Elsevier

The Lancet

Volume 360, Issue 9342, 26 October 2002, Pages 1301-1302
The Lancet

Research Letters
Comprehension during informed consent in a less-developed country

https://doi.org/10.1016/S0140-6736(02)11338-9Get rights and content

Summary

Few practical guidelines exist on how to ensure that research participants in less-developed countries understand the consent form before enrolment. 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 enrolment. 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.

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