Abstract
BackgroundMaximizing comprehension is a major challenge for informed consent processes in low-literacy and resource-limited settings. Application of rapid qualitative assessments to improve the informed consent process is increasingly considered useful. This study assessed the effects of Rapid Ethical Assessment (REA) on comprehension, retention and quality of the informed consent process.MethodsA cluster randomized trial was conducted among participants of HPV sero-prevalence study in two districts of Northern Ethiopia, in 2013. A total of 300 study participants, 150 in the intervention and 150 in the control group, were included in the study. For the intervention group, the informed consent process was designed with further revisions based on REA findings. Informed consent comprehension levels and quality of the consent process were measured using the Modular Informed Consent Comprehension Assessment (MICCA) and Quality of Informed Consent (QuIC) process assessment tools, respectively.ResultStudy recruitment rates were 88.7 % and 80.7 % (p = 0.05), while study retention rates were 85.7 % and 70.3 % (p < 0.005) for the intervention and control groups respectively. Overall, the mean informed consent comprehension scores for the intervention and control groups were 73.1 % and 45.2 %, respectively, with a mean difference in comprehension score of 27.9 % (95 % CI 24.0 % - 33.4 %; p < 0.001,). Mean scores for quality of informed consent for the intervention and control groups were 89.1 % and 78.5 %, respectively, with a mean difference of 10.5 % (95 % CI 6.8 -14.2 %; p < 0.001).ConclusionLevels of informed consent comprehension, quality of the consent process, study recruitment and retention rates were significantly improved in the intervention group. We recommend REA as a potential modality to improve informed consent comprehension and quality of informed consent process in low resource settings.Electronic supplementary materialThe online version of this article (doi:10.1186/s12910-016-0127-z) contains supplementary material, which is available to authorized users.
Highlights
Maximizing comprehension is a major challenge for informed consent processes in low-literacy and resource-limited settings
The current study investigated effects of Rapid Ethical Assessment (REA) on informed consent comprehension, study compliance and quality of informed consent in a low-income setting
Based on our findings, REA is associated with improved understanding of study concepts, purposes and procedures and participants’ perceptions of the informed consent process
Summary
Maximizing comprehension is a major challenge for informed consent processes in low-literacy and resource-limited settings. Important parameters in monitoring the quality of research implementation in addition to levels of study recruitment include levels recall and understanding of the informed consent information by study participants [3,4,5,6,7] To this effect, informed consent documents may require to be adapted to the local culture and the educational level of the population, which have been shown to strengthen research efforts, through improved recruitment and retention of participants who better understand their roles and responsibilities [8,9,10]. The effects of REA on study participants’ level of comprehension, recruitment and retention and quality of informed consent have not been documented
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