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US faults testing of AIDS drug on foster children

Rules NYC hospital violated safeguards

WASHINGTON -- The government has concluded that 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 US Department of Health and Human Services' Office for 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 children.

''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 told 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 advocates to protect their rights and interests.

Marilyn Castaldi, a spokeswoman for Columbia Presbyterian, did not return calls yesterday 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, including:

  • 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 children.

    Several of the research institutions, including Columbia Presbyterian, said last month that they did not believe they needed to provide advocates because their experiments held the promise of improved health for the children. Medical ethicists disagreed, saying the foster children 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 children 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 them live longer.

    The AP story prompted a congressional hearing, at which specialists testified that the standards for enrolling foster children in medical experiments varied widely across the country. Some lawmakers complained that the foster children 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.

    The Office for Human Research Protections 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 that raised concerns about a New York Post story documenting AIDS drug testing at a Catholic charity foster home.

    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.

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