Newborns' Blood Samples Are Used for Research Without Parents' Consent

By Rob Stein
Washington Post Staff Writer
Tuesday, June 30, 2009

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.

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