For the Innovation Law Beyond IP 2 conference, March 28-29 at Yale Law School
In 2009, the Texas Department of Health agreed to destroy a research biobank containing approximately 5.3 million infant blood samples. The samples, stored on index cards as dried blood spots, were collected over an eight-year period as part of a state program to screen newborns for genetic disorders and birth defects. The parents of each infant consented to the blood draw and the testing. Nevertheless, when four Texas parents discovered that the state retained the infant blood spots for future research, they sued (Beleno v. Lakey(W.D. Tex. 2009)). Andrea Beleno and the other parents alleged that the state’s use of infant blood spots for research purposes without their express consent violated their right to privacy under the Fourteenth Amendment, among other things. To settle the litigation, the state agreed to destroy its entire repository of more than five million infant blood spots, an invaluable and irreplaceable resource for biomedical research.
The result in Beleno is not unique. Individuals have been asserting the right to control the use of biological samples and data with increasing frequency. In a highly-publicized case involving the Havasupai tribe, Arizona State University agreed to return DNA samples and discontinue several lines of research following objections from tribe members (Havasupai Tribe v. Ariz. Bd. of Regents, 220 Ariz. 214, 217 (2008)). They argued that, although they may have consented to the use of their DNA for diabetes research, they did not consent to other uses, including research on schizophrenia and ancient human migration. After the tribe brought suit seeking $50 million in damages, the university settled, notwithstanding the fact that tribe members signed broad consent forms potentially authorizing the research.
It is axiomatic under U.S. law that there is no property interest in mere facts. Nevertheless, as these cases show, with respect to human genetic data, a de facto property regime has emerged in all but name. This regime has enabled individuals to exert strong proprietary rights over the use of data obtained from them, leading to instances in which research has been hindered or stopped, and in which valuable resources have been destroyed. The mechanism by which individuals have been able to assert control over “their” data is informed consent.
Originally implemented to avoid the abuses of Nazi-era medical experimentation on unwilling prisoners, the requirement that researchers obtain the informed consent of human research subjects has expanded to cover not only the conduct of biomedical experimentation, but any use of human genetic data. The recent focus on obtaining individuals’ permission to conduct research using data obtained from them has seemingly imparted property-like control over that data to individuals in a manner that is both ill-founded and potentially damaging to biomedical research.
In particular, the recently announced federal Precision Medicine Initiative, which will seek to enlist one million subjects for genetic research on a massive scale, will depend on the ability of researchers to perform a wide range of analyses, some of which have not yet been imagined. The threat that individual data subjects may be able to assert property-like rights to withdraw their data or prevent research on specific topics could limit the success of this ambitious program and others like it.
Looking to Calabresi and Melamed’s seminal analysis of property and liability rules [PDF], I have proposed that the property-like attributes of genetic data be eliminated. Specifically, I suggest that the informed consent requirement for noninvasive research be replaced by a liability rule regime in which abusive data practices are prohibited, but permissible research cannot be obstructed by individual data suppliers. Many such liability rules exist today and include prohibitions on genetic-based discrimination, the disclosure of private information and the use of deception and fraud in recruiting research subjects. The proposed approach would shift the landscape from one in which data-based research cannot occur without the consent of individual data subjects, to one in which research is presumptively permitted, but researchers face liability for overstepping the bounds of permitted activity. It is hoped that such an approach will enable socially-beneficial biomedical research to continue while still offering individuals protection against unethical and abusive research practices.
Jorge L. Contreras is Associate Professor in the College Of Law and Adjunct Associate Professor in Human Genetics at the University of Utah. He can be reached at cntreras at gmail.com.