BMC Medical Ethics
(Accessed 16 July 2016)
HIV/AIDS clients, privacy and confidentiality; the case of two health centres in the Ashanti Region of Ghana
While most studies on HIV/AIDS often identify stigmatization and patients’ unwillingness to access health care as critical problems in the control of the pandemic, very few studies have focused on the possible…
Jonathan Mensah Dapaah and Kodjo A. Senah
BMC Medical Ethics 2016 17:41
Published on: 16 July 2016
Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting
Adamu Addissie, Serebe Abay, Yeweyenhareg Feleke, Melanie Newport, Bobbie Farsides and Gail Davey
BMC Medical Ethics 2016 17:40
Published on: 12 July 2016
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.
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.
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).
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.