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U.S. Admitted AIDS Research Violated Rules

December 13, 2004

WASHINGTON (AP) _ U.S. health officials told Uganda’s government that a U.S.-funded study there on using an AIDS drug to protect babies violated federal safety rules even though they didn’t tell President Bush before he authorized shipping the drug to Africa.

The Department of Health and Human Services’ Office for Human Research Protections identified nearly nine-pages of problems with the National Institutes of Health research project on nevirapine in Uganda in a July 2002 letter that pointedly identified several violations of federal patient protection rules.

The letter also proposed numerous corrective actions.

``OHRP find that the ARC (the project’s oversight committee) failed to conduct continuing reviews of the above-referenced research as required by HHS regulations,″ the letter to Uganda’s National Council of Science and Technology said.

The letter identified problems that included lowering, without permission, the standards for disclosing bad reactions during the drug research, and giving patients information about the risks ``that may not have been understandable.″

It was sent just a month after Bush, unaware of NIH’s safety concerns about the research, authorized a $500 million initiative to use nevirapine throughout Africa to protect babies from getting HIV from infected mothers.

The Ugandan government thanked the U.S agency for its findings, adding it was sometimes difficult to meet ethical standards in poor countries.

``These conditions tend to dictate the level of compliance with the required ethical issues of biomedical research,″ the Ugandans replied.

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