WASHINGTON (AP) -- The government has concluded at least some AIDS drug
experiments involving foster children violated federal rules designed to ensure
vulnerable youths were protected from the risks of medical research.
The U.S. Department of Health and Human Services' Office of Human Research
Protections concluded that Columbia University Presbyterian Medical Center in
New York, where several foster children were enrolled in drug studies in the
1990s, failed to obtain and evaluate whether it had proper consent, information
and safeguards for the foster kids.
"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 the research hospital.
The hospital's "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 federally funded researchers in New
York, Illinois and several other states tested AIDS drugs on hundreds of foster
children since the 1980s, often without providing the children with special
advocates to protect their rights and interests.
Marilyn Castaldi, a spokeswoman for Columbia Presbyterian, did not immediately
return calls Wednesday and Thursday seeking comment.
But the hospital acknowledged in correspondence with the government that it was
"in the process of planning steps specifically to improve protections for
children, and particularly foster children."
The hospital told the government it is increasing the resources to its
Institutional Review Boards that monitor the safety of its experiments,
improving training for researchers and creating a Web-based system that ensures
necessary information for patient safety is collected.
The government cited Columbia Presbyterian in a letter dated May 23 with
violating rules in at least four AIDS studies involving foster children,
--Failing to "obtain sufficient information regarding the selection of wards of
the state and foster children as research subjects."
--Failing to "obtain sufficient information regarding the process for obtaining
permission of parents or guardians for wards of the state or foster children."
--Failing to have enough information to ensure the selection of patients for the
studies was "equitable."
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 AIDS drugs tests since the late 1980s, the states required
researchers to sign agreements promising to provide the advocates for all foster
Several of the research institutions, including Columbia Presbyterian, told AP
last month that 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.
Other states, like Wisconsin, said they wouldn't even consider using foster
children in such medical testing because of their vulnerabilities.
Foster care agencies and frontline researchers who enrolled foster kids said
they did so in an effort to get them cutting-edge drug treatments not available
in the marketplace during the AIDS crisis of the early 1990s and that their
efforts helped kids live longer.
AP's story prompted a congressional hearing, at which experts testified that the
standards for enrolling foster children in medical experiments varied widely
across the country. Some lawmakers complained that the foster kids had fewer
protections than prisoners.
The Bush administration told Congress it believed the current legal protections
for foster children were adequate if followed, but that it does not monitor
researchers to ensure that they have complied with the rules.
OHRP's ruling is the first that federal research involving AIDS drugs and foster
children violated federal protections. It was prompted by a complaint filed last
year by the Alliance for Human Research Protection, an advocacy group in New
York which raised concerns about a New York Post story documenting AIDS drug
testing at a Catholic charity foster home in the city.
The federal agency is withholding a decision on whether Columbia Presbyterian
should have provided the foster children with independent advocates until it
receives more information. But it criticized the hospital for not collecting
enough information to even make decisions on what regulations it needed to
comply with to protect the children.
The investigation "revealed no evidence" that the hospital's review board
"considered and made the required findings when reviewing this research
involving children," OHRP concluded.