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, Sanjay M. Mehendale

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)64-71
Number of pages8
JournalInternational health
Volume5
Issue number1
DOIs
StatePublished - Mar 2013

Keywords

  • Comprehension
  • Consent comprehension tool
  • Illiteracy
  • India
  • Informed consent process
  • Study related risks

ASJC Scopus subject areas

  • Health(social science)
  • Public Health, Environmental and Occupational Health

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