Audiovisual informed consent process in vaccine trials: Experience from North India

Madhu Gupta, Jaya Prasad Tripathy, Sanjay Verma

DOI: 10.20529/IJME.2018.043


Abstract

Audiovisual (AV) recording of the informed consent process in a clinical or vaccine trial to document the consent process of participants (especially from vulnerable populations), ensures preservation of their rights and well-being. This paper describes the AV consent process during a phase III rotavirus vaccine trial among healthy infants in Chandigarh and examines its effects. 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. AV recordings of these 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. All queries were patiently listened to and addressed, allaying most fears, especially those related to adverse events following intervention. The AV process ensured transparency and accountability of the investigators, responsive referral mechanism in case of adverse events, building an 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.

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