This is part of the discussion I always use when explaining the pros and cons of the new born screening test. It is very interesting that nobody within the system sees this as a problem for us. See my previous post on new born screening.
(CNN) — When Annie Brown’s daughter, Isabel, was a month old, her pediatrician asked Brown and her husband to sit down because he had some bad news to tell them: Isabel carried a gene that put her at risk for cystic fibrosis.
While grateful to have the information — Isabel received further testing and she doesn’t have the disease — the Mankato, Minnesota, couple wondered how the doctor knew about Isabel’s genes in the first place. After all, they’d never consented to genetic testing.
It’s simple, the pediatrician answered: Newborn babies in the United States are routinely screened for a panel of genetic diseases. Since the testing is mandated by the government, it’s often done without the parents’ consent, according to Brad Therrell, director of the National Newborn Screening & Genetics Resource Center.
In many states, such as Florida, where Isabel was born, babies’ DNA is stored indefinitely, according to the resource center.
Many parents don’t realize their baby’s DNA is being stored in a government lab, but sometimes when they find out, as the Browns did, they take action. Parents in Texas, and Minnesota have filed lawsuits, and these parents’ concerns are sparking a new debate about whether it’s appropriate for a baby’s genetic blueprint to be in the government’s possession.
“We were appalled when we found out,” says Brown, who’s a registered nurse. “Why do they need to store my baby’s DNA indefinitely? Something on there could affect her ability to get a job later on, or get health insurance.”
According to the state of Minnesota’s Web site, samples are kept so that tests can be repeated, if necessary, and in case the DNA is ever need to help parents identify a missing or deceased child. The samples are also used for medical research.
Video: Government has your baby’s DNAArt Caplan, a bioethicist at the University of Pennsylvania, says he understands why states don’t first ask permission to screen babies for genetic diseases. “It’s paternalistic, but the state has an overriding interest in protecting these babies,” he says.
However, he added that storage of DNA for long periods of time is a different matter.
“I don’t see any reason to do that kind of storage,” Caplan says. “If it’s anonymous, then I don’t care. I don’t have an issue with that. But if you keep names attached to those samples, that makes me nervous.”
DNA given to outside researchers
Genetic testing for newborns started in the 1960s with testing for diseases and conditions that, if undetected, could kill a child or cause severe problems, such as mental retardation. Since then, the screening has helped save countless newborns.
Over the years, many other tests were added to the list. Now, states mandate that newborns be tested for anywhere between 28 and 54 different conditions, and the DNA samples are stored in state labs for anywhere from three months to indefinitely, depending on the state. (To find out how long your baby’s DNA is stored, see this state-by-state list.)
Brad Therrell, who runs the federally funded genetic resource consortium, says parents don’t need to worry about the privacy of their babies’ DNA.
“The states have in place very rigid controls on those specimens,” Therrell says. “If my children’s DNA were in one of these state labs, I wouldn’t be worried a bit.”
The specimens don’t always stay in the state labs. They’re often given to outside researchers — sometimes with the baby’s name attached.
According to a study done by the state of Minnesota, more than 20 scientific papers have been published in the United States since 2000 using newborn blood samples.
The researchers do not have to have parental consent to obtain samples as long as the baby’s name is not attached, according to Amy Gaviglio, one of the authors of the Minnesota report. However, she says it’s her understanding that if a researcher wants a sample with a baby’s name attached, consent first must be obtained from the parents.
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Scientists have heralded this enormous collection of DNA samples as a “gold mine” for doing research, according to Gaviglio.
“This sample population would be virtually impossible to get otherwise,” says Gaviglio, a genetic counselor for the Minnesota Department of Health. “Researchers go through a very stringent process to obtain the samples. States certainly don’t provide samples to just anyone.”
Brown says that even with these assurances, she still worries whether someone could gain access to her baby’s DNA sample with Isabel’s name attached.
“I know the government says my baby’s data will be kept private, but I’m not so sure. I feel like my trust has been taken,” she says.
Parents don’t give consent to screening
Brown says she first lost trust when she learned that Isabel had received genetic testing in the first place without consent from her or her husband.
“I don’t have a problem with the testing, but I wish they’d asked us first,” she says.
Since health insurance paid for Isabel’s genetic screening, her positive test for a cystic fibrosis gene is now on the record with her insurance company, and the Browns are concerned this could hurt her in the future.
“It’s really a black mark against her, and there’s nothing we can do to get it off there,” Brown says. “And let’s say in the future they can test for a gene for schizophrenia or manic-depression and your baby tests positive — that would be on there, too.”
Brown says if the hospital had first asked her permission to test Isabel, now 10 months old, she might have chosen to pay for it out of pocket so the results wouldn’t be known to the insurance company.
Caplan says taking DNA samples without asking permission and then storing them “veers from the norm.”
“In the military, for instance, they take and store DNA samples, but they tell you they’re doing it, and you can choose not to join if you don’t like it,” he says.
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Thanks for this (and the previous article on PKU tests), Lisa. I'm going to copy them and give them out to clients making this choice, too.
I rarely have clients who refuse the test and I feel the same way as you do about submitting a blank card to report them.
Gloria in Canada
Thanks for this blog Lisa.
Whenever I present the info to parents about the NST and the storage off site (at a 'secure' location) of their baby's identified DNA for 25 years……………it generates discussion between parents.
Some seek further info.
Isn't this what us having information is all about ?
Sharing it and then the parents making an informed choice….. the outcome of which parents must take responsibility for.
Like you, I don't have definite opinion either way, I am not emotionally invested in the testing.
I just present the data.
The information re storage of data & access to it is clearly stated in the Genetic Health Services Vic handout which all parents are given when booking in to hospital ( & I would hope IPs provide women with it also).
It's entitled 'Newborn Screening Program for your Baby'.
I'd hope that parents choose to read the information BEFORE consenting to the test !
Brenda M
Hi Lisa.
I have just discovered your blog and think it may become my main source of inspiration! I am in the process of setting up as an independent midwife back in England, after completing my training in Swansea. Just wanted to say keep up the good work.
Ash.
Hi All
I am not a midwife, but I work in the area of Newborn Screening. Screening is definitely in the best interests of the child – the other 'stuff' is secondary and really needs to be presented that way. This is where things have come unstuck. Midwives haven't been given enough information and therefore, parents haven't either. In most places, the storage of cards is required by law, but there are options for parents to request their card back. Parents also have the right to prohibit the card being used for research if they so choose. The storage and use of cards really should not prevent parents from having their child screened. As with most things, it all comes down to education and receiving quality information.
I think I accidently deleted this.
Hi All
I am not a midwife, but I work in the area of Newborn Screening. Screening is definitely in the best interests of the child – the other 'stuff' is secondary and really needs to be presented that way. This is where things have come unstuck. Midwives haven't been given enough information and therefore, parents haven't either. In most places, the storage of cards is required by law, but there are options for parents to request their card back. Parents also have the right to prohibit the card being used for research if they so choose. The storage and use of cards really should not prevent parents from having their child screened. As with most things, it all comes down to education and receiving quality information.
Sorry about that anonymous, thank you for your comment.
You are right education and quality information is important. Trouble with government agencies is that it is only educational and quality if it gains complience to what they want. Hasn't it occured to you that what you say may not make a woman want this test?
Whether or not it is the law to keep the cards, the truth is, they are used for research purposes and even if returned the data is stored before hand.
I find it amusing that it is always assumed that midwives haven't received the correct information and neither has the woman. Google it, there is plenty of supportive information out there. There again women and midwives must be just thick.
Hi Lisa
I accept your comment about Govt agencies and the educational material they produce. I also fully accept that by telling parents about the storage and the access issues, they may choose to opt out of screening. But if they are informed of their options, they shouldn't have any reason to opt out – apart from a pure desire not to participate in screening, which they are entitled to do (in Australia anyway). They are entitled to say no to research and they can get their card back.
In my state, a tiny number of cards (1%) are used for research and this is done with parental consent. I acknowledge this is not the case in all states and countries. Once the card is returned to parents, there is no blood left in the lab with which to do research. The results data are stored – again by law, as with breastscreen, bowelscreen, papscreen…the electoral role…the Govt has all this data, it's no different.
With regard to 'assuming' midwives haven't received the correct information, the work I have been doing has been based on research and personal statements from midwives who state they ARE lacking appropriate information – no assumptions made. I'm sure midwives vary across the board in their knowledge levels – as does every professional. I in no way meant to infer that women and midwives were 'thick'. If you want to lay blame for lack of or mis-information, it should go towards the Govt as the funding agent for this program.
I work with midwives on a daily basis and I think they are fantastic. They are overworked and underpaid, but they love their jobs.
It's funny actually, the concern that is raised around card storage and access. In the next 5 years technology will provide us with the ability to genetically profile every baby at birth, for treatable and non treatable conditions. I think this stuff is more worthy of concern and debate than anonymous population based research using old bloodspots.
genetically profiling every baby at birth To me sounds horrendous. But now the population is socialised to having a baby's blood taken after birth, it will slide in unnoticed. it could become manditory and most people wouldn't see the big picture. Just like yourself they believe that if you were really informed then you wouldn't decline.
There are others like me out there, I have issues with storing any information of this sort
Your comment says you understand they may opt out but if they are informed they have no reason to.
THIS is a big problem to me. You really believe that if you give the information your way nobody would say no.
I'm interested in the state you are in so that I can follow up the parental consent. I understand that if there is no ethics panel involved there is no need for parental consent.
The midwives lacking information are those midwives at the hospital who do this screening without even knowing why let alone any ethical considerations.
I just ran across this, and the discussion between anonymous and Lisa. I am a mom of 4 homebirthed babies, at least two of which have not been screened. I believe there is a very much ignored point about a mother’s intuition here. I knew that my two babies who we deliberately chose not to screen were fine. I knew in my heart it was not necessary to poke and bleed them. I also knew the others were fine too, but didn’t feel a need to “avoid” the test. I believe there is a reason we are given “intuition” and it is important to listen to it. So, while some people would choose to go along with the test, given the right information, many of us don’t, even with lots of the “right” information, because our intuition leads us well.