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Revista Cubana de Pediatría
On-line version ISSN 1561-3119
Abstract
DIAZ ALVAREZ, Manuel. Principios de la bioética en la investigación del surfacén en recién nacidos prematuros. Rev Cubana Pediatr [online]. 1997, vol.69, n.3, pp. 149-157. ISSN 1561-3119.
An analysis was made from the point of view of bioethic principles, on the investigation of a phase III clinical trial regarding the application of Surfacen for the treatment of the respiratory distress syndrome of the newborn in Cuba. The team of investigators had to face a series of bioethic alternatives which evidenced the integrity of the team of workers. It was demonstrated that bioethic principles such as beneficience, efficiency, autonomy, and justice were taken into account to conduct the protocol of the investigation and during the performance of it. According to such analysis, it was justified that a history control group will be taken instead of a placebo control group for the comparison of the utilization of Surfacen. Also the parents' consent will be obtained after a verbal information by the doctor without the need of using a document of informed written consent.
Keywords : RESPIRATORY DISTRESS SYNDROME [drug therapy]; SURFACE ACTIVE AGENTS [therapeutic use]; CLINICAL TRIAL, PHASE III [publication type]; INVESTIGATIONAL NEW DRUG APPLICATION; BIOETHICS; CUBA.