Researchers Tested HIV Drugs on Foster Kids

Researchers Tested HIV Drugs on Foster Kids

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Government-funded researchers tested
AIDS drugs on hundreds of foster children over the past two decades, often without providing them a basic protection afforded in federal law and required by some states, an Associated Press review has found.

[…]

Several studies that enlisted foster children reported patients suffered side effects such as rashes, vomiting and sharp drops in infection-fighting blood cells as they tested antiretroviral drugs to suppress AIDS or other medicines to treat secondary infections.

In one study, researchers reported a “disturbing” higher death rate among children who took higher doses of a drug. That study was unable to determine a safe and effective dosage.

[…]

Advocates must be independent of the foster care and research agencies, have some understanding of medical issues and “act in the best interests of the child” for the entirety of the research, the law states.

However, researchers and foster agencies told AP that foster children in AIDS drug trials often weren’t given such advocates even though research institutions many times promised to do so to gain access to the children.

[…]

Researchers typically secured permission to enroll foster children through city or state agencies. And they frequently exempted themselves from appointing advocates by concluding the research carried minimal risk and the child would directly benefit because the drugs had already been tried in adults.

“Our position is that advocates weren’t needed,” said Marilyn Castaldi, spokeswoman for Columbia Presbyterian Medical Center in New York.

If they decline to appoint advocates under the federal law, researchers and their oversight boards must conclude that the experimental treatment affords the same or better risk-benefit possibilities than alternate treatments already in the marketplace. They also must abide by any additional protections required by state and local authorities.

[…]

Arthur Caplan, head of medical ethics at the University of Pennsylvania, said advocates should have been appointed for all foster children because researchers felt the pressure of a medical crisis and knew there was great uncertainty as to how children would react to AIDS medications that were often toxic for adults.

“It is exactly that set of circumstances that made it absolutely mandatory to get those kids those advocates,” Caplan said. “It is inexcusable that they wouldn’t have an advocate for each one of those children.

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AP’s review found that if children were old enough — usually between 5 and 10 — they also were educated about the risks and asked to consent. Sometimes, foster parents or biological parents were consulted; other times not.

Are you fucking kidding me????!!!! 5-10 year olds are NOT old enough to make these decisions.  They need parental/guardian consent forms for field trips, but they don’t need one for AIDS research?  

I don’t understand how the NIH could have funded research.  IRBs would/should not have allowed this.  IRBs were instituted specifically after horrific Nuremberg and Tuskeegee syphilis experiments.  

More on IRBs:
IRB FAQ

One of the things that IRBs are concerned with is:
Is a justification for the use of vulnerable groups provided? Does the study include additional safeguards to protect the rights and welfare of these groups?

Clearly, in this case, the answer is no.