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Researchers Spot Reason for Concern in Newborn Screening Amendment

The research community is concerned about a last-minute amendment that legislators attached to a recently enacted newborn screening law, requiring state health departments to garner parental consent before using their babies' deidentified blood spots for scientific studies.

President Barack Obama last year signed into law the Newborn Screening Saves Lives Reauthorization Act of 2014, which went into effect in mid-March. The act reauthorizes $20 million in funding for state-based newborn screening programs for treatable genetic disorders, and includes provisions to educate parents about screening and establish standards.

However, ethicists and policy experts from the NIH and the National Human Genome Research Institute have written an editorial in the Journal of the American Medical Association warning that the amendment on parental research consent can hurt public health investigations and have called for more discussion before changing consent policies.

In particular, the authors Michelle Bayefsky, Katherine Saylor, and Benjamin Berkman note that in the amendment what constitutes "research" is not clearly defined. "Even if a simplified parental consent process were implemented, there remain concerns that requiring explicit parental permission will reduce the number of available samples for research," they wrote. Five years ago, Minnesota adopted an opt-in policy for garnering parental consent before using newborn blood spots for research. The most recent data show that 60 percent of parents provided consent, even though other surveys had indicated 78 percent of parents would be willing to give their OK.

Around 98 percent of US newborns undergo a heel prick after birth to collect blood for screening as part of state-mandated programs. However, parents have sued health departments in Texas and Minnesota for retaining newborns' blood spots for research without their consent. In the Texas case, the health department had to destroy 5.3 million dried bloodspots samples in 2011, and in Minnesota, the health department had dump all samples collected before November 16, 2011.

According to the JAMA authors, the public's growing privacy concerns are justifiable, but the data from Minnesota suggest that consent procedures could deplete state dried bloodspot repositories, a valuable resource free of sample bias. These samples have helped diagnose leukemia and improved understanding of rare illnesses.

"Autonomy is a vital principle of medical and research ethics, but the benefits of public health research on dried bloodspots should be weighed against parental desire for the opportunity to consent to dried bloodspot research," the authors wrote. "A broader conversation is needed about changing consent norms in an era of genomic medicine, and it is not appropriate to single out dried bloodspot research."