Table 4.
Understanding/Perceptions of Research Risks and the Therapeutic Misconception
| Theme | Relevant Papers and Findings |
| Understanding of risks | • Patients (N = 102) had more difficulty vs. controls (N = 20) in identifying potential risks of enrolling in a (low-risk) real research study, although this appeared remediable with enhanced consent procedure.167 |
| Perceptions of risk/ possible harms | • Pts with SCZ rated varying, hypothetical research protocols as having different levels of potential harm, and pts' ratings frequently differed from those of psychiatrists, with pts rating the vignettes as more harmful.88,123 |
| • Survey study (N = 100 inpatients and outpatients) reported unwillingness to participate in a placebo-controlled medication trial, primarily because of concerns about potential harms.166 | |
| • Pts with SCZ (N = 25) were no more likely than controls (N = 23) to show optimistic bias in rating likelihood of personal risks of variety of adverse events.231 | |
| Therapeutic misconception | • Among varied psychiatric research participants, substantial proportion manifested therapeutic misconception.131 |
| • Using hypothetical clinical trial protocol, found therapeutic misconception prevalent (at least 1 item of 6 answered incorrectly by two-thirds of sample (N = 87 pts with SCZ or SAD); degree of therapeutic misconception negatively correlated with MacCAT-CR Understanding, Appreciation, and Reasoning scores, and with cognitive functioning, yet not associated with psychopathology.185 | |
| • When questioned about reasons for participating, some respondents indicated benefit-seeking and therapeutic misconception reasoning (N = 52 SCZ/SAD pts).172 |
Note: Abbreviations used: MacCAT-CR = MacArthur Competence Assessment Tool for Clinical Research;146 pts = patients; SAD = schizoaffective disorder; SCZ = schizophrenia. Unless otherwise specified, “patients” refers to patients with schizophrenia.