Shetty Yashashri C, Tripathi Raakhi, Marathe Padmaja A, Jalgaonkar Sharmila, Gajbhiye Snehalata, Katkar Janhavi
Pharmacology and Therapeutics, Seth GS (Gordhandas Sunderdas) Medical College & KEM (King Edward Memorial) Hospital, Mumbai, IND.
Institutional Ethics Committee, Seth GS (Gordhandas Sunderdas) Medical College & KEM (King Edward Memorial) Hospital, Mumbai, IND.
Cureus. 2023 Jan 31;15(1):e34433. doi: 10.7759/cureus.34433. eCollection 2023 Jan.
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.
印度新药临床试验法规于2013年11月发布了一项公告通知，要求从所有试验参与者处获得视听（AV）同意。鉴于印度关于AV同意的法规，对2013年10月至2017年2月提交给机构伦理委员会的研究AV记录报告进行了分析。检查了AV记录报告：每个项目的AV同意数量、AV记录的充分性、视频中的人数、根据附表Y涵盖的知情同意文件要素（ICD）、参与者对理解的确认、完成程序所需的时间、保密性的维护以及是否获得了再次同意。对七项AV同意的研究进行了监测。评估了85份已获得AV同意并填写的检查表。85份中有31份AV记录不清晰，49份同意书中缺少ICD要素，完成程序所需时间为20.03±10.83，页数为14.24±7.52（R=0.29，p<0.041）。85份同意书中有19份未维护隐私，有22次获得了再次同意。在AV同意过程中发现了不足之处。
