Comprehension during informed consent in a less-developed country.
Few practical guidelines exist on how to ensure that research participants in less-developed countries understand the consent form before enrollment. In a study of HIV-1 transmission in Haiti, participants were required to pass an oral examination on the contents of the consent form with a passing score of 12/15 (80%) before enrollment. 15 individuals were given information during a single meeting with a physician, and three (20%) passed. 30 subsequent volunteers were given information by a counsellor during three meetings, and 24 (80%) passed. Formal assessment of research participants' comprehension of the consent form should be considered as a routine step in the informed consent process in less-developed countries.
Fitzgerald
Daniel W
DW
Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, Port au Prince, Haiti.
Marotte
Cécile
C
Verdier
Rose Irene
RI
Johnson
Warren D
WD
Pape
Jean William
JW
D000328:Adult; D032882:Comprehension; D003906:Developing Countries; D004522:Educational Status; D005260:Female; D015658:HIV Infections / Q000635:transmission; D015497:HIV-1; D006205:Haiti; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D035842:Research Subjects