Law of Research with Humans and Animals

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Spring 2014 Course
Meets: M 1:10pm - 3:10pm in WCC Room 4061
2 classroom credits

Research is often defined as an attempt to gain generalizable knowledge through systematic generation and study of data. When conducted with human or animal subjects, the research process has become heavily regulated in the U.S. and in other national jurisdictions. This course will explore the history and development of legal rules and ethical precepts governing research, and will concentrate on those relating to research with human and animal subjects. We will consider, among other issues, the limits of applicability of these regimes; the various types of research to which regulations may or may not apply, and why (e.g., clinical trials, social science research, public health research, survey and political opinion research, oral history); the widespread reliance on peer review committees to consider ethics and scientific merit of proposed studies; the extent to which "group harms" (as opposed to individual harms) should be considered in the research approval process; and the potential conflict between these regulatory regimes, First Amendment freedoms, and academic traditions. Specifically, the course will cover the "Common Rule" governing federally funded research, analogous FDA regulations governing clinical trials, animal research regulations of the USDA and the U.S. Pubic Health Service, the EU Clinical Trials Directive, federal and state laws governing stem cell and genetic research, and to the extent they apply to reseach with humans, privacy regulations under HIPAA and the EU Data Privacy Directive. Attention will also be directed to research involving pediatric subjects, persons in correctional custody, pregnant woman and fetuses, and the decisionally impaired and mentally ill. As background, we will consider allegations of fraud in research, and how these allegations are investigated and resolved through complex, mandatory procedural regulations, and how these procedures intersect with the separate regulatory systems regarding research with humans and animals.

Subject Areas: Regulatory Law , Health Law .