Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting

Addissie, Adamu, Abay, Serebe, Feleke, Yeweyenhareg, Newport, Melanie, Farsides, Bobbie and Davey, Gail (2016) Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting. BMC Medical Ethics, 17 (1). ISSN 1472-6939

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Abstract

Background: Maximizing 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.

Methods: A 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.

Results: Study 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).

Conclusion: Levels 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.

Item Type: Article
Keywords: Informed consent process, Informed consent comprehension, Quality of informed consent, Rapid Ethical Assessment (REA), Ethiopia
Schools and Departments: Brighton and Sussex Medical School > Brighton and Sussex Medical School
Brighton and Sussex Medical School > Global Health and Infection
Brighton and Sussex Medical School > Clinical and Experimental Medicine
Research Centres and Groups: Centre for Global Health Policy
Depositing User: Rose McLafferty
Date Deposited: 09 Nov 2016 15:51
Last Modified: 21 Sep 2017 09:43
URI: http://sro.sussex.ac.uk/id/eprint/65391

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