Background:
A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed.
Methods:
In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions of 4,382 infants who were enrolled in the study. These questions were coded and analysed. Bivariate and multivariate analysis was conducted to examine factors influencing likelihood of participation in the informed consent process.
Results:
We found that the likelihood of parents asking questions during the informed consent process was strongly associated with education level, both parents being present, and location. Additionally, questions being asked was associated with which field supervisor was conducting the informed consent discussion.
Conclusions:
The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child’s participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease.