Trial reportBMC medical ethics2016
Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting.
Trial report in BMC medical ethics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Measuring and evaluating participant understanding of consent processes in clinical trials: a systematic review.Trials · 2026Pooled it
- Towards a more patient-centered clinical trial process: A systematic review of interventions incorporating health literacy best practices.Contemporary clinical trials · 2022Pooled it
- Mixing methods: How listening to researchers, healthcare workers, and community members can improve the design of studies testing medical innovations for Neglected Tropical Diseases.PLoS neglected tropical diseases · 2025Article
- Digital Informed Consent/Assent in Clinical Trials Among Pregnant Women, Minors, and Adults: Multicountry Cross-Sectional Evaluation of Comprehension and Satisfaction.JMIR human factors · 2025Article
- Understanding and processing informed consent during data-intensive health research in sub-Saharan Africa: challenges and opportunities from a multilingual perspective.Research ethics · 2025Article
- Informed consent in cervical cancer screening research in Butajira district, Ethiopia.Global bioethics = Problemi di bioetica · 2025Article
- Review
- Balancing Ethics and Culture: A Scoping Review of Ethico-Cultural and Implementation Challenges of the Individual-Based Consent Model in African Research.Journal of empirical research on human research ethics : JERHRE · 2024Article
- Readability and Comprehension of Anesthesia Informed Consent Forms in a Spanish County Hospital: An Observational Study.Nursing reports (Pavia, Italy) · 2024Article
- Comprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive study.BMC medical ethics · 2024Article
- Article
- Rapid ethical appraisal of stakeholder views on research prior to undertaking immunopathogenesis studies on podoconiosis in northeast Ethiopia during a period of social instability.Transactions of the Royal Society of Tropical Medicine and Hygiene · 2021Article
- Setting up a pragmatic clinical trial in a low-resource setting: A qualitative assessment of GoLBeT, a trial of podoconiosis management in Northern Ethiopia.PLoS neglected tropical diseases · 2021Article
- Adolescent perceptions about participating in HIV-related research studies.Children and youth services review · 2020Article
- Application of the rapid ethical assessment approach to enhance the ethical conduct of longitudinal population based female cancer research in an urban setting in Ethiopia.BMC medical ethics · 2018Article
- Pragmatism in practice: lessons learned during screening and enrollment for a randomised controlled trial in rural northern Ethiopia.BMC medical research methodology · 2018Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
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.
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