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Updated: Apr 23, 2026

Electrophysiological Measurements and Analysis of Nociception in Human Infants
Published on: December 20, 2011
When is waiver of consent appropriate in a neonatal clinical trial?
Mark S Schreiner1, Dalia Feltman2, Thomas Wiswell3
1The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania;
Abstract:
It is difficult to do scientifically rigorous research on treatments that must be administered urgently or emergently. Therefore, such treatments are often provided without a strong evidence base. Research would be facilitated if it were permissible to waive the requirement for parental consent. However, that raises a different set of concerns. Federal regulations allow waiver of the requirement for consent but only if studies meet certain conditions. Institutional review boards must decide whether those conditions are met. Sometimes, reasonable people disagree. We present and analyze a protocol for which investigators request a waiver of consent.
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