When Neonatal ICU Infants Participate in Research: Special Protections for Special Subjects

Neonatal ICU research poses unique concerns for infants and parents. Children are considered a vulnerable research population. Federal regulations specify special protections when children participate in research. These regulations determine the types of research approvable for children based on the balance of risks and benefit. Risk also determines whether one or both parents' consent is required for their infant's participation in research.