Residual Dried Blood and New Born Screening in Minnesota

Note: The Bioethics Program blog is moving to its new home on April 1, 2015. Be sure to change your bookmarks to http://bioethics.uniongraduatecollege.edu/blog/

by Courtney Jarboe, Bioethics Program Student

In Minnesota, residual dried blood (RDB) samples collected for newborn screening had been stored, retained, and used for research without parental consent. It had been presumed that the Minnesota Department of Health (MDH) had the statutory authority to do so. In 2011, the Minnesota Supreme Court ruled (in the case of Bearder v. Minnesota) that the newborn screening program was subject to the Genetic Privacy Act (2006) (pdf), which requires written consent for secondary uses of genetic information. This ruling led to revisions of newborn screening legislation and the destruction of 1.1 million newborn screening RDB samples. Since the legislative dust has settled, MDH has begun aggressive educational campaigns to rebuild trust and awareness between parents and healthcare providers in Minnesota and address information gaps in the public’s understanding of the newborn screening program and the associated research.

In February of this year, I received a letter from the Citizen’s Council for Health Freedom (CCHF), an organization that actively supported the nine families in Bearder v. Minnesota who sued to stop the use of RDB samples for research. (see image) The letter details CCHF’s concerns about the MDH newborn screening program. The letter also suggests that MDH can use the RDB and the associated child’s DNA without parent consent. Included with the letter were a letter addressed to MDH and a copy of the MDH ‘Directive to Destroy’ form.

CCHF disclosed in late March that they distributed the letter to roughly 10,000 parents across the state based on birth certificate records. Within just a week of CCHF’s distribution of the letter, MDH received 59 directives to destroy RDB samples and related results. This was more than the total number of requests in the previous 5 months before these letters were sent out.

I was particularly interested in this letter because of my master’s project on Minnesota’s newborn screening program. Because this wasn’t my first exposure to the newborn screening program in Minnesota, I realized that I might be able to help clarify some of the aspects of this letter that other parents should be aware of. First, CCHF claims that, “Consent requirements mean ownership claims. But now, only if you object will the State release ownership claims to your baby’s DNA.”  However, CCHF is asking parents to complete “the official state opt-out form” and return the “I Did It” postcard. However, this is misleading as the form is actually the ‘Directive to Destroy Newborn Screening Samples and Test Results’ form. CCHF does not inform these parents that they could submit a request to MDH to return the remaining samples back to them. The ‘Directive to Destroy’ may not be the best choice for every family. What if that family should avoid destroying the sample due their medical history?

CCHF also claims “Without consent, the law allows research to be conducted on your child.” After Bearder v. Minnesota, this claim is simply not true. MDH stores and retains residual dried blood samples and test results from infants that participated in the newborn screening program as of August 1, 2014. These samples are used for quality assurance testing and the development of new tests for the screening panel, but the law does not allow research to be conducted on these samples. If they should wish to do research, researchers and MDH must obtain written informed consent from parents in order to use samples (Parental Consent for Research Use of Newborn Screening Blood Spots and Test Results).

Parents who have questions about their state’s newborn screening program practices should consult with their primary care provider or state’s newborn screening program office. If their provider cannot provide the answers, the state’s newborn screening program should have staff available to assist them. For more information about Minnesota’s newborn screening program, visit the state’s website. Information about other state programs, including contact information can be easily found on Baby’s First Test.

Jarboe Minnesota Letter (1) Jarboe Minnesota Letter page 2 (1)

[The contents of this blog are solely the responsibility of the author and do not represent the views of the Bioethics Program or Union Graduate College.]

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One thought on “Residual Dried Blood and New Born Screening in Minnesota

  1. I live in the upper Midwest, and am somewhat (although not excessively) familiar with the Citizens’ Council for Health Freedom (originally Citizens’ Council on Healthcare), an organization that was originally created in the mid-1990s to oppose involuntary participation in HMOs and other “managed care” organizations.

    Initially more neutral on the political spectrum, CCHF has become increasingly right-wing libertarian during the past decade. Although CCHF is occasionally prone to hyperbole and factual error, their opinion on newborn DNA testing is essentially correct: most parents probably want their children tested, but do not want their children’s DNA stored indefinitely in a government database. Therefore, both testing and long-term DNA storage should be “opt-in” rather than “opt-out,” options parents who are not self-educated about genetic privacy rights are unlikely to learn about in their children’s birth hospitals.

    Long-term DNA storage is especially concerning in a nation that continues to erode its citizens’ civil liberties, gradually mutating into a police state: consider, for example, routine Fourth Amendment violations committed by the NSA and TSA. Newborn blood samples could eventually be used to create a genetic database of suspected enemies of the state, and no one familiar with bioethics can ignore the possibility of another Aktion Tiergartenstrasse 4 (T4) program.

    CCHF has been known to encourage parents to seek private newborn DNA testing.

    My own DNA is undoubtedly stored in a federal database because I am a regular blood donor, a practice I began before September 2001: had I not already been a blood donor when the surveillance society began to escalate, I might never have become one.

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