Decisional capacity and consent for schizophrenia research

IRB. Jul-Aug 2011;33(4):1-9.

Abstract

Background: Despite substantial research on overall decision-making capacity (DMC) levels in schizophrenia, factors causing individuals to make errors during decision-making regarding research participation or treatment are relatively unknown.

Methods: We examined the responses of 84 middle-aged and older patients with schizophrenia or schizoaffective disorder on a structured DMC measure—the MacArthur Competence Assessment Tool for Clinical Research—to determine the frequency and apparent cause of patients’ errors.

Results: Most errors were due to difficulty recalling the disclosed information (seen in 65.5% of patients), particularly the study’s procedures, potential risks/discomforts, and purpose. Errors attributable to concrete thinking, thought disorder or other psychotic symptoms, or perceived coercion were rarer.

Conclusions: Informed consent procedures might be improved for this population by providing information in a way that facilitates learning and memory, such as iterative disclosure of the information, corrective feedback, and emphasis of key points (e.g., the study’s purpose, procedures, and potential risks).

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Decision Making*
  • Female
  • Humans
  • Informed Consent*
  • Interview, Psychological
  • Male
  • Mental Competency*
  • Middle Aged
  • Research Subjects / psychology*
  • Schizophrenic Psychology*