How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India
How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India
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DOI：
10.1186/1472-6939-12-3
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发表时间：
2011-02-15
影响因子：
2.7
通讯作者：
Vaz, Mario
中科院分区：
文献类型：
--
作者：
Rajaraman, Divya;Jesuraj, Nelson;Vaz, Mario
背景：伦理人类受试者研究的必要条件是参与应该是知情的和自愿的。通过提问的方式参与知情同意过程是知情同意程度的一个指标。目的：本研究的目的是评估同意儿童参加印度一项观察性结核病（TB）研究的家长积极参与知情同意讨论的程度，并确定这种参与的相关性。方法：在一项南印度婴儿结核病的观察性队列研究中，负责获得知情同意的现场监督员记录了4382名参加研究的婴儿在知情同意讨论期间提出的问题。这些问题是按主题在后编码的。进行了双变量和多变量分析，以检查在知情同意过程中询问至少一个问题的相关因素。结果：4382名家长/监护人中有590名（13.4%）在知情同意过程中提出了任何问题。我们发现，父母在知情同意过程中提出问题的可能性与父母双方在场的教育水平和地点显著相关。结论：研究结果对在文化水平较低的农村地区规划知情同意程序具有启示意义。需要作出更大努力，为知情同意程序编写简单的参与性传播材料。此外，让父母双方参与关于孩子参与研究的讨论可能会增加真正知情同意的程度。最后，需要继续努力提高研究工作者在解释研究过程和使潜在的研究参与者放心方面的沟通技巧。
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.Aims: The 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.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 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.Results: In 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.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.