Fed Investigation Report: AIDS Drug Tests on Foster Kids Violated Rules

Fed Investigation Report: AIDS Drug Tests on Foster Kids Violated Rules

Thu, 16 Jun 2005

related link: OHRP Letter of Determination,
Columbia University Medical Center, May 23, 2005 (32 K pdf)

The Associated Press reports that an investigation by the U.S. Department of Health and Human Services’ Office of Human Research Protections (OHRP) 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.”

OHRP’s investigation found that 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.

In a letter dated May 23, the government cited Columbia Presbyteria 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.”

In its letter to the hospital, OHRP noted: “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 subject.”

“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.”

These Federal safeguards prohibiting the use of children in foster care for any but essential experiments intended for their best interest–and then, only with the consent and on-going monitorin by an independent advocate for each child, were adopted precisely to prevent their abuse and exploitation.

But the foster children enrolled in AIDS drug and vaccine trials –all of whom were children of color–were enrolled illegally. The children were denied the minimal protections, in part, because of a culture of arrogance that permeates the medical research community. That culture of lawless disregard for the disadvantaged in the community needs to be changed by Congressional action.

A law is needed to protect children and vulnerable adults from overreaching researchers who seem to think that ethical standards and Federal regulations are a matter for their discretion. A law is needed to make it a criminal offense to use a human being in medical experiments that faile to comply with Federal rules.

Questions remain about the death toll and the adverse events suffered by the children: how many children who were illegally enrolled in phase I and II drug and vaccine expeiments died? Nothing has been reported about the financial stakes in these pediatric AIDS trials.

As acknowledged by AP, The Alliance for Human Research Protection filed the complaint that led to the Federal investigation.

Contact: Vera Hassner Sharav
212-595-8974

Feds: Some AIDS Drug Tests Violated Rules
Updated: Thursday, Jun. 16, 2005 – 1:46 PM
By JOHN SOLOMON
Associated Press Writer

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, 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, 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.

(Copyright 2005 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.)

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