Patient and Psychiatrist Ratings of Hypothetical Schizophrenia Research Protocols: Assessment of Harm Potential and Factors Influencing Participation Decisions

• Published in: The American journal of psychiatry Vol. 159; no. 4; pp. 573 - 584
• Main Authors: Roberts, Laura Weiss, Warner, Teddy D., Brody, Janet L., Roberts, Brian, Lauriello, John, Lyketsos, Constantine
• Format: Journal Article
• Language: English
• Published: Washington, DC American Psychiatric Publishing 01-04-2002; American Psychiatric Association
• Subjects: Adult; Antipsychotic drugs; Attitude; Attitude of Health Personnel; Bioethics; Biological and medical sciences; Clinical trials; Clinical Trials as Topic; Decision making; Female; Humans; Informed Consent; Male; Medical research; Medical sciences; Mental Competency; Methodology. Experimentation; Middle Aged; Motivation; Participation; Patient Education as Topic; Patient Participation; Patients; Physician-Patient Relations; Placebos - therapeutic use; Problem Solving; Psychology. Psychoanalysis. Psychiatry; Psychopathology. Psychiatry; Risk Assessment; Schizophrenia; Schizophrenia - diagnosis; Schizophrenia - drug therapy; Schizophrenic Psychology; Surveys and Questionnaires; Techniques and methods; Ability; Human; Evaluation; Participation; Neuroleptic; Psychotropic; Attitude; Decision making; Toxicity; Treatment efficiency; Prediction; Schizophrenia; Patient; Experimental protocol; Psychiatrist; Psychosis; Ethics; Chemotherapy; Motivation; Sociodemographic factor; Scientific research; Risk factor; Informed consent; Comparative study; Empirical Approach; Mental Health Therapies; Biomedical and Behavioral Research
• ISSN: 0002-953X; 1535-7228
• DOI: 10.1176/appi.ajp.159.4.573

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. METHOD: 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.