Before they are even a week old, ninety-eight percent of the 4.3 million babies born annually in the United States have a small sample of blood taken from their heels. These newborn bloodspots (NBS) are then screened for a variety of inherited conditions and are often later stored in state-operated databases. Newborn screening itself is an important public health program and some have described these residual sample “biobanks” in equally positive terms. Although there are concrete benefits of newborn testing, there are also troubling consent and privacy issues raised by the screening, storage and use of the samples.
Newborn screening began in the United States as a series of state level pilot programs in the 1960s to test for PKU, a rare genetic condition that is easily treatable if caught early. The success of these early programs led to rapid adoption of newborn screening among all states in the US and the number of conditions screened for has grown progressively since with additional funding at the Federal level. Because of the singular history of newborn screening, it remains the only widespread health testing in the US conducted not by an individual’s doctor, hospital, or health care provider but by individual state departments of public health. This singular history can also account for a wide disparity in state law and policy with regards to parental consent, sample storage and use.