title: What we worry about when we worry about the ethics of clinical research.
abstract: Clinical research is thought to be ethically problematic and is subject to extensive regulation and oversight. Despite frequent endorsement of this view, there has been almost no systematic evaluation of why clinical research might be ethically problematic. As a result, it is difficult to determine whether the regulations to which clinical research is subject address the ethical concerns it raises. Commentators who consider this question at all tend to assume that clinical research is ethically problematic because it exposes some individuals to risks for the benefit of others. Yet, many other activities that expose some individuals to risks for the benefit of others are not subject to extensive regulation and oversight. This difference raises the question of whether clinical research is distinct from these activities in normatively relevant ways and, if so, what implications this difference (or differences) has for how clinical research should be regulated and conducted. The present manuscript attempts to answer this question by comparing clinical research to two other activities that expose some individuals to risks for the benefit of others. This comparison highlights an aspect of clinical research which has received relatively little attention, namely, the active role investigators play in exposing subjects to risks. I argue that this aspect explains much of the ethical concern expressed regarding clinical research. I end by considering the normative significance of this feature and the implications it has for how clinical research should be regulated and conducted.
authors.affiliation: Department of Bioethics, NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD 20892, USA. dwendler@nih.gov
authors.forename: David
authors.initials: D
authors.lastname: Wendler
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D032984:Ethics, Research; D006801:Humans; D007221:Industry; D007258:Informed Consent / Q000941:ethics; D033281:Nontherapeutic Human Experimentation / Q000941:ethics; D010372:Pediatrics; D012107:Research Design; D012108:Research Personnel / Q000941:ethics*; D035862:Vulnerable Populations