Suggestions(1)
Exact(3)
Communication plays a significant role in enhancing comprehension of consent information among patients [ 20].
The lack of comprehension of consent forms may be compounded in contexts in which education rates may be lower [ 29].
The role of the individual in research, whether as someone with disease who has been recruited as a case participant, or someone proven not to have the disease of interest and therefore enrolled as a control, may also affect engagement with the processes of research in a way that may affect comprehension of consent.
Similar(57)
Areas of debate address: pressure to participate [ 3, 8], limited comprehension of informed consent [ 3, 5, 8], verbal versus written documentation of informed consent [ 3, 5, 8], language and literacy barriers [ 3, 8], confidentiality [ 9], and individual vs. community decision-making processes [ 3, 5, 8].
Our study demonstrates that a locally appropriate informed consent tool can be developed and scientifically tested to ensure an objective assessment of comprehension of informed consent information among low and non-literate research participants.
The comprehension of informed consent is an integral part of clinical trials.
Though India is rapidly becoming a hub of clinical trials very few studies have dealt with the issue of comprehension of informed consent by the patients participating in these trials.
Comprehension of the consent form was assessed orally using a standard set of questions.
Five measures of comprehension of informed consent are reported.
This is a major step towards engendering comprehension of informed consent information among low-literacy participants.
The digitised audio questionnaire in local languages could be useful as a measure of comprehension of informed consent.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com