ArticleInternational health2013
Correlates of lower comprehension of informed consent among participants enrolled in a cohort study in Pune, India.
Article in International health, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed, 17 citations in OpenAlex.
- 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
- Recruitmentology and the politics of consent in clinical research.Lancet (London, England) · 2023Article
- What empirical research has been undertaken on the ethics of clinical research in India? A systematic scoping review and narrative synthesis.BMJ global health · 2021Article
- Participant understanding of informed consent in a multidisease community-based health screening and biobank platform in rural South Africa.International health · 2020Article
- Informed consent for controlled human infection studies in low- and middle-income countries: Ethical challenges and proposed solutions.Bioethics · 2020Article
- Assessment of Parents'/Guardians' Initial Comprehension and 1-Day Recall of Elements of Informed Consent Within a Mozambican Study of Pediatric Bacteremia.Journal of empirical research on human research ethics : JERHRE · 2018Article
- Why parents consent to their children's participation in genetic research: A study of parental decision making.Indian journal of medical ethicsArticle
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Authors and funding
6 authors at 4 institutions in 2 countries.
Funding
Abstract
backgroundOptimum comprehension of informed consent by research participants is essential yet challenging. This study explored correlates of lower comprehension of informed consent among 1334 participants of a cohort study aimed at estimating HIV incidence in Pune, India.
methodsAs part of the informed consent process, a structured comprehension tool was administered to study participants. Participants scoring ≥90% were categorised into the 'optimal comprehension group', whilst those scoring 80-89% were categorised into the 'lower comprehension group'. Data were analysed to identify sociodemographic and behavioural correlates of lower consent comprehension.
resultsThe mean ± SD comprehension score was 94.4 ± 5.00%. Information pertaining to study-related risks was not comprehended by 61.7% of participants. HIV-negative men (adjusted OR [AOR] = 4.36, 95% CI 1.71-11.05) or HIV-negative women (AOR = 13.54, 95% CI 6.42-28.55), illiteracy (AOR= 1.65, 95% CI 1.19-2.30), those with a history of multiple partners (AOR = 1.73, 95% CI 1.12-2.66) and those never using condoms (AOR = 1.35, 95% CI 1.01-1.82) were more likely to have lower consent comprehension.
conclusionsWe recommend exploration of domains of lower consent comprehension using a validated consent comprehension tool. Improved education in these specific domains would optimise consent comprehension among research participants.
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