The White House Cancer Moonshot and Precision Medicine Initiative both rely on DNA samples to conduct and promote research. This may be why, in a final act under the Obama administration, the Department of Health and Human Services issued a ruling last week to relax the requirements for researchers to acquire patient permission before using a person’s DNA samples.
The Federal Policy for the Protection of Human Subject — more frequently referred to as the Common Rule — no longer requires written consent from patients to conduct research using their DNA.
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“You have no control over how your DNA is being used for other people’s purposes,” said privacy advocate Twila Brase, who is also the president and co-founder of the Citizens’ Council for Health Freedom in St. Paul, Minnesota. “You will have no part if they make a significant profit because they have access to your DNA without your consent. It really says your DNA is public property as opposed to private property.”
“You have no control over how your DNA is being used for other people’s purposes.”
This ruling especially leaves the most vulnerable members of society out in the cold.
Blood Drawn from Newborns
Most states have a mandatory newborn infant blood screening process that includes an ever-increasing list of serious disorders, such as cystic fibrosis, adrenal hyperplasia, and propionic acidemia. Usually parents have no idea their children are being screened for these disorders — unless the tests come back positive.
Too often the tests come back as false positives, however. For every 10 children who test positive for cystic fibrosis, only one child will actually end up having the disease. For every child who actually has adrenal hyperplasia, there will be between 100 and 200 false positives. And if researchers find a genetic trait that isn’t included in the traditional screening, they could put it on the child’s permanent medical record without ever notifying parents, Brase said. Those records are “increasingly accessible through these new health information exchanges.”
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“There’s a collateral damage of newborn screening,” she explained. “The more conditions they test for in the newborn screening, the higher the chance for false positives.” The emotional trauma for these parents when they believe their child’s life is at risk cannot be measured adequately — and it’s a cost that came without their consent.
DNA Gets Filed Away
Many states collect multiple biospecimens to perform these newborn screenings — and they can hold onto these “blood spot cards” for years on end. California, Maine, Minnesota, and North Dakota, for instance, all store infant DNA specimens “indefinitely.” Other states such as Rhode Island, Washington, New York, and Massachusetts hold onto specimens for more than 20 years.
Even if you don’t mind that your child’s cells could be used to further cancer research and precision medicine, that’s not necessarily the only use they will ever fill.
“There are all sorts of bad and objectionable research that has been done — research, for instance, on a crime gene [or] a gay gene. Once the government holds your DNA, then the next legislature can decide to use it for something different,” Brase said. “There have been police departments and national security departments that have looked at using the newborn screening blood spots as a way to create a national DNA registry.”
Currently, police must have a warrant to collect your DNA — “yet the health departments are taking it all the time.”
The most famous example of privacy violation is that of Henrietta Lacks, a woman whose cervical cancer cells were duplicated, sold, and researched without her or her family’s consent. Her cells helped with the development of the polio vaccine. Researchers used them in the first gene-mapping experiments and shot them into space to see how cells would respond to zero gravity. Yet her children grew up in poverty and never saw a dime in profits from the prolific medical inventions that came as a result of her specimens.
Parents can request their child’s blood spot cards from the state, but most parents don’t even realize that their child’s DNA is in a government storage facility in the first place.
Only after losing significant lawsuits did the Texas state government incinerate the blood spot cards of millions of infants. Before that, the state had been leveraging the newborn cards for lab equipment.
“It’s sort of like if the government takes your bike, and you have to figure out how to get it back,” added Brase. “Nobody would let the government do that with their bike.”
But this isn’t just a bike in question. This is the full genetic code — the most personal data out there.