Comprehension during informed consent in a less-developed country

Lancet. 2002 Oct 26;360(9342):1301-2. doi: 10.1016/S0140-6736(02)11338-9.


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.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Comprehension*
  • Developing Countries*
  • Educational Status
  • Female
  • HIV Infections / transmission
  • HIV-1
  • Haiti
  • Humans
  • Informed Consent*
  • Male
  • Middle Aged
  • Research Subjects*