About 4 million babies are born in the United States each year, and within their first 48 hours nearly all have their heels pricked to test their blood for dozens of life-threatening genetic and metabolic problems. The heel stick test is considered such an important public health measure that states generally require it and do not ask parents for permission before it is completed.
But newborn screening lab tests typically don’t use half a dozen or so drops of blood collected on filter paper cards. So states hold on to leftover “blood spots,” as they’re called, often without the parents’ knowledge or consent. In recent years, privacy concerns have grown over the storage and use of content that sometimes spans decades.
Some states allow blood spots to be used in research studies, sometimes to third parties for a fee, or to law enforcement officials investigating a crime. Permitting these or other uses without the parents’ informed consent that they understand and agree to the use has prompted litigation by parents who want to make these decisions themselves and who want to protect their children’s rights. Want to protect medical and genetic information.
In May, Michigan officials reportedly agreed to destroy more than 3 million blood spots as part of a settlement in a lawsuit brought by parents who said they were given such clear information. They have not been found to be able to provide informed consent for the use of blood in research. Conduct The fate of millions of additional blood spots stored by the state will be decided at trial.
Philip L. Ellison, an attorney in Hemlock, Michigan, who is leading the case, said he became aware of the problem when his son was born five years ago. Alison’s son, Peyton, spent his first days in the neonatal intensive care unit after his blood sugar levels dropped sharply after birth. The next morning, Ellison said, he was approached by a hospital staffer who asked if he wanted to sign a consent form to donate blood from Peyton’s heel stick test to research.
The unexpected request raised alarm bells for Alison.
“We don’t know what will happen in the future in terms of information that can be extracted from our blood,” he said. It’s hard to know how the rules for using that blood might evolve over time, he said. “A program that first started for one purpose, to test for disease, has now expanded to medical research and then to law enforcement,” he said.
Michigan is a rare state that asks parents for permission to use leftover newborn blood spots in research. Most don’t, experts said. The state screens newborns for more than 50 diseases, such as cystic fibrosis and congenital hypothyroidism, because identifying and treating such diseases early in a child’s life is critical.
After that, whatever remains is 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 unidentified blood spots to study the link between viral infections at birth and the development of autism later in life, as well as the effects of chemicals known as PFAS on health outcomes. Maternal effects have been studied.
Chelsea Voth, spokeswoman for the Michigan Department of Health and Human Services, said parents have also asked that their children’s blood samples be sent to researchers to help diagnose a disorder or find a cause of death. Can be tried.
Michigan parents can request that the state destroy leftover blood stains if they don’t want the state to hold on to them.
Since the 1960s, states have screened newborn blood for conditions that can lead to catastrophic physical or mental disability or death if left undiagnosed and untreated. The federal government recommends about three dozen screening tests, but some states do more. Each year, an estimated 13,000 newborns with serious medical conditions are identified through newborn screening programs, according to data published by the federal Centers for Disease Control and Prevention.
Many public health experts strongly support mandatory newborn screening as an important component of infant medical care. But some accept to tell the parents what happens to the blood after the screening.
Dr. Beth Tarini, a pediatrician and associate director of the center, said, “I have always believed that parents have the opportunity to say ‘yes’ or ‘no’ to using their newborn’s leftover blood in research. Must meet.” “Because it’s not part of clinical care, it’s a different quality of engagement with parents,” says Dr.
In Michigan, 64% of parents agreed to participate, according to court documents in Ellison’s case.
Some public health experts say it’s important to encourage people to participate, because blood spot collections offer a rare opportunity for population-level research. People of European descent are often overrepresented in genetic databases, which can bias study results. But the newborn screening program covers everyone born in the United States.
“There is strong evidence that research conducted on samples of white people creates disparities in the benefits of biomedical research to those who are not white,” said Dr. Kyle Brothers, of the Norton Children’s Research Institute in Louisville, Kentucky. said a pediatrician and biologist at Tut.
After parents brought privacy-related lawsuits in Texas and Minnesota, respectively, in 2009 and 2011, millions of blood spots were destroyed.
Brothers said the willingness to participate in research programs reflects larger trends, including more emphasis on the individual and less on contributing to the common 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 Office of the Public Defender and the New Jersey Monitor, a nonprofit news site, allege that state police used a subpoena to obtain traces of the child’s blood. Who is now 9 years old. State Newborn Screening Laboratory. DNA analysis on the blood spot was conducted to gather evidence against the child’s father, who was represented by the public defender’s office, in connection with the 1996 sexual assault, the suit says. This effort allowed the police to obtain DNA. The lawsuit alleges that information without showing probable cause in court.
The lawsuit seeks to determine how many times in the past five years New Jersey law enforcement agencies have used the newborn screening lab as a tool in investigations and subjected defendants to “warrantless searches and seizures.” has made
New Jersey has kept the records on file 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 are not challenging the newborn blood screening program for diseases. “It’s a lack of transparency, and safety measures, and information about storage, and we don’t have any information about proper use,” he said.
Spokeswoman Nancy Kearney said the New Jersey Department of Health does not comment on pending litigation. Kearney did not respond to a request for information about the state’s practices and policies regarding the newborn screening program.
A recent Texas Law Review article found that more than a quarter of states lack policies regarding access to newborn blood samples and related information by law enforcement agencies, and that nearly a third lack access under certain circumstances. may allow
In Michigan, the state gives law enforcement only dried blood spots to identify a crime victim, Voth said. “Usually, it means someone is dead or missing,” he added.
Many physicians and biologists say that standards need to be established for the use of blood spots.
“It’s almost impossible for us to monitor potential uses of our data,” said Andrew Crawford, senior policy counsel for the Privacy and Data Project at the Center for Democracy and Technology. “That’s why restrictions on use are needed.”
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