Audiovisual informed consent process in vaccine trials: Experience from North India
This paper describes the AV consent process during a phase III rotavirus vaccine trial among healthy infants in Chandigarh
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.
This research was supported by the UK Department for International Development’s Operational Research Capacity Building Programme led by the International Union Against TB and Lung Disease (The Union)
Citation
Gupta M, Tripathy JP, Verma S. Audiovisual informed consent process in vaccine trials: Experience from North India. Indian J. Med. Ethics [Internet]. 2018; Available from: http://ijme.in/articles/audiovisual-informed-consent-process-in-vaccine-trials-experience-from-north-india/?galley=html
Links
Audiovisual informed consent process in vaccine trials: Experience from North India