Study

Faced with myriad health, safety, environmental, security and financial risks, how should societies respond?  This course studies the regulation of a wide array of risks, such as disease, food, drugs, medical care, biotechnology, chemicals, automobiles, air travel, drinking water, air pollution, energy, climate change, finance, violence, terrorism, emerging technologies, and extreme catastrophic risks. (Students may propose to research other risks as well.)

Across these diverse contexts, the course focuses on how regulatory institutions deal with the challenges of risk assessment (technical expertise), risk perceptions (public concerns and values), priority-setting (which risks should be regulated most), risk management (including the debates over "precaution" versus benefit-cost analysis, and risk-risk tradeoffs such as countervailing harms and co-benefits), and ongoing evaluation and updating.  It examines the rules and institutions for risk regulation, including the roles of legislative, executive/administrative, and judicial functions; the challenge of fragmentation and integration; the roles of oversight bodies (such as judicial review by courts, and executive review by US OMB/OIRA and the EU RSB); and the potential for international regulatory cooperation.

The course examines these issues through a comparative approach to risk regulation in the United States, Europe, and beyond (especially those countries of interest to the students in the course each year).  It examines the divergence, convergence, and exchange of ideas across regulatory systems; the causes of these patterns; the consequences of regulatory choices; and how regulatory systems can learn to do better.

This is a research seminar, in which students discuss and debate in class, while developing their own research.  We may also have some guest speakers.  Students' responsibilities in this course include active participation in class discussions, and writing a substantial research paper.  Students’ papers may take several approaches, such as analyzing a specific risk regulation; comparing regulation across countries; analyzing proposals to improve the regulatory system; or other related topics.

This course is Law 590, cross-listed as Environ 733.01 and PubPol 891.01.  Graduate and professional students from outside the Law School should enroll via those Environ and PubPol course numbers, and may contact the Nicholas School registrar, Erika Lovelace, e.love@duke.edu, or the Sanford School registrar, Anita Lyon, anita.lyon@duke.edu, with any questions about enrollment.  (The Law School does not use “permission numbers.”)

Data often is referred to as the “new oil” or the “new gold,” given its potential to help unlock many economic and social benefits ranging from making industries more innovative and efficient to aiding in drug discovery, combatting climate change, and identifying and addressing social disparities.  The exponential growth of data has enhanced the need to develop robust data governance and data sharing practices, which can implicate a broad range of legal and policy issues, including privacy, cybersecurity, intellectual property, antitrust, corporate, and emerging AI policies.  Since many U.S. organizations collect and process data in multiple countries, data governance and sharing systems often need to factor in the laws of multiple jurisdictions.The goal of the seminar is to give students a foundation in the key legal and policy issues shaping data governance and data sharing practices, and insight on how organizations are operationalizing data governance and data sharing in the quickly evolving legal environment.  The course addresses relevant US laws and policies as well as select international laws and policies in order to help prepare students to address data governance and sharing practices that extend across certain jurisdictions.  To accomplish these learning objectives, the seminar begins with an overview of data governance and a series of classes focusing on legal and policy issues implicated by data governance.  Next, the seminar includes a series of classes focused on data sharing, including emerging laws and policies promoting data sharing and contractual strategies and challenges for implementing data sharing.  Finally, the course will explore how policymakers are turning to certain technology solutions to help address competing legal and policy concerns such as protecting privacy, on the one hand, and promoting data sharing and transparency, on the other.