INDIANAPOLIS — The state of Indiana has been storing blood samples taken from newborns for health screenings for more than two decades to save for possible use in medical research without the consent of their parents, an Indiana Department of Health Department official says.
Bob Bowman, director of the department's Genomics & Newborn Screening Program, told WTHR-TV (http://bit.ly/1jpx3uo ) that the state collected blood samples of more than 2.25 million children born in Indiana since 1991 without telling the parents until it began asking permission in June 2013.
"That's why we are struggling right now to try to figure out what is the best and most appropriate thing to do," he said.
Parents say they don't understand why they weren't informed or asked permission. Sidney Blake, whose three young children were born in Indiana, said he is troubled by the practice.
"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 thing you should disclose up front."
Indiana, like most other states, conducts newborn screening tests on every baby born in the state. A few blood droplets are taken from each newborn's heel and collected on cards that are sent to a laboratory to be tested for more than 40 medical disorders that could be dangerous or deadly if not detected early. Parents and physicians are then notified.
"It's really to prevent bad outcomes for these children so they can reach their full potential," Bowman said.
But the health department didn't inform parents that the samples were being retained for possible use in medical research in a large warehouse in Indianapolis.
Dr. Eric Meslin, director of Indiana University School of Medicine's Center for Bioethics, said the state should have sought the permission.
"In medical research, you do need to get formal permission. You need to tell someone what you are planning to do," he said.
He said even though the samples have not been used for research, collecting blood for one purpose and warehousing it for another is not good public policy.
"I think it's very legitimate for people to be concerned and wonder 'What happened?'" he said.
Health Department spokesman Ken Severson told The Associated Press Indiana that law requires the agency to develop a system for using the dried blood spot cards for epidemiological survey and research purposes, but in a manner that does not identify the individual to whom the specimen belongs.
Indiana changed its policy last year and began asking parents whether they would allow their newborn baby's blood to be used for research. If they say no, the samples are destroyed after six months, lab director Barb Lesko said.
The state Health Department and the screening lab say the stored samples will not be released for research without permission. Bowman said he's not even sure the samples could be used for research because they have been kept in a warehouse with no temperature or humidity controls.
Bowman said he doesn't know why the state is continuing to keep the samples.
"Again, it's something we're struggling with," Bowman said. "It is a complex issue."
Meslin believes the state's dried blood could prove valuable for future studies.
"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," he said.
The health department has posted forms on its Web site at http://www.in.gov/isdh/20215.htm allowing parents to request their child's sample be destroyed or saved for medical research.
Information from: WTHR-TV, http://www.wthr.com/