Abstract
BackgroundInformed 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.Methods53 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.ResultsNPCs 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.ConclusionsThe 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.
Highlights
Informed consent is a key element of ethical clinical research
Demographic and clinical characteristics Of the 205 subjects eligible for this study, 103 were excluded or were unavailable to participate for various reasons (Fig. 1)
As our results has shown, lack of understanding in informed consent process may occur both in clinical population and in non psychiatric comparison subjects (NPCs), so we argue that routine evaluation of decisional capacity in greater-than-minimal-risk studies may be reasonable
Summary
Informed consent is a key element of ethical clinical research. Addicted population may be at risk for impaired consent capacity. The aim of this study is to assess the capacity of addicted individuals to provide consent to research. Obtaining informed consent is a cornerstone of biomedical research. Valid informed consent requires the researcher to ensure that the consent provided is voluntary and the patient is competent to make the decision [3]. In Spain, there are no defined guidelines as to who should assess patient decision-making competence or how such assessments should be accomplished. Spanish laws about informed consent in biomedical research touch upon a subject's decision-making capacity and indicate those situations where the capacity is limited without defining or specifying how it should be assessed [5, 6].
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