Coerced Participation in Clinical Trials: Conscripting Human Research Subjects

Lars Noah, University of Florida Levin College of Law


This paper focuses on a relatively recent initiative from the U.S. Centers for Medicare & Medicaid Services (CMS) 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 Food & Drug Administration’s more subtle and indirect methods for encouraging the production of knowledge. This paper roundly criticizes defenses of the CMS initiative published by prominent bioethicists affiliated with the National Institutes of Health. 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.