title: Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting.
abstract: 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.
authors.affiliation: Brighton and Sussex Medical School, Brighton, UK. adamuaddis@yahoo.com.|Addis Ababa University, Addis Ababa, Ethiopia. adamuaddis@yahoo.com.
authors.forename: Adamu
authors.initials: A
authors.lastname: Addissie
authors.affiliation: Ethiopian Public Health Institute, Addis Ababa, Ethiopia.
authors.forename: Serebe
authors.initials: S
authors.lastname: Abay
authors.affiliation: Addis Ababa University, Addis Ababa, Ethiopia.
authors.forename: Yeweyenhareg
authors.initials: Y
authors.lastname: Feleke
authors.affiliation: Brighton and Sussex Medical School, Brighton, UK.
authors.forename: Melanie
authors.initials: M
authors.lastname: Newport
authors.affiliation: Brighton and Sussex Medical School, Brighton, UK.
authors.forename: Bobbie
authors.initials: B
authors.lastname: Farsides
authors.affiliation: Brighton and Sussex Medical School, Brighton, UK.
authors.forename: Gail
authors.initials: G
authors.lastname: Davey
mesh_terms: D000293:Adolescent; D000328:Adult; D035843:Biomedical Research / Q000941:ethics*; D032882:Comprehension; D003430:Cross-Sectional Studies; D003906:Developing Countries; D026689:Ethical Analysis / Q000379:methods*; D005002:Ethiopia; D005260:Female; D006295:Health Resources; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D008875:Middle Aged; D018579:Patient Selection / Q000941:ethics*; D011247:Pregnancy; D000091402:Prohibitins; D016036:Seroepidemiologic Studies; D014777:Virus Diseases / Q000821:virology; D055815:Young Adult
keywords: Ethiopia; Informed consent comprehension; Informed consent process; Quality of informed consent; Rapid Ethical Assessment (REA)