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Remember — neonates also count as subjects!

Many studies involving pregnant women also collect information about the pregnancy outcome. These studies can include both interventional and chart review studies. If you work in this kind of research, please remember that if you collect anything about the newborn, such as gestational age at birth, length, weight, Apgar score, etc., the newborn then meets the definition of a human subject. Your protocol; new submission form; and any related documents, such as a consent form, must reflect the inclusion of newborns. That means that your subject count for a study involving 30 pregnant women age 18 and up that also involves collecting neonate data is 60, not 30; the relevant age ranges would be ages 0-6 years and 18 and up, not just 18 and up.

Here in the IRB offices, we’ve tried floating the argument that neonate data is really related to the mother’s pregnancy, so the neonates really didn’t need to be counted separately. We realized that that argument just wasn’t going to fly, however. So neonates are their own people, and their own separate research subjects.