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Lesley Jean Burgess Berna Gerber Kathleen Coetzee Marli Terblanche Gareth Agar Theunis JvW Kotze 1TREAD Research CC, Cardiology Unit, Department of Medicine, Stellenbosch University and Tygerberg Hospital, Parow, South Africa; 2University of Liverpool/Laureate Online Education, Liverpool, UK; 3Division of SpeechLanguage and Hearing Therapy, Faculty of Medicine and Health Sciences, Stellenbosch University Stellenbosch, South Africa Introduction: The informed consent process is a fundamental part of clinical trials and is driven by both a legal and ethical agenda. The process may be seriously compromised if trial participants sign the informed consent document without fully understanding its contents. In developing countries such as South Africa, this concern is important due to the potential vulnerability of these patients and their risk for research exploitation. Aim: To evaluate the understanding of 11 important components and concepts related to clinical research by adult trial participants in a developing country at the time of providing consent for trial participation. Methods: 46 consecutive adult patients who qualified and consented to being enrolled in ongoing cardiovascular risk clinical trials at TREAD Research in the Western Cape, South Africa, were included in this study. After giving informed consent, participants were subjected to both a close-ended (self-report) and an open-ended method (descriptive narrative) to assess their understanding of various components and concepts related to clinical research pertaining to the initial informed consent document. The descriptive narrative was recorded and then later transcribed and assessed by two independent assessors. Results: There was a marked difference between the two methodologies used to assess patient comprehension of the various components. With the exception of concepts voluntariness and right to withdraw, trial participants’ understanding of the informed consent document was poor – especially with regard to the following concepts: randomization, risks, placebo and blinding. Higher levels of comprehension were obtained for the participant selfreports and lower levels for the narrative descriptions. Conclusion: The participant comprehension at this site was poor, and the process for taking informed consent subsequently needs to be modified so as to improve informed consent comprehension.

open access journal of clinical trials

<p>An evaluation of informed consent comprehension by adult trial participants in South Africa at the time of providing consent for clinical trial participation and a review of the literature</p>