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米国のミネソタ州では同意を得ないで保管しいていた検査済みろ紙血を破棄

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2012年02月06日(Mon) 19:53 by drharasho

米国のミネソタ州では同意を得ないで保管しいていた検査済みろ紙血を破棄

Minnesota starts to destroy stored blood spots
http://www.nature.com/news/minnesota-starts-to-destroy-stored-blood-spots-1.9971

Court ruling that the state must get consent to store samples from newborn
screening could hinder biomedical research.

Meredith Wadman

03 February 2012


Heel-prick tests in Minnesota can be used to screen newborn babies for 53
serious diseases, but the samples are also crucial for biomedical research.

Minnesota's state health department has this week begun to destroy blood
samples that are routinely collected to diagnose serious inherited and congenital
diseases in newborn babies. It was compelled to do so by a state Supreme Court
decision that such samples cannot not be stored or used for anything except
diagnosis without the informed consent of the parents.

"We're going to begin destroying a valuable public health resource, the residual
blood spots from about 200 babies born in Minnesota each day," said Edward
Ehlinger, Minnesota's health commissioner, in a press release on 31 January.
He warned that the new policy “will compromise our ability to assure the quality
and accuracy of the newborn screening program". The Minnesota Department
of Health (MDH) will now actively ask parents for consent to store blood spots
collected from infants who have been diagnosed with one of the 53 diseases
tested for, and automatically destroy samples from children who have been
given the all-clear.

Until now, Minnesota, like several other US states, has not asked parents for
permission to store their children’s samples indefinitely and use them in research.
 The MDH holds at least one million such samples, collected since 1997. But
 the Minnesota Supreme Court ruled on 16 November in Bearder v. State of
Minnesota that by storing the blood spots, the MDH violates the state’s Genetic
Privacy Act, a 2006 law that requires informed, written consent for the collection,
storage, use and dissemination of any genetic information.

The MDH has not taken action on the court decision until this week because
it takes 71 days to check the samples for all 53 diseases. The hundreds of
thousands of samples collected before 16 November are being held in limbo and
cannot yet be destroyed, because they are evidence in two further screening-related
lawsuits that have been filed against the state. On 30 January, the state began
autoclaving and then shredding blood spots collected since the decision, which
 are stored on cards in freezers at the state’s public-health laboratory in St Paul.

Trust and consent

Bearder v. State of Minnesota was brought by nine families who wanted the state
 to obrtain written informed consent to collect, store or use infants' blood samples.
The lawsuit was spearheaded by the Citizens’ Council for Health Freedom in
St Paul. The group’s founder and president, Twila Brase, said yesterday that
 the court decision and sample destruction is good for research because it
preserves people’s trust in the scientific enterprise.

“The decision protects individual rights, privacy rights, patient’s rights,” says
Brase, a former nurse. “When parents or individuals find themselves used for
 research without their knowledge or consent, they begin to distrust not only
 the research enterprise but also the clinics, the hospitals and the doctors who
 take that information.”



But Jeff Murray, a medical geneticist at the University of Iowa in Iowa City,
says that the destruction of the samples “can do irreparable harm to bettering
newborn screening and ensuring as many babies as possible can grow up healthy”.
In addition to helping to develop new screening tests, he says, research using
 the blood spots allows scientists to track emerging infections and changes
 in infectious risks to newborns over time, informing public-health decisions.

Mark Schleiss, a pediatrician at the University of Minnesota Medical School
and Amplatz Children's Hospital in Minneapolis, is using anonymized newborn
blood samples from the state’s collection in an effort to develop a screening
test for cytomegalovirus (CMV) infection, the most common infectious cause
 of deafness in newborns1. He fears that families will conflate newborn screening
 itself with breach of their privacy and will opt out of the screening as well as
the storage. That could mean that debilitating conditions go undiagnosed.
“ I think it’s virtually certain that children will die or be disabled because of
 this,” he says.

Growing unease

Data provided to Brase's group by the MDH indicates that parental concern
about the genetic privacy of their newborns is on the rise. In 2003, two
 families asked the state to destroy their infant's blood sample, the written
results of the baby’s screening, or both. By 2010, that number had grown
 to 712 (See graph). Over the same period, the number of families opting
out of newborn screening altogether grew from 2 to 156.

The MDH says that lack of access to stored blood spots will hinder its work
 in several ways. For instance, validation of a new test to detect a condition
 called severe combined immunodeficiency will be delayed while
the department buys thousands of blood-spot samples from biobanks in
other states, at a cost of about US$10 each. The MDH also regularly uses
stored blood spots to validate new test kits, instruments and reagents.

Wylie Burke, chairwoman of the Department of Bioethics and Humanities
 at the University of Washington in Seattle, says that the lack of
an informed-consent process is part of the history of newborn screening,
and that “this is not necessarily a problem” — as long as the samples are
used for screening to find infants who need urgent treatment.

As for using the samples for research, the lesson from Minnesota
“is pretty clear”, says Burke. “Parents have a right to know when
 a researcher wants to use their child's blood sample for research,
and to be given the opportunity to agree or decline participation.”

    Nature
    doi:10.1038/nature.2012.9971


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