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Information disclosure, subject understanding, and informed consent in psychiatric research

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Law and Human Behavior

Abstract

Investigator information disclosure and subject understanding are examined in four psychiatric studies using data drawn from observation of 88 consent sessions. In an attempt to determine if subjects' understanding of research can be improved, three experimental methods of information giving (including the use of independent subject educators) are compared to standard investigator disclosure. Findings indicate that the use of experimental techniques generally increases the quality of information delivered to prospective subjects, with disclosures by subject educators generating the most complete information. Subject understanding was also found to be significantly associated with the quality of information provided. Diagnosis and level of psychopathology, however, were found to be the most important predictors of subject understanding, with schizophrenics and the highly impaired most likely to demonstrate poor comprehension. These results suggest that the degree of improvement in understanding obtainable for severely disordered subjects is substantially lower than it is for others. The implications of these findings for informed consent, the regulation of medical research, and the protection of human subjects are discussed.

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Authors and Affiliations

  1. Department of Sociology, University of Massachusetts, Boston

    Paul R. Benson

  2. Program in Law and Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, USA

    Loren H. Roth & Charles W. Lidz

  3. Program in Medicine and the Law, Department of Psychiatry, University of Massachusetts Medical Center, Worcester

    Paul S. Appelbaum

  4. Department of Medical Humanities, University of Texas Medical Branch, Galveston

    William J. Winslade

Authors
  1. Paul R. Benson
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  2. Loren H. Roth
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  3. Paul S. Appelbaum
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  4. Charles W. Lidz
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  5. William J. Winslade
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Additional information

Supported by the Foundations Fund for Research in Psychiatry. The authors thank Florence Cohen, Mary Scott Dewire, Mary Hagman, Janice Holden, and Michael Malkin, all of whom assisted in carrying out this study. We also wish to thank Charles Brody, Gray Cavender, Gene Fisher, Nancy Jurik, and Joseph Sheley for their valuable comments on earlier drafts of this article. Jane Tamae Kuroda ably prepared the manuscript.

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Benson, P.R., Roth, L.H., Appelbaum, P.S. et al. Information disclosure, subject understanding, and informed consent in psychiatric research. Law Hum Behav 12, 455–475 (1988). https://doi.org/10.1007/BF01044628

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