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Feds: Some AIDS Drug Tests Violated Rules

Associated | June 16, 2005
By JOHN SOLOMON

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.

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"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, 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."

 

 

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