Dev World Bioeth. 2024 Sep;24(3):243-253. doi: 10.1111/dewb.12417. Epub 2023 Aug 4.
Research ethics committees (RECs) have played a crucial role in expediting the review of research protocols amidst the COVID-19 pandemic. To improve their performance and identify areas of enhancement, a multicentric study was conducted in India by the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP). The study aimed to evaluate the preparedness of Indian RECs during the COVID-19 outbreak while conducting protocol reviews and comprehend the challenges they encountered. After obtaining ethics committee approval, a cross-sectional observational study was conducted using two validated questionnaires, one for REC member secretaries/chairpersons and another for REC members. The questionnaires consisted of 13 multiple-choice questions, 10 yes or no questions, and 2 open-ended questions each. The study was distributed to multiple RECs. A total of 109/200 participants, including 13 REC member secretaries, 12 chairpersons and 84 REC members from a total of 34 REC's, consented to participate in the study. During the COVID-19 pandemic, 23/25 (92%) of the RECs conducted online meetings. The most common challenges faced by RECs included risk-benefit analysis (12/25 RECs), review of informed consent (12/25 RECs), and protocols involving vulnerable populations (10/25 RECs). 65% of the REC members reported the need for ethics review training, and 66/84 REC members agreed or strongly agreed that RECs require training in COVID-19 protocol review. Additionally, 62/84 REC members agreed or strongly agreed that central/joint RECs should review multicenter COVID-19 protocols. RECs in India encountered difficulties while reviewing risk-benefit analyses, informed consent documents (ICDs), and COVID-19 protocols and they suggested providing training on these topics.
研究伦理委员会(RECs)在 COVID-19 大流行期间加快研究方案审查方面发挥了关键作用。为了提高他们的表现并确定需要改进的领域,印度的亚洲和西太平洋地区伦理审查委员会论坛(FERCAP)进行了一项多中心研究。该研究旨在评估印度 REC 在 COVID-19 爆发期间进行方案审查时的准备情况,并了解他们遇到的挑战。在获得伦理委员会批准后,使用两个经过验证的问卷进行了横断面观察研究,一个用于 REC 成员秘书/主席,另一个用于 REC 成员。问卷包括 13 个多项选择题、10 个是/否问题和 2 个开放式问题。该研究分发给多个 REC。共有 109/200 名参与者,包括 13 名 REC 成员秘书、12 名主席和来自 34 个 REC 的 84 名 REC 成员,同意参与该研究。在 COVID-19 大流行期间,25 个 REC 中的 23 个(92%)进行了在线会议。REC 面临的最常见挑战包括风险效益分析(25 个 REC 中的 12 个)、知情同意书审查(25 个 REC 中的 12 个)和涉及弱势群体的方案(25 个 REC 中的 10 个)。65%的 REC 成员表示需要伦理审查培训,66/84 的 REC 成员同意或强烈同意 REC 需要 COVID-19 方案审查培训。此外,62/84 的 REC 成员同意或强烈同意中央/联合 REC 应审查多中心 COVID-19 方案。印度的 REC 在审查风险效益分析、知情同意书(ICD)和 COVID-19 方案时遇到了困难,他们建议提供这些主题的培训。