title: Improving informed consent in clinical trials: a duty to experiment.
abstract: Practitioners of clinical trials have a responsibility to ensure that patients' participation in research be informed and voluntary. This responsibility implies that we should strive continuously to improve the effectiveness of methods for informing prospective research volunteers about experimental studies, thereby enhancing the protection of their interests. We should test innovations in informed consent in realistic contexts (i.e., in clinical trials) and with randomization, when it is appropriate, at the first opportunity. In this study, we develop a preliminary proposal to improve the quality of informed consent, based on experimentation with informed consent in ongoing clinical trials. We discuss the conceptual, ethical, organizational, and technical bases for such an effort.
authors.affiliation: Department of Veterans Affairs Cooperative Studies Program Coordinating Center, Palo Alto VAHCS, California, USA.
authors.forename: P W
authors.initials: PW
authors.lastname: Lavori
authors.forename: J
authors.initials: J
authors.lastname: Sugarman
authors.forename: M T
authors.initials: MT
authors.lastname: Hays
authors.forename: J R
authors.initials: JR
authors.lastname: Feussner
mesh_terms: D002755:Choice Behavior; D003657:Decision Making; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D016743:Mental Competency; D017063:Outcome Assessment, Health Care; D010358:Patient Participation; D010817:Physician-Patient Relations; D016032:Randomized Controlled Trials as Topic / Q000145:classification / Q000379:methods; D012107:Research Design; D018570:Risk Assessment; D012941:Social Responsibility; D014342:Truth Disclosure