Journal Article

Correlates of lower comprehension of informed consent among participants enrolled in a cohort study in Pune, India

Neelam S. Joglekar, Swapna S. Deshpande, Seema Sahay, Manisha V. Ghate, Robert C. Bollinger and Sanjay M. Mehendale

in International Health

Published on behalf of Royal Society of Tropical Medicine and Hygiene

Volume 5, issue 1, pages 64-71
Published in print March 2013 | ISSN: 1876-3413
Published online December 2012 | e-ISSN: 1876-3405 | DOI: http://dx.doi.org/10.1093/inthealth/ihs009
Correlates of lower comprehension of informed consent among participants enrolled in a cohort study in Pune, India

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Background

Optimum 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.

Methods

As 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.

Results

The 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.

Conclusions

We 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.

Keywords: Informed consent process; Comprehension; Consent comprehension tool; Illiteracy; Study related risks; India

Journal Article.  5373 words.  Illustrated.

Subjects: Community Medical Services

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