Enhancing the informed consent process in psychiatric outpatients with a brief computer -based method

• Published in: Psychiatry research Vol. 245; pp. 354 - 360
• Main Authors: Morán-Sánchez, Inés, Luna, Aurelio, Pérez-Cárceles, Maria D
• Format: Journal Article
• Language: English
• Published: Ireland Elsevier Ireland Ltd 30.11.2016
• Subjects: Adult; Biomedical Research - ethics; Comprehension; Computer-assisted; Consent form; Decision Making; Female; Humans; Informed Consent; Male; Mental Competency; Mental disorders; Mental Disorders - therapy; Middle Aged; Outpatients; Psychiatry; Research ethics; Decision-making; MacArthur Competence Assessment Tool for Clinical Research; Computer-assisted; Mental disorders; Diagnostic and Statistical Manual of Mental Disorders Text Revision; DSM-IV TR; MacCAT–CR; GAF; Global Assessment Functional Scale; SC; SD; informed consent; MMSE; standard consent; Consent form; Research ethics; IC; enhanced consent; Mini-Mental State Examination; EC; standard deviation
• ISSN: 0165-1781; 1872-7123
• DOI: 10.1016/j.psychres.2016.08.045

Abstract Informed consent is a key element of ethical clinical research. Those with mental disorders may be at risk for impaired consent capacity. Problems with procedures may also contribute to patient's ´difficulties in understanding consent forms. The present investigation explores if a brief technologically based information presentation of the informed consent process may enhance psychiatric patients understanding and satisfaction. In this longitudinal, within-participants comparison study, patients who initially were judged to lack capacity to make research decisions ( n =41) and a control group ( n =47) were followed up. Decisional capacity, willingness to participate and cognitive and clinical scores were assessed at baseline and after receiving the computer-assisted enhanced consent. With sufficient cueing, patients with impaired research-related decision-making capacity at baseline were able to display enough understanding of the consent form. Patient satisfaction and willingness to participate also increased at follow up. Implications of these results for clinical practice and medical research involving people with mental disorders are discussed.