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

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 brie...

Full description

Saved in:
Bibliographic Details
Published in:Psychiatry research 2016-11, Vol.245, p.354-360
Main Authors: Morán-Sánchez, Inés, Luna, Aurelio, Pérez-Cárceles, Maria D
Format: Article
Language:English
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
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:0165-1781
1872-7123
DOI:10.1016/j.psychres.2016.08.045