HEALTH LAW ETHICS & POLICY WORKSHOP SERIES
presents
Lars Noah
University of Florida
Coerced Participation in Clinical Trials:
Conscripting Human Research Subjects
Thursday, March 11, 2010
12:30 - 2:00
Solarium (room FA2), 84 Queen's Park
Abstract
This paper focuses on a relatively recent CMS initiative called "coverage with evidence development" (CED). The policy conditions Medicare beneficiaries’ access to certain new health care interventions on agreements to enroll as subjects in clinical trials. CMS has discovered a creative way to use its leverage in order to generate useful biomedical information, but it has done so in a manner that has more in common with the Pentagon’s often heavy-handed approach to the use of investigational drugs than with the FDA’s more subtle and indirect methods for encouraging the production of knowledge. My paper roundly criticizes defenses of the CMS initiative published by prominent bioethicists affiliated with NIH. It concludes that aspects of the CED policy run afoul of federal research regulations (which only represent ethical minima in any event) and portend potentially more radical assaults on patient autonomy in this country.
Biography
Lars Noah is a Professor of Law at the University of Florida, and he has taught courses in Torts, Products Liability, Medical Technology, Administrative Law, Medical Malpractice, Conflict of Laws, Food & Drug Law, and Civil Procedure. Professor Noah has published more than fifty scholarly articles on a wide range of subjects as well as a casebook with Foundation Press that focuses on the regulation of medical technologies. He has served as a visiting professor at Georgetown, Texas, Vanderbilt, George Washington, Hastings, and Washington & Lee, and he has worked with expert committees at the National Academy of Sciences and the National Institutes of Health. Before entering academia in 1994, Professor Noah clerked for Chief Judge Abner J. Mikva on the U.S. Court of Appeals for the D.C. Circuit and then practiced law for three years at Covington & Burling in Washington, D.C. He received his B.A. and J.D. from Harvard University.
A light lunch will be served.
For more workshop information, please go to our web site at www.law.utoronto.ca/healthlaw or contact Melissa Casco at m.casco@utoronto.ca
