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Legal Frameworks for the Storage and Use of Genetic Samples and Information (Conley & Davis)
Significance: All the core projects address ELSI issues related to large collections of samples. This legal analysis project is an effort to meld the various stakeholder theories of ownership of genetic samples. From case law and the legal literature, a number of theories have emerged for regulating the relationship among subject-donors, institutions, and individual investigators. Most recently, for example, a Missouri court held that tissue donors had made a “gift” to a university, and that the university’s consequent property rights defeated the ownership claim of the individual researcher (Washington Univ. v. Catalona, 437 F. Supp. 2d 985 (E.D. Mo. 2006)). An earlier, much-discussed case of Greenberg v. Miami Children’s Hosp. Research Inst., 254 F Supp. 2d 1064 (S.D. Fla. 2003) rejected fiduciary duty, lack of informed consent, fraud, and trade secret theories, but held open the possibility that an institution that capitalized on donated tissue samples might be liable to donors for unjust enrichment. Still other cases have analogized tissue donation to bailment, as when you leave clothes at a dry cleaner (e.g., York v. Jones, 717 F. Supp. 421 (E.D. Va. 1989). Drawing on such cases, legal writers have proposed trusteeship (Boyle, 2003), benefit-sharing (Gitter, 2004; Oberdorfer, 2004), commodity, and even “waste” models (Waldby & Mitchell, 2006) in relation to donated samples. Finally, precedents from outside the biobank area—for example, experience with the Native American Grave Protection and Repatriation Act, and the European Union’s Privacy Directive—underscore the reality that “ownership” and “privacy” are culture-specific concepts.
Research Question 1: How can different stakeholder views, extracted from data from the core projects and relevant legal documents, be used to identify different cultural models of biobank regulation in terms of access, control, use, ownership and other features?
Research Question 2: Is it possible to develop a regulatory model that is at once sensitive to cultural concerns and realistic from the perspective of legal specialists?
Outcomes: We will develop a model statute that is responsive to the themes that emerge from our data, the existing case law, and the legal commentary. Rather than being merely a reformulation of existing legal thinking, this model statute will incorporate many perspectives, particularly that of subjects, who are typically underrepresented in legal and scholarly discourse. After refining our proposal in consultation with our External Advisors, we will disseminate our statute for legislative consideration at the federal and state levels, both by direct contact and scholarly publication. The target audiences will include members and staff of relevant committees of the Congress and the state legislatures; the National Conference of Commissioners on Uniform State Laws, which proposes model statutes for enactment on a state-by-state basis; and the American Law Institute, which regularly promulgates model laws and “Restatements” of significant areas of law.
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