Gupta Madhu, Tripathy Jaya Prasad, Verma Sanjay
Additional Professor, Department of Community Medicine, School of Public Health, Postgraduate Institute of Medical Education and Research, Chandigarh, India.,
Senior Operational Research Fellow, International Union Against Tuberculosis and Lung Disease, The Union South East Asia Office, New Delhi 110 016 India.,
Indian J Med Ethics. 2018 Jul-Sep;3(3):179-185. doi: 10.20529/IJME.2018.043. Epub 2018 May 28.
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.
在临床或疫苗试验中对知情同意过程进行视听（AV）记录，以记录参与者（尤其是弱势群体）的同意过程，可确保维护他们的权利和福祉。本文描述了在昌迪加尔针对健康婴儿进行的III期轮状病毒疫苗试验中的AV同意过程，并考察了其效果。在被联系参与研究的155名参与婴儿的父母/监护人中，有50人不愿参与研究试验（不一定是AV同意过程）。在105名最初表示愿意参与试验的参与婴儿的父母/监护人中，所有人都同意接受AV同意过程；其中100人最终同意参与并被纳入研究。因此，在被联系者中参与率为64.5%（100/155），在接受AV同意过程者中参与率为95.2%（100/105）。对这100名患者代表的AV记录进行了转录，随后翻译成英文以进行文本的主题分析。55名参与者共提出了105个问题。所有问题都得到了耐心倾听和解答，消除了大多数担忧，尤其是与干预后不良事件相关的担忧。AV过程确保了研究者的透明度和问责制、不良事件发生时的响应性转诊机制、与参与者建立初步融洽关系、试验对象的全程疫苗接种，以及根据父母意愿提供免费私人护理咨询。AV同意过程的这些益处可能导致了更高的参与率。
