Informed Consent for the Use and Storage of Residual Dried Blood Samples from State-Mandated Newborn Genetic Screening Programs

Approximately four million newborn infants undergo state-mandated genetic screening annually through blood collection and metabolic disorder testing, generating caches of residual dried blood samples that states store indefinitely. While these screening programs provide clinical value by detecting metabolic abnormalities treatable during infancy, residual samples have been used in unrelated research and shared with third parties without parental informed consent, spawning litigation challenging the constitutional boundaries of nonconsensual sample use. Some advocates call for national uniform solutions requiring informed consent across all contexts, but Shayeb argues that while informed consent should protect against third-party sample disclosure, nonconsensual use of residual samples in research aimed at improving the state's newborn screening program likely falls within constitutional state authority. The article surveys the background of newborn genetic screening, including phenylketonuria testing's historic development and current mandatory screening programs that began in Massachusetts. Part II examines high-profile lawsuits exploring the major legal issues implicated in mandatory, nonconsensual testing and research. Shayeb concludes that allowing states to maximize constitutional authority while exercising such authority in a restrained manner accounting for public sentiment provides the superior approach to this biomedical dilemma.

Topics: Constitutional Law · Evidence & Procedure

Keywords: newborn screening · informed consent · genetic testing · phenylketonuria · PKU · dried blood samples · constitutional authority