About 4 million babies are born in the U.S. each year, and nearly all of them have an ankle sprain within the first 48 hours so 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 generally require it and do not ask parents’ permission before performing it.
But lab tests for newborn screening typically don’t use half a dozen or more drops of blood collected on filter paper cards. So states retain residual “dried blood spots,” as they’re called, often without the parents’ knowledge or consent. In recent years, privacy-related concerns have grown about the sometimes decades-long storage and use of material.
Some states allow blood stains to be used in research studies, sometimes by third parties for a fee, or provided to law enforcement personnel investigating crimes. Permitting these or other uses without the parents’ informed consent that they 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 agreed to destroy more than 3 million blood spots as part of a settlement of a lawsuit brought by parents who said they did not receive clear enough information to provide informed consent for the blood to be used in state research. Manage. The fate of the millions of additional bloodstains the state has accumulated will be determined at trial.
Philip L. Ellison, an attorney in Hemlock, Michigan, who is leading the case, said he became aware of the issue five years ago when his son was born. Ellison’s son, Patton, spent his first days in the neonatal intensive care unit after his blood sugar levels dropped rapidly after birth. The next morning, Ellison said, he was approached by a hospital worker who asked if he wanted to sign a consent form allowing Patton’s heel-stick test blood to be donated for research.
The unexpected request set off alarm bells for Ellison.
“We don’t know what the future will bring in terms of information that can be extracted from our blood,” he said. How those blood usage rules might evolve over time, he said, is hard to know. “A program that first started with one purpose, to test for disease, has now entered medical research and then law enforcement,” he said.
Michigan is the rare state that requires parents’ permission to use residual newborn blood spots in research. Most don’t, experts say. The state screens newborns for more than 50 diseases, such as cystic fibrosis and congenital hypothyroidism, because identifying and treating such illnesses early in a child’s life is crucial.
Afterward, what 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 de-identified blood spots to study the relationship between viral infection at birth and the development of autism later in life, as well as the effects of maternal exposure to chemicals known as PFAS on health outcomes.
Chelsea Uth, spokeswoman for the Michigan Department of Health and Human Services, said parents are asking their children to send blood spots to researchers to try to diagnose a disorder or find the child’s cause of death.
Michigan parents can request that the state destroy any remaining blood stains if they don’t want the state to retain them.
Since the 1960s, states have tested the blood of newborns for conditions that can cause devastating physical or mental disability or death if left undiagnosed and untreated. The federal government recommends that about three dozen screening tests be performed, but some states administer many more. According to data published by the federal Centers for Disease Control and Prevention, each year, approximately 13,000 infants are identified through newborn screening programs for serious medical conditions.
Many public health experts strongly support mandatory newborn screening as an important component of pediatric clinical care. But some are receptive to telling parents what the blood will look like after screening.
“I’ve always believed that parents should have the opportunity to say ‘yes’ or ‘no’ to having their newborn’s leftover blood used in research,” said Dr. Beth Tarini, a pediatrician and associate director of the Center for Children’s National Research in Washington, DC. “Because it’s not part of clinical care, it’s a different standard of engagement with parents,” says the Institute for Translational Research.
In Michigan, 64% of parents agreed to participate, according to court documents in Ellison’s case.
Encouraging people to participate is important, some public health experts say, because blood spot banks provide a rare opportunity for population-level research. People of European descent are often overrepresented in genetic databases, which can skew study results. But the newborn screening program includes virtually everyone born in the United States
“There is strong evidence that research conducted on white samples creates disparities in access to biomedical research for nonwhites,” said Dr. Kyle Brothers, a pediatrician and biologist at the Norton Children’s Research Institute in Louisville, Kentucky.
After privacy-related lawsuits were brought by parents in Texas and Minnesota in 2009 and 2011, respectively, millions of blood stains were destroyed.
Brothers says the reluctance to participate in research programs reflects a broader trend, one that places 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 case 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, alleged that state police used a subpoena to obtain blood stains from a child who is now 9 years old at the state’s newborn screening laboratory. The lawsuit states that a DNA analysis of the blood spot was conducted to gather evidence against the child’s father, who was represented by the public defender’s office, in a 1996 sexual assault. The effort allowed police to obtain DNA. Complaints, court information without showing probable cause.
It seeks to find out how many times New Jersey law enforcement agencies have used newborn screening labs as a tool in investigations and “warrantless searches and seizures” of defendants over the past five years.
New Jersey keeps the records on file for 23 years, said CJ Griffin, a lawyer representing the public defender’s office and the New Jersey Monitor in the case.
Griffin said his clients are not challenging the program to test newborn blood for disease. “It’s more a lack of transparency, and information about security, and storage, and we don’t have any information about appropriate use,” he said.
The New Jersey Department of Health does not comment on pending litigation, spokeswoman Nancy Carney said. Kearney did not respond to a request for information about state practices and policies related to newborn screening programs.
A recent Texas Law Review article found that more than a quarter of states lack policies on law enforcement access to newborn blood spot samples and related information, and about a third may allow access under certain circumstances.
In Michigan, the state provides law enforcement agencies with dried blood stains only to identify a crime victim, Uth said. “Usually, it means someone is killed or missing,” he added.
Many physicians and bioethicists say that standards need to be set for the use of blood stains.
“It’s almost impossible for us to monitor the potential uses of our data,” said Andrew Crawford, senior policy advisor for the Privacy and Data Project at the Center for Democracy and Technology. “So use needs to be limited.”
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