Ethical and normative aspects of a multicenter clinical study of pediatric oncology

Abstract

"The article aims to assess compliance with normative and ethical aspects of a multicenter clinical trial protocol in pediatric oncology. The analysis of the regulatory proceeding, as well as the process of obtaining the Consent of 180 patients from 16 institutions was undertaken through the medical records of patients. Ten of the sixteen centers submitted the Protocol to the Institutional Review Board. Regarding Informed Consent, 161 of 180 patients consented and signed by the researcher. The Coordination Study understands that there are some limitations related to these aspects, which was already expected because the study involved a significant number of institutions. For this reason, especially in multicenter projects, a more rigorous monitoring in terms of guidance and supervision of the regulatory proceeding as in the process of obtaining the Informed Consent, could prevent situations such as those encountered."