Lessons from the residual newborn screening dried blood sample litigation.

Abstract

Most babies born each year in the U.S. undergo mandatory newborn screening to detect serious medical conditions that can cause devastating effects if treatment is not initiated prior to the onset of symptoms. Not all of the blood collected from newborns is used during routine newborn screening, and many states retain the residual dried blood samples (DBS). DBS have a broad range of potential uses, from program evaluation to public health and biomedical research unrelated to newborn screening. State laws vary regarding whether parental consent is required to use DBS for secondary research, but federal now requires parental consent for the use of DBS in federally funded research.