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-- 11-0900-17586-1).
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.]
Bioethics researchers Paul Helft of the Fairbanks Center for Medical Ethics, and Eric Meslin of the Indiana University Center for Bioethics publish paper on patient attitudes towards biobanks - Biomedical research, social science and ethics scholars have been working for over a decade to understand attitudes toward biobanking; "Cancer Patients' Attitudes Toward Future Research Uses of Stored Human Biological Materials" continues the progress of this research. In response to a request for a comment for this blog, Helft noted that a better understanding of attitudes toward biobanking will help to establish: "Policy and best practices for informed consent for future, unspecified research". This newly published research, conducted by Helft, Meslin, and others, provides valuable information to anyone interested in recruiting research participants for, or in shaping the development of, human biobanks. "Our study", Helft remarked, "was one of the few which have assessed the attitudes of patients who actually gave tissue to a biobank under these conditions". The authors found that a significant minority placed restraints on or had reservations about unrestricted future research on their stored tissue. "In developing policy and best practices", said Helft, "we need to understand this group’s attitudes better". - J.O.Citation:Helft PR, Champion VL, Eckles R, Johnson CS, Meslin EM. Cancer Patients' Attitudes Toward Future Research Uses of Stored Human Biological Materials. JERHRE. 2007; Sept;2(3):15-22.Abstract: THE POLICY DEBATE CONCERNING INFORMED consent for future, unspecified research of stored human biological materials (HBM) would benefit from an understanding of the attitudes of individuals who contribute tissue specimens to HBM repositories. Cancer patients who contributed leftover tissue to the Indiana University Cancer Center Tissue Bank under such conditions were recruited for a mail survey study of their attitudes. Our findings suggest that a clear majority of subjects would permit unlimited future research on stored HBMs without re-contact and reconsent, and a significant minority appear to desire ongoing control over future research uses of their tissue. These differences merit further investigation and suggest that a policy of blanket consent for all future, unspecified research would be premature.Source: http://caliber.ucpress.net/doi/abs/10.1525/jer.2007.2.3.15[Note: PredictER Blog will announce more research from on attitudes toward predictive health research in the near future.]
When reflecting upon the greatest medical advancements in the last fifty years of medicine, certain broad and worthy categories come to mind. Imaging technology, drug design, and minimally invasive surgery have made great changes in how patients are treated. As a fourth year medical student, I routinely request a CT, suggest a regimen of Gleevac, or recommend a laproscopic procedure. All of these advances have made waves in the practice of medicine, public expectations, and medical education. Predictive health research, however, has not yet fully entered the medical school curriculum.
I doubt whether there is a single undergraduate who gains acceptance to medical school who cannot identify the names Watson or Crick or explain the basic function of DNA. By now, most students are also aware of the recent completion and publication of J. Craig Venter’s genome. Nevertheless, discussions with my peers suggest that medical students may not be fully prepared for the medical and ethical implications of recent genetic research. Predictive health research discoveries are taught, but the potential clinical applications are lost in translation--stuck somewhere on the path from the bench to the bedside . . . or, in my case, from the pages of the textbook to the patient.
For my generation of medical students, predictive health research has the potential to significantly change the practice of medicine. While programs like the Personal Genetics Education Project at Harvard are building interest in predictive health, and while the public is flooded by a confusing array of genetics news reports, what are medical schools doing to prepare future physicians for the predictive health revolution?
Medical students and educators should step up their efforts to join the conversation about the clinical promise and ethical issues of predictive health. We need to start thinking and talking about how we make use of the predictive tools we already have and how we will prepare for future tools. For example, how many of us are ready to explain to new parents the meaning of normal newborn screening results? Are we fully prepared to share the non-watered-down reasons for why we may want a fifty-year old man to get a colonoscopy? Are we ready to address the anxieties of a patient considering a genetic test to better determine her risk of breast cancer? Clearly, students and bloggers like Bertalan Meskó at ScienceRoll are doing their share to spread the word, but we should encourage our mentors and professors to join the discussion. What is the current state of predictive health, and where can we expect it to advance?
[Note: To encourage a public discussion of the ethical, legal and social implications of predictive health research, PredictER Blog will be inviting guest contributions from students, professionals, and interested members of the public. This post from Pat Barrett, a fourth year medical student at the Indiana University School of Medicine and a graduate student of the Indiana University School of Philosophy, is a fitting introduction to this new feature of PredictER Blog. -- J.O.]
