Decisional Capacity to Consent to Clinical Research Involving Placebo in Psychiatric Patients

• Published in: Journal of forensic sciences Vol. 61; no. 2; pp. 388 - 393
• Main Authors: Parmigiani, Giovanna, Mandarelli, Gabriele, Dacquino, Claudia, Pompili, Pieritalo, Lelli Chiesa, Giovanni, Ferracuti, Stefano
• Format: Journal Article
• Language: English
• Published: United States Blackwell Publishing Ltd 01.03.2016; Wiley Subscription Services, Inc
• Subjects: Adult; clinical research; Clinical Trials as Topic - ethics; Female; Forensic psychiatry; forensic science; Humans; Informed Consent; Male; Medical research; Mental Competency; Middle Aged; Patients; Placebos; Reasoning; research ethics; Research Subjects; Schizophrenia; Schizophrenic Psychology; forensic science; mental competency; schizophrenia; informed consent; research ethics; clinical research
• ISSN: 0022-1198; 1556-4029; 1556-4029
• DOI: 10.1111/1556-4029.13000

Evidence from a few studies indicates the existence of several issues related to psychiatric patients' decisional capacity to give informed consent to clinical research. Clinicians often face difficulties in acquiring valid informed consent in clinical practice and even more so in drug trials. Participants often fail to fully understand or retain information regarding the actual implications of research protocols. The Brief Assessment for Consent to Clinical Research (BACO) was developed to investigate capacity to consent to clinical trials and further compare patients with schizophrenia and healthy comparisons' decisional capacity. A method to avoid possible confounding effects of choosing a treatment regarding a current disease was applied. The study groups were administered the BACO and the MacArthur Competence Assessment Tool for Clinical Research. Psychiatric patients performed poorer in comprehending, appreciating, and reasoning abilities, than their healthy counterparts. Impaired cognitive functioning and psychiatric symptoms severity were associated with reduced capacity to consent.