By Andrea Flink
When the Supreme Court overturned Roe v. Wade last week, it struck at the Constitutional principle at the heart of abortion access: the right to privacy. Other privacy rights Americans hold dear – the rights to contraception, marriage equality, same sex intimacy — are all protected by the same principle that until last week protected the right to abortion and are now also in jeopardy.
This week the Rag introduces a new series by Andrea Flink, Senior Fellow at Fordham Law School’s Center on Law and Information Policy, exploring modern threats to our privacy, and steps we can take to protect it. We begin by looking at a New York state program that stores newborn blood spots, containing DNA, for potential use in research, with possible consequences most New Yorkers are not aware of. Future articles will address other topics including how our lives are being surveilled by the government and by private corporations who are amassing vast amounts of data about us with minimal regulation, including technologies that could help authorities track who is getting abortions and by whom.
Many of us willingly or unknowingly turn over troves of information about our lives every day with consequences we can only begin to anticipate. This series will help New Yorkers consider what personal information they are giving away, how it is being used, and whether they wish to protect it.
Forewarned is forearmed.
Part 1 — New York Stores Newborn Blood Specimens — for 27 Years
Anxious and unable to sleep on a stormy December night, Val Grebenin and his nine-months pregnant wife Anastasia left their Upper West Side apartment and made snow angels near Lincoln Center. Anastasia wore Val’s ski clothes since hers no longer fit. The next morning her water broke, and after eating the beef wellington that Val had cooked for their last meal as a family of two, they walked through the late afternoon snow to Mount Sinai West. Twenty-three hours later their daughter was born, 6 pounds 9 ounces, and a joy for the first-time parents.
Before Baby Grebenin and her parents went home, hospital personnel drew a tiny amount of blood from her, part of a little-known procedure done after each of the quarter million annual births in the state. The blood is drawn through a prick in the baby’s heel, then screened for 60 genetic disorders. Some blood remains after the screening, and this residual material – called blood spots, and containing the baby’s DNA – is shipped to a storage facility in Albany.
And there it remains, for 27 years.
That was news to Val Grebenin when the Rag spoke with him about his daughter’s birth. “I am surprised,” he said, learning that the state would keep blood spots containing his child’s DNA on file for decades. “I would have strongly objected if someone had asked.”
New York State doesn’t ask, though. The storage is part of the state’s mandatory newborn screening program; parents can only opt out of the screening if the parent or guardian “is a member of a recognized religious organization whose teachings and tenets are contrary to this testing,” according to the state Department of Health’s website.
The screening itself has the potential to save or improve a newborn’s life, by identifying rare, but serious, disorders at birth. If the screening reveals an abnormal result, program staff contact the responsible physician and a specialty care center, who plan for follow-up testing and consultation.
But while the screening program has a strong public health rationale, there isn’t a similarly compelling justification for the second part of the program – the storage and use of the newborn’s blood spots, which is done automatically, without seeking parental consent.
Jeffrey Hammond, deputy director of communications for the New York State Department of Health, told the Rag in an email, “[P]arents are given the opportunity to opt out (our website, the For Your Baby’s Health educational brochure and the pink copy provided with the baby’s lab ID number all have this information).”
Val Grebenin did not recall seeing the brochure or the pink copy referred to. “If I knew they were keeping my baby’s DNA for 27 years I surely would have kept it,” he said.
The state says residual newborn blood spots are kept for diagnostics and research. Many parents might be fine with that, but for those who aren’t, making them take the initiative to opt out of having their baby’s blood stored for 27 years, during which it can potentially be used for research, is not the same as parental consent, especially since they may not even be aware that the test took place.
Beth Haroules, senior staff attorney at the ACLU of New York (NYCLU), believes that parents should be informed, in advance, about the screening and asked to give their consent.
“It’s always better to permit a person, particularly when it comes to health issues and genetic material, to be able to have those discussions and weigh those considerations before opting in,” Haroules said in an interview with the Rag. “Opting out puts the burden on the parent to obtain the information and ask the questions.”
The American Association of Pediatrics also recommends that parents be informed and asked for consent in advance, so that they are more likely to comply with any necessary follow up. “After education and counseling about the substantial benefits of newborn screening, its remote risks, and the next steps in the event of a positive screening result, parents should have the option of refusing the procedure, and an informed refusal should be respected,” the group says in a policy statement.
According to the NYCLU’s Haroules, federal and state laws on privacy and genetic testing require consent for both the initial screening as well as the subsequent storage and use of the samples for research.
“You can’t just take it and test it and then recycle it and use it for years, because there’s research that hasn’t even been conceived of yet that has enormously serious consequences,” said Haroules. “The implications are just so far reaching and it’s just so casual. So many people don’t know that their kids’ DNA is potentially being harvested and used continuously.”
According to Hammond, the health department spokesman, the blood spots can be used for research without parental consent unless a newborn’s specimen is to be used in a manner that requires its source to be identified. New York assigns the blood spots a 9-digit random lab ID and stores them in Albany separately from their identifying information so that only health department staff with access to the laboratory information management system can attach a name to the specimen.
The NYCLU is not aware of any litigation to date challenging New York’s newborn screening program, but several lawsuits have challenged the legality of other states’ screening programs.
In a case that could have national implications, a federal court in Michigan ruled last year that storing and using newborn blood samples for research without parental consent is an unconstitutional violation of the parents’ fundamental right to control the medical care of their children.
The court ordered a trial to determine whether Michigan’s screening program, which was modified in 2010 to require parental consent to use the samples for research, can survive “strict scrutiny,” or whether the storage of the samples even with consent is unconstitutional under the Fourth and Fourteenth Amendments as an illegal seizure or denial of parents’ due process rights. A trial date is expected to be scheduled in August. (The initial screening of newborns for genetic disorders without consent is not at issue in the case.)
A Texas lawsuit led to the discovery that its Department of State Health Services was using newborn blood spots not only for research, but also as bartering chips with for-profit companies in exchange for lab equipment. And a subsequent Texas Tribune investigation revealed that the Texas health department had sent hundreds of newborn blood samples to the U.S. Armed Forces to build a national DNA database to help identify missing persons and solve cold cases, and also eventually build an international DNA registry for international law enforcement and anti-terrorism efforts.
According to the New York health department’s website, newborn blood spots “are used internally in the [newborn blood screening] program as well as externally by approved public health researchers and health care professionals.” The blood spots are also available to health care providers, medical examiners and the courts, who “may also request or subpoena dried blood specimens as part of an official investigation such as to determine the cause of death.” The Rag asked the New York health department who, other than their staff, has access to New Yorkers’ newborn blood spots for research on a de-identified basis but did not receive a response.
Haroules raised concern about possible “nefarious” uses of the blood spots, which contain DNA that might be requested (or subpoenaed) as part of an official investigation. “There are just so many uses without oversight or transparency that from where I sit I have to assume the worst, that it’s being used for nefarious purposes, none of which necessarily have any benefit to the individual.”
Haroules also lamented the lack of transparency regarding how the blood spots are used for research as well as the lack of input from medical ethicists in formulating appropriate safeguards.
“We don’t know enough about what they do with respect to third party access and research. We also don’t know enough about under what circumstances they re-identify the samples,” she said.
Even though the health department obtains parental consent before re-identifying samples for research, is it possible to ensure that an outside researcher can’t re-identify the newborn blood spots? Investigators have shown that the answer is almost certainly no.
“Everything can be reidentified if you have multiple pieces of information, even if the blood with DNA is stored separately,” said pediatrician Lainie Ross, who serves as associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. “We all knew you could do it, and researchers have proved it.”
Notably, the federal court in the Michigan case rejected the state’s argument that Michigan’s use of de-identified newborn blood spots (samples kept separately from any personal identifying information) for research should be permitted because it complies with federal regulations that don’t require consent for research on de-identified samples – since the samples themselves are not considered human subjects. According to Attorney Philip Ellison, who represents the child and parent plaintiffs in the Michigan case, the court agreed that “even though a program complies with a federal regulation, that doesn’t mean it’s constitutional.”
Ellison told the Rag in an interview, “The state isn’t telling moms and dads about the risk that their newborns’ DNA can be re-identified. The risk has only increased because of public databases and how data can be linked. The idea of perpetual anonymity is no longer true. Parents need to be told.”
Parents who allow (knowingly or unknowingly) their newborns’ blood samples to be used for research could end up contributing to medical advances. Last month scientists discovered the cause of Sudden Infant Death Syndrome (SIDS) by comparing blood spots of newborns who had died from SIDS and other unknown causes to blood from healthy infants. The researchers found a defect in the part of the brain that controls arousal from sleep and breathing.
Even if their children don’t benefit, some parents might find scientific breakthroughs a justification for the 27-year storage program (though health department spokesman Hammond said the state does not go through blood spots to determine which contain a newly discovered condition, like the recent SIDS research).
But storage lasts so long that a newborn’s blood spots are still in the state facility long after that newborn has reached the age of majority. Thus, the state is storing and potentially using the blood and DNA of adults without their consent, even though the government can’t take DNA of adults without consent except under limited circumstances (as will be discussed in Part 2 of this series).
“No one denies the public health benefit that exists,” said Haroules. “But New Yorkers should not have to compromise on privacy rights and should be able to consent to taking and using what is an integral part of a person’s genetic makeup.”
As for why New York chose 27 years as the length of time to store newborn blood spots, Hammond responded: “21 years of age + 6 years.” The Rag asked for an explanation of the significance of “21 plus 6 years,” but at that point the health department stopped responding to Rag inquiries.
Parents who want to opt out of having their baby’s blood stored for diagnostic purposes or used for research can follow these guidelines and fill out this form so long as their child is under 21, after which the form must be filled out by the adult.
The opt-out form gives several choices – to exclude a sample from research but allow for diagnostics; to allow use for research only after written approval; or to have the sample destroyed when the newborn is eight weeks old.
Parents with questions can email the Newborn Screening Program at firstname.lastname@example.org or call (518) 473-7552.
Newborn Screening Program Staff said parents wishing to have their child’s blood spots destroyed but who no longer have their “pink slip” can still complete the form but should be sure to provide the date of birth, hospital of birth, mother’s maiden name and child’s sex. NSP Staff also noted that anyone 21 or older must fill out the form themselves.
I once attended a lecture by a lawyer who spoke about this issue from a broader perspective. In the U.S. Constitution there is no right to privacy. It can be inferred from other Amendments, but there is no clear right. What’s the proof? In cases where privacy comes up against the First Amendment, the First Amendment always wins. (For example, think about Europe’s “Right to be forgotten” which forces Google & other search engines to remove particular names. The U.S. courts have ruled that encroaches on the First Amendment.)
Thanks for putting it so succinctly, that’s very interesting
Thank you for this terrific article!
As long as Trump goes free, there is no law that we must obey!
Anything under the sun can be put to good or evil use. I can think of lots of good reasons to accumulate data. However, if there is corruption in the management and application of the data, then that leads to evil uses. We are seeing this play out at the highest levels of our government and that is why corruption needs to be stopped. Now, if you are of a mind that corruption is inevitable, then the data gathering itself becomes the problem. Seems to me either we as a society must address corruption or undisclosed and unauthorized data acquisition, one or the other.
WSR, you are on fire with the journalism lately, thank you! This was all eye opening news to me. I don’t even know how I feel about it (ok, my gut reaction is it’s pretty creepy) but I am happy to be aware it’s happening.
Many of the ethical questions presented here are important to consider, but a lot of potential risks of NBS sample storage that are described are way overblown or could only occur if the state’s NBS program or research acted unlawfully and in contradiction to existing ethical and IRB guidelines.
For example, re-identification of DNA samples is deeply unethical and is against research policy at US research institutions. Researchers who re-identify samples would A) need to invest a considerable amount of effort and money to do so and B) would be making an easily career-ending decision.
Similarly, the lawsuit in Texas about misuse of NBS samples was exactly that – misuse. That is why it was deemed unlawful and the responsible parties were held accountable.
I agree that the justification for storage of these samples should be examined, but the author here barely scratches the surface of the potential research benefit vs. risk to individual. NBS samples are an invaluable resource to understand state-level concerns regarding environmental exposures, infectious agents, and population genetics – and of course in the development of potentially life-saving treatment for genetic disorders. All this without any physical risk to the individual.
Furthermore, this article doesn’t provide an adequate description of the already stringent privacy safeguards in place that must be complied with to use NBS samples in research. Research projects using (already de-identified) NBS samples must be approved by an Institutional Review Board each year, likely required approval from NBS program entities as well, and are legally bound to comply with national and state legislation regarding research. Additionally, there is already strong consensus that NBS samples should never be used by the criminal justice system.