title: A placebo controlled trial for an NMO relapse prevention treatment: Ethical considerations.
abstract: This paper addresses the ethical acceptability of a proposed placebo controlled trial of a new intervention as a possible relapse prevention treatment for Neuromyelitis Optica (NMO). In the analysis of this controversial ethical issue, the author points out significant factors that are often overlooked or ignored, such as the life-long implications for study participants and others living with the disease, and also addresses commonly noted issues, such as vulnerability, benefits, harms, and justice that always require attention in research review.
authors.affiliation: Icahn School of Medicine at Mount Sinai, One Gustave Levy Place, Box 1076, Annenberg 12-42, NY 10029, USA. Electronic address: rosamond.rhodes@mssm.edu.
authors.forename: Rosamond
authors.initials: R
authors.lastname: Rhodes
mesh_terms: D018849:Controlled Clinical Trials as Topic / Q000941:ethics*; D006801:Humans; D009471:Neuromyelitis Optica / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy*; D055502:Secondary Prevention / Q000941:ethics*
keywords: Evidence; Justice; NMO; Placebo controlled trial; Research ethics