Each year, doctors collect blood from more than 4 million babies in the US as part of the routine genetic screening programs required by all 50 states. To ensure accuracy and reproducibility as well as facilitate the development of new diagnostic tests, state public health laboratories retain residual blood samples for later analysis. But according to a new study out this week, most states do not explicitly require that parents are informed that their children’s blood samples are kept or used for research purposes.

“State departments of health that retain dried blood samples and use them for research without specific authorization may be operating beyond the scope of their legal authority,” Michelle Lewis, a research scholar at Johns Hopkins University’s Berman Institute of Bioethics in Baltimore, and her co-authors write in the journal Pediatrics.

In the last two years, the lack of disclosure has led to outrage among parents. In 2009, for example, parents sued the Texas Department of State Health Services, triggering the court-ordered destruction of more than 5 million blood specimens that had been obtained without parental consent. As we reported last year, this action could derail future investigations of birth defect disorders and the development of detection methods.

Now, in a detailed analysis of the laws on all US state books, Lewis and her colleagues show that Texas is one of just eight states that require parents explicitly sign off on their children’s blood samples being used for research purposes.

Lewis warns that secrecy could lead to more parents refusing to participate in newborn screening, which could lead to the under-diagnosis of treatable genetic conditions and curtail invaluable research. “It is vital that state policies regarding the retention and use of residual samples not undermine the public’s trust in state newborn screening programs so that these programs can continue to protect the health of our nation’s children,” she said in a statement.

A public backlash could also jeopardize the fledgling US Newborn Screening Translational Research Network, which was established in 2008 by the National Institute of Child Health and Human Development and the American College of Medical Genetics to help coordinate state screening and research programs and facilitate the long-term study of poorly understood genetic conditions.

Image: Eric T. Sheler / Wikipedia