Experiência do comitê de ética em pesquisa de uma instituição pública federal especializada em Saúde Cardiovascular: um estudo observacional
Experiência do comitê de ética em pesquisa de uma instituição pública federal especializada em Saúde Cardiovascular: um estudo observacional
Data
2025
Autores
Silva, Aline Sandra Pereira
Journal Title
Journal ISSN
Volume Title
Publisher
Instituto Nacional de Cardiologia
Resumo
Introdução: A pesquisa é essencial para a produção de conhecimento e sua
regulamentação garante sua efetividade através dos Comitês de Ética em Pesquisa
(CEP), um recurso metodológico que pode ser utilizado para gerir, acompanhar e
avaliar as atividades do CEP visando principalmente o aprimoramento de sua
gestão, são os indicadores de desempenho. Objetivos: conhecer a experiência do
CEP, caracterizar o perfil dos projetos avaliados, conhecer o perfil dos membros,
pesquisadores e participantes, analisar o processo de tramitação dos projetos e
desenvolver indicadores de desempenho para o monitoramento de suas atividades.
Métodos: trata-se de estudo retrospectivo, documental, descritivo e quantitativo,
foram coletados dados de protocolos de pesquisa submetidos ao CEP através da PB
no período de 01/2013 a 12/2022 através de um banco de dados elaborado na
plataforma Redcap. Resultados: Foram avaliados 345 projetos, dos quais 70%
eram da própria instituição. A maioria tinha abordagem quantitativa (87%) e eram
estudos observacionais descritivos (40,3%) ou analíticos (33,3%). Predominaram as
ciências da saúde (93,6%), com foco em síndromes coronarianas (22,7%). Os
pesquisadores eram, em sua maioria, mulheres (60,9%); os participantes, adultos
(84%) e pacientes (73%). O CEP era composto majoritariamente por mulheres,
enfermeiros e mestres. A checagem documental foi ágil (0 2 dias). O tempo para o
primeiro parecer foi elevado e variável nos primeiros anos (35 50 dias),
descumprindo o prazo legal; a partir de 2017, reduziu, chegando a 8 dias em 2021.
Aprovaram-se 44,9% na primeira análise. A resposta às pendências tornou-se mais
estável após 2019. As principais pendências envolveram o TCLE (45%) e a
metodologia (42,6%). O tempo total para aprovação foi mais alto e instável até 2016,
com melhora nos anos seguintes. A submissão de relatórios parciais (14,7%) e finais
(média de 12,5/ano) foi considerada insatisfatória. Conclusão: Os resultados deste
estudo demonstram através da análise dos indicadores de desempenho, que o CEP
da instituição tem evoluído continuamente em termos de eficiência e qualidade na
tramitação de protocolos de pesquisa.
Introduction: Research is essential for the production of knowledge, and its regulation ensures effectiveness through Research Ethics Committees (REC). A methodological tool that can be used to manage, monitor, and evaluate REC activities primarily aimed at improving its management is the use of performance indicators. Objectives: profile of evaluated projects; to identify the profile of members, researchers, and participants; to analyze the project review process; and to develop performance indicators for monitoring its activities. Methods: This is a retrospective, documentary, descriptive, and quantitative study. Data were collected from research protocols submitted to the REC through the Brazil Platform between January 2013 and December 2022, using a database developed on the REDCap platform. Results: A total of 345 projects were evaluated, 70% of which originated from the institution itself. Most had a quantitative approach (87%) and were observational studies, either descriptive (40.3%) or analytical (33.3%). The predominant field was health sciences (93.6%), with a major focus on coronary syndromes (22.7%). The majority of researchers were women (60.9%), while research participants were mostly adults (84%) and patients (73%). The REC was predominantly composed of women, nurses, and individuals with a master's degree. Document verification was prompt (0-2 days) The time to issue the first opinion was longer and more variable in the early years (35 50 days), exceeding the 30-day legal deadline; however, from 2017 onward, this timeframe decreased, reaching a median of 8 days in 2021. A total of 44.9% of the projects were approved in the first review. Responses to pending issues became more consistent after 2019. The main sources of pending issues were the informed consent form (45%) and the methodology (42.6%). The overall time to final approval was higher and more variable until 2016, with improvements and greater predictability in subsequent years. Submission of partial (14.7%) and final reports (an annual average of 12.5 projects) was considered unsatisfactory. Conclusion: The results of this study demonstrate, through the analysis of performance indicators, that the institution's REC has shown continuous improvement in efficiency and quality in the processing of research protocols.
Introduction: Research is essential for the production of knowledge, and its regulation ensures effectiveness through Research Ethics Committees (REC). A methodological tool that can be used to manage, monitor, and evaluate REC activities primarily aimed at improving its management is the use of performance indicators. Objectives: profile of evaluated projects; to identify the profile of members, researchers, and participants; to analyze the project review process; and to develop performance indicators for monitoring its activities. Methods: This is a retrospective, documentary, descriptive, and quantitative study. Data were collected from research protocols submitted to the REC through the Brazil Platform between January 2013 and December 2022, using a database developed on the REDCap platform. Results: A total of 345 projects were evaluated, 70% of which originated from the institution itself. Most had a quantitative approach (87%) and were observational studies, either descriptive (40.3%) or analytical (33.3%). The predominant field was health sciences (93.6%), with a major focus on coronary syndromes (22.7%). The majority of researchers were women (60.9%), while research participants were mostly adults (84%) and patients (73%). The REC was predominantly composed of women, nurses, and individuals with a master's degree. Document verification was prompt (0-2 days) The time to issue the first opinion was longer and more variable in the early years (35 50 days), exceeding the 30-day legal deadline; however, from 2017 onward, this timeframe decreased, reaching a median of 8 days in 2021. A total of 44.9% of the projects were approved in the first review. Responses to pending issues became more consistent after 2019. The main sources of pending issues were the informed consent form (45%) and the methodology (42.6%). The overall time to final approval was higher and more variable until 2016, with improvements and greater predictability in subsequent years. Submission of partial (14.7%) and final reports (an annual average of 12.5 projects) was considered unsatisfactory. Conclusion: The results of this study demonstrate, through the analysis of performance indicators, that the institution's REC has shown continuous improvement in efficiency and quality in the processing of research protocols.
Description
Palavras-chave
Comitês de Ética em pesquisa, Ética em pesquisa, Indicadores de
gestão, Ethics Committee, Research, Ethics, Research, Management Indicators.
Citação
Silva ASP. Experiência do comitê de ética em pesquisa de uma instituição pública federal especializada em Saúde Cardiovascular: um estudo de observacional. Rio de Janeiro. Dissertação [Mestrado Profissional em Ciências Cardiovasculares] - Instituto Nacional de Cardiologia;2025.