State can't store samples for use in research without parental consent.
In a victory for privacy advocates, the Minnesota Supreme Court ruled Wednesday that a state health program that screens newborns for potential illnesses can't store the blood samples for additional public health research without parental consent.
The two-year-old case has pitted the genetic-privacy rights of families against science designed to advance public health and has put the state Department of Health on the defensive more than once.
Under Wednesday's ruling, the Health Department can continue to automatically screen the blood samples in order to detect medical problems and intervene.
But to the dismay of some researchers, the court concluded that the blood droplets now taken from all newborns in Minnesota are protected under the 2006 Genetic Privacy Act as "genetic information." The court rejected the department's assertion that it can store and disseminate the blood samples for additional research. For that, parental consent will now be required, the court ruled.
"The commissioner's power to conduct health studies does not include unlimited authority to use the genetic information,'' according to the decision. "Use of genetic information for purposes other than the screening of newborn children and for follow-up services requires written informed consent.''
Minnesota Health Commissioner Dr. Ed Ehlinger said his agency is studying the ruling to determine whether it endangers the program. "This important public health program protects Minnesota babies from serious congenital and heritable disorders,'' he said.
The screening covers more than 50 diseases and disorders. On average, the program tests 73,000 newborns annually and discovers about 100 confirmed disorders.
Newborn screening has been around since 1965, but exploded in the past decade with the advent of tandem mass spectrometry, which allows a simultaneous test for a large number of genetic diseases. Between 2001 and 2006, Minnesota moved from screening for five disorders to 53, and is now among just a handful of states that test for the entire slate of conditions recommended by the American College of Medical Genetics.
Pediatricians say that new babies can initially appear healthy, but suddenly get very sick from these conditions. Screening allows early intervention with drugs or special diets to ward off developmental problems or even death.
'It's like they hijack it'
Ryan Hagelstrom of Chaska, one of the people who filed the lawsuit in 2009, said the requirement for parental consent for the additional research should not detract significantly from the pool of infant blood samples. He said the extra studies have been designed to expand the universe of childhood diseases that can be detected early through screening.
"I think most people will opt in,'' he said.
He said that what bothers him about the arrangement is that most parents aren't told that the drawn blood can be stored indefinitely and used in later studies. According to documents in the case, the blood is viable for research for 20 years.
"It's like they hijack it on the back end,'' Hagelstrom said. "Who knows what the state could possibly do with this down the road?''
'Public health at its best'
The Mayo Clinic has been a partner of the state's Newborn Screening Program, and at least one official there said Wednesday's ruling has the potential to undermine public health and the well-being of Minnesota children.
"This is not some sort of dirty research,'' said Dr. Piero Rinaldo, co-director of Mayo's Biochemical Genetics Laboratory in Rochester. "This is public health at its best. What is wrong with that?''
Rinaldo said the decision is a blow to the country's best newborn screening program. He said the consent requirements could make the work more difficult, if not impossible.
"I don't have the stomach to talk about it,'' he said. "Time will tell.''
Rinaldo said reduced participation in efforts to expand the program will inevitably cost some family the kind of early intervention that could save a child's life.
The court said the screening program does not violate Minnesota's 2006 Genetic Privacy Act, passed at the behest of privacy advocates, as long as it is limited to screening for childhood diseases, reporting those test results, maintaining a registry of positive cases for the purpose of follow-up care and storing those test results as required by federal law.
The justices overruled the Minnesota Court of Appeals, which had affirmed a lower court's decision to throw out the lawsuit, and sent the case back to district court to determine whether the 28 families who brought the suit in 2009 are entitled to any remedies.
Tony Kennedy • 612-673-4213