title: Decisional Capacity to Consent to Clinical Research Involving Placebo in Psychiatric Patients.
abstract: 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.
authors.affiliation: Department of Neurology and Psychiatry, University of Rome "Sapienza", viale dell'Universitá 30, 00185, Rome, Italy.
authors.forename: Giovanna
authors.identifier: http://orcid.org/0000-0002-7998-2443
authors.initials: G
authors.lastname: Parmigiani
authors.affiliation: Department of Neurology and Psychiatry, University of Rome "Sapienza", viale dell'Universitá 30, 00185, Rome, Italy.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Mandarelli
authors.affiliation: Department of Anatomical, Histological Forensic and Orthopaedic Sciences, University of Rome "Sapienza", viale Regina Elena 336, 00185, Rome, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Dacquino
authors.affiliation: Department of Neurosciences, Mental Health and Sensory Organs, University of Rome "Sapienza", via di Grotta Rossa 1035, 00189, Rome, Italy.
authors.forename: Pieritalo
authors.initials: P
authors.lastname: Pompili
authors.affiliation: Department of Neurosciences, Mental Health and Sensory Organs, University of Rome "Sapienza", via di Grotta Rossa 1035, 00189, Rome, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lelli Chiesa
authors.affiliation: Department of Neurology and Psychiatry, University of Rome "Sapienza", viale dell'Universitá 30, 00185, Rome, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Ferracuti
mesh_terms: D000328:Adult; D002986:Clinical Trials as Topic / Q000941:ethics; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D016743:Mental Competency; D008875:Middle Aged; D010919:Placebos; D035842:Research Subjects; D012565:Schizophrenic Psychology
chemical_list: D010919:Placebos
keywords: clinical research; forensic science; informed consent; mental competency; research ethics; schizophrenia