%0 Journal Article
%T Principios de la bio¨¦tica en la investigaci¨®n del surfac¨¦n en reci¨¦n nacidos prematuros
%A D¨ªaz ¨¢lvarez
%A Manuel
%J Revista Cubana de Pediatr£¿-a
%D 1997
%I Editorial Ciencias M¨¦dicas
%X 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.
%K respiratory distress syndrome [drug therapy]
%K surface active agents [therapeutic use]
%K clinical trial
%K phase iii [publication type]
%K investigational new drug application
%K bioethics
%K cuba.
%U http://scielo.sld.cu/scielo.php?script=sci_abstract&pid=S0034-75311997000300001&lng=en&nrm=iso&tlng=en