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U.S. News

No Foster Children Died From Participation in New York HIV Drug Trials; Race Not a Selection Factor, Report Says

January 28, 2009

Foster children in New York City who participated in clinical drug trials for HIV/AIDS medications did not die as a result of participation in the study, and researchers did not specifically select children to participate based on race, according to a report released Wednesday by the Vera Institute of Justice, the New York Times reports. In the late 1980s, the city's Administration for Children's Services developed a policy allowing HIV-positive foster children to enroll in drug trials. According to the Times, hundreds of children received HIV medications in numerous trials conducted until 2005 (Foderaro, New York Times, 1/28). After allegations that ACS might have mismanaged the trials, the city in 2005 hired the Vera Institute to evaluate whether the agency had the necessary permission to include the children in the trials, if the children met the studies' medical criteria and if the enrollments were appropriate given the medical knowledge at the time (Kaiser Daily HIV/AIDS Report, 5/9/05).

For the report, the institute interviewed several people involved with the trials and reviewed case files, documents and correspondence. According to the Times, the researchers concluded that city officials had "acted in good faith and in the interests of the children." Although 25 children receiving treatment died during the trial time period, the institute found that none of the 532 children involved in the trials died as a direct result of the medications. The study also found that ACS did not specifically select children of certain racial backgrounds to participate in the trials. Although the foster children who enrolled in the trials were predominantly black and Hispanic, this corresponded to the demographics of HIV-positive children in the city at the time. In addition, the report refuted the claim that ACS removed children from families who objected to the trials. However, the researchers also found that the agency kept insufficient records and did not always follow correct protocol. According to the report, a medical advisory panel did not review 30 trials involving 64 children, even though city policy requires such a review. In addition, 21 children participated in trials that the panel had reviewed but not recommended. In both cases, 13 enrollments occurred before the children were placed in foster care, according to the study. The researchers also found that ACS lacked informed consent forms from biological parents or guardians for 21% of cases, despite city regulations requiring such forms.

Timothy Ross, co-director of the Vera project, called the lack of consent forms "disturbing" but added that the institute "read through an amazing volume of material" and concluded that the children's services agency "did research on the rules and regulations that applied, and developed a reasoned policy" for enrolling the children in the trials. However, "[t]here were clearly breakdowns in the implementation of this policy," Ross said. John Mattingly, ACS commissioner, said the report "puts to rest the most egregious charges" made a few years ago. He added, "No children were yanked from their homes. That is all completely false." According to Mattingly, ACS already has taken steps to ensure proper enforcement of city policies in any future medical trials involving foster children. The agency has improved its case record cataloguing and archiving systems, established an electronic retrieval system and mandated more reviews by a family court for cases when a parent is not available to provide consent. Currently, no children are enrolled in medical trials in the city, the Times reports (New York Times, 1/28).

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Online The report is available online.

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Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2009 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.



  
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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.
 
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