Consent issues nix blood samples

More than 5 million blood samples used by researchers in Texas since 2002 must be destroyed because they were stored without parental consent, according to a lawsuit settlement signed by a federal court judge in Texas earlier this month (December 14). Image: Wikimedia commons, Nevit Dilmen"The fact that the court case ruled to have all of them destroyed takes Texas back to square one," linkurl:Richard Finnell;http://genetics.tamu.edu/faculty/rick_finnell of Texas A&M Health Science Center wrot

Jef Akst

| 2 min read

Image: Wikimedia commons,
Nevit Dilmen

"The fact that the court case ruled to have all of them destroyed takes Texas back to square one," linkurl:Richard Finnell;http://genetics.tamu.edu/faculty/rick_finnell of Texas A&M Health Science Center wrote in an email to The Scientist. "It is very disappointing." The linkurl:Texas Department of State Health Services;http://www.dshs.state.tx.us/default.shtm (DSHS) has been collecting blood samples from a small prick on the heel of babies since the early 1960s, and the samples at issue were collected through the linkurl:program;http://www.dshs.state.tx.us/newborn/default.shtm between 2002 and May of this year. The program collects about 800,000 specimens annually from about 400,000 newborns, and screens for 28 different diseases. As of 2002, the state department started storing these blood samples for possible use in research protocols, as opposed to destroying them after a certain period of time. Collectively, these samples offered an enormous database from which scientists could investigate birth defects and pediatric disorders that, particularly for rare disorders, other recruiting methods may never have been able to obtain. On March 12, 2009, the Texas Civil Rights Project sued the Texas Department of State Health Services and Texas A&M University acting on behalf of five plaintiffs for keeping children's bloodspots without the parents' consent. Since 2001, the bloodspots have supported around 35 research projects by outside researchers "focused on diagnosing and treating diseases that affect children," said DSHS assistant press officer Allison Lowery, ranging from clubfoot to hearing loss to children's cancers. The 10,000 to 12,000 bloodspots already released to other institutions can continue to be used by those researchers, Lowery said, but as no consent was given for the storage and use of these samples, all remaining samples in the DSHS' possession or at Texas A&M must be destroyed by April 13, 2010. "DSHS believes settling this lawsuit is in the best interest of this program's core mission to screen all newborn babies in Texas for life-threatening disorders," the department linkurl:said in a statement;http://www.dshs.state.tx.us/news/releases/20091222.shtm released yesterday (December 22). "Newborn screening saves children's lives, and settling this lawsuit allows us to continue operating this critical program." As of May 27 of this year, new legislation allows parents to opt out of the storage program. By November 2, the state had received approximately 6,900 signed opt-out forms, out of nearly a quarter of a million Texas babies. Those that don't opt out of the program will contribute their children's bloodspots to rebuilding the collection that is to be destroyed.
**__Related stories:__***linkurl:Testing Fetal DNA;http://www.the-scientist.com/article/display/15553/
[20th June 2005]*linkurl:Rapid Newborn Screening by Mass Spectrometry;http://www.the-scientist.com/article/display/15014/
[25th October 2004]