On May 18, the House Ways and Means Subcommittee on Human Resources held a hearing in response to press reports that foster children participated in HIV/AIDS drug trials without being afforded the basic protections required under federal and state law. According to the Associated Press, the research was conducted in Illinois, Louisiana, Maryland, New York, North Carolina, Colorado, and Texas.
In his opening statement, Chair Wally Herger (R-CA) underscored the importance of allowing foster children to participate in clinical drug trials to receive state-of-the-art treatments, but stated that there must be a balance between the “hope and risk” associated with these trials. Noting that there are federal and state regulations concerning the participation of foster children in clinical trials, he expressed his concern that these protections are often “not enforced or inadequate.”
Ranking Member Jim McDermott (D-WA) agreed, stating that Congress must decide what is in the best interest of the children participating in the clinical trials. Pointing out that foster children could easily “be taken advantage of by the system,” he urged for increased supervision over their participation.
Principal Deputy Assistant Secretary for Planning and Evaluation at the Department of Health and Human Services (HHS) Donald Young gave a historical perspective of the HIV/AIDS crisis in the early 1990s: “Nearly three-quarters of the 3,000 pediatric AIDS cases reported by the Centers for Disease Control and Prevention in 1991 were in children with at least one parent who was an intravenous drug user. Many of these children were placed in foster care because the caretaker parent had died or become incapacitated by AIDS, or because of neglect, abuse or abandonment associated with parental drug abuse…It is estimated that through 1989, that between 16 and 22 percent of pediatric AIDS patients were children in foster care. This significant overlap between risk factors for HIV and the need for foster care meant that pediatric AIDS became a particular concern for child welfare agencies in large cities, where most pediatric AIDS cases were concentrated.” He explained that in 1989, “most state laws allowed only for ‘standard medical treatment’ for children in foster care. But because there were no standard treatments for HIV-infected children, this limitation represented a critical barrier to medical care for children with HIV. The [HHS] recommended that ‘state and local child welfare agencies should create systems to manage the participation of children in foster care in special medical treatment and experimental trials.’”
Dr. Young explained that today, “child welfare agencies continue to differ in their policies regarding whether or under what circumstances children in foster care may be enrolled in clinical trials. Information gathered from several state foster care agencies suggest that the 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 ad litem. Some states continue to preclude the enrollment of foster children in experimental trials altogether, or will provide permission on behalf of the child only if the biological parents also give permission for the child’s participation.” He added, “Under the federal foster care program, health care decisions on behalf of individual foster children are left to states that are acting as parents with respect to children in their custody and that are responsible for assuring the health care needs of foster children are met. With respect to enrolling children in particular clinical trials, the procedures established for each study by the IRB [Institutional Review Board] and researcher, working with the federal human subjects regulations…would guide children’s participation.”
Alan Fleischman, a physician, pediatrician, and medical ethicist in New York, was a member of two Institutional Review Boards for research involving human subjects in the late 1980s and early 1990s. He explained that in New York, “the Administration for Children’s Services, the agency responsible for supervision of foster children, developed mechanisms that made enrollment of foster children in clinical trials possible. Local Institutional Review Boards for research involving human subjects, like ours in the Bronx, approved the NIH treatment trials for use in all children infected with HIV and helped investigators and the Administration for Children’s Services to develop mechanisms to allow enrollment of children in foster care. The consent of biological mothers was obtained when possible, agency permission on an individual basis was obtained, and foster parents were involved in these discussions because of their need to administer treatments and bring children back for follow-up visits to the hospital.” Highlighting achievements made in pediatric HIV/AIDS research, he stated, “Because of clinical trials conducted in the 1990s, there are effective treatments to prevent children from becoming infected in utero and standard treatments for the small number of children who are infected. AIDS in children has become a chronic disease with less than 1% mortality each year for children treated in AIDS centers in the U.S. Children in foster care infected with HIV are getting standard treatment and are rarely participating in clinical trials because it is no longer a matter of life and death.”
Wisconsin Department of Health and Family Services Deputy Secretary Roberta Harris explained that in Wisconsin, “we have not approved medical research on foster children as a class, or any subgroup of foster children, because we believe it is our responsibility to provide as much of a safe, nurturing environment for the children in foster care as possible.” She noted that there are cases in which “a representative of the Wisconsin child welfare system is granted court-appointed legal custodianship or guardianship and would have the ability to approve the participation of a foster child in medical research. In these instances, it is our position that approval for such research participation should not be given solely on the basis of the child being a foster child, but rather reviewed on a case-by-case basis for medical benefits.” Ms. Harris outlined the following prerequisites for the participation of a foster child in a clinical trial:
Testifying on behalf of the American Academy of Pediatrics, Dr. Moira Ann Szilagyi expressed the academy’s support for HHS regulations stating that “children in foster care should not be considered for studies which contain the prospect of greater than minimal risk and in which there is no direct benefit to the child.” She added, “For these studies, it is only appropriate to consider using children in foster care under certain circumstances, such as if the research is related to their status as wards of the state. In other words, they should only be included when involvement of children in foster care is necessary since the research aims to answer a question related to conditions specifically affecting children in foster care. In these rare instances, it is imperative that an advocate be appointed to act on behalf of the child for the duration of the study to assist the child and foster family for the [following] reasons: to navigate medical issues, ensure that the child’s medical care needs are being met, assist the child in determining whether to participate, and provide a source of continuity for the child and legal guardians throughout the duration of the study.”
