Ethical Committee on Human Research at the Federal University of Santa Maria: a study on the main pending issues in the approval of projects

• Autor(a) principal: Heinz, Gabriela
• Data de Publicação: 2021
• Outros Autores: Zucatto, Luis Carlos
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Revista de Gestão e Avaliação Educacional
• Texto Completo: http://periodicos.ufsm.br/regae/article/view/67392
• topic: Comitê de Ética em Pesquisa. Plataforma Brasil. Ética em Pesquisa

Initially motivated by the discoveries of the atrocities that occurred in experiments during World War II, research ethics became a recurrent theme in the scientific environment. It aims to guide researchers in the conduct of their activities, in order to protect research participants from possible risks and harms and also to ensure the potentiation of benefits, with social return. In this sense, the National Health Council established in 1996 the National Commission on Research Ethics to manage the research ethics committees, which evaluate research projects involving human beings. Based on this context, the objective of this study was to identify the most recurrent pending issues in the opinions issued by the Committee on Ethics in Research with Human Beings of the Federal University of Santa Maria. Data were collected in Platform Brazil, focusing on the opinions issued by the CEP/UFSM in the period from 2016 to 2019, which totaled 1,128. The sample, with confidence interval parameters of 95% and margin of error of 5% resulted in 376 opinions to be analyzed. In the data analysis the guidance of Bardin (2011) was observed, with categories of analysis defined after the event. The pending issues found in the opinions relate to aspects of the Informed Consent Form, methodology, formalities required in the other mandatory documents, and discordant information provided in the project, Platform Brazil and attached documents. It is concluded that its users lack training activities on the preparation of documents and legislation.