Background
Informed consent is a
key element of ethical clinical research. Addicted population may be at risk
for impaired consent capacity. However, very little research has focused on
their comprehension of consent forms. The aim of this study is to assess the
capacity of addicted individuals to provide consent to research.
Methods
53 subjects with DSM-5
diagnoses of a Substance Use Disorder (SUD) and 50 non psychiatric comparison
subjects (NPCs) participated in the survey from December 2014 to March 2015.
This cross-sectional study was carried out at a community-based Outpatient
Treatment Center and at an urban-located Health Centre in Spain. A binary
judgment of capacity/incapacity was made guided by the MacArthur Competence
Assessment Tool for Clinical Research (MacCAT–CR) and a clinical interview.
Demographics and clinical characteristics were assessed by cases notes and the
Mini-Mental State Examination, the Global Assessment Functional Scale and the
Clinical Global Impression Scale.
Results
NPCs performed the best
on the MacCAT–CR, and patients with SUD had the worst performance, particularly
on the Understanding and Appreciation subscales. 32.7 % SUD people lacked
research-related decisional capacity. There were no statistically significant
differences between the groups in terms of capacity to consent to research.
Conclusions
The findings of our
study provide evidence that a large proportion of individuals with SUD had
decisional capacity for consent to research. It is therefore inappropriate to
draw conclusions about capacity to make research decisions on the basis of a
SUD diagnosis. In the absence of advanced cognitive impairment, acute
withdrawal or intoxication, we should assume that addicted persons possess
decision-making capacity. Thus, the view that people with SUD would ipso facto
lose decision-making power for research consent is flawed and stigmatizing.
Below: MacCAT-CR scales scores in
SUD. Abbreviations: MacCAT-CR, MacArthur Competence Assessment Tool for
Clinical Research; SUD, Substance Use Disorders; NS, Non significant
Full article at: http://goo.gl/i6RhhQ
By: Inés Morán-Sánchez, Aurelio Luna, Maria Sánchez-Muñoz, Beatriz Aguilera-Alcaraz, and Maria D. Pérez-Cárceles
Mental Health
Centre (Health Service of Murcia), Real St 8, E-30201, Cartagena (Murcia),
Spain
Department of
Legal and Forensic Medicine, Biomedical Research Institute (IMIB), Regional
Campus of International Excellence “Campus Mare Nostrum”, Faculty of Medicine,
University of Murcia, (Murcia), Spain
Isaac Peral
Health Centre (Health Service of Murcia), Ulloa St 6. E 30300, Cartagena
(Murcia), Spain
Inés Morán-Sánchez, Email: se.mrac@narom.seni.
More at: https://twitter.com/hiv
insight
No comments:
Post a Comment