Blood Samples Raise Questions of Privacy
Some Samples Are Stored and Used For Research Without Parents' Consent

The Washington Post | June 30, 2009
By Rob Stein

Matthew Brzica and his wife hardly noticed when the hospital took a few drops of blood from each of their four newborn children for routine genetic testing. But then they discovered that the state had kept the dried blood samples ever since -- and was making them available to scientists for medical research.

"They're just taking DNA from young kids right out of the womb and putting it into a warehouse," said Brzica, of Victoria, Minn. "DNA is what makes us who we are. It's just not right."

The couple is among a group of parents challenging Minnesota's practice of storing babies' blood samples and allowing researchers to study them without their permission. The confrontation, and a similar one in Texas, has focused attention on the practice at a time when there is increasing interest in using millions of these collected "blood spots" to study diseases.

Michigan, for example, is moving millions of samples from a state warehouse in Lansing to freezers in a new "neonatal biobank" in Detroit in the hopes of helping make the economically downtrodden city a center for biomedical research. The National Institutes of Health, meanwhile, is funding a $13.5 million, five-year project aimed at creating a "virtual repository" of blood samples from around the country.

The storage and use of the blood is raising many questions, including whether states should be required to get parents' consent before keeping the samples long-term or making them available to scientists, and whether parents should be consulted about the types of studies for which they are used. The concern has prompted a federal advisory panel to begin reviewing such issues.

"There has not been a good national discussion about the use of these samples," said Jeffrey Botkin, a pediatrician and bioethicist at the University of Utah who is studying policies and attitudes about the newborn blood samples as part of a federally funded project. "Genetics is an area that touches a nerve. The public is concerned about massive databases."

Hospitals prick the heels of more than 4 million babies born each year in the United States to collect a few drops of blood under state programs requiring that all newborns be screened for dozens of genetic disorders. The programs enable doctors to save lives and prevent permanent neurological damage by diagnosing and treating the conditions early.

Although parents are usually informed about the tests and often can opt out if they object for religious and other reasons, many give it little thought in the rush and exhaustion of a birth. And parents are generally not asked for permission to store the samples or use them for research.

Each state determines what is done with the blood spots afterward. The District discards them after a year. Virginia saves them for up to 10 years but does not allow them to be used for research, officials said. Maryland has been storing blood spots since 2004 and may make its inventory of about 350,000 samples available to researchers. At least nine other states also keep the blood spots indefinitely.

"We consider them a national treasure," said Sharon Terry of the Genetic Alliance, a coalition that promotes genetics research. "We think they offer us the beginnings of a national blood bank to understand disease at an early age and follow people longitudinally over time."

The stored samples are mostly used to validate the accuracy of newborn screening and evaluate new tests. But scientists are also using them for other types of research, including to study specific genetic disorders, explore the frequency and causes of birth defects, decipher how genes and environmental factors interact, and probe whether exposure to chemical pollutants early in development plays a role in cancer and other diseases.

Research projects are only approved, officials in Maryland and other states said, after undergoing careful scientific and ethical review. In most cases, all identifying information is stripped from the samples.

"I've never heard anyone complain that their privacy was violated or their dried blood was used for something that negatively impacted them," said Michael S. Watson of the American College of Medical Genetics, which has the NIH contract to create an electronic database of newborn blood samples from across the country.

But the states can still link each sample to an individual child -- and that worries some parents, patient groups, bioethicists and privacy advocates, especially with advances in genetics and electronic data banks linking medical information from different sources.

"It's fine and good to say these can't be identified, but how real is that?" said Hank Greely, a Stanford University bioethicist. "Just because you don't have a name or Social Security number doesn't mean you can't identify it. Once we start using DNA for more and more things like regular medical records, somebody could do a cross-check and say whose blood it is."

As scientists continue to discover new genetic markers, many wonder what such databases might reveal.

"I'm not a big scaremonger about the dangers of DNA medicine," Greely said. "But you could use someone's DNA to make some inferences about their future health, about their future behavior, and if you got samples from their parents or a DNA databank, you can make inferences about family relationships."

Because of those and other concerns, parents and privacy activists in Minnesota are asking that more than 800,000 blood spots that have been stored without parents' approval since 1997 be destroyed.

"Once learning the genetics of one child, you could see an insurance company seeing that possibility for the next child and making it clear that this is a preexisting condition that the company would not cover. Or perhaps an employer that found out about it wouldn't want to have us as an employee," said Twila Brase of the Citizens' Council on Health Care in St. Paul.

Guaranteeing Privacy

The Minnesota case prompted a similar parents' lawsuit in March against Texas, which since 2002 has stored an estimated 4 million samples. The litigation spurred the Texas legislature to require the state health department to start getting parents' permission to store the samples and honor requests that samples be destroyed. But the lawsuit is still pending over what should be done with the samples already on file.

"I don't want to sound paranoid, but I'm not comfortable with a governmental agency having this information, with potentially the ability to share it with sister governmental agencies, such as criminal agencies," said Maryann Overath, an Austin lawyer with two sons who sued the state.

Law enforcement agencies have been cataloguing millions of DNA fingerprints in recent years, raising similar concerns.

State officials argue that strict safeguards protect the privacy of information associated with the newborn blood samples and say details about a child's medical history are provided to researchers only if parents are contacted individually for approval.

"Privacy is very important, and we protect it every way we can," said David Orren, the Minnesota health department's chief legal counsel.

In Michigan, officials plan to start asking new parents for permission to include their children's samples in the stockpile. But officials decided it would be impractical to try to contact the parents of all 3.5 million children whose samples are already on file. Instead, they are publicizing the biobank to allow parents to object if they don't want their children's samples included.

But even if the question of consent is resolved, other issues remain.

"There might be some research that offends moral sensibilities of citizens, such as research into prenatal screening for some genetic condition that might lead some parents to make a decision to selectively abort affected fetuses," said Tom Tomlinson, a bioethicist at Michigan State University.

Concerned that the debate might undermine the newborn screening programs, the federal Advisory Committee on Heritable Disorders in Newborns and Children will discuss the issue in September.

"There are obviously legal and ethical issues that need further discussion," said R. Rodney Howell, who chairs the committee. "Unfortunately we live in a world of conspiracy theories. We want to inform people that these spots are retained in some states and that they are carefully guarded. We want to be totally transparent."