UPDATE: May 2018
State Biobank Stores Every Baby’s DNA. Who Else Has Access?
The #ReportersNotebook entry below was first published in 2015. Since then, we’ve identified new concerns. Please also see the updated story here:
If you or your child was born in California after 1983, your DNA is likely being stored by the government, may be available to law enforcement and may even be in the hands of outside researchers.
Like many states, California collects bio-samples from every child born in the state. The material is then stored indefinitely in a state-run biobank, where it may be purchased for outside research.
State law requires that parents are informed of their right to request the child’s sample be destroyed, but the state does not confirm parents actually get that information before storing or selling their child’s DNA.
Reporter Julie Watts has learned that most parents are not getting the required notification. She also discovered the DNA may be used for more than just research.
In light of the Cambridge Analytica-Facebook scandal and the use of unidentified DNA to catch the Golden State Killer suspect, there are new concerns about law enforcement access, and what private researchers could do with access to the DNA from every child born in the state.
For more information on how your child’s specimen might have been used for research, email newsmom.com@gmail.com
#ReportersNotebook 2015
Do you know if your child’s DNA is being stored in a government database? If you live in California, or at least 20 other states, it likely is.
In this report for CBS San Francisco, we took a closer look at the life-saving “Newborn Screening Test.”
No one disputes the need for, or benefits of, the mandatory genetic screening program. However, the controversy stems from the lack of disclosure about what they do with your child’s newborn blood spot DNA after the test.
For decades, state governments have been collecting, storing and “selling” babies’ DNA to private companies for research without parental consent—DNA from a blood test that you pay for.
Newborn Screening Test
Every baby born in the U.S. is pricked on the heel at birth so that their blood can be screened for rare genetic disorders. The test is required by law and is even performed following home births.
The Newborn Screening Program allows babies with rare genetic disorders to receive early diagnosis and treatment, often saving their lives.
SaveBabies.org outlines the screening process and the benefits of the test. It also highlights stories of lives saved because of the test.
Genetic screening really is a miracle of modern science.
However, in at least a couple dozen states, the blood spots that are used for the screening are not destroyed after the test.
Now, storing your child’s DNA is not inherently a bad thing. State researchers use the stored blood spots to come up with new genetic tests for other diseases, ultimately saving more lives.
What They Don’t “Tell” You
The issue for many, however, is the fact that some states store and sell your babies’ DNA without your consent or even knowledge.
In addition to state researchers, law enforcement and lawyers can obtain your child’s DNA, and private companies can purchase it for research.
(Note: The California Newborn Screening Program insists that the state does not profit from the sale of blood spots, rather private companies reimburse the state for costs incurred—often tens of thousands of dollars per blood spot.)
Parents do have the right to ask that the blood spots be destroyed, but did you know they even existed? Most don’t.
We asked the California Department of Public Health how it informs parents their child’s blood spots will be stored after the Newborn Screening Test. The state response made me laugh out loud.
The information for parents about storage and use of blood spots is provided on pages 12 and 13 of the Newborn Screening brochure. In addition to being available on the internet in multiple languages, healthcare providers give the brochure to parents prenatally and at birthing centers and hospitals.
Between trying to figure out how to nurse my newborn, change a diaper, sleep train my baby, learn the “5 S’s,” find time to shower, research vaccines, get to doctors’ appointments, interview nannies and deal with insurers, it never occurred to me to comb through the four folders of forms and information I was sent home from the hospital with to find that brochure so I could flip to page 12 and 13.
You’d better bet I did just that, though, as soon as I started researching this story. You know what I found? A “Newborn Screening Test Request Form (TRF),” filled out in a stranger’s handwriting that didn’t even have a spot for my signature.
Requesting/Destroying Your DNA
California’s genetic testing program began in 1980, so I took advantage of my rights in California to request information about how my DNA had been used.
Turns out the state didn’t begin “storing the DNA” until 1983.
So, I requested the same information about my sister and my daughter, but I was told that their specimens had “not been used for research.”
I then asked to have my daughter’s DNA/blood spot card returned to me so that I could ensure it would not be used without my consent. This is the response I received:
Unfortunately, department policy does not allow for specimens to be released to an individual, “The Newborn Screening Program tests newborn specimens to provide medical results for disorders for which we screen. The residual specimens may be used for research concerning diseases of women and children. When requested by parents or an adult who was screened as a child, the California Department of Public Health (CDPH) will destroy newborn screening specimens so that they are not available for research or CDPH will send a portion of the specimen safely to another facility for further medical testing. CDPH does not release individual specimens to members of the public pursuant to requests by those individuals.”
So in short, you should trust that the agency that took your child’s DNA without your consent will destroy it upon request. They will not return that DNA to you even though it’s technically yours. I have not yet asked if they will return it to my pediatrician.
Also, note this disclaimer from the state:
You have a right to ask the Newborn Screening Program not to use or share your or your newborn’s information and/or specimen in the ways listed in this notice. However, we may not be able to comply with your request.
Though, keep in mind that by destroying your child’s sample, you are preventing researchers from using it to come up with new, potentially life-saving, tests. California has one of the largest databases in the country, and as a result can test for more genetic disorders than any other state.
After hearing from parents whose children have been saved by those tests, I opted to request that the state simply mark my daughters “specimen” as “do not use for outside research.”
Privacy
Now, to be clear, the state does not sequence the DNA, so it’s not exactly a “DNA database.” Rather, the state stores your child’s blood spots, which can then be sold for research.
It’s the researchers that extract–and potentially sequence–your child’s DNA.
The state claims the information is “de-identified,” so your baby’s DNA can’t be tracked back to the child. However, Yaniv Erlich of Columbia University and the New York Genome Center says there is no way to guarantee that.
As we point out in our CBS Report:
His research demonstrated how easy it is to take anonymized DNA, cross-reference it with online data and connect it to a name. “You need to have some training in genetics, but once you have that kind of training the attack is not very complicated to conduct,” he said.
Once he realized that there’s no guaranteed privacy when it comes to DNA, Erlich took it a step further and created dna.land. It’s essentially a crowd-sourced database where people voluntarily donate their DNA to share with scientists.
Its motto: “Know your Genome to help science.” Similar to 23 and me, you can also find long-lost relatives at dna.land. However, dna.land is free and run by academics at Columbia University and the New York Genome Center.
Is the state database legal?
Even if researchers couldn’t track your child’s DNA back to your child, the states can. They obviously have to be able to find your DNA if you ask to have it destroyed.
We requested public records and found that the state also hands over that DNA to law enforcement. It can be, and often is, subpoenaed. However, as far as we know, no one has yet been convicted of a crime based on their blood spot DNA in the state’s database.
A fairly new federal law requires that any federally-funded researchers using newborn blood spots must first get parental consent. However, that does not apply to state-funded or privately-funded research.
For now, the legal right to store and sell the dried blood spots is determined by each state. However, Pediatrics reported some states “may be acting outside the scope of their legal authority.”
Parents in Texas sued the state for selling their children’s blood without consent. It was later determined that the state sold blood spots to pharmaceutical companies for research and “loaned” it to the U.S. Armed Forces.
The state settled with the families out of court and subsequently destroyed the DNA taken without parental consent. Texas has now enacted a law allowing parents to “opt in” to the program.
The Minnesota Department of Health (MDH) was also sued for establishing a biobank without parental consent. Samples were allegedly used for research by drug companies and equipment manufacturers.
The Minnesota Supreme Court ruled that written, informed consent is required for storage, use or dissemination of any remaining blood samples or test results after completion of a newborn screening.
Ultimately the state was forced to destroy hundreds of thousands of test samples and results. Minnesota later enacted a law requiring written informed consent before newborn samples can be used for research.
That is something the medical community in California is trying to avoid.
We asked the California Department of Public Health why it does not allow parents to opt in, or at least provide informed consent, before storing and selling a child’s DNA. The state declined an interview and ultimately provided this response after our story aired.
Healthcare providers at California’s many birthing facilities give parents informational brochures about opting-out of blood spot storage. Since parents of newborns have many other concerns shortly after birth, this procedure allows them to make that decision at any time, without pressure. Parents can then contact the California Department of Public Health (CDPH) and learn more about their options from knowledgeable professionals who are directly involved with the Newborn Screening Program.
Again, I had to point out to the state that neither I, nor any new mother I’ve spoken with, recall ever being informed that our child’s DNA would be stored and/or sold after their genetic test.
I’ve now asked if they keep any records or have any evidence that parents are, in fact, informed. I’ve also asked the state to elaborate on why parents are not offered the opportunity to provide “informed consent for the storage and sale of their child’s blood spots at some point during in the 9 months leading up to the delivery.” I am still awaiting a response.
Lawmakers Trying To “Fix It”
Earlier this year, California Assemblyman Mike Gatto introduced the DNA Privacy Bill that would require the state to get informed consent from parents before storing and selling a child’s DNA.
“Whenever data is stored, data can fall into the wrong hands. Imagine the discrimination a person might face if their HIV status, or genetic predisposition to a mental disorder were revealed to the public,” said Gatto. “Parents should have the right to protect their children and people should have the right to control how their personal medical records are used once they reach adulthood.”
The bill was strongly opposed by the biotech, medical and research communities. However, after five revisions, the only remaining opposition was from the California Hospital Association. CHA declined to comment for our story.
Here are excerpts from the opposition to informed consent:
The California Hospital Association (CHA): ...this bill would also increase the administrative burdens on hospitals, physicians, and new mothers which, in turn, will increase health care costs.The University of Southern California (USC): California's database is internationally recognized as a critical public health asset and allows for the study of these rare diseases among its diverse communities.The American Academy of Pediatrics and March of Dimes (CA Chapters): ... oppose any amendments that would link consent for storage and research of newborn screening blood spots with the initial collection and testing of the blood spots.California Children's Hospital Association (CCHA): ... the current California blood spot database is an internationally recognized public health asset because of its size and diversity.... Implementing an informed consent policy will require significant financial resources...The University of California (UC): ... this measure could significantly limit the availability of the valuable data and biosamples collected by the CNSP for research use.
The bill ultimately failed. Gatto says he will re-introduce it next year.
Bottom Line
The bottom line is that newborn genetic testing saves lives. Without access to the stored blood spots from the millions of babies born every year, researchers say they would not have been able to create the life-saving tests to begin with.
The question remains: Should parents have the right to consent/opt in to the state storing and selling their child’s DNA after the test is performed?
Currently, the state admits it does not obtain consent, and the industries that benefit from the program are fighting to keep it that way. The general belief is that many parents would not consent if given the option, and the scientific community would ultimately suffer.
Chime in on Facebook:
Should the state get to store and sell your/your child’s DNA without your consent?
Would you consent if they told you what they were doing?
Read More:
This might come as a surprise to California natives in their 20s and early 30s: The state owns your DNA.
Source: DNA Data From California Newborn Blood Stored, Sold To 3rd Parties « CBS San Francisco
On the day they’re born, nearly all American babies have their heels pricked with a needle.
Every year, approximately 4 million newborns in the U.S. are screened for congenital disorders, and about 12,500 of these infants are diagnosed with an inherited condition.
Source: The government owns your DNA. What are they doing with it
Parents have the right to protect their newborn’s DNA.
Source: Newborn Screenings Violate DNA Privacy Rights – US News
For the first time, researchers can now sequence the genomes of newborns with mystery conditions in 26 hours
Source: Genetic Testing in Newborns Gets a Critical Breakthrough | TIME
NOTE: This story was updated to include an additional statement from the state that was received after the story initially arid.
Julie,
After looking at the link you provided, it appears I can REQUEST my children’s info not be shared, but our masters in Sacramento may not be able to comply. As far as destroying it, what exactly are they destroying? The actual sample or the digital files? I’ve never put any faith in federal, state or local bureaucracies and so far I have yet to be disappointed.
https://www.cdph.ca.gov/HealthInfo/Documents/NPP_Newborn_Screening-final_6-14.pdf
Here is the relevant text as well as the fact they charge for any requests to receive a copy of the info on my 2 children:
Individual Rights and Access to Information The Newborn Screening Program must have your written permission to use or give out personal or health information about you for any reason that is not described in this notice. You can revoke your authorization at any time, except if the Newborn Screening Program has already acted because of your permission by contacting the Chief of the Genetic Disease Screening Program at 850 Marina Bay Parkway, F175, Richmond, CA 94804.
I love this part:
“You have the right to look at or receive a copy (you will be charged)”
of your or your newborn’s health information and receive a list of instances where we have disclosed health information about you or your newborn for reasons other than screening, payment or related administrative purposes. You have a right to ask that the Newborn Screening Program contact you only in writing, or at a different address, post office box, or telephone number. Newborn Screening Program will contact you the way you have asked if this is necessary to keep you safe.
Another great part:
“You have a right to ask the Newborn Screening Program not to use or share your or your newborn’s information and/or specimen in the ways listed in this notice. However, we may not be able to comply with your request”
In other words: POUND SAND!
What is unfortunate about this is, this test can save lives but many of my families are now opting out of the testing because they don’t want their child’s DNA shared…
Rachel, I would LOVE to chat with you offline about your findings. Will you please email me? newsmom.com@gmail.com.