Abstract

LOPEZ-PACHECO, MC; PIMENTEL-HERNANDEZ, C; RIVAS-MIRELLES, E  and  ARREDONDO-GARCIA, JL. Regulations governing humans’ clinical research and requirements to be met by a research center to participate in a clinical trial in Mexico. Acta pediatr. Méx [online]. 2016, vol.37, n.3, pp.175-182. ISSN 2395-8235.

We reviewed national and international scientific, ethical and regulatory principles needed to conduct clinical research in Mexico, with emphasis on the capability that has the General Health Law, trough the Federal Commission for the Protection against Sanitary Risk to regulate, control, and promote health. We colected steps and requirements that need to be accomplished by the principal investigator and research center to participate in the conduction of multicenter and multiregional clinical research studies, with federal or private funding.

Keywords : clinical research; ethics; Good Clinical Practices; COFEPRIS; General Health Law; principal investigator; research center.

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