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NIH-Sponsored AIDS Drug Trials "Often" Did Not Appoint Advocates for Foster Child Participants, Associated Press Reports

May 5, 2005

NIH-funded HIV/AIDS drug trials involving hundreds of HIV-positive foster children in at least seven states "often" did not appoint independent advocates for the children, according to a review of the studies conducted by the Associated Press, the AP/Long Island Newsday reports. The studies tested AIDS-related medication in hundreds of HIV-positive foster children, allowing the children to receive treatment from "world-class" researchers but also exposing them to the risks of research and potentially serious side effects of the trial drugs, according to the AP/Newsday (Solomon, AP/Long Island Newsday, 5/5). The research among foster children was "most widespread" in the 1990s and was conducted in at least seven states, including Illinois, Louisiana, Maryland, New York, North Carolina, Colorado and Texas, according to the AP/San Francisco Chronicle. More than 48 HIV/AIDS-related drug studies involved foster children, most of whom were poor or minority and ranged in age from infants to late teens, according to government records and interviews, the AP/Chronicle reports. In several of the studies, foster child participants reported side effects, including vomiting, rashes and rapid declines in their CD4+ T cell counts, according to the AP/Chronicle (Solomon, AP/San Francisco Chronicle, 5/4). Some children died during the studies, although state or city agencies could not find evidence that any of the children's deaths being caused by the experimental drugs, according to the AP/Newsday.

Recommendations for Advocates
Since 1983, the government has required that researchers and oversight boards appoint independent advocates for foster children enrolled in a certain type of study that involved "greater than minimal risk and lacked the promise of direct benefit," according to the AP/Newsday (AP/Long Island Newsday, 5/5). The advocates must be independent of the foster care agencies, have some understanding of the medical issues involved in the study and "act in the best interests of the child" throughout the research, according to the AP/Chronicle (AP/San Francisco Chronicle, 5/4). However, child advocates were not appointed for "most" of the NIH-funded AIDS-related studies, despite written promises from research institutions that guardians would be assigned, according to the AP/Newsday. Illinois and New York foster agencies required research institutions to sign documents promising to appoint advocates for the children, regardless of the potential risks and benefits of the studies. However, Illinois officials said that none of the nearly 200 Illinois foster children involved in the trials were appointed advocates, and New York officials found records showing that advocates were assigned to only 142 of the 465 children involved in research in that state, according to the AP/Newsday. In addition, some research institutions, including Children's Memorial Hospital in Chicago and Johns Hopkins University in Baltimore, said they did not provide advocates for foster children participating in studies, the AP/Newsday reports. Some states, including Tennessee and Wisconsin, do not allow foster children to participate in clinical trials, and California requires a judge's order to allow their participation, according to the AP/Newsday.

Researchers Say Advocates Not Needed
Many researchers who enrolled foster children in studies through city or state agencies and "frequently" exempted themselves from appointing advocates by concluding that the research would directly benefit the children and involve minimal risk, the AP/Newsday reports. "Our position is that advocates weren't needed," Marilyn Castaldi, spokesperson for Columbia-Presbyterian Medical Center in New York, said. NIH did not directly track whether researchers appointed advocates for the children; instead, the agency relied on medical review boards made up of volunteers at each research site, according to the AP/Newsday. NIH officials estimate that of the 13,878 children enrolled in pediatric AIDS studies funded by the government since the late 1980s, 5% to 10% of them were foster children, according to the AP/Newsday (AP/Long Island Newsday, 5/5).

An unnamed spokesperson for the Office for Human Research Protections said that the agency has a "single, open case investigation" against Columbia-Presbyterian Medical Center, according to the Houston Chronicle. However, the spokesperson added, "I can't speak to any other (institution) or what may happen in the future" (Hopper, Houston Chronicle, 5/4). Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania School of Medicine, said advocates should have been appointed for the children because the 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," according to the AP/Newsday. "It is exactly that set of circumstances that made it absolutely mandatory to get those kids those advocates," Caplan said, adding, "It is inexcusable that they wouldn't have an advocate for each one of those children." Some of the researchers said that advocates were not required because the researchers "protected the children's interest by carefully explaining risks and benefits to state guardians, foster parents and the children themselves," the AP/Newsday reports. "I understand the ethical dilemma surrounding the introduction of foster children into trials," Mark Kline, a pediatric AIDS expert at Baylor College of Medicine, who does not recall appointing advocates for foster children enrolled in his studies, said. He added, "To say as a group that foster children should be excluded from clinical trials would have meant excluding these children from the best available therapies at the time. From an ethical perspective, I never thought that was a stand I could take" (AP/Long Island Newsday, 5/5).

Institute of Medicine Recommendations
An Institute of Medicine study of Institutional Review Boards -- which are responsible for appointing advocates for foster children who are participating in clinical trials -- concluded that the boards "were overworked, were inappropriately dominated by scientists and lacked focus on patient safety," according to the AP/Las Vegas Sun. "As modern IRBs have tended to become larger and to reflect a broader range of scientific expertise, some IRB deliberations have tended to be dominated by the scientific perspective, increasing the potential to marginalize the perspectives of nonscientist members and those who focus on ethics-based concerns," IOM reported in 2002. IOM said a major problem with IRBs is that they have been taking on too many issues without adequate resources, which has forced them to reduce their focus on patient protection, according to the AP/Sun. IOM recommended that IRBs focus more narrowly on patient protections and eliminate tasks such as investigating researchers for potential conflicts of interest, according to the AP/Sun (Solomon, AP/Las Vegas Sun, 5/4).

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