Monitoramento e avaliação de eventos adversos: a experiência do Hospital de Clínicas de Porto Alegre / Monitoring and evaluation of adverse events: the experience at Hospital de Clínicas de Porto Alegre
Based on national and international regulations, one of the the Research Ethics Committees (REC) have the attribution to protect human beings involved in research. According to these documents, REC should not only review all the researchprotocols, but also monitor adverse events (AE) reported by the investigator. This monitoring activities must be agile and critical, guiding its actions by evaluation of risk/benefit associated to each study. The Grupo de Pesquisa e Pós-Graduação of the Hospital de Clínicas de Porto Alegre (HCPA) introduced, in 2001, the Program of Monitoring of Risks and Adverse Events, developed by the Laboratório de Pesquisa em Bioética e Ética na Ciência