Some government-funded researchers who tested anti-HIV drugs on foster children over the past two decades violated federal rules designed to protect vulnerable youths, U.S. investigators have concluded. Researchers at the Columbia University Medical Center and New York Presbyterian Hospital failed to obtain and evaluate whether they had proper consent, information, and safeguards for foster children, said the Department of Health and Human Services' Office of Human Research Protections.
"When some or all of the subjects (e.g., children) are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the HHS regulations to protect the rights and welfare of these subjects," the federal agency wrote to the research hospital.
The researchers' "records demonstrate a failure...to obtain sufficient information regarding such safeguards with respect to the enrollment of wards of the state or foster children," the agency concluded.
The Associated Press reported May 4 that researchers in New York, Illinois, and several other states funded by the National Institutes of Health had tested anti-HIV drugs on hundreds of foster children since the 1980s, often without providing the children with independent advocates to protect their rights and interests.
Marilyn Castaldi, a spokeswoman for Columbia, said Thursday the facility was still in the process of responding to the investigative findings but that "we take seriously our responsibility to protect children or anyone who receives care at our medical center." The two research locations said in correspondence with the government that they were "in the process of planning steps specifically to improve protections for children, and particularly foster children."
Federal rules require researchers to provide independent advocates to foster children in a narrow class of experiments that pose more than a minimal risk and do not hold the likelihood of improved health for the test patients. Those rules also require the researchers to follow any additional safeguards imposed by state and local authorities. In New York City and Illinois, where more than 650 foster children combined were enrolled in anti-HIV drug tests since the late 1980s, the states required researchers to sign agreements promising to provide the advocates for all foster children.
Several research institutions, including Columbia, told the Associated Press last month they did not believe they needed to provide the advocates because their experiments held the promise of improved health for the children. Medical ethicists disagreed, saying the foster kids were vulnerable and required the added protection. Some states said they wouldn't even consider using foster children in such medical testing because of their vulnerability. (AP)