Secretaria 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.
Departamento de Política de Medicamentos e Assistência Farmacêutica, Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz. Rio de Janeiro RJ Brasil.
Cien Saude Colet. 2024 Oct;29(10):e01582023. doi: 10.1590/1413-812320242910.01582023. Epub 2023 Oct 11.
This paper presents the structuring dimensions of the CEP-Conep System in order to understand the actions promoted by the National Research Ethics Commission in response to demands for the processing and ethical analysis of research protocols related to COVID-19 in 2020. Based on CEP-Conep System public documents, an assessment of legislation, from 1988 to 2020, and its extension in terms of the number of Committees, users, and protocols, from 2012 to 2020 was presented. The minutes of Conep's Ordinary Meetings (RO), for 2020, of a confidential nature, were analyzed, to verify adaptations to the pandemic. At the end of 2020, the System had 844 Committees, 854,741 users, and 701,791 analyzed protocols. The Commission centralized the analysis of COVID-19 protocols, in January 2020, and promoted three decentralizations, as more knowledge was generated, with vaccine protocols for COVID-19 remaining centralized. The history of the CEP-Conep System provided ballast for the adoption of management, educational and communication measures that accelerated the approval of protocols and made the process transparent. The absence of indicators made it impossible to evaluate the performance in 2020, which was apparently satisfactory.
本文介绍了 CEP-Conep 系统的结构维度，以了解国家伦理研究委员会在 2020 年针对处理和伦理分析与 COVID-19 相关研究方案的要求所采取的行动。基于 CEP-Conep 系统的公开文件，对从 1988 年到 2020 年的立法进行了评估，并对从 2012 年到 2020 年的委员会数量、用户数量和协议数量进行了扩展。分析了 Conep 2020 年的普通会议（RO）的非公开会议记录，以验证对大流行的适应情况。2020 年底，该系统拥有 844 个委员会、854741 名用户和 701791 个已分析协议。该委员会于 2020 年 1 月集中分析 COVID-19 协议，并在更多知识生成后推动了三次分散化，而 COVID-19 疫苗协议仍保持集中化。CEP-Conep 系统的历史为管理、教育和沟通措施的采用提供了依据，这些措施加速了协议的批准，并使过程透明。由于缺乏指标，无法评估 2020 年的绩效，而 2020 年的绩效显然是令人满意的。
