Ownership Interests in Research Outputs of Genomic Citizen Science Initiatives

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PROJECT SUMMARY/ABSTRACT Ms. Christi Guerrini is research faculty in the Center for Medical Ethics and Health Policy at Baylor College of Medicine (BCM). BCM is a premier academic health science center known for excellence in education, research, and patient care. The BCM main campus is located in the Texas Medical Center, which is the largest medical center in the world. The Center for Medical Ethics and Health Policy at BCM was established in 1982 and has created an academic culture defined by and supportive of collaborative research and teaching. Supported by NIH, PCORI, NEH, the Greenwall Foundation, the Milbank Memorial Fund, the Ford Foundation, and other private foundations, the Center's faculty have engaged in collaborative research that has resulted in more than 550 publications in the peer-reviewed literature, 150 chapters in medical and scientific textbooks, 100 chapters in scholarly monographs, and 35 edited or authored books. Ms. Guerrini is a graduate of Harvard Law School (JD 2001) and the University of Virginia (BA 1998), and she is currently a graduate student at University of Texas School of Public Health (MPH expected 2016). She was a practicing intellectual property attorney before transitioning to academia and has served as a full-time instructor in law schools in New York and Chicago. Ms. Guerrini recently completed an intellectual property fellowship at Chicago-Kent College of Law. She has published in academic law journals and this spring will have additional articles published in the peer-reviewed literature. Ms. Guerrini has served as an invited presenter or moderator at multiple legal conferences and colloquia, including the Supreme Court Intellectual Property Review, PatCon, the Law and Society Association Annual Meeting, the Chicago Intellectual Property Colloquium, and the Licensing Executives Society (US & Canada) Annual Meeting. Although Ms. Guerrini's academic and professional experiences to date have provided her a solid foundation in normative analysis and empirical methods, she will benefit from additional training to achieve her long-term career goals. These goals include becoming (1) an independent investigator and leader in the study of ELSI issues related to emerging models of biomedical research and (2) an expert in the conduct of qualitative and experimental studies to collect data that will inform health policies. To achieve these goals, Ms. Guerrini has proposed focused training in the following areas: theoretical and applied ethics; qualitative research design and data analysis; and conjoint analysis design and data analysis. The proposed plan also includes advanced instruction in genomics. The training will consist of formal coursework in ethics and genomics at Baylor College of Medicine and formal coursework in qualitative methodology and statistics at University of Texas School of Public Health, in addition to intensive training in conjoint analysis methodology at Johns Hopkins Bloomberg School of Public Health. This coursework and the proposed research will be conducted under the guidance of primary mentor Dr. Amy L. McGuire of BCM and co-mentors Dr. Sheryl A. McCurdy of University of Texas School of Public Health and Dr. John F.P. Bridges of Johns Hopkins Bloomberg School of Public Health. In addition, Dr. Richard Gibbs of BCM and Ms. Sharon Terry of Genetic Alliance will advise on the project as needed. The proposed research concerns the question of ownership claims and interests in the outputs of genomic research conducted in a collaborative “citizen science” context. The internet is providing opportunities for citizen scientists to participate in the design and conduct of studies, and these initiatives are increasingly prevalent in the field of genomics, where web-based portals are collecting genetic sequencing data and connecting individuals to genomic studies requesting varying levels of involvement. It is unclear, however, whether genomic citizen scientists have legitimate claims to the outputs of that research—i.e., the findings, written products, and discoveries that are the results of the studies that they support. This research will identify gaps in practice, policy, principles, and preferences relevant to ownership interests in genomic citizen science outputs to provide a normative and empirical foundation from which to develop best practices and policies that will promote public trust and engagement in biomedical research.