In March, the Newborn Screening Saves Live Reauthorization Act of 2014 went into effect. The act, which is an extension of the Newborn Screening Saves Lives Act of 2008, reauthorizes nearly $20 million in funding and expands state-based infant screening programs. It also contains a controversial amendment that requires informed consent for any federally funded research activities using newborn dried bloodspots.
Infant screening programs have been in place in the United States for more than 50 years. The programs, which are mandatory in 48 states, test newborns for more than 30 serious, but treatable, genetic disorders by taking a small sample of blood through a heel prick at birth. Collected samples are placed onto a small piece of filtered paper, known as a Guthrie card, and sent to a laboratory for testing. Results are then shared with the infant’s physician and parents.
In many states, the cards have historically been retained after the initial screening and used for quality assurance purposes, program evaluation activities, and/or biomedical research. However, a provision in the Newborn Screening Saves Lives Act of 2014 may change that. An amendment, which was added to the legislation at the last minute, amidst pressure from privacy advocates, states:
Research on newborn dried blood spots shall be considered research carried out on human subjects meeting the definition of section 46.102(f)(2) of title 45, Code of Federal Regulations, for purposes of Federally funded research conducted pursuant to the Public Health Service Act until such time as updates to the Federal Policy for the Protection of Human Subjects (the Common Rule) are promulgated pursuant to subsection (c).
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