By Professor Jorge Contreras for BiolawToday.org.
As “big data” analytical techniques become increasingly prominent in biomedical research, attention is being drawn to the generation and character of large biomedical data repositories. In a chapter that is forthcoming in Governing Medical Knowledge Commons (Katherine Strandburg, Brett Frischmann & Michael Madison, eds., Cambridge Univ. Press 2017, in press), I analyze the role that the state has played with respect to the generation and management of large repositories of scientific data, situating it within the context of commons theory and the organization of common pool resources. Extending beyond the traditional “big science” conception of the state as creator/provisioner of large-scale scientific data pools, and the literature of state-based innovation incentives, it identifies nine distinct but interdependent roles that the state has played in assembling and maintaining scientific data sets.
It uses as a case study the U.S. federal government’s engagement with genomic research projects beginning with the Human Genome Project and encompassing a range of subsequent federally-funded, public-private and private sector genomics research projects. It then assesses the potential roles that the state may play in the formation and maintenance of new pools of biomedical data, namely data from clinical trials. The analytical framework described in this chapter offers a means by which state engagement with data-intensive research projects may be compared across agencies, fields and national borders. This framework may be used to assess the effectiveness of state engagement in such research programs and to configure state engagement in new data commons in a manner that can enhance the efficiency and effectiveness of data sharing arrangements and improve overall social welfare.
In addition to his position at the College of Law, Professor Contreras holds an adjunct faculty appointment in the Department of Human Genetics at the University of Utah School of Medicine and serves as a Senior Policy Fellow at American University Washington College of Law. He has written and spoken extensively on the institutional structures of intellectual property, technical standardization and biomedical research, particularly in the areas of genomics and genetics. He currently serves as a member of the Advisory Council of NIH’s National Center for the Advancement of Translational Sciences (NCATS) and the Board of the Cures Acceleration Network (CAN), and previously served as Co-Chair of the National Conference of Lawyers and Scientists (NCLS) and a member of the National Advisory Council for Human Genome Research (NACHGR). At the University of Utah, he serves on the Scientific Advisory Board of the Utah Genome Project, the Executive Steering Committee of the Center for Clinical & Translational Science and the Oversight Board of the Veterans Administration Genealogy Project. Professor Contreras’s work has appeared in a range of scientific, policy and legal publications including Science, Nature, Nature Biotechnology, Nature Reviews Drug Discovery, Telecommunications Policy, Standards Engineering, Jurimetrics, Arizona State Law Journal, American University Law Review, Utah Law Review, Antitrust Law Journal, Berkeley Technology Law Journal, Ecology Law Quarterly and Harvard Journal of Law and Technology. He is the founding editor of SSRN’s Law, Policy and Economics of Technical Standards eJournal, and was the winner of the Standards Engineering Society’s (SES) 2011 and 2015 scholarly paper competitions. He received his J.D. degree from Harvard Law School and a BSEE and BA degree from Rice University.