A Texas court case settlement is a victory for genetic privacy but also highlights the need for states to start obtaining informed consent of the parents when dealing with DNA of newborns, according to a Minnesota organization that has fought state administrators there over the issue.
“The state of Texas has taken first steps to restoring the genetic privacy rights of Texas children,” said Twila Brase, chief of Citizens Council on Health Care. “This is a wonderful Christmas present for Texas citizens.”
She cited reports from the San Antonio Express News that under a federal lawsuit settlement, state officials agreed to destroy an estimated 5.3 million blood samples collected from newborns that were kept on file by the state without parental permission.
The case was addressed by Jim Harrington of the Texas Civil Rights Project, which found state officials had been keeping the samples without permission.
“This is about consent,” Harrington told the newspaper.
The blood samples had been on file as blood spots on cards.
Andrea Beleno, mother of one of the plaintiffs, said her goal was to “make sure that our children’s privacy was being protected and that the state is respecting our rights.”
But Nancy Dickey, president of the Texas A&M Health Science Center, lamented the “loss” of the private information.
“We are saddened … that a superb database has been lost,” she told the San Antonio newspaper.
“The Texas Department of Health should never have stored or analyzed the DNA and unique genetic codes of its newborn citizens,” said Brase. “It is only right that they destroy the genetic information that they have stored and given to researchers without legal authority or the consent of parents.”
She said state legislatures in all 50 states need to require their health departments to get written fully informed consent from parents prior to any collection, storage or use of newborn DNA.
Brase long has battled over the privacy of newborn DNA in her state. In the latest step in one of the disputes, a judge ruled the state can take and keep the genetic codes.
The decision from Hennepin County District Judge Marilyn Rosenbaum dismissed a case brought by members of nine families who alleged the state was going beyond what it was authorized to do.
Although not part of the lawsuit, Brase has been monitoring the dispute since its beginning, battling the state Department of Health, which reportedly has been taking and warehousing newborns’ genetic makeup for years but not following “written consent requirements.”
The group has cited a number of cases in which the state’s genetic-privacy act law apparently was ignored, or there was an attempt to ignore it.
For example, one grandmother reported:
“My daughter signed a paper stating she did not want
the PKU test done because of the DNA stealing (I was there when she
did that). The nurse huffed out of the room saying that stuff doesn’t
happen. After my grandchild was born, a different nurse took the
baby. My daughter heard my granddaughter start crying. She found out
her heel was getting pricked. My daughter became furious stating
that she signed off on not getting the test. The nurse said there was
nothing in her chart saying that. My daughter demanded the blood
sample back. The nurse said they’d destroy it, but my daughter
demanded it back and got it.”
Brase has warned the collection and assembly of DNA on an entire generation of citizens largely is unnoticed, but such newborn screening “represents the largest single application of genetic testing in medicine.” She’s issued an extensive report on the problem.
“Suppose … expanded screening of an infant reveals not a fatal and incurable disease but instead a host of genetic variants, each of which merely confers elevated risk for some condition or other,” her report said. “Who is to say at what point an uncovered defect becomes serious enough to warrant preventing the birth of other children who might carry it? At what point have we crossed the line from legitimate family planning to capricious and morally dubious eugenics?”
In this case, Brase said, the judge presented only “extremely weak” arguments.
“There is no law on the books in Minnesota to support the health department’s current practice of indefinite storage, use and sharing of newborn DNA for research without parent consent. The law that is on the books, the Minnesota genetic-privacy law, forbids it,” she said.
“We understand that the order will be appealed. The appeal is essential for the protection of individual genetic privacy, DNA property rights, human subject rights, and parent and individual consent rights. We look forward to the appeal,” she said.
Brase explained the state’s 2006 genetic-privacy law requires informed and written consent for the collection, storage, use and dissemination of genetic information contained in the blood spots taken routinely from newborns.
But the judge found “the blood samples taken pursuant to the (newborn screening) program are biological samples, not genetic information as defined.”
However, Brase told WND the program to which the judge referred has an opt-out provision for parents, but they often are not told.
The privacy law specifically requires written informed consent for the collection, stating, “Unless otherwise expressly provided by law, genetic information about an individual: (1) may be collected by a government entity … only with the written informed consent of the individual; (2) may be used only for purposes to which the individual has given written informed consent; (3) may be stored only for a period of time to which the individual has given written informed consent; and (4) may be disseminated only: (i) with the individual’s written informed consent.”
But the judge dismissed as irrelevant the opinion of an administrative law judge who ruled in 2007 the Minnesota Department of Health was violating the state genetic-privacy law by storing and conducting genetic research on newborn blood which has been collected solely for the purpose of newborn genetic testing.
Brase said most states do not require parental consent for newborn genetic testing or for the government to keep the genetic results. Most states now keep DNA results for a period of time – some indefinitely.
Further, her report said most parents “have no idea that government is doing the testing or retaining the data and DNA.”
“It is not hard to imagine the day when any discovered but nonsymptomatic condition could
become a ‘pre-existing condition’ for which private insurers would not pay. The eugenic
implications are obvious. Thus, the growing collection of genetic test results and newborn DNA
could easily enable a eugenics agenda on the part of government agencies and private industry,” the report said.