The Regulation of Human-Subject ResearchA human subject of research is someone "about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information." "Human subject research" thus includes much of the biomedical and social-science research done in universities and hospitals today. The federal government requires institutions receiving federal funds to license and monitor every instance of human-subject research. This is primarily done by an "institutional review board." This course will study the IRB system as a problem in regulatory choice. The course's overarching question will be: Does the IRB system do more good than harm?This overarching question will lead us to many subsidiary questions. Need human-subject research be regulated at all? Have any convincing justifications been advanced for regulating it? How great are the harms the IRB system prevents? How great are the costs "in dollars, distress, disease, and death" the system imposes? What ethical ideas underlie the system? Are they defensible? Does the IRB system infringe principles of free speech and of academic freedom? What standards are supposed to guide IRB decisions? How do IRBs make decisions? How well do they make decisions? Does the IRB system comply with constitutional requirements of due process? What is the incentive structure that shapes IRB decisions and that has shaped the development of the IRB system? Can the central regulatory method of the IRB system "informed consent " accomplish the purposes expected of it? What other methods of regulating human-subject research are already in place? What other methods might be devised? While the course presents a classic lawyer's question " how should a social enterprise be legally regulated" the answer to the question depends on insights from many fields. Consequently, I expect to invite historians, sociologists, psychologists, psychiatrists, physicians, lawyers, and "human-subject researchers" to visit the class. Similarly, the readings will be drawn from many fields, especially from the empirical literature in medical journals that provides the primary window into the work of IRBs. We will also read portions of manuscripts of books and articles currently being written on the IRB system, including the draft of a book on the IRB system I am writing with an MD/JD from Baylor. Finally, the course may be coordinated with a small conference of experts on the IRB system. I currently anticipate that grades for the course will be based on a paper (or papers) and class participation.
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