The U.S. Senate is preparing to vote on a bill that has a promising name but a frightening reality. The “Newborn Screening Saves Lives Reauthorization Act of 2014” (H.R. 1281) passed the House in late June and, if approved by the Senate and signed into law, would provide $99.5 million to state newborn screening programs and research initiatives.
A little-known danger of the bill is that it does not include parental consent requirements for state storage, use, analysis and sharing of newborn DNA and newborn genetic test results.
Most states conduct newborn screening on every newborn. Within 48 hours after birth, a few drops of blood from the baby’s heel are squeezed onto a special card, sent to a state lab and tested for up to 50 genetic disorders. While parents support newborn screening, most parents do not know it’s a state government program or that some states store and use the newborn’s blood spots (DNA) and test results without parental consent for purposes beyond newborn screening.
According to our research, nine states currently store all or some newborn DNA indefinitely; eight additional states store it for more than 20 years, and four states (California, Iowa, Massachusetts and Michigan) make newborn DNA available to researchers through a ‘virtual repository’ set up by the federal government, but only Michigan requires parental consent for research. Additionally, four states (California, Maine, Utah and Washington) claim newborn DNA as state government property.
Yet, studies show most parents do not support genetic research using newborn DNA without parental consent (See “Not Without My Permission,” – Beth A. Tarini, MD).
The federal government has acknowledged that DNA is identifiable and cannot be de-identified, stating, “none of these [research] statutes was written with an eye toward the advances that have come in genetic and information technologies that make complete de-identification of biospecimens impossible and re-identification of sensitive health data easier.” (Notice of Advance Rulemaking, Human Subjects Research Protections, Federal Register, July 26, 2011).
As the American Academy of Pediatrics reports, the storage and use of newborn DNA has generated much controversy, “primarily because of public concerns over the lack of parental knowledge and consent for these activities.” Further, “there is currently little guidance to aid new state policy development to address the concerns of program professionals, investigators, and the general public.” (“Retention and Research Use of Residual Newborn Screening Bloodspots,” Pediatrics, Dec. 23, 2012).
The ACLU also warns, “Proceeding with [research by states and third parties] is not only improper, but also risks undermining the public trust and goodwill upon which newborn screening programs depend.” (Letter to SACHDNC, May 14, 2010).
Despite these serious concerns, the bill now before the Senate expands and encourages research using newborn DNA and genetic test results without parental consent requirements. H.R. 1281 adds new federal responsibilities to the current Hunter Kelly Newborn Screening Research Program, which are possible only by using newborn DNA collected by state agencies.
Specifically, the bill authorizes the Secretary of HHS to conduct “pilot studies on conditions recommended by the Advisory Committee on Heritable Disorders in Newborns and Children to ensure that screenings are ready for nationwide implementation.”
The National Institutes of Health (NIH) is already moving toward decoding the entire genetic blueprint of a child at birth. In September 2013, the agency awarded $25 million to four institutions to develop a whole-genome sequencing program for newborn screening. Couple this with state storage, use and sharing of newborn DNA — without parental knowledge or consent — and soon we arrive at a future in which government agencies own, dissect and will be empowered to use and manipulate the unique, identifiable genetic code of every child in America.
Given the fact that many states are already violating the genetic privacy and DNA property rights of newborn citizens — with the funding and encouragement of the federal government — Congress should use this opportunity to require any state agency or entity receiving federal dollars for newborn screening to obtain informed written parental consent for genomic sequencing and for the storage, use, analysis and sharing of their child’s DNA and genetic information.
Anything less is a violation of the child’s Fourth Amendment rights and the right of individuals to control who, if anyone, knows the genetic secrets housed in their DNA.