title: The fair transaction model of informed consent: an alternative to autonomous authorization.
abstract: The doctrine of informed consent in bioethics has relied on the view that consent is valid when it represents a patient or research subject's autonomous authorization. In this article we challenge this reigning conception of the validity of informed consent in clinical research, focusing in particular on the problem of the therapeutic misconception. We argue that the autonomous authorization model of informed consent suffers from four defects: (1) it fails to do justice to the relevance of risk-benefit considerations in shaping the criteria for the validity of consent, (2) it compromises the interests of subjects by preventing them from consenting to research participation with less than substantial understanding when doing so would likely be consistent with their preferences and beneficial to them or at least be unlikely to cause them harm, (3) it jeopardizes the interests of investigators by denying them fair notice regarding when the consent of research subjects can be considered valid and thus make it permissible for them to be enrolled in research, and (4) it threatens the reasonable limits on the responsibility of investigators to assure the adequacy of subjects' understanding of what research participation involves. In place of the autonomous authorization model, we present and defend a fair transaction model of informed consent, which better reflects the values served by consent.
authors.affiliation: Department of Clinical Bioethics at the National Institutes of Health, USA.
authors.forename: Franklin G
authors.initials: FG
authors.lastname: Miller
authors.forename: Alan
authors.initials: A
authors.lastname: Wertheimer
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards / Q000639:trends; D032882:Comprehension / Q000941:ethics; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D028681:Moral Obligations; D028701:Patient Rights / Q000592:standards; D018579:Patient Selection / Q000941:ethics; D026684:Personal Autonomy; D012108:Research Personnel; D035842:Research Subjects / Q000523:psychology / Q000600:supply & distribution; D055990:Therapeutic Misconception / Q000941:ethics / Q000523:psychology