant in. In case of participants who were illiterate, AV consenting was done in the presence of an impartial witness.

AV recordings of the 100 patient representatives were transcribed and later translated into English for a thematic analysis of the text. A total of 105 queries were raised by 55 participants. The majority of the queries were around whom to consult in case of any emergency (22; 21%), risks to the baby as a result of the vaccine (20; 19%), vaccination schedule and any change in the schedule (15; 14%), and what would happen if they had to go out of the city (10; 9.5%). Among those who gave consent to participate in the study, it was seen that those who were educated up to middle school and matriculation were more likely to ask questions of the researchers compared to those who were educated less than that or more.

The authors/investigators worked to patiently listen to and address all queries, allaying most fears, especially those related to adverse events following intervention. They state: "The AV consent process takes a considerable amount of time, but it is a one-time activity and deserves the time it warrants." They contend that the AV process ensured: transparency and accountability of the investigators, a responsive referral mechanism in case of adverse events, an opportunity to build initial rapport with the participant, complete vaccination of the trial subjects, and provision for free private care consultation, depending upon the willingness of the parents. These benefits of the AV consent process might have led to a higher participation rate.

Based on their experience, the authors/investigators recommend that the regulatory agencies further standardise the AV consent process by: (i) formulating a list of frequently asked questions with answers supplied by individual study investigators, and (ii) specifying the technical specifications of devices to be used for AV recording.

In conclusion: "The participation rate in this vaccine trial, among those who underwent the AV consent process, was very high due to the descriptive and rigorous process followed. The findings of this study will assist researchers involved in conducting vaccine/clinical trials to understand the importance of the AV consent process and build their capacity to narrate all the study procedures in detail, including the likely side effects of the investigational product. It will also assist them in dealing with participant queries with increased confidence."