Evaluation of the current status of ethics committees in India using the National Accreditation Board for Hospitals and Health-care Providers, Central Drugs Standard Control Organization (CDSCO), and Department of Health Research databases.
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引用次数: 0
Abstract
Purpose/aim: Ethics committees (ECs) have gained much importance since the introduction of the New Drugs and Clinical Trials Rules 2019. The committee report authored by Prof. Ranjit Roy Chaudhury suggested the need for accreditation of Institutional ECs. We aimed to enumerate the registered and accredited ECs across different geographical regions in India and to assess the adequacy of EC standard operating procedures (SOPs).
Materials and methods: Our study was conducted between August and October 2022. The registration status of ECs was obtained from the Central Drugs Standard Control Organization (CDSCO) and Department of Health Research (DHR) websites. Information on accreditation status was obtained from the National Accreditation Board for Hospitals and Healthcare Providers (NABH) website. Registration data were categorized region-wise and available SOPs were collected from respective hospital websites and analyzed for adequacy.
Results: We found that 1400 ECs in India were registered under CDSCO and 952 under DHR. Maharashtra had the largest number of registered ECs. Puducherry, Delhi, and Daman and Diu had the highest density of ECs. Bihar, Himachal Pradesh, and Jharkhand had the lowest. Only 299 ECs had their composition listed, and 111 had SOPs available on their websites. Most ECs lacked SOPs related to reviewing clinical trial agreements, compensation, and dealing with participant complaints.
Conclusion: The advent of the New Drugs and Clinical Trials 2019 has created a definite impetus for increased responsibilities of ECs in India. Yet the registered ECs are not evenly distributed across the country. Moreover, it is disheartening to note that 90% of ECs in the country do not have NABH accreditation. Only a handful of ECs had SOPs posted on their websites.
目的/目的：自2019年《新药和临床试验规则》出台以来，伦理委员会（ec）变得越来越重要。由Ranjit Roy Chaudhury教授撰写的委员会报告建议，有必要对院校教育委员会进行认证。我们旨在列举印度不同地理区域的注册和认可的EC，并评估EC标准操作程序（sop）的充分性。材料和方法：我们的研究于2022年8月至10月进行。ECs的注册状态从中央药品标准控制组织（CDSCO）和卫生研究部（DHR）网站获得。有关认证状况的信息来自医院和医疗保健提供者国家认证委员会（NABH）网站。登记数据按地区分类，并从各医院网站收集可用的标准操作程序，并分析其充分性。结果：印度有1400例ECs按CDSCO登记，952例按DHR登记。马哈拉施特拉邦注册的选举委员会数量最多。普都切里、德里、达曼和第乌的密度最高。比哈尔邦、喜马偕尔邦和贾坎德邦的得分最低。只有299个ec列出了其成分，111个ec在其网站上提供了标准操作程序。大多数ECs缺乏与审查临床试验协议、赔偿和处理参与者投诉相关的标准操作规程。结论：2019年新药和临床试验的出现为印度ec的责任增加创造了明确的动力。然而，注册的选举委员会并没有均匀地分布在全国各地。此外，令人沮丧的是，该国90%的ECs没有NABH认证。只有少数几个ec在其网站上发布了标准操作规程。
期刊介绍：
This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
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