Furor over newborn blood samples: a cry for upfront education and transparency

 

Former Berman Institute fellow studies parents’ views about state storage practices


The Texas plaintiffs in a lawsuit over their state’s practice of storing newborn blood samples for disease research without parental consent inspired this headline from CNN: “The government has your baby’s DNA.”


The samples, stored as dried blood spots, were initially obtained by pricking the heels of newborns to enable mandatory screening for genetic diseases, childhood cancer and other disorders. Such tests are required in every state and the District of Columbia.


The parents sued in federal court, alleging that the Department of State Health Services retaining residual newborn blood samples without their permission constituted an unlawful search and seizure. The lawsuit was settled, leaving the issue of legality unresolved, and Texas now seeks parental consent to store the samples.


But Texas is not alone. In fact, in most states, parents don’t even know that newborn screenings occur—let alone that the residual blood spots are retained.


As reported by the Associated Press, leftover samples are mainly used to double-check that newborn tests are accurate. The parents’ outrage over not knowing that their children’s blood samples were being banked, and not having any say over how they might be used, seemed like an overreaction to some in the face of a well-meaning, public health program.


Then, in the wake of the Texas lawsuit, a subsequent news story reported on Feb. 22 that the state health department sent 800 of those same samples—anonymized—to an Armed Forces laboratory building a national mitochondrial DNA (mtDNA) registry. That revelation reignited the parents’ ire.


Beyond the headline

 


“What happens to that blood varies from state to state,” said Michelle Lewis, J.D., M.D., a former Greenwall Fellow at the Johns Hopkins Berman Institute of Bioethics who has conducted a survey assessing parents’ views about the retention of residual blood-screening samples. “Nobody really has a good picture of exactly what’s going on.”


The screening of newborns in the United States for treatable genetic diseases began 50 years ago, with the test for the inherited disease phenylketonuria. Today, almost 90 percent of U.S. born babies are screened for about 30 diseases, and more than half of states keep the residual samples for six months or longer.


“I don’t think anybody knows for sure how and where they’re being stored right now,” said Lewis, a pediatrician and attorney currently serving as a visiting faculty member in the College of Medicine at Penn State University. “In the not too distant past, some states were just sticking them in file cabinets.”


Because the screenings are overseen at the state level, laws are inconsistent that govern the storage of the samples, how they can be used and whether or not parents must be informed or given an opportunity to consent. In Mississippi, state law prohibits research of any sort on residual blood samples, Lewis said, adding that other states have not addressed the issue at all.


Responding to growing medical privacy concerns, most state legislatures have taken steps to safeguard genetic information beyond the protections provided for other types of health information, according the National Conference of State Legislatures. At the federal level, the Genetic Information Nondiscrimination Act prohibits discrimination in health coverage and employment based on genetic information.


Meanwhile, the lawsuit in Texas should serve as a warning to states that have yet to figure out how to honor people’s privacy and consent concerns, while simultaneously preserving the resource that the residual samples represent.


Storing newborn blood spots


For public health labs, storing the samples for later use in improving newborn screening methods is essential. And from the scientific community’s perspective, having a blood sample from every baby born in the United States would be tremendously beneficial for research. But the situation becomes more challenging when states or institutions want to use them for purposes unrelated to the program.


Texas and other states should be more transparent in using stored samples, and must “do a better job educating the public about research in general,” Lewis said. She suggests the introduction of safeguards so that samples would only be used for medical research approved by an ethics committee or state institutional review board.


Other laws and regulations could restrict the types of institutions that have access to the samples, or prohibit specific agencies altogether from acquiring them, Lewis added.


A step in the right direction is the five-year effort by the American College of Medical Genetics to develop a national network for state newborn screening programs and clinical centers with a $13.5 million contract from the National Institutes of Health. The project includes establishing a repository, either virtual or physical, for samples from around the country.


The network could lead to greater communication among state programs, and subsequently, some consistency in regard to informed consent practices and policies about future use.


Meanwhile, per the settlement agreement, Texas has destroyed more than 5 million newborn blood samples that dated back to 2002.

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Michael Pena
Michelle Lewis

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