@article{33d736aaa7934b2ebc47055fadc94722,
title = "Assessment of Parents{\textquoteright}/Guardians{\textquoteright} Initial Comprehension and 1-Day Recall of Elements of Informed Consent Within a Mozambican Study of Pediatric Bacteremia",
abstract = "Participants{\textquoteright} understanding of key elements of a research protocol is essential to their ethical enrollment in the study. Ongoing participation should be based on continued comprehension and consent, which presumes a high degree of recall. Many obstacles can prevent full understanding of information about the research protocol. This study{\textquoteright}s aim was to evaluate the comprehension and 1-day recall of the elements of informed consent by the parents/guardians of children enrolled in a clinical study in Mozambique. We developed a 10-question test based on the study{\textquoteright}s informed consent document. We asked participants to answer questions shortly after being read the informed consent document and again the following day. Participants who did not demonstrate good or reasonable understanding at enrollment were provided the information again as a refresher. Overall high rates of initial comprehension demonstrate that attention to the informed consent process can result in Mozambicans{\textquoteright} informed, voluntary participation in clinical trials.",
keywords = "Mozambique, elements of informed consent, ethics, informed consent, recall, understanding",
author = "Ossemane, {Ezequiel B.} and Moon, {Troy D.} and Jahit Sacarlal and Esperan{\c c}a Sevene and Darlene Kenga and Wu Gong and Elizabeth Heitman",
note = "Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Research reported in this publication was supported by the Fogarty International Center, Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health under Award Number R25 TW009722, as well as the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number R01 AI112295. Funding Information: Ezequiel B. Ossemane is a recent MPH graduate funded through the Vanderbilt University–Mozambique Collaborative Research Ethics Education program (NIH FIC R25 TW009722). This manuscript represents work conducted toward completing of his Master{\textquoteright}s thesis. He was involved in the design of the study, collecting and analyzing data, and writing and revisions of the manuscript drafts.",
year = "2018",
month = jul,
day = "1",
doi = "10.1177/1556264618767780",
language = "English (US)",
volume = "13",
pages = "247--257",
journal = "Journal of Empirical Research on Human Research Ethics",
issn = "1556-2646",
publisher = "University of California Press",
number = "3",
}