2020年CEP-Conep系统:应对COVID-19,挑战和经验教训
Carlos Cezar Flores Vidotti1, Ângela Esher2, Claudia Garcia Serpa Osorio-de-Castro2
1Secretaria de Vigilância em Saúde e Ambiente, Ministério da Saúde. SRTVN 701, Via W 5 Norte, lote D, Edifício PO 700, 7º andar. 70719-040 Brasília DF Brasil. carlosvidotti@gmail.com.
Ciencia & saude coletiva
|September 18, 2024
概括
国家研究伦理委员会 (CEP-Conep) 通过集中和分散协议分析来适应COVID-19的需求. 尽管面临挑战,管理措施加速了伦理审查,尽管缺乏绩效指标.
科学领域:
- 生物伦理学生物伦理学
- 公共卫生政策 公共卫生政策
- 研究伦理治理研究伦理治理
背景情况:
- 在全球范围内,COVID-19大流行给研究伦理审查系统带来了前所未有的挑战.
- 巴西国家研究伦理委员会 (CEP-Conep) 系统在2020年面临着对COVID-19研究协议的伦理分析需求的增加.
- 了解系统的结构维度和适应是评估其响应的关键.
研究的目的:
- 在2020年COVID-19大流行期间分析CEP-Conep系统的结构维度.
- 了解国家研究伦理委员会的行动,以响应对COVID-19研究协议的处理和伦理分析的要求.
- 评估系统的立法演变,增长和与流行病相关的适应.
主要方法:
- 来自CEP-Conep系统的公共文件的分析.
- 对1988年至2020年的立法进行评估.
- 从2012年到2020年对系统增长 (委员会,用户,协议) 的审查.
- 2020年Conep普通会议记录的机密分析.
主要成果:
- 到2020年底,CEP-Conep系统包括844个委员会,854,741名用户,并分析了701,791个协议.
- 委员会最初于2020年1月集中了COVID-19协议,后来随着知识的发展实施了三个去中心化阶段,而疫苗协议仍然集中.
- 采用了管理,教育和沟通策略,加快了协议批准和提高透明度.
结论:
- 在疫情期间,CEP-Conep系统的历史基础促进了适应性管理策略.
- 该系统在处理日益增加的伦理审查要求方面表现出灵活性.
- 缺乏绩效指标阻碍了对2020年应对措施的全面评估,尽管显然取得了成功.
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