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Most states unclear about storage, use of babies' blood samples, new study finds

y screened for a variety of genetic disorders, including phenylketonuria (pku) and sickle cell disease. State newborn screening programs began in the 1960s, and today, nearly all of the 4 million babies born each year in the United States undergo the procedure.

Once the screening has been completed, a small amount of dried blood often remains. This residual blood is often used for quality-assurance purposes to improve the operation of state newborn screening programs. Sometimes, the samples are also used for other types of biomedical research, including research unrelated to newborn screening.

Yet, state law in only 13 states specifies how residual samples of infant blood might be used. But these purposes often are often stated in broad language, according to Lewis and her co-authors. Among the detailed findings the researchers reported:

  • Laws in 20 states address the retention and/or use of babies' blood samples.
  • In 18 states, newborn screening laws fail to address the retention or use of the samples or their related information.
  • Information related to newborn screening is deemed confidential in 26 states although limitations on that protection vary.
  • Ten states specify the purposes for which information from the newborn blood samples may be used, such as public-health purposes, scientific research and research concerning medical, psychological or sociological issues.
  • In four states, the samples become state property; in two of these states, parents can object in writing.
  • Only eight states require that parents be provided information regarding the retention of newborn blood samples.

Overall, most states lack any requirement that parents be informed that their child's blood samples may be retained for future use, the researchers found. This was the problem in Texas, which settled out of court with the suing families last year. As part of the settlement agreement, the state Department

Contact: Michael Pena
Johns Hopkins Medical Institutions

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