About 4 million babies are born in the United States each year, and in their first 48 hours of life, almost all of them have their heel pricked to draw a blood sample and test it for life-threatening genetic and metabolic problems.
Heel prick testing is considered such a crucial public health measure that states often require it, and parental permission is not required before testing.
But these lab tests don’t use all the blood drops collected on filter paper cards. As a result, states keep leftover “dried blood stains,” often without parental knowledge or consent.
In recent years, concerns have grown over privacy issues and the use of the material, which is sometimes stored for decades.
Some states allow them to be used in research studies, sometimes by third parties for a fee, or provided to law enforcement personnel investigating a crime. Allowing these and other uses, without informed parental consent, has prompted lawsuits from parents seeking to protect their children’s medical and genetic information.
In May, Michigan authorities agreed to destroy more than 3 million bloodstains as part of a settlement in a lawsuit brought by parents who claimed they were not given clear enough information to consent to the use of blood in research. that the state could carry out.
The fate of millions of additional bloodstains, stored by the state, will be determined at trial.
Philip L. Ellison, a lawyer from 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 few days in the neonatal intensive care unit after his blood sugar levels dropped precipitously after birth. According to Ellison, he was approached the next morning by a hospital employee asking him to sign a consent form allowing Patton’s heel prick blood to be donated for scientific research.
The unexpected request put Ellison on alert.
“We don’t know what the future holds in terms of the information that can be extracted from our blood,” he said, adding that it’s hard to know how the standards for using that blood might evolve over time. “A program that started with a single purpose, to detect diseases, has now moved into medical and police investigation,” he noted.
Michigan is the only state that asks parents for permission to use leftover bloodstains from newborns. According to experts, most do not. The state screens newborns for more than 50 diseases, such as cystic fibrosis and congenital hypothyroidism, because it’s crucial to identify and treat these diseases early in a baby’s life.
What’s left is then stored for up to 100 years and, if the parents agree, can be used in research approved by the Michigan Department of Health and Human Services.
Some recent studies have used deidentified bloodstains to study the relationship between viral infection at birth and later development of autism, as well as the health impact of maternal exposure to manufactured chemicals known as PFAS.
Parents have also asked that their children’s bloodstains be sent to researchers to help diagnose a disorder or to try to find a reason for a child’s death, according to Chelsea Wuth, a spokeswoman for the Department of Health and Human Services. from Michigan.
Michigan parents can request that the state destroy leftover bloodstains if they do not want the state to keep them.
Since the 1960s, states have tested the blood of newborns for diseases that can cause devastating physical or mental disabilities, or death, if not diagnosed and treated.
The federal government recommends about three dozen screening tests, but some states do many more. An estimated 13,000 seriously ill babies are identified each year through newborn screening programs, according to data released by the Centers for Disease Control and Prevention (CDC).
Many public health experts support mandatory newborn screening as a critical component of clinical infant care. But some accept that parents can decide what happens to the blood after screening.
“I’ve always believed that parents should have the opportunity to say ‘yes’ or ‘no'” to their babies’ leftover blood being used for research,” said Dr. Beth Tarini, a pediatrician and director of the Center for Translational Research. of the National Institute for Children’s Research in Washington, DC “Because it’s not part of clinical care, we’re looking at a different standard of engagement with parents.”
In Michigan, 64% of parents consented, according to court documents from the Ellison case.
According to public health experts, it is important to encourage parent involvement because bloodstain deposits provide a rare opportunity for population-level research.
People of European descent are often overrepresented in genetic databases, which can bias study results. However, the newborn screening program includes virtually everyone born in the United States.
“There is compelling evidence that research conducted with samples from non-Hispanic whites creates disparities in the benefits of biomedical research for non-whites,” said Dr. Kyle Brothers, a pediatrician and bioethicist at the Norton Children’s Research Institute in Louisville, Ky.
Following privacy-related lawsuits filed in 2009 and 2011 by parents in Texas and Minnesota, respectively, millions of bloodstains were destroyed.
Brothers said the unwillingness to participate in research programs reflects broader societal trends, including a greater emphasis on the individual and less on contributing to the general good.
For those who might argue that parental privacy concerns are overblown, a recent lawsuit in New Jersey raises troubling questions.
In a public records lawsuit, the New Jersey Public Defender’s Office and the New Jersey Monitor, a nonprofit news site, accuse state police of using a subpoena to obtain a bloodstain from a child, now 9 years old, from the state newborn screening lab.
The lawsuit alleges that a DNA analysis of the bloodstain was performed in order to gather evidence against the boy’s father, who was being represented by the public defender’s office, in connection with a sexual assault committed in 1996. According to the lawsuit, this allowed police to obtain the DNA information without having to prove probable cause in court.
The lawsuit seeks to find out how often, in the past five years, New Jersey law enforcement has used the newborn testing lab as a tool in investigations and subjected defendants to “warrantless searches and seizures.” .
New Jersey keeps 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 his clients aren’t suing the program that tests newborns’ blood for disease. “It’s more about the lack of transparency, the need for safeguards and storage information, and we don’t have any information on whether it’s used properly,” she added.
The New Jersey Department of Health does not comment on pending litigation, spokeswoman Nancy Kearney said. Kearney did not respond to a request for information about the state’s practices and policies related to the newborn screening program.
A recent article in the Texas Law Review revealed that more than a quarter of states lack policies on law enforcement access to newborn bloodstain samples and related information, and that nearly a third party may allow access in certain circumstances.
In Michigan, the state provides law enforcement with dried bloodstains only to identify a crime victim, Wuth said. “Normally, this means that someone has been killed or has disappeared,” he added.
Many doctors and bioethicists say that it is necessary to establish standards for the use of bloodstains.
“It’s almost impossible for us to control how our data is used,” said Andrew Crawford, an adviser to the data and privacy project at the Center for Democracy and Technology. “That’s why you have to put limitations on use.”
This story was produced by KHN (Kaiser Health News), a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
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