By Twila Brase

from GeneWatch 27-1 | Jan-Apr 2014

While there is little disagreement over the value of newborn screening, what happens after the screening is causing a contentious debate nationwide.

At issue is whether state government officials are permitted to automatically keep the DNA and genetic test results of every newborn or whether parents must be asked before the child's genetic information is stored, used, and shared for analysis, research and other state government purposes.

Most parents do not know that newborn screening is genetic testing. But as Dr. Jeffrey Botkin at the University of Utah's Department of Pediatrics and Medical Ethics has said, newborn screening is the "largest single application of genetic testing in medicine."

In the past, newborn blood and test results were destroyed after the testing was done and the results were reported. But increasingly, state health departments have started storing, using and sharing the child's genetic information for research and analysis - without parental consent. Therein lies the rub.

Our efforts to protect the genetic privacy rights of all babies began in Minnesota. In 2003, we launched a proposal to repeal the requirement that state legislators determine the conditions tested for which every child is tested through newborn screening. Instead, the Department of Health proposed to give that discretion solely to the Commissioner of Health, allowing the commissioner to expand screening ad infinitum without parental consent.

After we testified that newborn screening is a government genetic testing program over which parents have no control, legislators enacted a dissent (opt-out) option for the screening. We preferred affirmative consent (opt-in), but this provides some protection as the federal government moves toward full genomic sequencing for newborn screening.

During our negotiations with the Department, we were surprised to learn that the newborn screening genetic test results and the collected bloodspots were being stored. The retention, starting in July 1986 for the test results and in July 1997 for the bloodspots, was being done without parental knowledge, parental consent or legislative authority. Legislators compromised with the Department, allowing parents to request that their child's DNA and genetic test results be destroyed - but the law did not mandate that parents be told they had that right. And most were never informed.

The opt-out provision allowed the entire storage and use program to continue outside of parental awareness. To highlight the Department's secret stash of newborn bloodspots, we dubbed the issue "Baby DNA Warehousing."

In 2007, an administrative law judge found the Department's storage, use and sharing in direct violation of the Minnesota Genetic Privacy Act of 2006. Health officials refused to budge, instead withdrawing the proposed rules. For the next three years, health officials continued to store and use newborn genetic information as the Department tried unsuccessfully to exempt newborn screening from the state's genetic privacy law. On March 11, 2009, nine parents brought together by our organization sued the State of Minnesota.

Meanwhile, our organization's efforts had attracted the attention of a Texas news reporter who subsequently discovered Texas was also storing newborn DNA. After she reported the infringement, a Texas mother filed a lawsuit on March 12, 2009.

In both cases, the courts ruled in favor of the parents. In Texas approximately 5.2 million stored blood spot cards were destroyed by court order. In Minnesota, the lawsuit went to the Minnesota Supreme Court. At every juncture, state health officials argued that the child's newborn screening results and bloodspots were not genetic information. On November 16, 2011, the Court disagreed. In January 2014, as part of the settlement agreement, approximately 1.2 million stored blood spot cards were destroyed.

Unfortunately, the Minnesota Genetic Privacy Act has a loophole. The law does not govern genetic information governed by another state law. In 2012, the newborn screening law was amended to require parent consent for storage, use and dissemination of genetic information. Thus the privacy act and its penalties no longer protect genetic information acquired through newborn screening.

In 2013, the legislature specifically exempted newborn screening from the genetic privacy law. This year, the Department has returned with legislation to repeal the parental consent requirements added in 2012. In addition, the bill makes Baby DNA storage indefinite - forever - and removes parental consent requirements for genetic research.

Despite one's genetic code being the most private of private property, newborn bloodspots have been called a "national treasure." As noted in a 2010 article published by the American Bar Association,

"Scientists realized that the NBS samples contained a wealth of genetic information on just about every baby born in the United States. States began storing the NBS samples for research and, in some cases, even sent samples to biobanks. In 2003 and 2007, the US military received 800 NBS samples from the Texas Department of State Health Services in order to 'help develop a mitochondrial DNA database for use by law enforcement.' In Michigan, millions of NBS samples in a state warehouse were used to create a 'neonatal biobank' in Detroit in the hopes of making the city a center for biomedical research. The Minnesota Department of Health also collected newborn blood samples and kept them indefinitely, sharing them not only with hospitals, but private research institutions - all without parental consent."

Oklahoma, looking at the lawsuits taking place in Texas, took definitive action to protect genetic privacy. Oklahoma Senate Bill 1250 was signed into law on May 10, 2010, prohibiting the "unauthorized storage, transferring, use, or databasing of DNA from any newborn child without express parental consent."

Texas, despite two lawsuits on the issue, still allows the newborn's DNA to be stored for two years and used for genetic research (test development) during that time. Meanwhile, Michigan stores the newborn's DNA without consent but allows parental dissent for storage and requires parental consent for research using the stored bloodspots.

Government storage and use of newborn DNA remains essentially a state secret. The public does not know. At last count, 18 states keep newborn DNA samples 10 years to indefinitely. In 2009, the federal government awarded a contract to the American College of Medical Genetics to develop a National Newborn Screening Translational Research Network to, among other things, create a physical or virtual repository of newborn DNA "stored by state newborn screening programs and other resources." Currently four states participate in a virtual repository, or as the URL notes, a "tissuelocator": California, Iowa, Michigan and New York.

In addition, PEDIATRICS reports that 18 states have not addressed the retention and use of newborn DNA. Four states claim the child's DNA as state government property. Only three states require parents to be told they can opt-out of the DNA storage and use program, and only five states actually let parents request the destruction of the stored bloodspots.

In a paper called "Not Without My Permission," Dr. Beth Tarini reported significant parental reluctance to participate in research if consent was not obtained. In fact, only 28.2 percent of parents were "very or somewhat willing" to have their child's DNA used for research without their permission. Another Michigan study found that citizens "affirmed the principle of voluntary informed participation in research."

Katherine Drabiak-Syed of the Indiana University Center for Bioethics argues that "informed consent should be required for both storage and research following the screening process, and parents should retain the right to refuse their infant's participation in the state's biobank despite the potentially great social benefit derived from the sample." She notes that retention and research are "human subjects research" but that the federal government has not classified it as such, leaving children and their parents vulnerable to various violations.

Disregarding individual rights poses a serious danger to newborns. As the ACLU notes in a May 14, 2010 letter chastising the national newborn screening committee's decision to not support consent requirements for storage and use of newborn DNA:

"As individuals increasingly feel that their babies' blood is being taken for one purpose and then used against their will and beyond their control for other unspecified purposes, there is a real risk that the public will lose trust in the newborn screening program. The program saves lives. It would truly be tragic if the expanding use of newborn blood for unconsented-to research were to result in parents declining to have their infants screened in the first instance. Public sentiment that samples are being misused, or that individuals are being misled or not given a say in their use could lead to a political backlash undermining the support upon which those very research projects ultimately depend."

Parents know instinctively that their child's DNA is not government property. They worry about how the genetic information could be used against their child. State and federal laws should recognize the individual's privacy and property rights over their own genetic information. All opt-out (dissent) provisions should be eliminated in favor of affirmative written informed parental consent requirements. Anything less threatens the public's trust and fails to acknowledge the essential rights of individuals.


Twila Brase is President and Co-founder of Citizens' Council for Health Freedom.

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