The findings, published in The Lancet, reflect concern that research volunteers may not fully understand the study in which they are enrolled or their rights as participants. This is of particular significance in developing countries, where participants are often poor, illiterate, unfamiliar with the conduct of medical research and have different views on disease causality.
The study also concludes that formal assessment of research participants' understanding of the consent process should be a routine step in clinical trials in developing countries. Indeed, the research found that only 20 per cent of participants about to enter an HIV programme in Haiti, who were given conventional (Western) explanations of the consent process, passed an oral test to assess their understanding.
In contrast, 80 per cent of those participants who were given more in-depth explanations by a Haitian social worker — including the communication of key messages using visual props — passed the test.
"We conclude that research participants in a less-developed country can comprehend a complex consent form if sufficient care is taken to provide them with information," says Daniel Fitzgerald from Cornell University Medical College, New York, who led the study.
"However, our findings indicate that the standard consent process of a single meeting between investigator and volunteers might be insufficient, and that new technologies should be developed to improve the informed consent process."
In an accompanying commentary article in The Lancet, Paul Farmer from Harvard Medical School, Boston, says that "all medical and public-health researchers would like a magic bullet that would make research undeniably ethical. But there is no magic bullet. There is only the complex and difficult process of linking research in resource-poor settings to the services demanded by poor people."
He adds: "The alternative prospect — a world in which medical research is dedicated wholly to the diseases of the affluent — is too painful to contemplate."
© SciDev.Net 2002
Link to The Lancet study by Daniel Fitzgerald et al*
Link to Paul Farmer's Commentary*
* Free registration to The Lancet is needed to view these documents
Photo credit: © Pan American Health Organisation