States review storing babies’ blood testing over privacy worries


Every year, around 4 million newborns are born in the United States, and within their first 48 hours, virtually all of them are pricked in the heel so that their blood may be tested for dozens of life-threatening genetic and metabolic disorders. The heel-stick test is seen as such an important public health measure that states normally demand it and parents are not asked for permission before to its administration.

However, newborn screening laboratory tests typically do not use all of the approximately six blood droplets collected on filter paper cards. Thus, states retain the remaining “dried blood spots,” as they are known, frequently without parental knowledge or consent. In recent years, privacy concerns regarding the often decades-long preservation and usage of the content have increased.

Some states permit the use of blood spots in scientific projects, sometimes by third parties for a charge, or the provision of blood spots to law enforcement authorities investigating a crime. Permitting these or other uses without parents’ informed consent that they understand and agree to the use has sparked litigation from parents who wish to make these decisions themselves and protect the medical and genetic information of their children.

In May, it was revealed that Michigan officials agreed to delete more than 3 million blood spots as a partial settlement in a lawsuit brought by parents who claimed they did not get sufficient information to provide informed consent for the blood to be used in state-sponsored research. The trial will determine the destiny of millions of more blood spots stored by the state.

Five years ago, Philip L. Ellison, an attorney from Hemlock, Michigan, who is spearheading the lawsuit, became aware of the issue upon the birth of his son. Patton, the newborn son of Ellison, spent his first days in the neonatal intensive care unit because his blood sugar levels dropped rapidly. The following morning, according to Ellison, a hospital employee contacted him and asked if he would sign a consent form permitting the blood from Patton’s heel-stick test to be used for study.

The unanticipated request rang warning bells for Ellison.

He stated, “We do not know what the future holds in terms of the information that can be pulled from our blood.” It is difficult to predict how the restrictions for utilizing this blood might change over time, he said. “A program whose original intent was to detect disease has now spread to medical research and eventually to law enforcement,” he explained.

Michigan is one of the few states that requires parental consent before using newborn blood spots for study. Most do not, experts said. The state checks babies for more than 50 ailments, including cystic fibrosis and congenital hypothyroidism, because early detection and treatment of such conditions are essential.

The leftover material is then preserved for up to one hundred years and, with parental consent, may be used for research approved by the Michigan Department of Health and Human Services. Recent research have utilized de-identified blood spots to examine the association between viral infection at birth and the development of autism later in life, as well as the effect of maternal exposure to man-made chemicals such as PFAS on health outcomes.

According to Chelsea Wuth, a representative for the Michigan Department of Health and Human Services, parents have also requested that their children’s blood samples be given to researchers to assist diagnose a disorder or determine the cause of a child’s death.

If parents in Michigan do not want the state to keep the blood spots, they can request that the state destroy them.

Since the 1960s, states have screened newborn blood for illnesses that, if undiagnosed and untreated, can cause debilitating physical or mental disability or death. The federal government recommends approximately thirty screening tests, but several states undertake far more. According to data published by the federal Centers for Disease Control and Prevention, around 13,000 newborns with significant medical issues are found annually through newborn screening programs.

As a vital component of clinical care for infants, newborn screening is highly supported by a number of public health professionals. However, some are sympathetic to giving parents a say in the blood’s disposition after screening.

Dr. Beth Tarini, a pediatrician and the associate director of the Center for Translational Research at Children’s National Research Institute in Washington, D.C., stated, “I have always believed that parents should have the option to say ‘yes’ or ‘no’” regarding the use of their newborns’ leftover blood for research. Since it is not part of the clinical care, it requires a distinct level of parental commitment.

According to court documents in Ellison’s case, in Michigan 64% of parents consented to participation.

Blood spot repositories give a rare chance for population-level study, according to some public health professionals, thus it is vital to encourage people to participate. People of European heritage are frequently overrepresented in genetic databases, which can distort research results. However, the newborn screening program encompasses practically all U.S. newborns.

Dr. Kyle Brothers, a pediatrician and bioethicist at the Norton Children’s Research Institute in Louisville, Kentucky, stated, “There is significant evidence that research conducted on samples of white people produces inequities in the advantages of biomedical research for non-white people.”

Parents in Texas and Minnesota filed cases related to privacy in 2009 and 2011, resulting in the destruction of millions of blood spots.

According to Brothers, reluctance to participate in research programs reflects bigger tendencies, such as a greater emphasis on the individual and a diminished emphasis on contributing to the common good.

A recent New Jersey lawsuit presents disturbing considerations for those who would argue that parents’ privacy worries are exaggerated.

In a public documents complaint, the New Jersey Office of the Public Defender and the New Jersey Monitor, a non-profit news organization, allege that the state police obtained an infant blood spot from the state’s newborn screening laboratory via a subpoena. The lawsuit states that a DNA study was performed on the blood spot in order to gather evidence against the child’s father, who was being defended by the public defender’s office, in connection with a 1996 sexual assault. The initiative allegedly allowed authorities to obtain the DNA information without presenting a judge with probable cause.

The complaint wants to determine how frequently New Jersey law enforcement agencies have used the newborn screening facility as an investigative tool and subjected defendants to “warrantless searches and seizures” during the past five years.

CJ Griffin, an attorney for the public defender’s office and the New Jersey Monitor in the complaint, stated that New Jersey maintains the records for 23 years.

Griffin stated that her clients are not contesting the neonatal blood testing program. “It’s more the lack of openness, safeguards, and storage information, and we have no information regarding acceptable use,” she explained.

Nancy Kearney, a representative for the New Jersey Department of Health, stated that the agency does not comment on pending lawsuits. Kearney did not respond to a request for information about the state’s newborn screening program methods and policies.

According to a recent article published in the Texas Law Review, more than a quarter of states lack regulations on law enforcement access to newborn blood spot samples and related information, while almost a third may enable access under certain conditions.

Wuth stated that the state of Michigan only provides law enforcement authorities with dried blood stains to identify the victim of a crime. “Typically, this indicates a death or disappearance,” she noted.

Numerous clinicians and bioethicists claim that blood spot usage standards must be established.

Andrew Crawford, senior policy counsel for the privacy and data project at the Center for Democracy and Technology, stated, “It’s practically hard for us to supervise the potential applications of our data.” Therefore, it is necessary to impose restrictions on its use.

KHN (Kaiser Health News) is a national news organization that delivers in-depth health-related journalism. KHN, with Policy Analysis and Polling, is one of KFF’s three primary running programs (Kaiser Family Foundation). KFF is an endowed nonprofit organization that provides information on national health issues.


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