In BC, a lawsuit is now underway, after it was discovered that about 800,000 newborn blood samples, together with names and birth dates, had been stored on information cards since 1999, in a storage facility operated by a private contractor; and the blood samples had been shared with researchers – WITHOUT THE PARENTS KNOWLEDGE, MUCH LESS THEIR CONSENT. (1)
CONCERNS:
1. This is, in fact, a DNA database. “DNA is your personal signature, and it uniquely identifies us” (Jennifer Puck, University of California, San Francisco) (5)
2. These spots are being shared with researchers, without the parents knowing who the researchers are, who they work for, what kind of research they are doing, to whom they subcontract, etc.
3. Bill 11, passed in May 4, 2010, gives the Minister of Health power to collect, gather, use and share personal information without any notice to or consent from affected individuals.. In other words, your personal information can be shared with governmental and law enforcement agencies, without notice or consent. The B.C. Civil Liberties Association (BCCLA) is trying to have this reversed. (7)
4. The information may be used to discriminate against the individuals by employers, banks, insurance companies, your child’s future spouse, etc. “You could make inferences about their future health, about their future behaviour, and if you got samples from their parents or a DNA databank, you can make inferences about family relationships.” (4)
5. The DNA also provides information on other family members (8)
6. The researchers/private companies may manipulate, alter or splice the DNA. (3)
7. The amount of information that can be obtained from DNA is expected to increase (8)
8. The genetic information could be used for unethical purposes such as human cloning,etc.(5)
9. De-identified blood samples are linked to personal information and you can trace the link. The blood samples are stored with a code number in one place that can be easily matched to names stored in another place. (4)
10. The blood samples and other information could be accessed by pharmaceutical and biotechnology companies, commercial companies who might bias or manipulate research findings. (10)
11. “The dark side is the commercial value of the human body. If the nature of the specifics of a given individual is available to the people searching for organ matches, the finding of a match might be someone who is not dead. Yet. (Ultra Bob) (5)
12. How securely is access controlled or is it like our hospitals, where audits have shown that almost anyone could access information. It has also been suggested that there isn’t any system, no matter how good, that can’t be abused and “once it’s out there, it’s out there” (10) And it’s not just hackers that are a concern but employees with, for example, a flashdrive which can be put into a database to download information.
13. Conflict of interest – “…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!” (11)
14. Ownership – Who owns the specimens and anything created from the specimens. (10)
15. Cost – It apparently costs quite a lot to store the blood samples in the right climatic environment. Is this how you want our health care dollars spent? (3)
Medical people certainly had lots of opportunity to tell people and ask for their consent. They verbally explained why the “heel prick” (taking a newborn’s blood) was important for testing for diseases, they handed out pamphlets, and there was a website. But apparently not one person in the medical field, in over 800,000 births, mentioned that the children’s blood was being stored indefinitely and used by others. Apparently no one in the medical field thought people would be interested in knowing the bloodspots were being stored and shared (or so they say), despite the fact that this had become an issue worldwide. (2)
In 2002, the public forced South Carolina to pass a law regulating the collection, storage, and use of blood samples. (9)
In Texas a lawsuit was settled when the state agreed to destroy the stored blood spots. New legislation requires parental consent and allows parents to opt out and all projects must also be published on the agency’s newborn screening website. However, a second lawsuit has been filed because they (the plaintiffs) had not been told, during the first lawsuit, despite asking numerous times, that the blood spots had been sold, traded and bartered. (13)
Blood spot samples apparently were also sent to the U.S. Department of Defense and Homeland Security. The U.S. Department of Defense, who were using the blood samples to build an international database, reportedly destroyed the samples (of course, you never really know, do you???). (13)(6)
A Dublin hospital has stored the DNA of all the people born in the country since 1984, creating a database. This was done without the individual’s or parents knowledge, and apparently in contravention of the law; and despite having an ethics committee. (14)
Now that this issue about the children’s blood spots has been brought into the open by the public, the BC Newborn Screenings Program has a notification on its website regarding storage. But, of course, it only mentions the positive and not the negative aspects of storing the blood samples. It allows parents to fill out and submit a form requesting the destruction of the blood spot (opt out), as opposed to being asked for their written permission to store/use the blood spot (opt in). It seems that the blood spot cannot be stored unless the parent agrees to it being used by others.
What happens if your form gets “lost”. The medical/researcher people could say they never received it. It would be hard to prove them wrong. On the other hand, if they must have a signed paper before storing/sharing the blood samples/name/DOB then they would have to have the paper on file to prove they have a legal right to store/share the blood samples.
So what happens to everyone else’s health samples. For example, when you go for a physical or an operation and blood/tissue samples are taken, are they being stored somewhere? What else has the medical/political people decided we don’t need to know.
Some comments that I thought were particularly interesting:
Researcher | 10:11 a.m. Feb. 9, 2010
“I have worked in research for over 10 years. My job is to make sure that everyone obeys the law. When it comes to human research, the law is designed to protect the people who are the subject of research. Blood and tissue samples are your property even after they have been removed from your body, and researcher(s) can only do with them what they have gained your legal consent to do. That is the issue here. These researcher(s) do not have legal consent to do what they are doing. So many researchers feel like this is a hindrance. They would prefer to just be able to do whatever they want. They all think that what they are doing is for the greater good. If it is going to produce valuable results, it can and should be done legally. If you don’t think these regulations are necessary, do an internet search on the Nuremberg Code, the Tuskeegee experiment, etc. Whether you care what happens to your child’s samples or not, it is in everyone’s best interest that researchers are forced to be accountable for what they do, and gain the proper consent. “(5) In BC, the politicians have taken the right to give legal consent, to decide what happens to your body parts, from you and given it to themselves.
“It’s fine and good to say these can’t be identified, but how real is that?” said Hank Greely, a Stanford University bioethicist. “Just because you don’t have a name or Social Security number doesn’t mean you can’t identify it. Once we start using DNA for more and more things like regular medical records, somebody could do a cross-check and say whose blood it is.” (12)
One: Telling people that their biospecimens are retained and used for important research, that strict privacy and confidentiality protections are in place, and that “we’re good stewards” of the biospecimens without providing accessible, clear information about those policies, fails to meet even minimum standards of transparency.
Two: Failure to acknowledge that public attitudes and values about consent, genetic research, and privacy/confidentiality may conflict with those of researchers and policymakers can lead to public distrust of biospecimen research and impede important research.
Three: Genuine public engagement in developing policies for biobanking initiatives takes time and resources. But the payoff – trust in the research enterprise and willingness to provide biospecimens – is worth the effort. (9)
IT’S YOUR DNA AND IT DOESN’T GET ANY MORE PERSONAL THAN THAT. (Michelle Salas)
1. The Globe & Mail, May 11, 2010, Jane Armstrong, Vancouver Parent Challenges Unauthorized Archiving Of Infant’s Genetic Blueprint
2. CBC News, May 12, 2010, Scott Applewhite, Storing B.C. Babies’ blood violates privacy: group
3. Infowars Ireland, February 8, 2010, Newborns’ DNA Routinely Harvested For Government Bio Banks
4. In the Media, February 26, 2009, Barbara Sowell, DNA Testing Without Parental Consent?
5. Deseret News, February 8, 2010, Lauran Neergaard, Blood tests of newborns stirring major ethics debate
6. American-Statesman, May 10,2010, Mary Ann Roser, State agency swaps babies’ blood for supplies
7. British Columbia Civil Liberties Association, May 12, 2010, New law may create largest DNA database in Canada
8. Statement of Claim filed with the Supreme Court of Canada, May 14, 2010, British Columbia Civil Liberties Association website www.bccla.org
9. The Hastings Centre Report, September 8, 2009, Karen J. Maschke, Disputes over Research with Residual Newborn Screening Blood Specimens
10. Exploring existing and deliberated community perspectives of newborn screening: informing the development of state and national policy standards in newborn screening and the use of dried blood spots; Ian Muchamore, Luke Morphett and Kristine Barlow-Stewart, December 13, 2006
11. The Scientist – Magazine of the Life Sciences, December 23, 2009, Consent issues nix blood samples, Anonymous poster – Non-Profit banking of DNA from blood for Profit
12. Washington Post, June 30, 2009, Rob Stein, Newborns’ Blood Samples Are Used for Research Without Parents’ Consent
13. Infowars Ireland, NaturalNews, February 20, 2010, Ethan A. Huff, Texas ordered to destroy five million blood samples illegally taken from babies without consent
14. Sunday Times, December 27, 2009, TJ McIntyre, “Is Temple Street Hospital Holding A De Facto National DNA Database