DETROIT (AP) — The state of Michigan has agreed to destroy more than 3 million stored baby dried blood spots, a partial settlement in an ongoing lawsuit over consent and privacy in the digital age.
Under state direction, hospitals have routinely pricked the heels of newborns to draw blood for more than 50 rare diseases. That practice, which is widespread in the US, is not being challenged. Rather, the dispute is over the leftover samples.
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One drop of blood from each child is stored in Lansing, while five more are sent to the Michigan Neonatal Biobank in Detroit for safekeeping under controlled climate conditions.
Scientists can pay a fee to use samples stored in Detroit for various research projects. Research on newborn blood spots also occurs in other states, especially California, New York and Minnesota, where they can be preserved for decades.
Texas in 2009 agreed to destroy millions of places to settle a privacy lawsuit.
Since 2010, Michigan must have parental permission to use research sites. But attorney Philip Ellison argues that the program still violates constitutional protections against searches and seizures and may not be fully understood by parents who are presented with forms amid the fog of childbirth.
Ellison says the consent form and a related brochure are vague and make no reference, for example, to state blood sample collection fees used by scientists.
“If moms and dads say, ‘Use them. I don’t care,’ it’s their business,” he told The Associated Press. “But the state is not giving them enough information to make an informed decision. … Most people don’t remember signing anything. My wife had a cesarean section. She was still in a daze 12 hours later from all the drugs they injected into her to give birth.”
Ashley Kanuszewski acknowledged that she signed forms allowing blood samples from two babies to be added to the research bank, but she does not remember receiving an informational brochure at the hospital.
“I don’t like not knowing where or what they’re using it for,” said Kanuszewski, one of four parents who filed a lawsuit in 2018.
In May, after four years of litigation, the health department said it would destroy certain blood drops stored in Lansing for the next 18 months and stop adding them to that inventory, according to an agreement filed in federal court in Bay City.
Those places number 3.4 million, spokeswoman Lynn Sutfin said.
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Sutfin declined to explain why the state agreed to get rid of them, citing ongoing litigation. But in 2021, US District Judge Thomas Ludington said the state did not have specific parental permission to keep a single leftover bloodstain in Lansing.
The state has described them as places parents could use should future health questions arise.
The agreement to destroy those places does not end the case. Still in play: Millions that are under the control of the state at Wayne State University in Detroit and available for research, including many from before May 2010, when the health department began asking for parental consent.
In the coming months, Ludington will conduct a trial to try to determine how many drops of blood are actually needed for newborn disease screening, including calibration of critical test equipment, among other issues.
The health department is defending how it runs the program. Emphasize that research spaces are not stored unless parents or guardians give permission. Stains can also be destroyed on demand, although the number of people who take that step each year is very small.
A code, not someone’s name, is attached to blood samples that are stored in Detroit, making the privacy risk during the investigation “very low,” the state said.
“We only allow activities related to public health for the benefit of all, for the public good, to get better tests in the future, to find out more and so on,” Sandip Shah, director of the public health laboratory at the University, said in an interview. condition. with lawyers
The department publishes a list of approved research. Last year, the state, for example, approved that scientists use 3,600 blood drops from newborns to determine exposure to so-called forever chemicals known as PFAS in West Michigan. Other projects have involved for-profit companies.
“How this court resolves the issues raised by the plaintiffs could have a dramatic impact on the biomedical research environment, potentially freezing scientific progress critical to protecting public health,” the Association of Public Health Laboratories said. .
In 2009, Texas agreed to destroy millions of newborn blood drops that were kept without consent. Stains obtained since 2012 are now destroyed after two years, unless Texas parents agree to longer storage for research.
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