AUSTIN (KXAN) – When Andrea Beleno was expecting her first child, she never dreamed his blood would become the focus of a federal lawsuit.
Neither did the other families who are suing the State of Texas to protect the medical privacy of their children.
Each year, more than 400,000 babies are born in Texas. State law mandates that before newborns leave the hospital, his or her heel will be pricked and five drops of blood are collected.
Two weeks later, their pediatrician collects another five drops of blood. The blood cards are submitted to the Texas Department of State Health Services as part of the Newborn Screening program. One or two drops are used to screen for a list of serious medical conditions.
The parents are not objecting to the screening. They object to what the state is doing with the leftover blood samples.
Beginning in 2002, the State began saving the leftover specimens, unbeknownst to parents and without their consent.
“It made me really mad that nobody asked me if they could keep my sons DNA,” said Andrea Beleno.
Her son’s DNA was among millions of banked samples stored at Texas A&M Health Science Center School of Rural Public Health.
“It makes me suspicious and I think there’s really no reason for the state to have a database of the blood of and the DNA of every single person who has been born here,” said Beleno. “There’s no legitimate reason for that.”
The state said there is a legitimate reason: Research.
According to court documents, the state admits some of the blood samples collected for the newborn screening program were used for other purposes, but said it was done in accordance with federal and state law.
“The government still has to ask,” said Boleno. “They can’t just take it. And everyone has the right to make that decision for themselves.”
Jim Harrington, an attorney for the Texas Civil Rights Project, who is representing Beleno and the other families in the federal lawsuit, said it violates the Fourth and 14th Amendments of the U. S. Constitution.
”It’s a bad thing,” said Harrington. “You have to consent to give up the right. And in this case it’s your right of privacy and your kid’s right of privacy.”
The lawsuit prompted change in the Texas Legislature. House Bill 1672 allows the State to keep and use the samples for research, but requires parents be informed and given the option of having their children’s leftover blood samples destroyed after screening. The state has 60 days to destroy the blood cards after receiving the official notification form from parents.
The form directs the state to destroy the card containing the dried blood spots, but does not insure any information gathered from the generic material is deleted.
According to the Use and Storage of Newborn Screening Bloodspot Cards information provided to parents, identifying information linking a child to a particular bloodspot is not allowed outside of the Department of State Health Services without advance consent of the child’s parent or guardian unless otherwise provided by law.
Patient privacy expert Dr. Deborah Peel said those words, “unless otherwise provided by law” create a huge loophole.
“It’s not secret, it means they can share it and use it for research for public health,” said Peel. “There are many laws that allows the use of samples, like newborn blood samples for public health uses and screening and so forth. So, no, you are not protected. That allows all kinds of people to see it.”
House Bill 1672 allows the stored samples to be used in research if approved by what is called an Institutional Review Board. IRB’s are supposed to safeguard privacy and protect patients, but are not open to the public.
The IRB board appointed to oversee research on the stored bloodspots consists almost entirely of State employees. Harrington says that makes the process questionable.
“This is not a true independent professional review board,” he said.
Perhaps most concerning, is the confidentiality clauses added to the new law that were designed to protect the identity of the newborns. The law states that reports, records and information obtained or developed by the department are confidential and are exempt from the Texas Public Information Act, and are not subject to subpoena.
In addition, anyone involved in the program, including state employees or employees of a contractor or subcontract can be compelled to testify in any kind of judicial proceeding as to the existence or contents of any records, reports or information.
The law does not allow for public disclosure of information such as who is involved and what kind of research is being conducted using the stored blood samples.
Jim Harrington said that is a problem.
“The reason we brought the suit was because of their secret, surreptitious conduct and then they turn around and are doing the exact same thing again,” said Harrington. “And every time, of course, the government is not open and clear and transparent, it raises flags all over the place about what’s really oing on and what are they really up to?”
The issue of retaining newborn screening samples is not unique to Texas. Other states are dealing with the same issues. Balancing privacy issues with what is in the best interest of the public is a fine line. The federal government has invested millions in regional and national newborn screening collaborations.
National DNA Database
In 2006 and 2007, then, Senator Obama, filed legislation that would create a national DNA database. The same bill was filed by Sen. Patrick Kennedy in 2008 . The bills required parental consent, but all three died in the Senate.
Study finds support by some parents
Not everyone is opposed to collecting, storing and using DNA from the newborn screening program for later use. A study by the University of Michigan found that when asked for consent, only 24 percent of parents objected to using their newborns blood samples for research. That number jumped to 72 percent of parents who were somewhat or very unwilling when asked if the samples could be used without permission.
Andrea Beleno said she may have consented, if asked. But after seeing how the State of Texas has handled the issue, her mind is made up.
“For me and my family,” said Beleno, “No, you can’t have our DNA.”
So far, more than 8,200 other families have made that same decision to opt out of allowing the state to use their child’s genetic material.