[Clinical Research without Direct Profit in Children and the Best Interest Standard]. / La Investigación Clínica sin Beneficio Directo en Niños y el Estándar del Mejor Interés.

Clinical research has an ambivalent nature for the benefits it promises and the risks we inevitably incur. When the subjects involved are minors, ethical issues become more complicated. The ethical importance of the matter is revealed especially when assessing clinical trials in which children are exposed to high risk (it can involve even the subject's live), because those children have no legal skill to decide about the question, and when the big institutions (pharmaceutical companies, universities or public institutions) give preference to research 'progress', over the welfare of the minors. In this paper we analyze on which criteria research involving children is uphold, as well as the standards that should be applied in this activity, and we will detain particularly in the valuation of the use of placebo, especially when the children involved in a trial do not receive a direct profit from it.

La investigación clínica sin beneficio directo en niños y el estándar del mejor interés / Clinical research without direct profit in children and the best interest standard

La experimentación clínica tiene un carácter ambivalente por los beneficios que promete y los riesgos que inevitablemente se contraen. Cuando los sujetos implicados son menores, las cuestiones éticas se complican. El calado ético de la cuestión se pone de manifiesto especialmente cuando se valoran ensayos clínicos en los que se expone a los niños a riesgos elevados (que pueden implicar incluso la vida del sujeto), dado que los niños que no tienen la capacidad legal para decidir sobre la cuestión, y cuando las grandes instituciones (empresas farmacéuticas, universidades o instituciones públicas) anteponen el ‘progreso’ de la investigación al bienestar de los menores. En estas páginas vamos a analizar sobre qué criterios se sustenta la investigación en niños, así como cuáles son los estándares que se deben aplicar en dicha actividad, y nos detendremos particularmente en la valoración del uso de placebo, especialmente cuando los niños implicados en un estudio no reciben un beneficio directo del mismo

Clinical research has an ambivalent nature for the benefits it promises and the risks we inevitably incur. When the subjects involved are minors, ethical issues become more complicated. The ethical importance of the matter is revealed especially when assessing clinical trials in which children are exposed to high risk (it can involve even the subject’s live), because those children have no legal skill to decide about the question, and when the big institutions (pharmaceutical companies, universities or public institutions) give preference to research ‘progress’, over the welfare of the minors. In this paper we analyze on which criteria research involving children is uphold, as well as the standards that should be applied in this activity, and we will detain particularly in the valuation of the use of placebo, especially when the children involved in a trial do not receive a direct profit from it