Surveying the Indian research ethics committee response to the COVID-19 pandemic

IF 0.9 3区哲学 Q3 ETHICS

Developing World Bioethics Pub Date : 2023-08-04 DOI:10.1111/dewb.12417

Yashashri C. Shetty, Sudha Ramalingam, Paresh Koli, Karthikeyan Shanmugam, Rajmohan Seetharaman

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引用次数: 0

Abstract

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.

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调查印度研究伦理委员会对 COVID-19 大流行病的反应。

在 COVID-19 大流行期间，研究伦理委员会 (REC) 在加快审查研究方案方面发挥了至关重要的作用。为了提高伦理委员会的绩效并确定需要加强的领域，亚洲和西太平洋地区伦理审查委员会论坛 (FERCAP) 在印度开展了一项多中心研究。该研究旨在评估印度区域医疗中心在 COVID-19 爆发期间进行方案审查的准备情况，并了解它们遇到的挑战。在获得伦理委员会批准后，研究人员使用两份经过验证的调查问卷进行了横断面观察研究，其中一份针对区域协调中心成员秘书/主席，另一份针对区域协调中心成员。问卷包括 13 道选择题、10 道 "是 "或 "否 "题和 2 道开放式问题。研究报告分发给了多个区域经济委员会。共有 109/200 人同意参与研究，其中包括来自 34 个区域经济共同体的 13 名区域经济共同体成员秘书、12 名主席和 84 名区域经济共同体成员。在 COVID-19 大流行期间，23/25（92%）个区域执行委员会举行了在线会议。区域医疗中心面临的最常见挑战包括风险效益分析（12/25 个区域医疗中心）、知情同意书审查（12/25 个区域医疗中心）和涉及弱势群体的方案（10/25 个区域医疗中心）。65% 的 REC 成员表示需要接受伦理审查培训，66/84 的 REC 成员同意或非常同意 REC 需要接受 COVID-19 方案审查培训。此外，62/84 名区域执行委员会成员同意或非常同意中央/联合区域执行委员会应审查多中心 COVID-19 方案。印度的 REC 在审查风险效益分析、知情同意文件 (ICD) 和 COVID-19 方案时遇到了困难，他们建议提供有关这些主题的培训。

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来源期刊

Developing World Bioethics 医学-医学：伦理

CiteScore

4.50

自引率

4.50%

发文量

审稿时长

>12 weeks

期刊介绍： Developing World Bioethics provides long needed case studies, teaching materials, news in brief, and legal backgrounds to bioethics scholars and students in developing and developed countries alike. This companion journal to Bioethics also features high-quality peer reviewed original articles. It is edited by well-known bioethicists who are working in developing countries, yet it will also be open to contributions and commentary from developed countries'' authors. Developing World Bioethics is the only journal in the field dedicated exclusively to developing countries'' bioethics issues. The journal is an essential resource for all those concerned about bioethical issues in the developing world. Members of Ethics Committees in developing countries will highly value a special section dedicated to their work.