Study

What are the government policies that support science? How is science regulated and controlled? What can science contribute to law and policy? How do the states, the federal government and international agencies interact to set science policy? How do disparate regulations and law impact research and translation? How is scientific research funded? These questions and more will be explored by looking at the interaction of law, science, and policy. The class is a mix of law, ethics and science students, and learning how to talk to one another in a common language is an important element of the course. Classes will include consideration and analysis of cases studies. There are no prerequisites for the course and there is no requirement that students have either graduate or upper-level undergraduate training in the sciences. Course evaluation (i.e. your grade) will be based on class participation and a final exam.

All MA, PhD and JD/MA students should register under BIOETHIC 704 – approval of professor is required. All law students (other than JD/MAs) should register under LAW 333.

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.”)