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来自英国研究伦理委员会成员的证据,说明什么是好的研究伦理审查,以及可以改进什么。

Evidence from UK Research Ethics Committee members on what makes a good research ethics review, and what can be improved.

机构信息

Health Research Authority, Stratford, London, United Kingdom.

School of Health and Care Professions, University of Portsmouth, Portsmouth, United Kingdom.

出版信息

PLoS One. 2023 Jul 3;18(7):e0288083. doi: 10.1371/journal.pone.0288083. eCollection 2023.

Abstract

The rapid development of vaccines and other innovative medical technologies in response to the COVID-19 pandemic required streamlined and efficient ethics and governance processes. In the UK the Health Research Authority (HRA) oversees and coordinates a number of the relevant research governance processes including the independent ethics review of research projects. The HRA was instrumental in facilitating the rapid review and approval of COVID-19 projects, and following the end of the pandemic, have been keen to integrate new ways of working into the UK Health Departments' Research Ethics Service. In January 2022 the HRA commissioned a public consultation that identified strong public support for alternative ethics review processes. Here we report feedback from 151 current research ethics committee members conducted at three annual training events, where we asked members to critically reflect on their ethics review activities, and to share new ideas or ways of working. The results showed a high regard for good quality discussion among members with diverse experience. Good chairing, organisation, feedback and the opportunity for reflection on ways of working were considered key. Areas for improvement included the consistency of information provided to committees by researchers, and better structuring of discussions by allowing signposting of the key issues that ethics committee members might need to consider.

摘要

为应对 COVID-19 大流行,疫苗和其他创新医疗技术迅速发展,这需要简化和高效的伦理和治理流程。在英国,健康研究管理局(HRA)负责监督和协调多项相关研究治理流程,包括对研究项目进行独立伦理审查。HRA 在促进 COVID-19 项目的快速审查和批准方面发挥了重要作用,大流行结束后,HRA 一直热衷于将新的工作方式融入英国卫生部的研究伦理服务中。2022 年 1 月,HRA 委托进行了一次公开咨询,该咨询确定了公众对替代伦理审查流程的强烈支持。在这里,我们报告了在三次年度培训活动中对 151 名现任研究伦理委员会成员的反馈意见,我们要求成员批判性地反思他们的伦理审查活动,并分享新的想法或工作方式。结果显示,成员们对具有不同经验的成员之间进行高质量讨论给予了高度评价。良好的主持、组织、反馈以及反思工作方式的机会被认为是关键。需要改进的领域包括研究人员向委员会提供信息的一致性,以及通过标记伦理委员会成员可能需要考虑的关键问题来更好地组织讨论。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f898/10317218/b0943952140e/pone.0288083.g001.jpg

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