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Public Health

Ethical standards under suspicion

National Health Council suspends research in malaria in the state of Amapá

EDUARDO CESARProject was analyzing the various types of malaria-transmitting mosquitoes EDUARDO CESAR

The research project called Heterogeneity of malaria vectors in Amapá has been interrupted by a decision of the National Health Council (CNS), after a series of denouncements cast suspicion of the ethical procedures of the project. Councilors and representatives of the CNS decided to verify in loco the accusation of the public prosecutor’s office of the municipality of Santana, that researchers were using as human guinea pigs about 40 inhabitants from the municipality of São Raimundo do Pirativa, in exchange for a daily payment of R$ 12. The use of “human bait” in research and the payment for the service are breaches of Resolution 196/96 of the CNS, which establishes standards for investigations that involve human beings.

The suspicions came as a surprise: the research is coordinated by the American NGO Institutional Review Board, financed by the University of Florida/National Institutes of Health, of the United States, and involves researchers from the University of São Paulo (USP); from the Aggeu Magalhães Institute, from the Oswaldo Cruz Foundation (Fiocruz); and Amapá Study and Research Institutes. Moreover, the project had been approved by Fiocruz’s ethics in research committee and in the CNS’s National Ethics in Research Committee. “When the research was approved in 2001, it didn’t mention payment to collaborators, nor their use as human bait”, says Gisele Saddi Tanus who represents the users’ segment on the council.

The project, which has the objective of analyzing the various types of malaria transmitters in the region, ought to be concluded in March 2006, says José Maria Soares Barata, from the Faculty of Public Health at USP, a consultant for the project. The results will provide input for preventive measures.

The protocol of the research provides for the mosquitoes being captured alive, marked, and then set free, for it to be possible to measure their time of life. “We have collectors in three communities. Besides São Raimundo, in São João and Santo Antônio as well”, says Mércia Arruda, a researcher from the Aggeu Magalhães Institute. These collectors – all adults, literate and over 18 years old – were trained to capture the mosquito with the assistance of a glass tube. “They knew that the mosquito had to be captured before biting. We do not accept insects with blood.” They all signed terms of consent and, she guarantees, knew of the risk of exposure. They would, in fact, receive R$ 20.00 by way of a food and transport allowance.

Resolution 196 recognizes that all research with humans involves risks. Nevertheless, it is allowed when it makes it possible to understand, prevent or alleviate a problem that affects the well-being of the subjects or of the community, or when the benefits are greater than the damages. “In three years, only five of our volunteers have caught malaria, that is to say, 8% of the total of the cases recorded in the region”, says Alan Kardec Galardo, responsible for the research in Amapá.

The denouncements, though, tell of how, in 2003, 20 collectors were invited to feed with their own blood about a hundred mosquitoes, to be marked and recaptured, which was not foreseen in the project. Robert Zimmerman, from the University of Florida, one of the coordinators of the project, told the O Estado de S. Paulo newspaper in an interview that the collectors were exposed to mosquito bites for a short period of time, with the intention of evaluating the survival rate of the insects. “We realized that it was not a good idea”, he  said. It is said that none of the 20 volunteers submitted to the bites contracted malaria. Zimmerman said that he does not see any problem in using human bait, that he is surprised, and that the complaints are groundless. “I have been working with malaria since 1986”, he argues. The Brazilian researchers felt duped. “The protocol of the research did not foresee this.” It is now up to the CNS and the Senate’s Human Rights Commission to determine the truth of the facts.