House Subcommittee Hears Testimony Regarding Protections for Foster Children Who Participate in Clinical TrialsHHS Deputy Assistant Secretary Donald Young testifying on Wednesday before the House Ways and Means human resources subcommittee said current federal regulations are sufficient to ensure foster children enrolled in federally funded clinical trials are properly protected, but some lawmakers said a congressional investigation into the guidelines is needed, the AP/Miami Herald reports. The subcommittee called the hearing to examine the issue of involving foster children in medical research studies following an Associated Press report published earlier this month that found that hundreds of foster children have participated in HIV/AIDS clinical trials since the late 1980s without having independent advocates appointed for their protection (Solomon, AP/Miami Herald, 5/19). Federal law requires the appointment of advocates for foster children in studies where there is "greater-than-minimal risk" of complications and the benefits are not as certain as approved treatments, the AP/CNN.com reports (AP/CNN.com, 5/18). Researchers who conducted NIH-funded HIV/AIDS drug trials involving HIV-positive foster children in at least seven states often did not appoint independent advocates for the children, despite policies requiring the assignments, according to the report. The studies tested AIDS-related medication in hundreds of HIV-positive foster children, allowing the children to receive treatment from top researchers but also exposing them to the risks of research and potentially serious side effects of the trial drugs. The research among foster children was most widespread in the 1990s and was conducted in Colorado, Illinois, Louisiana, Maryland, New York, North Carolina and Texas (Kaiser Daily HIV/AIDS Report, 5/5).
Young Testimony, Congressional Reaction
Young at the subcommittee hearing on Wednesday said, "We are not aware of any changes that we believe need to be made. But if there are (problems) identified, we'd be very happy to consider them and make decisions on how best to proceed." Young said the Bush administration recognizes the "importance of continued vigilance" of researchers and institutional review boards to ensure regulations involving enrolling foster children are "adhered to," but he added that the administration believes drug testing is "essential" to ensure the best pediatric medicines reach the marketplace, according to the AP/Herald (AP/Miami Herald, 5/19). Rep. Pete Stark (D-Calif.) said that prisoners involved in medical research have guaranteed advocates to oversee all participation in clinical trials and suggested future legislation that would include similar protections for foster children, the Washington Post reports. "I think we'd sleep a little better at night if we put in a requirement that children have sufficient advocacy," Stark said (Otto, Washington Post, 5/19).
Varying State Policies, Other Testimony
Young said HHS has found a "wide variance" among the states of procedures in obtaining permission to enroll foster children in clinical trials, and the Bush administration is examining how best to protect "the most vulnerable in our population," the AP/CNN.com reports. "Information gathered from several state foster care agencies suggests that authority to provide permission for other than standard medical treatment typically lies either with the judge supervising the foster care case, with a senior official within the foster care agency or with a guardian," Young said, adding that some states preclude foster children from being enrolled in any studies and some "provide permission on behalf of the child only if the biological parents also give permission for the child's participation" (AP/CNN.com, 5/18). Marjorie Speers, executive director of the Association for the Accreditation of Human Research Protections Programs, recommended that institutional review boards include a children's health expert and be required to meet annual education requirements. Alan Fleischman, a medical ethicist, said that research on foster children can be conducted safely and ethically, adding that the "only way to provide the best treatment to any child with HIV at that time was through the clinical trials -- the drugs were just not available any other way" (AP/Miami Herald, 5/19).