Originally published June 28 2005
Federal officials: Some drug trials on children with HIV, AIDS violated regulations
by Mike Adams, the Health Ranger, NaturalNews Editor
According to the New York Times, a Columbia University Medical Center committee that oversees the use of patients as subjects in medical research violated federal regulations in the 1990s during drug research tests on children with HIV and AIDS, although the specific nature of the violations has not been released.
Federal officials have found that a Columbia University Medical Center committee that oversees the use of patients as subjects in medical research violated federal regulations in the 1990's in the case of four research projects.
In the projects, experimental drugs were tested in children, including foster children, with AIDS or who were H.I.V.-positive.
The Office for Human Research Protections informed Columbia in a letter last month that the medical center's institutional review board had "failed to obtain sufficient information" concerning the selection of foster children as subjects, the process for getting their parents' or guardians' permission and certain additional safeguards.
The exact nature and significance of the violations were unclear yesterday.
A spokeswoman for the agency, Pat El-Hinnawy, declined to say what information the review board had failed to obtain, whether the information would have affected the board's decision to approve the projects and whether any children were harmed.
The findings come at a time when questions have been raised nationally about the participation of foster children in drug trials during the 1980's and 1990's, when hundreds of babies in New York City alone were born H.I.V.-positive and when there were at first no treatments approved for children.
Under federal regulations, foster children may participate in clinical trials as long as a parent or guardian has given permission, and if the risk is minimal or there is some prospect of direct benefit for the child.
The four trials cited in the letter were supported by the National Institutes of Health and involved dozens of medical centers nationwide.
"We stand behind the clinical aspects of these trials," Marilyn Castaldi, the spokeswoman, said in an interview.
"It's not an issue of safety or harm."
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