Both the Belmont Report and the Common Rule emphasize the importance of the distinction between research and treatment. An essential requirement of informed consent to research has always been that patients recruited into studies must understand that the researcher-subject relationship and its attendant rights and responsibilities are fundamentally different from the relationship between physician and patient. In fact, since 1982, much empirical work has been devoted to assessing the danger that patient-subjects (not to mention other stakeholders) might misunderstand this critical distinction; that is, that they might fall prey to the “therapeutic misconception.”7 At the same time, a lively conceptual debate has developed regarding the relationship between research and treatment, primarily but not exclusively in the context of clinical trials.8 ELSI researchers have made significant contributions to these literatures, beginning by questioning the term “gene therapy” as applied to early-phase gene transfer research.9
