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.The city’s Administration for Children’s Services has hired the Vera Institute of Justice to investigate charges that the city inappropriately allowed foster children to take part. The agency has said that it has found no evidence that it acted wrongly. Some 465 foster children took part between 1988 and 2001, the agency says.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. All clinical trials, even with adults, must have the approval of the institutional review board in the center where the trial is taking place.The four trials cited in the letter were supported by the National Institutes of Health and involved dozens of medical centers nationwide. They occurred between 1993 and 2002. In a statement, a Columbia spokeswoman said the studies “were instrumental in extending lifesaving H.I.V. treatments to children.” More...
