0326/2023 - O Sistema CEP-Conep em 2020: enfrentamento da Covid-19, desafios e lições aprendidas The CEP-Conep System in 2020: coping with the Covid-19, challenges and lessons learned
Esse artigo apresenta dimensões estruturantes do Sistema CEP-Conep para compreender as ações promovidas pela Comissão Nacional de Ética em Pesquisa nas respostas às demandas de tramitação e análise ética de protocolos de pesquisa relativos à Covid-19, no ano de 2020. Foi elaborado estudo de caso a partir de documentos públicos do Sistema CEP-Conep, para evidenciar seu marco regulatório, de 1988 a 2020, e sua extensão em termos de quantidade de Comitês, usuários e protocolos, de 2012 a 2020. Foram examinadas as atas das Reuniões Ordinárias (RO) da Comissão, de 2020, de caráter sigiloso, para caracterizar as adaptações à pandemia. No final de 2020, o Sistema contabilizava 844 Comitês, 854.741 usuários, e 701.791 protocolos analisados. A Comissão centralizou a análise de protocolos de Covid-19, em janeiro de 2020, e promoveu três descentralizações, à medida que mais conhecimento era gerado, permanecendo centralizados os protocolos de vacinas para Covid-19. O histórico do Sistema CEP-Conep proveu lastro para a adoção de medidas de gestão, educativas e de comunicação que aceleraram a apreciação de protocolos e deram transparência ao processo. A ausência de indicadores não permitiu avaliar a performance em 2020, aparentemente satisfatória.
Palavras-chave:
Ética em pesquisa; Comitês de ética em pesquisa; pesquisa; COVID-19.
Abstract:
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,1988 to 2020, and its extension in terms of the number of Committees, users, and protocols,2012 to 2020. 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 Comission 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.
The CEP-Conep System in 2020: coping with the Covid-19, challenges and lessons learned
Resumo (abstract):
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,1988 to 2020, and its extension in terms of the number of Committees, users, and protocols,2012 to 2020. 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 Comission 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.
Vidotti, C.C.F, Esher, A., Osorio-de-Castro, C.G.S.. O Sistema CEP-Conep em 2020: enfrentamento da Covid-19, desafios e lições aprendidas. Cien Saude Colet [periódico na internet] (2023/Out). [Citado em 05/10/2024].
Está disponível em: http://cienciaesaudecoletiva.com.br/artigos/o-sistema-cepconep-em-2020-enfrentamento-da-covid19-desafios-e-licoes-aprendidas/18952?id=18952
