title: How clinical trials really work rethinking research ethics.
abstract: Despite prevalent concerns about the ethical conduct of clinical trials, little is known about the day-to-day work of trials and the ethical challenges arising in them. This paper reports on a study designed to fill this gap and demonstrates a need to refine the oversight system for trials to reflect an understanding of this day-to-day work. It also illuminates ethical challenges that cannot be addressed by the oversight system and so necessitate a rethinking of the ethics of clinical trials.
authors.affiliation: Center for Bioethics, University of Minnesota, USA.
authors.forename: Debra A
authors.initials: DA
authors.lastname: DeBruin
authors.forename: Joan
authors.initials: J
authors.lastname: Liaschenko
authors.forename: Anastasia
authors.initials: A
authors.lastname: Fisher
mesh_terms: D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic / Q000941:ethics*; D026724:Ethical Review; D028744:Ethics Committees, Research; D004993:Ethics, Nursing; D032984:Ethics, Research; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D008297:Male; D008875:Middle Aged; D033262:Narration; D009723:Nurse-Patient Relations / Q000941:ethics*; D009726:Nurses; D018579:Patient Selection / Q000941:ethics*; D012107:Research Design; D012108:Research Personnel / Q000941:ethics*; D035844:Researcher-Subject Relations / Q000941:ethics*; D014481:United States; D057188:Workflow; D016526:Workload