MacCAT-CR: a way to legitimate the informed consent process in clinical research

Abstract

Informed consent is an essential ethical component of clinical trials, however, there are still many doubts about its proper realization nowadays. Consent is usually obtained formally, but there are doubts about the competence of participants in a clinical trial to decide whether to participate. From there, a concern arises with the use of instruments capable of assessing the participants’ competence to express a decision. The MacArthur Competence Assessment Tool (MacCAT-CR) can be considered as an appropriate tool for assessing the informed consent process, as it can evaluate participants’ ability to express a decision about their participation in each clinical trial. We review the application of MacCAT-CR in studies involving participants without cognitive impairment, representative of most individuals who generally participate in clinical trials. Our results demonstrate that few studies are evaluating the use of this tool to assess the competence of reasonable participants since most studies are focused on evaluating the consent process in individuals with limited autonomy. Here we discuss the ethical relevance of ensuring that the autonomy of research participants is manifested by assessing the effectiveness of the consent process, especially in developing countries.