- Background: Persons with aphasia are particularly vulnerable when taking part in research studies. The process of informed consent (IC) depends on a number of factors, which may be compromised in aphasia. Very little research has been conducted on the process, and the issue is often neglected in published research. Aims: The aim of the research was to identify potential facilitators and barriers to the process of IC, focusing on verbal and nonverbal components of the interaction. Methods Procedures: As part of a larger study, the IC process for three trial participants was examined in detail. Specific portions of the enrolment process dealing with the explanation of the concepts placebo, randomisation, and double blind were analysed. Our methods were qualitative and comprised systematic observation and analysis of video- recorded recruitment as well as feedback sessions with these participants after the study had been completed and their participation in the research was over. Outcomes Results: Results demonstrated that the process ofBackground: Persons with aphasia are particularly vulnerable when taking part in research studies. The process of informed consent (IC) depends on a number of factors, which may be compromised in aphasia. Very little research has been conducted on the process, and the issue is often neglected in published research. Aims: The aim of the research was to identify potential facilitators and barriers to the process of IC, focusing on verbal and nonverbal components of the interaction. Methods Procedures: As part of a larger study, the IC process for three trial participants was examined in detail. Specific portions of the enrolment process dealing with the explanation of the concepts placebo, randomisation, and double blind were analysed. Our methods were qualitative and comprised systematic observation and analysis of video- recorded recruitment as well as feedback sessions with these participants after the study had been completed and their participation in the research was over. Outcomes Results: Results demonstrated that the process of IC was widely discrepant. There were marked differences in the way that the participants reacted to the process and in the behaviours of the clinician during each enrolment, also differences in terms of length of enrolment and the degree of confidence with which the researchers believed consent had been authentic. We also present a review of published research on informed consent in aphasia, with this evidence suggesting that IC is often neglected and at best difficult to obtain. Paradoxically, attempts to facilitate the process seemed to have an inhibitory effect. Conclusions: There are multiple influences on the process of IC in aphasia, which include the potential for therapeutic misconception. The process seems particularly jeopardised in qualitative and clinical research. There are many possible reasons why a person might agree to take part in a trial, but there are numerous pitfalls and barriers to the process. Recommendations for policy and practice are made, and a model proposed for enhancing IC in aphasia.…
