Assessment of Parents'/Guardians' Initial Comprehension and 1-Day Recall of Elements of Informed Consent Within a Mozambican Study of Pediatric Bacteremia.

Journal: Journal of empirical research on human research ethics : JERHRE

Volume: 13

Issue: 3

Year of Publication: 2019

Affiliated Institutions:  Vanderbilt Institute for Global Health, Nashville, TN, USA. Eduardo Mondlane University, Maputo, Mozambique. Vanderbilt University, Nashville, TN, USA.

Abstract summary 

Participants' 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'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'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' informed, voluntary participation in clinical trials.

Authors & Co-authors:  Ossemane Ezequiel B EB Moon Troy D TD Sacarlal Jahit J Sevene Esperança E Kenga Darlene D Gong Wu W Heitman Elizabeth E

Study Outcome 

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Statistics
Citations :  American Cancer Society. What are the legal requirements of informed consent? 2016 May 20; Retrieved December 14, 2016, from http://www.cancer.org/treatment/findingandpayingfortreatment/understandingfinancialandlegalmatters/informedconsent/informed-consent-legal-requirements-of-consent.
Authors :  7
Identifiers
Doi : 10.1177/1556264618767780
SSN : 1556-2654
Study Population
Male,Female
Mesh Terms
Adult
Other Terms
Mozambique;elements of informed consent;ethics;informed consent;recall;understanding
Study Design
Study Approach
Country of Study
Mozambique
Publication Country
United States