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New approach required for obtaining informed consent in less-developed countries

N.B. Please note that if you are outside North America the embargo date for all Lancet press material is 0001 hours UK time Friday 25 October 2002

Lancet

Authors of a research letter in this week's issue of THE LANCET highlight the difficulty of obtaining valid consent from people in less-developed countries who are about to participate in medical research.

Few practical guidelines exist on how to ensure that research participants in less-developed countries understand the consent form before enrolment. Daniel W Fitzgerald from Cornell University Medical College, New York, USA, and colleagues compared the understanding of the consent process among prospective participants about to enter an HIV-1 research programme in Haiti; 15 potential participants were given conventional (western-style) explanations from one physician;30 further participants were given three explanatory sessions with the help of a counsellor.

All potential participants were required to score at least 80% in an oral test to assess their understanding of the consent process; only 20% of participants given conventional explanations passed the eligibility test, compared with 80% of people given in-depth explanations by a counsellor, who was a qualified Haitian Social Worker; in-depth explanations included the communication of key messages assisted by visual material, including anatomical diagrams.

Daniel Fitzgerald comments: "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. However, our findings indicate that the standard consent process of a single meeting between investigator and volunteer might be insufficient, and that new techniques should be developed to improve the informed consent process."

In an accompanying Commentary (p 1266), Paul Farmer from Harvard Medical School, Boston, USA, concludes: "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. The alternative prospect-a world in which medical research is dedicated wholly to the diseases of the affluent-is too painful to contemplate."

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Contact: Dr Daniel W Fitzgerald, Division of International Medicine and Infectious Diseases, Cornell University Medical College,
Room A-421, 1300 York Avenue, New York, NY 10021, USA;
T) 212-746-6320;
F) 212-746-8675;
E) dfitzgerald@gheskio.org

Dr Paul Farmer, Department of Social Medicine, Harvard Medical School,
641 Huntington Avenue, Boston, MA 02115, USA;
T) 617-432-3715;
F) 617-432-6045;
E) paul_farmer@hms.harvard.edu

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