title: Patient and psychiatrist ratings of hypothetical schizophrenia research protocols: assessment of harm potential and factors influencing participation decisions.
abstract: OBJECTIVE
  A central ethical issue in schizophrenia research is whether participants are able to provide informed consent, particularly for protocols entailing medication washouts or placebo treatments. Few data show how patients with schizophrenia and psychiatrists assess such scientific designs regarding potential harm, willingness to participate, and the relative influence of clinicians, family members, and financial incentives upon participation decisions.
  
  
  METHODS
  In this preliminary study, structured interviews were conducted with schizophrenia patients (N=59), and parallel surveys were completed by attending and resident psychiatrists (N=70). Four hypothetical research protocols were rated. Patients were asked about their own views; psychiatrists provided both their personal views and predictions of patient views.
  
  
  RESULTS
  Patients and psychiatrists both perceived substantially different levels of harm across the four protocols, identifying significantly greater harm for medication washouts or placebo treatments. Participants were less willing to enroll in protocols perceived as more harmful. Schizophrenia patients found enrollment decisions relatively easy. Patients and psychiatrists indicated that doctor recommendations, monetary incentives, and, to a lesser extent, family preferences had a mild influence on participation decisions.
  
  
  CONCLUSIONS
  Given hypothetical protocols with variable design elements, schizophrenia patients and psychiatrists made meaningful and discerning harm assessments and participation decisions. These findings suggest that schizophrenia patients may have strengths in the research consent process that may not be fully recognized. The impact of outside influences upon research enrollment decisions remains uncertain. While psychiatrists were often accurate in predicting patient responses, data suggest the importance of clarifying views of individual patients regarding specific protocols.
authors.affiliation: Empirical Ethics Group, University of New Mexico School of Medicine, Albequerque 87156-5326, USA. lroberts@salud.unm.edu
authors.forename: Laura Weiss
authors.initials: LW
authors.lastname: Roberts
authors.forename: Teddy D
authors.initials: TD
authors.lastname: Warner
authors.forename: Janet L
authors.initials: JL
authors.lastname: Brody
authors.forename: Brian
authors.initials: B
authors.lastname: Roberts
authors.forename: John
authors.initials: J
authors.lastname: Lauriello
authors.forename: Constantine
authors.initials: C
authors.lastname: Lyketsos
mesh_terms: D000328:Adult; D001290:Attitude; D001291:Attitude of Health Personnel; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D016743:Mental Competency; D008875:Middle Aged; D009042:Motivation; D010353:Patient Education as Topic; D010358:Patient Participation; D010817:Physician-Patient Relations; D010919:Placebos / Q000627:therapeutic use; D011340:Problem Solving; D018570:Risk Assessment; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D011795:Surveys and Questionnaires
chemical_list: D010919:Placebos