Genetic Property

Abstract

Under U.S. law, there is no property interest in mere facts. But with respect to factual data relating to human genes, a de facto property regime has emerged in all but name. The level of control that individuals have exerted over genetic data exhibits the classic hallmarks of Blackstonian property: the right to exclude, the right to destroy, dead hand control, divisibility, and alienability. This degree of control has arisen through an expansive interpretation of the ethical requirement of informed consent. Notwithstanding the ongoing evolution of federal research regulations that permit some data-based research to proceed without extensive consent requirements, actions sounding in state property law pay little heed to these regulatory procedures. The resulting property-like regime over genetic data has enabled individuals to bring litigation disrupting and even halting valuable biomedical research and leading to the destruction of valuable research resources.

Looking to Calabresi’s and Melamed’s seminal analysis of property and liability rules, I propose that the property-like treatment of genetic data be replaced by a combination of existing and new regulations of researcher conduct (liability rules) to protect individuals from abusive research practices. This approach would shift the landscape from one in which data-based research cannot occur without the consent of individual research participants to one in which research is presumptively allowed, but researchers face liability for overstepping the bounds of permitted activity.

Keywords: genetic, data, genome, privacy, HIPAA, Common Rule, Informed Consent, IRB