Health and scientific research with human beings: the conformation of the resulting damages and the brazilian method of inspection

• Autor(a) principal: Meireles Araújo, Ana Thereza
• Data de Publicação: 2018
• Outros Autores: Alegria, Lívia
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Cadernos Ibero-Americanos de Direito Sanitário (Online)
• Texto Completo: https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/465
• topic: Damage Liability; Ethics; Research; Informed Consent; Responsabilidad Civil; Ética en Investigación; Consentimiento informado; Responsabilidade Civil; Ética em Pesquisa; Consentimento Livre e Esclarecido

Objective: This article objectives to analyze the legal treatment and the procedure adopted by Brazil on clinical research with basis on the Resolution nº 466/2012 from National Health Council towards the occurrence of damages due to the project. Methodology: The research was carried out in nature bibliographical references, in books and articles of the legal area, in ordinary legislations and related resolutions, as well as in articles published in periodicals of the Health area. Results: Damages must be avoided and, when occurring, must provide also an compensation to those who were harmed. Conclusion: Any damages resulting from the experiments should be avoid and noted during the curse of the project, since the moment of the informed consent’s signature to the stage of inspection from the National Ethics and Research Committee and Research Ethics Committees. The completion of a closest monitoring is essential to prevent this damages and to indemnify the participant. Furthermore, it guarantees that the process of consent is being held on a satisfactory form.