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Feds: Some AIDS Drug Tests Violated Rules
  By JOHN SOLOMON .c The Associated Press
WASHINGTON (AP) - Some government-funded researchers who tested AIDS 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 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 AIDS 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 ``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.''
They told the government they were increasing the resources going to the Institutional Review Boards that monitor the safety of experiments, improving training for researchers and creating a Web-based system to ensure necessary information for patient safety was collected.
The government cited Columbia and 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 ``equitable'' selection of patients for the studies.
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 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 AP 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 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.
``These studies, which took place in the 1990s, were instrumental in extending lifesaving HIV treatments to children,'' Castaldi said Thursday.
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 did not monitor researchers to ensure that they had complied with the rules.
OHRP's investigation 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 in the city.
The federal agency is withholding a decision on whether Columbia and Presbyterian should have provided the foster children with independent advocates until it receives more information. But it criticized the institutions 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.
06/16/05 19:11 EDT
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