Biobanking is making headlines in the popular press once again –this time because the state of Minnesota passed legislation to indefinitely store blood samples from newborns unless parents fill out paperwork expressing their desire to opt-out.
Since the collected samples could potentially be used for uncovering the genetics for diseases, the new legislation has been described as a victory for population-based research. However, privacy activists and others are voicing concerns.
Here’s a brief run-down of the key factors surrounding this legislation, slated to go into effect on August 1:
How are blood samples collected from newborns in Minnesota?
Within 24 to 48 hours after birth, a nurse will prick the newborn’s heel and rub a few drops of blood on a newborn screening card. The card also contains information about the identification of the baby and the mother, as well as the baby’s height and weight. The card is then sent to the Minnesota Department of Health for processing and testing.
What exactly is stored, and for how long?
The storage process is where biobanking comes in – the newborn screening card is a form of dried blood spot. Dried blood spots are an efficient form of storage that can be densely packed and don’t require refrigeration. DNA and biomarkers extracted from the spots can be used in population-scale studies long in to the future. The Minnesota bill allows dried blood spots and diagnostic test results to be stored indefinitely unless parents sign an opt-out form.
How different is the Minnesota bill from the policies of other states?
All states require newborns to be screened for potentially life-threatening diseases. Although there is no official national oversight of the procedure, the US Health Resources and Services administration recommends screening for 31 different conditions. Most states don’t allow for indefinite storage of samples and test results, though.
What research can benefit from the stored samples?
According to the Minnesota Department of Health, the stored blood spots will be used in public heath studies attempting to identify biomarkers behind birth defects, childhood cancer and chronic disease. The database of spots can also be used to help identify missing or deceased children.
What are the concerns over privacy?
Parents and privacy activists are mostly concerned about the opt-out nature of the bill. They argue that new parents are presented with an unfair burden by being asked to read, understand and sign the forms opting out of indefinite storage, especially directly following the stress accompanied with childbirth. The ACLU of Minnesota called the bill “a dangerous effort to enable unlimited retention and minimize parental consent,” and noted “obtaining informed consent for the retention and later use after newborn screening for all purposes is not only possible but practical.”
Consent is a difficult issue to tackle in biobanking because it combines questions of privacy and personal freedom with the efficacy of a research biobank. Do the benefits of a state-wide newborn blood spot database outweigh the concerns of parents, the ACLU and other organizations? It will be interesting to continue to follow this legislation, given that a lawsuit forced the Minnesota Department of Health to destroy some one million samples earlier this year.