title: The rationale and ethics of medication-free research in schizophrenia.
abstract: Schizophrenia research is receiving intense scrutiny from an ethical perspective. Medication-free protocols present a most vexing dilemma in that they greatly enhance the opportunity for advancing knowledge but also raise the prospect of withholding known effective treatment. In this article, we discuss the purpose of medication-free protocols in new drug development and nontreatment research. Potential benefits and risks associated with drug discontinuation are evaluated, and methods for minimizing risk and increasing benefits are proposed as guidelines for the protection of individual subjects. The complex problem of informed consent also is addressed. Medication-free research in schizophrenia is difficult, but it can be conducted relatively, safely with freely consenting, competent subjects. Assurance that studies meet this standard is required. We believe that such investigations can meet high standards of ethics and subject protection, and that a radical revision of procedures for research review and implementation is not indicated.
authors.affiliation: Department of Psychiatry, University of Maryland School of Medicine, Baltimore, USA.
authors.forename: W T
authors.initials: WT
authors.lastname: Carpenter
authors.forename: N R
authors.initials: NR
authors.lastname: Schooler
authors.forename: J M
authors.initials: JM
authors.lastname: Kane
mesh_terms: D000208:Acute Disease; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D028642:Persons with Psychiatric Disorders; D018579:Patient Selection; D012107:Research Design / Q000592:standards*; D035842:Research Subjects; D018570:Risk Assessment; D012559:Schizophrenia / Q000188:drug therapy / Q000628:therapy; D012565:Schizophrenic Psychology; D028761:Withholding Treatment
chemical_list: D014150:Antipsychotic Agents