Wednesday, September 26, 2007

Minnesota and Genetic Privacy: Why the Rule of Law is Good for Research

On March 23, 2007 Minnesota Administrative Law Judge Barbara Neilson ruled on the ongoing controversy regarding genetic privacy and blood specimens collected during newborn screening. The Citizen’s Council on Healthcare’s (CCH) claimed that the Minnesota Department of Health (MDH) was unlawfully retaining and using the specimens. In addition to prompting Minnesota privacy advocates like Craig Westover to ask: "Does the End Justify the Genes?", this dispute between the public health advocacy group and state raised the question: Is the government exempt from legal requirements relating to genetic specimens in the name of improving public health?

Parents Required to Opt-Out

MDH has been collecting and storing newborn blood specimens since 1997; however, in 2003 the legislature added a provision which required parents to sign a form to indicate they wanted the blood specimen destroyed after the screening tests. If parents do not sign this form, the MDH stores the specimen indefinitely and uses it, as well as disseminates it to other institutions, for genetic research to develop new screening tests.

CCH maintained that MDH’s assumption they could retain the blood specimens if parents did not specifically request their destruction was faulty and ran counter to other Minnesota laws. ALJ Neilson and Chief ALJ Raymond Krause ruled that the original law did not expressly authorize retention or research use and could not be justified based on an assumption. Over MDH’s vigorous objections, ALJ Neilson held that the collection, retention, and use of the blood specimens must be interpreted along with Minnesota’s Genetic Privacy Act (
144.125, Minnesota Statutes 2006). This law explicitly requires that an individual’s genetic specimen:

  • May only be used for the purposes to which the individual has given informed consent;

  • May only be stored for a period of time to which the individual has given consent;

  • Requires affirmative consent to disseminate the specimen.

  • A Losing Strategy

    The MDH, in this controversy, exemplifies the creative lengths to which parties will go to evade the laws which seemingly obstruct research progress. Although Minnesota's government sponsored projects and research to improve public health are worthy endeavors, they are not exempt from privacy protections. Here, MDH’s failure to comply with the law’s provisions requiring actual consent is a grave shortcoming. There is no question that newborn blood screening tests have been essential for early detection, diagnosis, and proper treatment of debilitating diseases. MDH estimates that Minnesota screens more than 73,000 newborns and diagnoses approximately 100 infants with disorders annually (Report of the Administrative Law Judge Barbara L. Neilson In the Matter of the Proposed Amendments to Rules Governing Newborn Screening, Minnesota Rules, Chapter 4615, January 23, 2007--

    What's Next?

    The MDH has recently announced they are working with legislators to create new screening policies that will comply with the law; in the interim, the department is retaining all specimens. As the policies are revised, let's hope that the MDH avoids the quiet paternalism of its recent practices. As the controversy demonstrates, such behavior sparks backlash and eventually leads to loss of public trust. Although the MDH may have realized some immediate gains in collecting blood samples for research, bypassing the community and the law is not a long-term strategy for success. If parents lose faith in state departments of health, they may refuse to donate newborn blood samples for research or, in the worst case, these parents may refuse newborn screening for their children. In such a scenario, the ultimate "ends" are lamentable and the "means" are unjustified; everyone loses: parents, children, researchers, communities, and industries.
    -- K.D.

    [Katherine Drabiak is a 3rd year law student at the Indiana University School of Law-Indianapolis. She is interested in issues related to genetic privacy and conflicts between federal and state regulations which result in legal ambiguities in field of biomedical research.]

    1 comment:

    Max Power said...

    Your point is well taken that MDH employs a strategy which fails both to secure their long term interests and puts the entire service of newborn screening at risk. Further still, MDH's retention of specimens seems to fly in the face of specific legislation and clear rulings which make their actions illegal. The efforts of MDH toward predictive health are robust, but are not commendable. The saving grace in this case may be that although MDH is holding ten years of specimens illegally, it has only been clearly illegal since the time the 2006 genetic privacy law was interpreted this fall. More clearly, this is not the MDH acting as a large sinister organization interested in profitting illegally off of public biological specimens, rather it is a branch of an organization which otherwise operates for great public good which may have unknowingly failed to comply with the confusing and possibly misdirected legislation--a recurring theme in predictive health.