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New York City Foster Children in HIV/AIDS Clinical Trials

Findings
Vera’s review of the child welfare files identified 532 New York City foster children who
participated in 88 clinical trials and observational studies between 1985 and 2005. Of the 88
clinical trials and observational studies, 65 involved trials of new medications for HIV or its
associated conditions. Forty-four of the 65 trials involved antiretroviral drugs.
Vera reviewers found little or no evidence in the information examined for some of the concerns
that prompted Children’s Services to initiate this study.

1. Many children—inside and outside of foster care and clinical trials—died because of
   complications of HIV/AIDS during the late 1980s and 1990s. Eighty of the 532 children who
   participated in clinical trials or observational studies died while in foster care; 25 of them
   died while enrolled in a medication trial. Vera medical staff did not find, however, that any
   child’s death was caused directly by clinical trial medication.
2. An examination of data from the New York City Department of Health and Mental Hygiene,
   though not conclusive, suggests that HIV-positive foster children who were enrolled in
   clinical trials and/or observational research studies did not experience an increased risk of
   death from their enrollment in clinical trials.
3. The child welfare files contained information indicating that some children experienced
   serious toxicities, or side effects, from trial medications, such as reduced liver function or
   severe anemia. These toxicities were consistent with toxicities described in published articles
   about the trials. Vera reviewers found many instances where a physician made adjustments to
   a child’s treatment in light of these problems as required by the clinical trial protocol.
4. Where documentation allowed reviewers to make a determination, children in foster care met
   age, HIV status, and disease stage criteria for inclusion in the specific trials in which they
   were enrolled as described in the trial protocol. Reviewers found that two of the 532 children

met exclusion criteria for the medication trials in which they were enrolled.

5. Of the children who participated in trials, Vera identified two who were HIV exposed, but for
   whom there was evidence suggesting they might not have been infected with HIV. Vera
   project leaders informed Children’s Services about these two cases. Children’s Services
   subsequently responded that inquiries to state and local agencies had confirmed a diagnosis
   that made it appropriate for one of the children to participate in the clinical trial. Children’s
   Services has not provided additional information on the second child, who died of causes
   unrelated to clinical trials participation.
6. In 1988, when city officials first considered the participation of foster children in clinical
   trials, the child welfare agency conducted a lengthy review of state and federal research
   regulations. The social services commissioner and his staff were aware of concerns about the
   participation of African American and Latino children in medical research and they consulted
   with several medical experts, including the National Medical Association (an organization of
   African American physicians). The standard the agency developed for approving trials—that
   every child in foster care enrolled in a trial have the possibility of benefiting from that trial—
   exceeded that of federal regulations. The policy also required that researchers obtain
   informed consent from a birth parent when parental rights remained intact.
7. In response to physicians’ and some advocates’ requests for faster trial approvals, the child
   welfare agency changed its policy in 1991. The new policy called for a medical advisory
   panel (MAP) of physicians to review and make a recommendation to the commissioner on enroll in a trial.
8. Many files document medical researchers’ discussions of the risks and potential benefits of
   trial enrollment with a birth parent and the parent’s subsequent permission to enroll the child.
   In several cases, parents did not want their children in a clinical trial and the child did not
   participate in the trial.
9. Children in foster care appeared to participate in trials at rates that suggest they were not
   specially targeted for enrollment into HIV/AIDS clinical trials. Foster children made up 30
   percent of all New York City enrollments in 16 trials of medical interventions for which citylevel data were available. Thirteen percent of these enrollments occurred prior to the child’s
   entry into foster care, with participation extending into the period they were in foster care.
10. Children in foster care who participated in HIV/AIDS clinical trials were predominantly
    African American and Latino (64 percent African American and 30 percent Latino). This
    demographic profile paralleled the demographics of children with HIV infection in New
    York City (58 percent African American, 35 percent Latino).
11. There was no evidence in the child welfare files of children being removed from their
    families by Children’s Services because a parent refused to consent to a child’s participation
    in a clinical trial. Three-quarters of the children entered foster care before age one year and
    more than half entered directly from a hospital after birth. Families faced many issues such as
    substance use, unemployment, and poverty that were exacerbated by the medical needs of
    children and parents with HIV/AIDS.
12. Several files documented differences of opinion between child welfare staff and both birth
    and foster parents concerning antiretroviral medications prescribed outside of clinical trials
    and after the approval of the medication by the U.S. Food and Drug Administration (FDA).
    These differences were resolved on a case-by-case basis. Sometimes this involved continued
    monitoring and alternative treatments; in other cases it resulted in removal from parents or
    legal guardians or the transfer of a child to a new foster home.
13. Vera reviewers found no evidence in the child welfare files, clinical trial protocols, or
    interviews that children, parents, foster parents, foster care agencies or staff, or child welfare
    agencies or staff received incentive payments for children to participate in clinical trials.
    Vera’s study of this issue was limited to information in child welfare, policy files, and public
    information from the NIH on the funding of their clinical trials.

The Vera review also found evidence that supported some concerns about the participation of
foster children and their families in clinical trials. This evidence includes violations of state
regulations, Children’s Services’ own policies for clinical trial review and enrollment, and
federal regulations for protecting human subjects. (see Report)

Recommendations

There is a continuum of situations in which children might be considered for clinical trials. Each
point on this continuum contains a different set of risks and potential benefits. For children in
foster care there are additional concerns. These include the effect enrollment in a trial will have
on placement stability and how close a child is to entering a permanent home where adoptive
parents can assume decision-making responsibility.
Some people feel that child welfare agencies should not allow children in foster care to
participate in any clinical trials. In support of their position, they often cite the history of medical
research involving African American and Latinos and the vulnerability of foster children. Others
feel that children in foster care, including African American and Latino children, should have the
same chance to participate in the development of new treatments as other children and that they
should not be denied access to a promising new medication because they are no longer in their
parents’ care. It is not the Vera Institute’s role to take a position in this debate: elected and
appointed officials, in consultation with community and professional representatives, are charged
with making clinical trials policy for foster children.
The knowledge gathered in this study does, however, provide a basis for Vera and its Clinical
Trials Advisory Board to make recommendations for those policymakers who do decide to allow
foster children to participate in clinical trials. The recommendations presented here are aimed, in
part, at remedying the problems that this report identifies. Children’s Services has developed a
new clinical trials policy. The recommendations below can be seen as a set of benchmarks that
child welfare staff, elected representatives, and community advocates can use to measure
progress in addressing the concerns this report raises. (see Report for more details)

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