At the end of 2009, the Texas Department of State Health Services (DSHS) settled a law suit and agreed to destroy over five million stored newborn blood spots. The Texas Civil Rights project, which filed the complaint, objected to the fact that bloodspots were stored for research purposes without the consent of the parents. At the beginning of February, Adam Doerr, of Genomics Law Report, evaluated the legal implications and assessed the impact on the future of newborn blood spot biobanking. He believes researchers and the American College of Medical Genetics might wish to become more directly involved in future litigation.
Although the Texas case has settled, litigation continues in Minnesota—a story that CNN reported on February 4: The government has your baby’s DNA. In this case, parents are, likewise, concerned about the research use and storage of blood spots without consent. One parent, Annie Brown, explained: “Why do they need to store my baby’s DNA indefinitely? Something on there could affect her ability to get a job later on, or get health insurance.”
States are beginning to address this issue legislatively. Recently, Oklahoma Senator Jonathan Nichols introduced a “Bill to ban unauthorized use of infant DNA” in the state. The bill left the state’s Senate Judiciary Committee and is waiting for a vote. The Senator explained the motivation for the legislation: “The problem we’ve seen in other states is that some medical facilities have been keeping those samples and using them for unauthorized research …. We don’t want that to happen in Oklahoma.”
At the same time, the U.S. government is working on national recommendations. Lauran Neergaard of the Associated Press, in Debate in US over blood from newborn safety tests, quotes Sharon Terry, activist and member of the Advisory Committee on Heritable Disorders in Newborns and Children: “It’s a critical thing that we take action …. Done well and done right, there will be an enormous benefit overall to the system.”
More recently, and adding to the controversy in Texas, Emily Ramshaw at The Texas Tribune, reports that a 800 blood samples were given to the Armed Forces DNA Identification Laboratory (AFDIL) to build a forensic DNA database. The forensic database will be used to help “crack cold cases,” but the notion that unsuspecting parents have contributed samples without consent to a law enforcement database raises the privacy and liberty hackles of many Texans. The attorney representing the Texas Civil Rights project, Jim Harrington, believes DSHS (knowing the forensic research project would soon be in the news) was extra-motivated to settle the suit: “This explains the mystery of why they gave up so fast.”
For a thorough review of the ethical and legal issues in newborn blood spot banking, including the law suits in Texas and Minnesota, see Katherine Drabiak-Syed’s recent PredictER Law and Policy Update: Newborn Blood Spot Banking: Approaches to Consent.
Related Newborn Blood Spot News and Links:
Jon Walker. S.D. sidesteps ethics debate over blood from baby screenings. Argus Leader. February 9, 2010.
Link: National Newborn Screening & Genetics Resource Center
Link: PredictER News: “newborn screening”
OTHER RESEARCH ETHICS NEWS
Marilynn Marchione. AP IMPACT: Testing curbs some genetic diseases. (AP) Google News. February 16, 2010.
Pam Belluck. Wanted: Volunteers, All Pregnant. The New York Times. February 15, 2010.
Radhieka Pandeya. Tougher law on human clinical research likely. livemint.com [India]. February 8, 2010.
Margaret McCartney. The trials of age. Financial Times. February 6, 2010.
Kelli Grant. A Stem Cell Debate. Keloland.com. February 5, 2010.
Celeste Lipkes. Survey of study participants fuels ethics debate. The Johns Hopkins News-Letter. February 4, 2010.
Christine Hall. Regulating Industry-Funded Science Could Harm Patient Safety, Report Finds. Competitive Enterprise Institute News. February 4, 2010.
Linda A. Johnson. Glaxo CEO: Time to diversify, help poor countries. (AP) Google News. February 2, 2010.