title: Trial design and informed consent for a clinic-based study with a treatment as usual control arm.
abstract: Employing the National Institute of Mental Health-funded Prevention of Suicide in Primary Care Elderly Collaborative Trial as a case study, we discuss 2 sets of ethical issues: obtaining informed consent for a clinic-based intervention study and using treatment as usual (TAU) as the control condition. We then address these ethical issues in the context of the debate about the quality improvement efforts of health care organizations. Our analysis reveals the tension between ethics and scientific integrity involved with using TAU as a control condition and the difficulty in designing high-quality research in a community-based setting.
authors.affiliation: Department of Health Services Administration and Center for Bioethics and Health Law, University of Pittsburgh, 3708 5th Ave., Pittsburgh, PA 15213, USA. degen@pitt.edu
authors.forename: H B
authors.initials: HB
authors.lastname: Degenholtz
authors.forename: L S
authors.initials: LS
authors.lastname: Parker
authors.forename: C F
authors.initials: CF
authors.lastname: Reynolds
mesh_terms: D000368:Aged; D003153:Community Health Services; D035061:Control Groups; D003866:Depressive Disorder / Q000628:therapy*; D030881:Disclosure; D006299:Health Services for the Aged; D006801:Humans; D007258:Informed Consent; D008605:Mental Health Services; D017063:Outcome Assessment, Health Care; D011320:Primary Health Care; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D012306:Risk; D000092864:Suicide Prevention
keywords: Biomedical and Behavioral Research; Mental Health Therapies