AIDS drug experiments involving foster children violated federal rules

[Guest guest]

By JOHN SOLOMON, Associated Press Writer

1 hour, 17 minutes ago

 

 

 

WASHINGTON - 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.

 

 

http://news./s/ap/20050616/ap_on_he_me/aids_foster_kids