Special Ethics Challenges in Neonatal Trials
Neonatal trials—those involving newborns, especially preterm or critically ill infants—represent one of the most ethically sensitive areas in clinical research. Neonates are considered a highly vulnerable population due to their inability to consent, physiological immaturity, and heightened susceptibility to harm. As such, ethical oversight in neonatal trials must be more stringent than in almost any other patient group.
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