Newborns receive routine heel prick tests, but states should retain these samples

Newborns receive routine heel prick tests, but states should retain these samples

Nearly 4 million babies are born in the United States each year, and within the first 48 hours, nearly all are pricked in the heel so that their blood can be tested for dozens of life-threatening genetic and metabolic problems. The heel-stick test is considered such an important public health measure that states typically require it and parents are not asked for their permission before it is administered.

But newborn screening lab tests generally don't use all of the half-dozen or so drops of blood collected on filter paper cards. So states hold on to the leftover “dried blood stains,” as they are called, often without the knowledge or consent of parents. In recent years, privacy concerns have grown regarding the storage and use of the material, sometimes for decades.

Some states allow the blood stains to be used in research studies, sometimes for a fee by third parties, or for use by law enforcement officials investigating a crime. Allowing these or other uses without the informed consent of parents to understand and agree to the use has led to lawsuits from parents who want to make these decisions themselves and who want to protect their children's medical and genetic information.

In May, Michigan officials reportedly agreed to destroy more than 3 million blood stains as a partial settlement in a lawsuit filed by parents who said they were not given enough clear information to provide informed consent for the blood to be used for government research. The fate of millions of additional blood samples held by the state will be decided in court.

Philip L. Ellison, a lawyer in Hemlock, Michigan, who is leading the lawsuit, said he became aware of the problem when his son was born five years ago. Ellison's son Patton spent his first days in the neonatal intensive care unit after his blood sugar levels dropped precipitously after birth. The next morning, Ellison said, he was approached by a hospital employee who asked him if he wanted to sign a consent form allowing the blood from Patton's heel prick test to be donated for research purposes.

The unexpected request set alarm bells ringing for Ellison.

“We don’t know what the future will hold in terms of information that can be extracted from our blood,” he said. How the rules for using that blood might evolve over time is difficult to know, he said. “A program that began with a single purpose, to test for disease, has now crept into medical research and then law enforcement,” he said.

Michigan is the rare state to ask parents for permission to use leftover blood spots from newborns in research. Most don't, experts said. The state screens newborns for more than 50 diseases such as cystic fibrosis and congenital hypothyroidism, as it is crucial to detect and treat such diseases early in a child's life.

Whatever is left over is saved for up to 100 years and, if parents consent, they may be used for research purposes approved by the Michigan Department of Health and Human Services. Some newer ones Studies have used anonymized blood spots for testing the relationship between viral infection at birth and the development of autism later in life and the effects of maternal exposure to manufactured chemicals known as PFAS about health consequences.

Parents have also asked that their children's blood spots be sent to researchers to help diagnose a disorder or try to find a reason for a child's death, said Chelsea Wuth, a spokeswoman for the Michigan Department of Health and Human Services.

Michigan parents can request that the state destroy the leftover blood stains if they don't want the state to keep them.

Since the 1960s, states have been testing the blood of newborns for diseases that can cause devastating physical or mental disabilities or death if left undiagnosed and untreated. The federal government recommends conducting about three dozen screening tests, but some states conduct far more. A treasured one every year 13,000 infants with serious illnesses are identified through newborn screening programs, according to data released by the federal Centers for Disease Control and Prevention.

Many public health experts strongly support mandatory newborn screening as a critical component of the clinical care of infants. However, some are willing to give parents a say in what happens to the blood after screening.

"I have always believed that parents should have the opportunity to say 'yes' or 'no' when their newborns' leftover blood is used in research," he said Dr. Beth Tarini a pediatrician and associate director of the Center for Translational Research at the Children's National Research Institute in Washington, D.C. "Because it's not part of clinical care, it's a different standard of collaboration with parents."

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In Michigan, 64% of parents said they agreed to participate Court documents in Ellison's case.

It's important to encourage people to participate, some public health experts say, because the bloodstain repositories provide a rare opportunity for population-level research. People of European descent are often overrepresented in genetic databases, which can bias the results of studies. But the newborn screening program includes virtually everyone born in the United States

“There is strong evidence that research conducted on samples from white people results in disparities in the benefits of biomedical research for people who are not white,” he said Dr. Kyle brothers Pediatrician and bioethicist at Norton Children’s Research Institute in Louisville, Kentucky.

After privacy-related lawsuits were filed in 2009 and 2011 by parents in Texas and Minnesota, respectively, millions of bloodstains were destroyed.

Brothers said the reluctance to participate in research programs reflects larger trends, including a greater emphasis on the individual and less on contributions to the greater good.

For those who might argue that parents' privacy concerns are overblown, a recent lawsuit in New Jersey raises troubling questions.

In a public records lawsuit, the New Jersey Office of the Public Defender and the New Jersey Monitor, a nonprofit news site, allege that state police used a subpoena to obtain an infant blood spot from a child, now 9, at the state newborn screening laboratory. The lawsuit states that DNA analysis of the blood stain was conducted to collect evidence against the child's father, who was represented by prosecutors in connection with a sexual assault committed in 1996. The effort allowed police to obtain the DNA information without having to prove probable cause in a court, the lawsuit claims.

The lawsuit seeks to determine how often in the last five years New Jersey law enforcement has used the newborn screening lab as an investigative tool and subjected defendants to "warranty searches and seizures."

New Jersey has retained the records for 23 years, said CJ Griffin, an attorney representing the public defender's office and the New Jersey Monitor in the lawsuit.

Griffin said her clients don't question the program to test newborns' blood for disease. “It's more the lack of transparency, safeguards and information about storage, and we don't have information about appropriate use,” she said.

The New Jersey Department of Health does not comment on pending litigation, said spokeswoman Nancy Kearney. Kearney did not respond to a request for information about the state's practices and policies related to the newborn screening program.

A recent one Texas Law Review article found that more than a quarter of states do not have policies governing law enforcement access to newborn blood samples and related information, and that nearly a third may allow access under certain circumstances.

In Michigan, the state gives law enforcement dried blood stains just to identify the victim of a crime, Wuth said. “Usually this means someone has been killed or is missing,” she added.

Many clinicians and bioethicists say standards for the use of blood spots need to be established.

“It is almost impossible for us to monitor the potential use of our data,” he said Andrew Crawford, senior policy counsel for the Privacy and Data Project at the Center for Democracy and Technology. “Therefore, its use must be restricted.”

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