A couple of weeks ago, the Texas Tribune reported on an investigation of the archiving of blood samples taken from newborn infants: "DNA Deception".
For decades, the state has screened newborns for a variety of birth defects, pricking their heels and collecting five drops of blood on a paper card. Until 2002, the cards were thrown out after a short storage period. But starting that year, the state health department began storing blood spots indefinitely, for “research into causes of selected diseases.” Four years later, DSHS began contracting with Texas A&M University’s School of Rural Public Health to warehouse the cards, which were accumulating at a rate of 800,000 a year. State health officials never notified parents of the changes; they didn’t need consent for the birth-defect screening, so they didn’t ask for it for research purposes. The agency’s rationale was that it let parents who asked opt out of the newborn blood screening and de-identified all of the samples before shipping them off (emphasis added).
So much for informed consent. "We're from the government, and we're here to help you."
The state was sued by parents last year and rapidly settled the lawsuit before pre-trial discovery. Now, it is suspected that the state was trying to avoid drawing attention to some of the uses of the blood samples -- including several hundred which were used to develop a forensics database of mtDNA variants.
E-mails indicate that in 2003, when the agency started to release blood spots for outside research, officials knew they had a parental consent issue on their hands — but tried to avoid it. When a researcher proposed a project, the director of birth defects monitoring wrote that he’d “prefer to not have to go through” the process of getting consent. Another agency official responded that parents "never consented for blood spots to be used for research. … On the other hand, I believe [the health department] already uses (deidentified?) blood spots for some research, so that might not be a big deal.”
All states now test for metabolic disorders in newborns; the tests require only a blood spot on treated paper. The National Newborn Screening and Genetics Resource Center has more information on the specific tests and a very up-to-date list by state. It is amazing to me, as someone who has had four kids in the last ten years, just how quickly these screening programs became universal.
It is therefore hard for me to believe that Texas is going to be an exception. Surely we'll discover that some other states are archiving these blood samples instead of destroying them? Checking them out to researchers for no-consent research?