ArticleBMJ open2014
Digitised audio questionnaire for assessment of informed consent comprehension in a low-literacy African research population: development and psychometric evaluation.
Article in BMJ open, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.
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Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 citations in OpenAlex.
- Measuring and evaluating participant understanding of consent processes in clinical trials: a systematic review.Trials · 2026Pooled it
- Comparative Effectiveness of eConsent: Systematic Review.Journal of medical Internet research · 2023Pooled it
- Acceptability and effectiveness of a study information video in improving the research consent process for youth: a non-inferiority trial.BMJ global health · 2025Trial
- Trial
- A multimedia consent tool for research participants in the Gambia: a randomized controlled trial.Bulletin of the World Health Organization · 2015Trial
- Acceptability of the R21/Matrix-M malaria vaccine alongside existing malaria interventions in the trial context.BMJ global health · 2025Article
- Assessment of Consent Comprehension Among Kenyan Adolescents, Young Adults, and Parents: Comparison of Enhanced and Standard Consenting Procedures.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 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
- Exploring the Barriers to and Motivators for Using Digital Mental Health Interventions Among Construction Personnel in Nigeria: Qualitative Study.JMIR formative research · 2021Article
- Informed consent for controlled human infection studies in low- and middle-income countries: Ethical challenges and proposed solutions.Bioethics · 2020Article
- A qualitative study on aspects of consent for genomic research in communities with low literacy.BMC medical ethics · 2020Article
- An adapted instrument to assess informed consent comprehension among youth and parents in rural western Kenya: a validation study.BMJ open · 2018Article
- Informed consent for clinical treatment in low-income setting: evaluating the relationship between satisfying consent and extent of recall of consent information.BMC medical ethics · 2017Article
- Reasons for participating in a randomised clinical trial: The volunteers' voices in the COSTOP trial in Uganda.Contemporary clinical trials communications · 2017Article
- Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing.Journal of clinical research & bioethics · 2014Article
Corrections and comments
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Authors and funding
9 authors at 6 institutions in 4 countries.
Funding
Abstract
objectiveTo develop and psychometrically evaluate an audio digitised tool for assessment of comprehension of informed consent among low-literacy Gambian research participants.
settingWe conducted this study in the Gambia where a high illiteracy rate and absence of standardised writing formats of local languages pose major challenges for research participants to comprehend consent information. We developed a 34-item questionnaire to assess participants' comprehension of key elements of informed consent. The questionnaire was face validated and content validated by experienced researchers. To bypass the challenge of a lack of standardised writing formats, we audiorecorded the questionnaire in three major Gambian languages: Mandinka, Wolof and Fula. The questionnaire was further developed into an audio computer-assisted interview format.
participantsThe digitised questionnaire was administered to 250 participants enrolled in two clinical trials in the urban and rural areas of the Gambia. One week after first administration, the questionnaire was readministered to half of the participants who were randomly selected. Participants were eligible if enrolled in the parent trials and could speak any of the three major Gambian languages. OUTCOME MEASURE: The primary outcome measure was reliability and validity of the questionnaire.
resultsItem reduction by factor analysis showed that 21 of the question items have strong factor loadings. These were retained along with five other items which were fundamental components of informed consent. The 26-item questionnaire has high internal consistency with a Cronbach's α of 0.73-0.79 and an intraclass correlation coefficient of 0.94 (95% CI 0.923 to 0.954). Hypotheses testing also showed that the questionnaire has a positive correlation with a similar questionnaire and discriminates between participants with and without education.
conclusionsWe have developed a reliable and valid measure of comprehension of informed consent information for the Gambian context, which might be easily adapted to similar settings. This is a major step towards engendering comprehension of informed consent information among low-literacy participants.
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