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In March 2013, the pediatric research community was rocked when the Office for Human Research Protections of the Department of Health and Human Services determined that the informed consent documents in the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT), a National Institutes of Health–funded, Neonatal Network multicenter study, failed to include, or adequately address, basic elements of informed consent as required by Health and Human Services regulations. A firestorm of controversy ensued and continues to this day.1- 3
Fleischman AR, Solomon MZ. Comparative Effectiveness ResearchEthical and Regulatory Guidance. JAMA Pediatr. 2014;168(12):1089-1090. doi:10.1001/jamapediatrics.2014.1764