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Abstract：
Clinical trial regulations for new drugs in India released a gazette notification for obtaining audiovisual (AV) consent from all trial participants in November 2013. The reports of AV recordings of the studies from October 2013 to February 2017 submitted to the institutional ethics committee were analyzed in view of the Indian regulations on AV consenting. The reports of AV recording were checked: number of AV consents for each project, adequacy of AV recording, number of persons in the video, informed consent document elements (ICD) covered as per Schedule Y, confirmation of understanding by the participant, the time taken to complete the procedure, maintenance of confidentiality, and whether reconsent was taken. Seven studies of AV consent were monitored. Eighty-five (85) AV-consented and filled checklists were evaluated. The AV recording was not clear in 31/85, ICD elements were missing in 49/85 consents, time taken to complete the procedure was 20.03 ± 10.83 with the number of pages being 14.24 ± 7.52 (R= 0.29 p<0.041). In 19/85 consents, privacy was not maintained and on 22 occasions, reconsent were taken. There were deficits found in the AV consent process.
摘要：
印度新药临床试验法规于2013年11月发布了一份公报通知，要求获得所有试验参与者的视听（AV）同意。鉴于印度关于AV同意的规定，分析了2013年10月至2017年2月提交给机构伦理委员会的研究的AV记录报告。检查了AV记录的报告：每个项目的AV同意数，AV记录的充分性，视频中的人数，附表Y涵盖的知情同意书要素(ICD)，确认参与者的理解，完成该程序所需的时间，保密,以及是否再次同意。监测了七项AV同意研究。评估了八十五（85）个AV同意和填写的清单。31/85的AV记录不清楚，49/85的ICD元素丢失，完成手术所需的时间为20.03±10.83,页数为14.24±7.52(R=0.29p<0.041).在19/85同意中，隐私没有得到维护，有22次，再次同意。在AV同意过程中发现了缺陷。
