Resumo

AIRES, Mariana Tschoepke; PARENTE, Ana Alice Amaral Ibiapina; JUNQUEIRA, José Cesar da Fonseca  e  LANDGRAF, Jocelene de Fátima. TWENTY TWO YEARS EXPERIENCE OF THE RESEARCH ETHICS COMMITTEE OF THE PEDIATRIC INSTITUTE AT THE UFRJ. Regae: Rev. Gest. Aval. Educ. [online]. 2022, vol.11, suppl.1, e71955.  Epub 21-Maio-2024. ISSN 2318-1338.  https://doi.org/10.5902/2318133871955.

The Research Ethics Committee - CEP - of Instituto de Puericultura e Pediatria Martagão Gesteira - IPPMG - has completed twenty-two years. IPPMG is a pediatric institute related to the Federal University of Rio de Janeiro - UFRJ -, developing assistance, academic, extension and research activities. This paper describes its establishment process and its activities, from 2000 to September 2022. Its history was obtained through an interview with the first coordinator, Professor Marcelo Land. The quantitative of projects approved each year was assessed from 2001 to September 2022. The time spent from the protocol or amendment submission to the final decision wass assessed from data registered at Plataforma Brasil, in the period between 2018 and August 2022. The mean and standard deviation were obtained, as well as the minimum and maximum number of days. From 2001 to 2022, 1.128 research projects were approved by the CEP IPPMG/UFRJ. From 2018 to 2021, 326 decisions were reported, with an average approval of 65% research protocols each year. The maximum number of days for the ethical decision decreased this period, 167 days in 2018 to 84 days in 2021, with the average time for ethical decision of a non-approval opinion being longer in all years. In its 21 years, the CEP IPPMG/UFRJ had a significant ammount of research protocols, with a constant average time for decision, but for a longer time for analysis in non-approved protocols. Challenges are the large volume of research protocols evaluated by the IPPMG/UFRJ CEP, their complexity and the vulnerability of the institution research participants.

Palavras-chave : ethics committees; vulnerable populations; pediatrics.

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