文章基本信息

标题：O conceito de risco nas resolues brasileiras que regulamentam a reviso ética da pesquisa envolvendo seres humanos
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作者：Pedro Bruno Silva Lemos ; Francisco José Alves de Aquino
期刊名称：Research, Society and Development
电子版ISSN：2525-3409
出版年度：2021
卷号：10
期号：7
页码：1-19
DOI：10.33448/rsd-v10i7.15917
语种：English
出版社：Grupo de Pesquisa Metodologias em Ensino e Aprendizagem em Ciências
摘要：This article analyzed the concept of risk in Brazilian regulations on ethics in research involving human beings. In methodological terms, this work was developed through bibliographic and documentary research, centered on a data analysis approach, primarily a qualitative one. The main objective of this work was to address how each Brazilian normative regarding ethical aspects in research that presupposes the participation of human beings conceptualized risk and established criteria that would allow its ethical analysis and measurement. It was evident, therefore, the importance/centrality of the concept of risk for the ethical assessment carried out by the CEP/CONEP System. In addition, it was observed that the current resolutions, Resolutions CNS n° 466/2012 and n° 510/2016, establish a gradation of the risks of research with human beings in levels. In this sense, it was emphasized that the aforementioned resolutions condition the processing of protocols to the gradation of the measured risks. However, it was found that the current ethical standards do not define the criteria that would guide the process of risk classification and grading in research with human beings. Finally, it was emphasized that the two current resolutions refer to the CNS ethical guideline that would deal with the criteria for measuring risk levels in research involving human beings, but it was found that this standard has not yet been developed.
关键词：Research Ethics;Human Experimentation;Risk Evaluation and Mitigation;Ethics committees; Research.