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Comprehension during informed consent in a less-developed country

This study examined the effectiveness of two different methods of informing prospective participants about HIV research in Haiti. The first group of participants received information in a single interview with a physician. In a subsequent assessment of their understanding, only 20 per cent passed a questionnaire test.

The consent procedure was then modified to include three meetings with a Haitian social worker over 7-10 days before a final meeting with a physician-researcher. Of those participants agreeing to take part in the research, 80 per cent passed the comprehension test.

Noting the lack of practical guidelines on how best to inform and test the understanding of research participants in developing countries, Fitzgerald and colleagues conclude that a formal assessment of comprehension should be a routine part of the consent process.

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