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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

By | December 23, 2009

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 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]
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Comments

Avatar of: anonymous poster

anonymous poster

Posts: 2

December 23, 2009

why not contact the parents and obtain consent instead of discarding all the samples?

December 24, 2009

The blog has discussed a little of the merits of the case. Yet, destruction 5 million samples looks like a collosal waste. I guess that review petition or an appeal is indicated, without prejudice to the ever raising standards of consent. It appears that the action by the state health agency was not-for-profit; it has broader public interest as the intention. If so, annonymous use of samples to obtain grouped data would not hurt morality. Even within the framework of Law there needs to be a strong argument to keep the blood samples in the safe custody of the Court Receiver and the State may obtain consents in retrospect from the parents. The State must seek an opportunity from the Courts to complete the formality of consent to respect the spirit of the Law and Court Orders. People can see reason. There is a strong probability of at least 70 per cent parents giving their assent, if an appropriate campaign is undertaken. Otherwise losing 5 million samples is a substantial loss to Science.
Avatar of: anonymous poster

anonymous poster

Posts: 31

December 24, 2009

Once again someone who has too little to do has caused a great tragedy for society. Perhaps my cynicism is speaking, but I see these things as "rice bowl" issues for lawyers and bioethicists. The former initiate a lucrative class action lawsuit and the latter show that, once again, they are needed to help us poor, deluded fools navigate through the levels of absurdity that they have imposed upon us. Unfortunately, the standard seems to be to protect individuals from every possible risk, no matter how miniscule or insignificant, and to ignore the benefits to society as a whole. If there were any justice in this universe, and there clearly is not, then the people who brought this lawsuit would suffer something to their children that these destroyed samples might have prevented or at least illuminated. Unfortunately, other people will be the victims while the plaintiffs can remain smug in their knowledge that they saved the world from trivial risks.
Avatar of: Bernard Carroll

Bernard Carroll

Posts: 4

December 24, 2009

\nIt's too bad Richard Finnell of Texas A&M Health Science Center didn't point to the positive value of this collection of blood samples. What has been learned in the projects that received these samples to date?\n\nThat said, I believe the program operated in good faith and that it is not appropriate to apply today's evolving consent standards to yesterday's good faith acts.
Avatar of: anonymous poster

anonymous poster

Posts: 15

December 24, 2009

Blood samples from donors, whether it is with or without consent, are used to identify genetic risk factors for diseases now-a-days. Typically single nucleotide polymorphisms (SNPs) are tell tale markers that can be used to screen for susceptibility to any disorders and to identify the best possible treatment to be given to an individual - for the greater public good or so it might seem. \n\nThe untold story is how "non-profit" hospitals stand to gain big time by patenting these SNPs for commercial diagnostic operations even when they collect the blood samples with your consent to be sued anonymously. Just look at the conflict of interest statement in any pharmacogenomics journal today and you will find that the head of each of the major studies and a select group of investigators, funded by public tax payers money from NIH, and YOUR DNA, are going to make huge profits from royalties and huge salaries these physicians-researchers earn because they control proprietary samples that are otherwise hard to come by. Just by tying a SNP to a treatment outcome or diagnostic outcome, there are big profits in the healthcare business to be made; with no real innovation! Hence, one wonders about the real motivation underlying collection of blood samples with consent and especially without consent - a cure or a profit!
Avatar of: Lenore Martin

Lenore Martin

Posts: 6

December 25, 2009

I passed the bioethics review at my university but as everyone mentioned, the standards for informed consent keep getting higher and one must be careful to keep up. Like the others, if you care about scientific research and improving the health of our children, then of course the priority would be to somehow save as many of these samples as possible, while still preserving the patient's rights to control the disposition of their samples because the informed consent procedures have changed in the meantime and they may not have understood how long the samples would last. My question is about all the discarded tissue samples and parts of samples left over (as was apparent in this case) once a diagnostic test is finished. I was under the impression (am I wrong now?how do you handle this?) that an unidentifiable sample of human tissue (say some outdated blood from the blood banks, or some infectious disease cultures, for example) that were taken for a legitimate healthcare-related purpose could alternatively be used in research instead of destroyed, without needing additional specific consent (other than the general "teaching hospital type" broad consent forms)? I am concerned about ALSO honoring the wishes of individuals (like myself) who feel it is a CRIME to throw out the useful material taken from my body in excess of what is needed (which always happens to prevent having to re-sample the patient)! Those of us who want to help medical progress in this way should have the right to "opt in" and donate all excess tissue taken from our bodies to benefit the lifesaving research that is going on in our country and around the world. There must be a way to both ensure personal privacy and still protect universal access to valuable human tissue samples.
Avatar of: anonymous poster

anonymous poster

Posts: 29

December 25, 2009

I agree that this is a loss for science, but it has been corrected this year with legislation to require an opt-out from the affected parents in the future: \nhttp://www.mysanantonio.com/news/state/State_to_destroy_millions_of_newborn_blood_samples.html\n\nAlso, however misguided the plaintiffs may be, neither they nor their attorneys benefited financially from their suit, so presumably their motives were privacy related, not an attempt to get rich.

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