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Determining when impairment constitutes incapacity for informed consent in schizophrenia research

Department of Psychiatry, Bioethics Program, and Center for Behavioral and Decision Sciences in Medicine, University of Michigan, Ann Arbor, Michigan

Paul S. Appelbaum, MD

Department of Psychiatry, Columbia University, New York

Jeffrey Swan, MA

Department of Psychiatry, University of Rochester, Rochester, New York

T. Scott Stroup, MD, MPH

Department of Psychiatry, University of North Carolina, Chapel Hill, North Carolina

Joseph P. McEvoy, MD

Department of Psychiatry, Duke University, Durham, North Carolina

Donald C. Goff, MD

Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts

Dilip V. Jeste, MD

Department of Psychiatry, University of California San Diego and VA San Diego Healthcare System, San Diego, California

J. Steven Lamberti, MD, Adrian Leibovici, MD and Eric D. Caine, MD

Department of Psychiatry, University of Rochester, Rochester, New York, USA

Correspondence: Dr Scott Y. H. Kim, 300 North Ingalls, Ann Arbor, MI 48109-0429, USA. Email: scottkim{at}umich.edu

Declaration of interest D.C.G. is on the advisory boards of several pharmaceutical companies. Funding detailed in Acknowledgements.

Background Although people with schizophrenia display impaired abilities for consent, it is not known how much impairment constitutes incapacity.

Aims To assess a method for determining the categorical capacity status of potential participants in schizophrenia research.

Method Expert-judgement validation of capacity thresholds on the sub-scales of the MacArthur Competence Assessment Tool - Clinical Research (MacCAT–CR) was evaluated using receiver operating characteristic (ROC) analysis in 91 people with severe mental illness and 40 controls.

Results The ROC areas under the curve for the understanding, appreciation and reasoning sub-scales of the MacCAT–CR were 0.94 (95% CI 0.88–0.99), 0.85 (95% CI 0.76–0.94) and 0.80 (95% CI 0.70–0.90). These findings yielded negative and positive predictive values of incapacity that can guide the practice of investigators and research ethics committees.

Conclusions By performing such validation studies for a few categories of research with varying risks and benefits, it might be possible to create evidence-based capacity determination guidelines for most schizophrenia research.

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