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

BMC Medical Ethics

Research Article

Mario Vaz¹  Divya Rajaraman¹  Nelson Jesuraj¹  Lawrence Geiter²  Sean Bennett²  Harleen MS Grewal³ 

[1] Division of Epidemiology, St John's Research Institute, Bangalore, India;Formerly with AERAS Global TB Vaccine Foundation, Maryland, USA;The Gade Institute, Section for Microbiology and Immunology, University of Bergen, Bergen, Norway;Department of Microbiology and Immunology, Haukeland University Hospital, Bergen, Norway;

关键词: Consent Process;    Informed Consent Process;    Field Supervisor;    Study Team Member;    Develop Country Setting;   

DOI  :  10.1186/1472-6939-12-3

 received in 2010-07-09, accepted in 2011-02-15,  发布年份 2011

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© Rajaraman et al; licensee BioMed Central Ltd. 2011