Parents Outraged at Warehousing of DNA Saved from Newborn Baby Screening Programs and Used for Clinical Laboratory Testing
After Laboratory Tests are Conducted, Newborn Screening Cards are Saved for Research
For decades, pathologists and clinical laboratory scientists have been part of a seemingly innocuous public health practice begun in the 1960s: newborn blood testing. Now, because of recent advances in genetic tests and molecular diagnostics, growing numbers of parents are concerned about how the government handles the DNA of their newborn babies.
Laboratories and clinical data warehouse facilities across the nation are in possession of millions of cards, each which carries spots of heel-prick blood taken from a newborn baby. These cards contain the samples used to perform laboratory tests required by law to screen newborn infants for a number of devastating genetic diseases. This screening identifies about 5,000 babies each year that require early treatment appropriate to their condition to minimize or prevent damage or even death.
The controversy surrounds what happens next to these specimen cards. Beginning around 2000, many states began storing the test cards instead of discarding them. These cards are sometimes offered as samples for use in medical research, often in pediatrics. Scientists consider these saved DNA samples to be an invaluable resource.
The practice of storing the cards was legitimized in a law called The Newborn Screening Saves Lives Act of 2007 (signed by President Bush in 2008). The bill allows the government to maintain a central clearinghouse of current information on newborn screening, establishes a set of required genetic tests and a surveillance system for tracking the health outcomes of individuals diagnosed at birth with a genetic defect, and allows the government to use the DNA contained on the cards in genetic research. The controversy lies in the fact that the law does not require healthcare providers to get parental consent for their newborn babies’ DNA to be used for these purposes.
This has caused outrage among some parents, who are concerned about the unknown consequences of having their babies’ DNA stored and available for research. Several groups of parents filed lawsuits in federal court to prevent use of their babies’ DNA without parental consent. A suit filed last year by five Texas families was settled in December, when the state agreed to destroy all samples taken before May 27, 2009. That date was chosen because the Texas legislature passed a law, effective on that date, allowing the state to keep the DNA samples for research unless the parents specifically object.
This unfolding controversy pits the right of families to keep their DNA information private against society’s need for access to data to help advance medical science. It provides pathologists and clinical laboratory professionals with insights about how consumers want control over their DNA.
In a further twist to the controversy in Texas, it came to light in February of this year that Texas was not only keeping the DNA data for research, but it also supplied 800 DNA samples to the U.S. military in 2003 and 2007 to help develop a mitochondrial DNA database for use by law enforcement. The Texas Department of State Health Services did not disclose this use during the recent federal suit. Discovery of this act created new outrage among those parents who object to having their baby’s DNA stored without their consent.
State health officials in Texas say the database is supposed to help identify missing persons. A second suit, asking for these samples to either be destroyed or parental consent be obtained, could come later this year.
In light of the Texas suit, other states are re-examining their handling of newborn tests. It is likely that more laws requiring parental consent and/or parental education about the practice of storing the newborn blood spot cards will be enacted. A study by bioethicist Aaron J. Goldenberg , Ph.D., M.P.H. , of Case Western Reserve University found that about 75% of parents would be willing to consent to their baby’s DNA being used for research, as long as they were asked in advance. Most parents, however, oppose research use without consent.
For clinical pathology laboratories, this heightened consumer sensitivity about the storage of DNA and its use in research is a reminder that it would be timely to review existing administrative protocols to obtain informed patient consent and to track retention of specimens used for DNA research and other purposes.
In the public health community, officials are concerned that parents wary of these DNA warehousing programs may look for ways to avoid having their newborn baby tested. In such cases, this would remove an important safety net for those newborns who have genetic conditions that, if diagnosed and treated early, live a better quality of life because of this clinical care. -K. Branz