Lessons from the residual newborn screening dried blood sample litigation.

journal of law, medicine & ethics Background 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.1 Not all of the blood collected from newborns is used during routine newborn screening, and many states retain the residual dried blood samples (DBS).2 DBS have a broad range of potential uses, from program evaluation to public health and biomedical research unrelated to newborn screening.3 State laws vary regarding whether parental consent is required to use DBS for secondary research,4 but federal now requires parental consent for the use of DBS in federally funded research.5 The use of DBS for secondary research without explicit parental permission has generated controversy, culminating in lawsuits against health departments in Texas, Minnesota, and Indiana. The issues raised by the lawsuits extend beyond the legal question of whether states had statutory authority to retain DBS for secondary use. Additional aspects of state practices related to the retention and use of DBS have been of concern to some parents.