Assessment of parents'/guardians' initial comprehension and 1-day recall of elements of informed consent within a mozambican study of pediatric bacteremia
J. empir. res. hum. ethics
; 13(3): 1-19, jul. 2018. tab, ilus, mapa, graf
Article
in English
| RSDM
| ID: biblio-1526772
Responsible library:
MZ1.1
ABSTRACT
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
Full text:
Available
Collection:
National databases
/
MZ
Database:
RSDM
Main subject:
Bacteremia
/
Biomedical Research
/
Consent Forms
Limits:
Adult
/
Child, preschool
/
Female
/
Humans
/
Infant
/
Male
Country/Region as subject:
Africa
Language:
English
Journal:
J. empir. res. hum. ethics
Year:
2018
Document type:
Article
Institution/Affiliation country:
Eduardo mondlane university/MZ
/
Vanderbilt institute for global health/US
/
Vanderbilt university/US