ArticleBMC medical ethics2012
Assessing the quality of informed consent in a resource-limited setting: a cross-sectional study.
Article in BMC medical ethics, 2012. 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.
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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.
- Participants' understanding of informed consent in clinical trials: A systematic review and updated meta-analysis.PloS one · 2024Pooled it
- Participants' understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis.Bulletin of the World Health Organization · 2015Pooled it
- Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting.BMC medical ethics · 2016Trial
- 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
- Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan Africa.Therapeutic innovation & regulatory science · 2024Article
- Compliance with research ethics in epidemiological studies targeted to conflict-affected areas in Western Ethiopia: validity of informed consent (VIC) by information comprehension and voluntariness (ICV).BMC medical ethics · 2024Article
- Beyond translations, perspectives for researchers to consider to enhance comprehension during consent processes for health research in sub-saharan Africa: a scoping review.BMC medical ethics · 2023Article
- Guardians and research staff experiences and views about the consent process in hospital-based paediatric research studies in urban Malawi: A qualitative study.BMC medical ethics · 2022Article
- Understanding of Critical Elements of Informed Consent in Genomic Research: A Case of a Paediatric HIV-TB Research Project in Uganda.Journal of empirical research on human research ethics : JERHRE · 2022Article
- Article
- 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
- Novel Use of Hydroxyurea in an African Region With Malaria: Protocol for a Randomized Controlled Clinical Trial.JMIR research protocols · 2016Article
- Evaluation of the Informed Consent Process of a Multicenter Tuberculosis Treatment Trial.AJOB empirical bioethics · 2015Article
- Informed consent practices for surgical care at university teaching hospitals: a case in a low resource setting.BMC medical ethics · 2014Article
- A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting.BMC medical ethics · 2014Article
- A Cross-Sectional Study on the Diet and Nutritional Status of Adolescent Girls in Zambézia Province, Mozambique (the ZANE Study): Design, Methods, and Population Characteristics.JMIR research protocols · 2014Article
- Evaluating the quality of informed consent and contemporary clinical practices by medical doctors in South Africa: an empirical study.BMC medical ethics · 2013Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University.
methodsData were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies had been administered to each study participant.
resultsOf the 600 participants interviewed, two thirds (64.2%, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9%, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7%, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7%, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50% less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95% CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care.
conclusionsMost of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care.
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Registered trials
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