Omission allowed human subjects to be used in Amapá experimentation

08/01/2006 - 18h51

Nielmar de Oliveira
Reporter - Agência Brasil

Rio - A mistake in the Portuguese version of a research project on malaria was presumably responsible for permitting riverside dwellers in the state of Amapá to be used as guinea pigs in 2003, when, as part of the project, they were bitten by mosquitoes that transmit the disease.

The study was funded by the United States National Institutes of Health (NIH) in the amount of US$ 1 million and was coordinated by the University of Florida, in partnership with the Oswaldo Cruz Institute Foundation (Fiocruz), the University of São Paulo (USP), and the National Health Foundation (FUNASA).

According to Fiocruz researcher Mércia Arruda, the Portuguese version failed to include a sentence referring specifically to the use of human subjects in one of the phases of the research. This practice is prohibited in Brazil. "Somehow the person who translated the document left out the sentence that referred to this experiment, and this was a way for the project to be approved by the National Ethics in Research Commission (CONEP)," she informed.

The document also received the approval of the Fiocruz and USP ethics councils. "The ethics committee bodies have only the Portuguese version, and the English version was presented only to the university in the US," Arruda added.

She says that Fiocruz is in favor of investigating possible subterfuges. "We will always be on the side of the individuals and organs that are going to investigate these accusations, in order to make the document as transparent as possible."

According to the researcher, the project got underway in May, 2003, and was supposed to be concluded in April, 2006, if it had not been interrupted by a CONEP decision. She explains that, when the project began, experimentation involving human subjects was carried out, because, at the time, the fieldwork was conducted by the American, Robert Zimermman, who was only familiar with the English version of the project.

He was assisted by Alan Kardec, a researcher who works for the state of Amapá. Kardec replaced the Dutch scientist, Jacó Voorhano, who did the translation. According to Arruda, it was Kardec who sounded the alarm on the use of human subjects. "After being alerted by a call from Kardec, the USP ordered this part of the research to be halted immediately," she affirmed.

Translation: David Silberstein