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亚洲研究伦理委员会应对 COVID-19 大流行的准备情况:一项多国家调查。

The readiness of the Asian research ethics committees in responding to the COVID-19 pandemic: A multi-country survey.

机构信息

Drug Discovery and Development Center, Thammasat University, Pathum Thani, Bangkok, 12120, Thailand.

Clinical Coordination and Training Center, Strategic Initiative in Developing Capacity in Ethical Review (SIDCER), Thammasat University, Pathum Thani, 12120, Thailand.

出版信息

F1000Res. 2024 Jan 8;13:19. doi: 10.12688/f1000research.143138.1. eCollection 2024.

Abstract

BACKGROUND

COVID-19 is a highly challenging infectious disease. Research ethics committees (RECs) have challenges reviewing research on this new pandemic disease under a tight timeline and public pressure. This study aimed to assess RECs' responses and review during the outbreak in seven Asian countries where the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) networks are active.

METHODS

The online survey was conducted in seven Asian countries from April to August 2021. Two sets of online questionnaires were developed, one set for the chairs/secretaries and another set for the REC members.The REC profiles obtained from the REC members are descriptive in nature. Data from the chairs/secretaries were compared between the RECs with external quality assessment (SIDCER-Recognized RECs, SR-RECs) and non-external quality assessment (Non-SIDCER-Recognized RECs, NSR-RECs) and analyzed using a Chi-squared test.

RESULTS

A total of 688 REC members and 197 REC chairs/secretaries participated in the survey. Most RECs have standard operating procedures (SOPs), and have experience in reviewing all types of protocols, but 18.1% had no experience reviewing COVID-19 protocols. Most REC members need specific training on reviewing COVID-19 protocols (93%). In response to the outbreak, RECs used online reviews, increased meeting frequency and single/central REC. All SR-RECs had a member composition as required by the World Health Organisation ethics guidelines, while some NSR-RECs lacked non-affiliated and/or layperson members. SR-RECs reviewed more COVID-related product development protocols and indicated challenges in reviewing risk/benefit and vulnerability (0.010), informed consent form (0.002), and privacy and confidentiality (P = 0.020) than NSR-RECs.

CONCLUSIONS

Surveyed RECs had a general knowledge of REC operation and played a significant role in reviewing COVID-19-related product development protocols. Having active networks of RECs across regions to share updated information and resources could be one of the strategies to promote readiness for future public health emergencies.

摘要

背景

COVID-19 是一种极具挑战性的传染病。研究伦理委员会(RECs)在紧迫的时间和公众压力下审查新大流行病相关研究面临挑战。本研究旨在评估七个 SIDCER 网络活跃的亚洲国家的 REC 应对和审查情况。

方法

2021 年 4 月至 8 月,在七个亚洲国家进行了在线调查。制定了两套在线问卷,一套用于主席/秘书,另一套用于 REC 成员。从 REC 成员那里获得的 REC 概况具有描述性。使用卡方检验比较了外部质量评估(SIDCER-认可的 RECs,SR-RECs)和非外部质量评估(非 SIDCER-认可的 RECs,NSR-RECs)的 REC 之间主席/秘书的数据。

结果

共有 688 名 REC 成员和 197 名 REC 主席/秘书参加了调查。大多数 REC 都有标准操作程序(SOPs),并具有审查所有类型方案的经验,但 18.1%的 REC 没有审查 COVID-19 方案的经验。大多数 REC 成员需要特定的 COVID-19 方案审查培训(93%)。针对疫情爆发,REC 采用在线审查、增加会议频率和单一/中央 REC。所有 SR-RECs 的成员组成均符合世界卫生组织伦理准则要求,而一些 NSR-RECs 缺乏非附属人员和/或非专业人员成员。SR-RECs 审查了更多与 COVID-19 相关的产品开发方案,并表示在审查风险/获益和脆弱性(0.010)、知情同意书(0.002)和隐私和保密性(P=0.020)方面存在挑战,而 NSR-RECs 则没有。

结论

调查的 REC 对 REC 运作有一般了解,并在审查 COVID-19 相关产品开发方案方面发挥了重要作用。在区域内建立活跃的 REC 网络,共享最新信息和资源,可能是为未来突发公共卫生事件做好准备的策略之一。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/704b/11333877/acf25d3061d6/f1000research-13-156768-g0000.jpg

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