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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Guatemala, the GDR and Research Ethics Policy Development

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

by Andrei Famenka, Bioethics Program Alum (2013)

When it was first announced, I was particularly intrigued by a recent webinar called, ‘Gonorrhea, Guatemala and Gung-Ho Researchers: The Role of Controversy in Shaping Research Ethics Practice and Policy’. This particular topic was of special interest to me because of my interests in research ethics policymaking and the role of social, cultural, and economic factors in this process.

As good as the webinar was, it highlighted a peculiar fact: although a good deal of attention has been paid to unfair research conducted in developing countries, such as Guatemala Gonorrhea study, such analyses have primarily focused on the impact of these controversial studies on research ethics policy development in the United States. Missing from these analyses is the impact that the scandals have had on research ethics policies in developing and transitional countries where the unfair practices have occurred. This lack of analysis is significant because these controversies often fail to lead to policy changes in developing and transitional countries.

One of the latest examples of unethical research which didn’t result in any policy modification comes from Eastern Europe. It has recently come to light that just before the fall of the ‘iron curtain’, some major Western pharmaceutical companies conducted hundreds of controversial drug trials in the German Democratic Republic (GDR, the Communist former country of East Germany), in which more than 50,000 East German patients served as guinea pigs—many without their knowledge or consent. More than 600 drugs were tested on unwitting East German patients, including prematurely born infants, alcohol addicts, and people diagnosed with depression. Moreover, despite suspicions that some of the trials resulted in several fatalities, the participating hospitals were reluctant to investigate.

Despite hot debates in the media, the controversy over this unethical research didn’t push policymakers in the countries of Eastern and Central Europe to revise the current policies and programs on the protection of human subjects. And yet, recent research on Baltic countries, Belarus, and Poland clearly demonstrates these policies are lacking.

Although it has become almost a proverb that research ethics was ‘born in scandal’, a closer look at the history of research ethics provides evidence that no matter how big a scandal might be, it can result in policy change only if it resonates with broader social movements or shifts in public views, ideas, and values. In fact, outrageous scandals, hot debates, and profound controversy can serve only as triggers or catalyzers of change under the right socio-political, cultural, and economic conditions. This reflects the views presented by Ezekiel Emanuel and Christine Grady when they argue that over the past 70 years, the system of research oversight in the United States has evolved through four distinct stages. These stages embodied different values and perspectives on research and reflect dominant views in general society. Research oversight changed as these dominant views evolved over time.

Central and Eastern European countries still lack a strong civil society and sufficient levels of political freedom, economic and social opportunities, and transparency guarantees. The enabling conditions for a strong set of research ethics policies is not sufficiently in place. Attempts to force these policies would only create confusion about the underlying ethical values and the goals of the research oversight.

The way to ensuring the protection of human research subjects in transitional countries is most likely to be a long and difficult one, as it involves efforts to reshape some basic elements of society. In this regard, training programs are an important part of the process, but these will only be successful when they are coupled with broader social changes.

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