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Perceptions of Ownership of Biological Samples (Rothschild, Evans, Conley, Corbie-Smith, Henderson, Dressler, Davis)
Significance: One of the major trends in genomic scale-up is the creation of centralized DNA banks whose “deposits” are made available to researchers through a variety of mechanisms. The implications of contributing biological samples to such biobanks are complex given that the claim of ownership of human tissue for research purposes takes place at many levels with many claimants. Claims of ownership from subjects of medical research have been explored extensively and taken up by the courts. The claim of ownership by individual investigators has rarely been studied, but has gained in importance as public-private partnerships and the public’s interest in genetic research have increased. This project explores investigator norms of ownership. In the P20 pilot study at UNC, we found that investigators’ perceptions of ownership of biologic samples were not based on knowledge of institutional or federal policy and guidelines, but rather were informed by a kind of institutional ethos that conferred individualized ownership. Investigators said, “I assume I would take my samples with me if I left the University,” and “I’m sure the University couldn’t sell my samples.” We hypothesize this perspective differs depending on research context and have designed an exploratory study that will document the perspectives of researchers working under different institutional cultures. Understanding possible differences in perspectives is important as academic institutions, the federal government, and private industry increasingly endeavor to collaborate on large-scale genomic research. If well-run biobanks are the future of biologic sample research, it is essential to understand what policies will encourage investigators to participate fully and enthusiastically, and what policies will be most fair and equitable with adequate protection to subjects, investigators, and institutions. Project findings will assist in establishing clear guidelines for ownership, transmission, and sharing of genetic material and data; and lead to recommendations for ownership and data sharing policies. This project also provides an important opportunity for cross-CEER collaboration and collaboration with other research sectors less commonly involved in ELSI studies. This project has the following two research questions:
Research Question 1: What ELSI issues are posed by new technologies for collecting, storing, and sharing of DNA samples, for investigators and administrators in public and private academic institutions, private industry, and government research?
Research Question 2: How can the results of this study be utilized to ensure the most efficient and judicious development of centralized DNA banking facilities?
Outcomes: Challenges for large biobanks include participation by investigators, equitable intellectual property policies, and safe confidential storage. Results from this project can be used to structure a user-friendly biobank by anticipating concerns and misunderstandings of investigators and administrators, and will result in policy-relevant publications and reports to inform workable policies for biobanks that encourage participation and ensure consistency with institutional and federal guidance.
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