title: [When the information provided to participants of a comparative effectiveness trial ends up in the court: The opening of Pandora's box?].
authors.affiliation: Investigación Clínica, Programa BUC (Biociencias UAN+CSIC), Centro de Excelencia Internacional, Universidad Autónoma de Madrid, Madrid, España. Electronic address: Rafael.dalre@fuam.uam.es.
authors.forename: Rafael
authors.initials: R
authors.lastname: Dal-Ré
authors.affiliation: Servicio de Neonatología, Departamento de Pediatría, Hospital Universitario La Paz, Facultad de Medicina, Universidad Autónoma de Madrid, Madrid, España.
authors.forename: Félix
authors.initials: F
authors.lastname: Omeñaca
authors.affiliation: Departamento de Medicina Preventiva, Salud Pública e Historia de la Ciencia, Universidad Complutense, Madrid, España.
authors.forename: Diego
authors.initials: D
authors.lastname: Gracia
mesh_terms: D057186:Comparative Effectiveness Research / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards; D034462:Dissent and Disputes / Q000331:legislation & jurisprudence; D005060:Europe; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000592:standards; D010102:Oxygen Inhalation Therapy / Q000009:adverse effects / Q000941:ethics / Q000379:methods; D010353:Patient Education as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000592:standards; D018579:Patient Selection / Q000941:ethics; D016032:Randomized Controlled Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards; D012107:Research Design; D012178:Retinopathy of Prematurity / Q000517:prevention & control; D014481:United States