Newborns get routine heel blood tests, but should states save those samples?
Nearly 4 million babies are born in the United States each year, and within their first 48 hours, nearly all are heel pricked so their blood can be tested for dozens of life-threatening genetic and metabolic conditions. Heel testing is considered such a crucial public health measure that states generally require it and parents are not asked for permission before it is done.
But lab tests for newborn screenings typically don’t use all of the half-dozen drops of blood taken from filter paper cards. Thus, states preserve the remains of “dried bloodstains,” as they are called, often without the knowledge or consent of the parents. In recent years, privacy concerns have grown over the storage and use of hardware, which sometimes lasts for decades.
Some states allow bloodstains to be used in research studies, sometimes by third parties for a fee, or provided to law enforcement investigating a crime. Allowing these or other uses without the informed consent of parents, which they understand and agree to use, has resulted in legal action from parents who wish to make these decisions themselves and seek to protect medical information and genetics of their children.
In May, Michigan officials reportedly agreed to destroy more than 3 million bloodstains as part of a partial settlement of a lawsuit filed by parents who said they had not been given enough information clear to provide informed consent for blood to be used in research that the state may have. conduct. The fate of millions more bloodstains stored by the state will be determined at trial.
Philip L. Ellison, a Hemlock, Michigan attorney who is spearheading 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 plummeted after birth. The next morning, Ellison said, he was approached by a hospital staff member who asked if he wanted to sign a consent form authorizing Patton’s heel 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 the rules for using that blood might change over time, he said, is hard to know. “A program that first started for one purpose, to test for disease, has now crept into medical research and then into law enforcement,” he said.
Michigan is the rare state that asks parents for permission to use newborn blood remains in research. Most don’t, experts said. The state screens newborns for more than 50 diseasessuch as cystic fibrosis and congenital hypothyroidism, because identifying and treating these conditions early in a child’s life is crucial.
Then whatever remains is stored until 100 years and, if parents agree, may be used in research approved by the Michigan Department of Health and Human Services. Some recent studies have used anonymized bloodstains to study the relationship between viral infection at birth and the development of autism later in life, as well as the impact of maternal exposure to manufactured chemicals known as PFAS on health outcomes.
Parents have also requested 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, said Chelsea Wuth, spokeswoman for the Department of Health. Michigan Health and Human Services.
Michigan parents can ask the state to destroy leftover bloodstains if they don’t want the state to keep them.
Since the 1960s, states have screened the blood of newborn babies for conditions that can lead to devastating physical or mental disabilities or death if not diagnosed and treated. The federal government recommends that about three dozen drug tests be done, but some states are doing many more. Each year, we estimate 13,000 infants with serious medical conditions 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 an essential part of clinical care for infants. But some are receptive to parents having a say in what happens to the blood after the screening.
“I’ve always believed that parents should be given the opportunity to say ‘yes’ or ‘no'” to having the remains of their newborns’ blood used in research, said Dr Beth Tarinipediatrician 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 engagement with parents.”
In Michigan, 64% of parents consented to participate, according to court documents in Ellison’s case.
Encouraging people to participate is important, some public health experts say, because bloodstain deposits offer a rare opportunity for population-level research. People of European ancestry 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 samples from white people creates disparities in the benefits of biomedical research for people who are not white,” said Dr Kyle Brotherspediatrician and bioethicist at the Norton Children’s Research Institute in Louisville, Kentucky.
After privacy lawsuits were filed in 2009 and 2011 by parents in Texas and Minnesota, respectively, millions of bloodstains were destroyed.
Brothers said a reluctance to participate in research programs reflects broader trends, including a greater emphasis on the individual and less on contributing 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 lawsuit against the public records, the New Jersey Office of the Public Defender and the New Jersey Monitor, a nonprofit news site, accuse state police of using a subpoena to obtain an infant bloodstain from a child who is now 9 years old from the state newborn screening lab. The lawsuit says DNA analysis was performed on the bloodstain so that evidence could be gathered against the child’s father, who was represented by the public defender’s office, in connection with a 1996 sexual assault. This effort allowed the police to obtain the DNA. information without having to show a court probable cause, the suit alleges.
The lawsuit seeks to find out how many times over the past five years New Jersey law enforcement has used the newborn screening lab as an investigative tool and subjected defendants to “warrantless searches and seizures.”
New Jersey is keeping 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 don’t take issue with the newborn blood testing program for diseases. “It’s more the lack of transparency, safeguards and information about storage, and we don’t have any information about proper use,” she said.
The New Jersey Department of Health does not comment on ongoing litigation, spokeswoman Nancy Kearney said. Kearney did not respond to a request for information on state practices and policies related to the newborn screening program.
A recent Texas Law Review article found that more than a quarter of states lack policies on law enforcement access to neonatal bloodstain samples and related information and nearly a third may allow access in some circumstances.
In Michigan, the state gives law enforcement dried bloodstains only to identify a crime victim, Wuth said. “Usually it means someone was killed or missing,” she added.
Many clinicians and bioethicists argue that standards for the use of bloodstains should be established.
“It is 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. “That’s why you have to put limits on the use.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health issues. Along with policy analysis and polling, KHN is one of the three main operating programs of KFF (Kaiser Family Foundation). KFF is an endowed non-profit organization providing information on health issues to the nation.
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