title: [Clinical Research without Direct Profit in Children and the Best Interest Standard].
abstract: 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.
authors.affiliation: Pontificio Istituto Giovanni Paolo II. Roma. juan.iniesta.saez@gmail.com.
authors.forename: Juan
authors.initials: J
authors.lastname: Iniesta Sáez
authors.affiliation: Pontificio Istituto Giovanni Paolo II. Roma. mldipietro@rm.unicatt.it.
authors.forename: María Luisa
authors.initials: ML
authors.lastname: Di Pietro
mesh_terms: D026688:Bioethical Issues; D035843:Biomedical Research / Q000941:ethics*; D002648:Child; D006801:Humans; D018570:Risk Assessment; D014495:Universities