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 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. (shrink)

Human biological tissue samples are an invaluable resource for biomedical research designed to find causes of diseases and their treatments. Controversy has arisen, however, when research has been conducted with laboratory specimens either without the consent of the source of the specimen or when the research conducted with the specimen has expanded beyond the scope of the original consent agreement. Moreover, disputes have arisen regarding which party, the researcher or the source of the specimen, has control over who may use (...) the specimens and for what purposes. The purposes of this article are: to summarize the most important litigation regarding the use of laboratory specimens, and to demonstrate how legal theory regarding control of laboratory specimens has evolved from arguments based upon property interests in biological samples to claims that the origins of laboratory specimens have privacy interests in their genetic information that should be protected. (shrink)

There may be compelling reasons to return to parents a limited subset of results from research conducted using residual newborn screening dried blood samples. This article explores the circumstances under which research results might be returned, as well as the mechanisms by which state newborn screening programs might facilitate the return of research results. The scope of any responsibility to return results of research conducted using DBS should be assessed in light of the potential impact on the primary mission of (...) state newborn screening programs. (shrink)