TY - JOUR
T1 - Correlates of lower comprehension of informed consent among participants enrolled in a cohort study in Pune, India
AU - Joglekar, Neelam S.
AU - Deshpande, Swapna S.
AU - Sahay, Seema
AU - Ghate, Manisha V.
AU - Bollinger, Robert C.
AU - Mehendale, Sanjay M.
PY - 2013/3
Y1 - 2013/3
N2 - 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.
AB - 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.
KW - Comprehension
KW - Consent comprehension tool
KW - Illiteracy
KW - India
KW - Informed consent process
KW - Study related risks
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U2 - 10.1093/inthealth/ihs009
DO - 10.1093/inthealth/ihs009
M3 - Article
C2 - 24029848
AN - SCOPUS:84883173742
SN - 1876-3413
VL - 5
SP - 64
EP - 71
JO - International health
JF - International health
IS - 1
ER -