Abstract
BackgroundA 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.AimsThe aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation.MethodsIn 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 for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process.ResultsIn total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location.ConclusionsThe 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.
Highlights
A requisite for ethical human subjects research is that participation should be informed and voluntary
Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process
The analysis reported in this paper contributes to debates about how to increase researchers’ engagement with research participants, by focusing on the process of consent for enrolling children in a community-based prospective study to assess the incidence of pulmonary tuberculosis (TB) in infants in rural South India
Summary
A requisite for ethical human subjects research is that participation should be informed and voluntary. An essential requirement for ethical research is that participation in trials should be informed and voluntary. Medical research in children poses particular concerns for informed consent because of children’s status as a vulnerable population, legally incompetent to make decisions about their own participation in research studies [4]. A child’s parent or legal guardian usually serves as a proxy consenter, making decisions about research participation on behalf of the child. Household decision-making processes and gender differences in attitudes towards health research mean that researcher decisions about which parent to approach for consent can have implications for the process of informed consent in terms of the amount of information requested by potential research subjects, as well as ultimate decisions about whether or not to participate [5,6,7,8]
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