Indiana storing blood & DNA of 2 million children without parent - 13 WTHR Indianapolis

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Indiana storing blood & DNA of 2 million children without parents' consent

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INDIANAPOLIS - As word of an Eyewitness News investigation spreads through Holliday Park, parents admit they are surprised.

"You're kidding, right? I had no idea," said Ramon Moore, playing catch with his 7-year-old son, Xavier.
"I didn't know that at all," agreed Holly Ruth, holding her 3-month old son, Lincoln.
"Nobody ever told me," echoed Mallory Ervin, chasing her 4-year-old son, Theo, on the playground.

Xavier, Lincoln, Theo and millions of other Indiana children all have something in common: the state of Indiana is storing their blood and DNA in an undisclosed state warehouse.

"I'm curious why they didn't share that," said Ervin. "It now makes me think ‘what are they hiding?' As a parent, I'd absolutely like to know."

13 Investigates has discovered the Indiana State Department of Health is holding the blood samples of more than 2.25 million Hoosier children – without their parents' permission. If your children were born in Indiana since 1991, chances are their blood and DNA is among the state's massive collection.

Following WTHR's investigation, state health officials are now seeking input on what to do with the blood samples after admitting they don't have the consent needed to use them for anything. 

How Indiana got your kids' DNA

Indiana, like most other states, conducts a newborn screening test on every baby born within its borders. As required by state law, a nurse or midwife takes a few drops of blood from the heel of each newborn. (There is a limited exemption for families citing religious objections.)

The blood is collected on a special card and sent to the state's Newborn Screening Lab in downtown Indianapolis. That's where researchers quickly test the blood to look for more than 50 medical disorders that could be dangerous – and even deadly – if not detected early. Parents and physicians are notified of the results.

"It's really to prevent bad outcomes for these children so they can reach their full potential," said Bob Bowman, director of ISDH's Genomics & Newborn Screening Program. "We can prevent severe mental retardation and even death."

By nearly all accounts, the program is considered a public health success story. Each year, it identifies about 200 children who have serious metabolic, genetic or endocrine conditions. Newborn screenings help detect genetic heart defects in another 45 Indiana babies annually, and newborn hearing loss is identified in about 200 more babies, thanks to Indiana's Newborn Screening Program.

Very few parents object to the state collecting their baby's blood for the purpose of detecting health problems.

But there's another part of the program most parents were never told about. For decades, ISDH has been keeping the leftover blood samples for possible use in medical research. And the health department admits it never asked parents' permission to do that.

"No, we did nothing to notify parents," said Bowman. "That's why we are struggling right now to try to figure out what is the best and most appropriate thing to do."

Warehouse full of blood

State health officials say its collection of dried blood and DNA is currently stored in 666 bankers boxes in a large warehouse in Indianapolis. ISDH agreed to provide 13 Investigates with a photo that shows rows of boxes stacked on shelves inside the warehouse, but it would not allow WTHR to visit the warehouse or say where the warehouse is located.

"Right now we have samples dating back to 1991, so there are approximately 2.25 to 2.5 million samples currently being held," said Bowman. "We do have a lot."

Because the boxes contain blood sample cards for almost all children born in Indiana over the past 23 years, they contain the DNA of native Hoosiers who are toddlers, adolescents, teenagers – even recent college graduates.

According to Bowman, the blood samples have been detached from personal identifying information, which is maintained separately in a state computer database.

Health officials have been storing all of the leftover blood in case it is requested for medical research. ISDH has received several requests but, so far, has not agreed to release the blood samples, realizing it did not obtain proper consent to do so.

Ethical dilemma

"In medical research, you do need to get formal permission. You need to tell someone what you are planning to do. That was not happening," said Dr. Eric Meslin, director of the IU School of Medicine's Center for Bioethics. Even though the samples have not been used for research, he says collecting blood for one purpose and then warehousing it for another is not good public policy.

"I think it's very legitimate for people to be concerned and wonder ‘What happened?' I think it's a natural human reaction [to say] ‘You've got something of mine and I don't know about it?' In a situation like this, you need to ask permission," he said.

Sidney Blake, whose three young children were all born in Indiana, says the lack of consent is troubling.

"As a parent, if something is going to be done with my child's blood, I definitely would like to know that," Blake said. "I just think it's the type of of thing you should disclose up front."

Other parents say the state's failure to disclose its intentions undermines what might otherwise be an acceptable concept.

"I'm all for research, but I want to know about it," said Ervin. "I think because they didn't obtain the proper consent, I'd ask the state to destroy what they have without my permission."
   
"That is the risk," explained Meslin. "The tragedy would be people misinterpreting silence as some kind of devious plan when, in fact, it was just people forgetting to ask. To be ethically smart, legally smart, scientifically smart, you just have to ask."

New state policy

Asking is exactly what the state health department is now doing. Last year it changed its notification policy for newborn screening tests. Parents are now asked up front whether they will allow their newborn baby's blood to be used for research. And if they say no, their child's blood sample is no longer kept for decades.

"Those are stored in the lab for six months, after which time we destroy them," said lab director Barb Lesko.

But that new policy applies only to newborn screenings conducted within the past twelve months. What about all the blood samples collected before that -- the more than 2 million blood samples now stored away in boxes in a state warehouse?

"We don't have consent for those samples to do additional testing, so right now they are just sitting there, waiting for determination on what to do with them next," Lesko explained.

Both ISDH and the screening lab insist newborn blood will NOT be released for research without parental permission -- permission the state does not have.

And even if the state did have proper consent, 13 Investigates has discovered the state's massive collection of blood might be unfit for research. 

Indiana now stores its newer blood samples in locked freezers maintained at sub-zero temperatures. That helps preserve and protect the blood's DNA. But older samples have been kept for decades in a warehouse with no temperature or humidity controls. The state admits that could be a significant problem.

"At this particular point in time we don't even know how many of the older samples could be used for research," said Bowman. Asked if the state's more than 2 million stored blood samples might be useless, Bowman responded: "It's possible, yes."

So the state is holding onto millions of baby blood samples for research even though the blood might no longer be scientifically viable. And even if it is, the state doesn't have your permission to use the blood for research anyway.
    
It begs the question: Why is the blood still being kept at all?

"Again, it's something we're struggling with," Bowman replied with a deep sigh. "It is a complex issue."

You get to decide

In response to WTHR's investigation, the state health department has decided to allow you to decide what happens to your children's blood samples.

Do you want them kept for research or do you want the state to destroy them?

The choice is now yours.

"We are eager to hear what parents have to say," Bowman said. "We know there are some parents who would definitely like those samples destroyed. There are some parents who would like those samples kept. Determining how to exactly figure out which parents would want those samples kept and which ones would want them destroyed is presenting a challenge for us."

ISDH has created new consent forms that parents can now obtain online.  There are two separate forms: one that allows parents to request a blood sample be destroyed and another that gives parental consent for a blood sample to be stored and used for research. They are available now on a redesigned ISDH website.

Parents who have children born in Indiana between 1991 and 2013 are encouraged to download the forms and send them to the state.

If you would like a newborn screening notification form, you can find them here.

If you want the state health department to mail you a form, you can call or e-mail ISDH at the contact information listed below:

Genomics and Newborn Screening Program
Division of Maternal and Child Health
Indiana State Department of Health
Attn: Holly Heindselman
2N Meridian St., 2E
Indianapolis, IN 46204
Website: www.nbs.in.gov
Phone: 1.888.815.0006
Email: ISDHNBS@ISDH.IN.GOV

Consider your options carefully

Some privacy advocates argue states should have strict limits placed on the blood samples they collect from newborn babies.

"It's one thing for newborn blood samples to be tested for a specific set of newborn genetic conditions; it's entirely another for the government to grant itself the right…to use them for genetic research without parental knowledge or consent," wrote Twila Brase, president of Citizens' Council for Health Freedom, a national organization dedicated to protecting patient and privacy rights.

Her organization believes state and federal efforts to expand newborn screening programs can be a "back-door effort to bypass parental rights, collect and store newborn DNA and expand government access to the genetic code of Americans."

Those who agree may be inclined to ask the state to destroy their children's blood samples, which the state health department has stored without consent for possible research projects.

Kristine McCormick hopes parents will make a different choice: give the state permission to use your children's stored blood for future research.

McCormick lost her 5-day-old daughter, Cora, to a congenital heart defect one year before Indiana included congenital heart defect testing as part of its newborn screening program. At the time, researchers were still developing the test that may have saved Cora's life.

"I know it's scary to think that your daughter's blood is stored somewhere. But I think it's a lot scarier to attend your daughter's funeral," she said. "Research wasn't in time to save my child's life, but the research that could be done on the blood spots that are stored … who knows where this research could lead. It could save a lot of babies."

Meslin believes the state's collection of dried newborn blood could prove to be valuable for future studies on a variety of topics such as autism, and he says discarding the blood would be "a terrible waste."

"We are in the midst of a genetic revolution," the ethicist said. "We have the ability to learn more and more from little bits of blood and biopsy material. If we throw all that away, it means any scientific value is lost – lost forever. That's not in the public interest."

Lesko says regardless of a parent's decision, the state's Newborn Screening Lab will comply.

"As a parent, you want to have control over what's done with part of your child," said Lesko. "It's important for us to be as transparent as we can be, and we want parents to make the final decision."
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