Study Description and Findings

Separate teams of medical and child welfare reviewers examined the child welfare files of 796 children. Vera researchers also reviewed policy documents and correspondence, clinical trial protocols, federal and state regulations, and material from the National Institutes of Health and the federal Office of Human Research Protections, and conducted dozens of interviews. To ensure its independence, the project was overseen by an advisory board chaired by Dr. Richard Dudley, a member of Vera’s board of trustees and a founding member of the National Black Leadership Commission on AIDS, and Vera retained full editorial control over the final report.

The review found that between 1985 and 2005, 532 children in the New York City foster care system participated in 88 clinical trials and observational studies, including 65 trials of new medications to treat HIV or associated conditions. No evidence was found indicating that children were removed from their families to participate in clinical trials or that children died because of medications they took in these trials. However, Vera reviewers did find that federal and state regulations and policies that protect individuals in research studies were not always followed. For example, three children were enrolled in a phase I clinical trial even though Children’s Services’ policy barred participation in such trials.

Why This Work is Important

There is a continuum of situations in which officials might consider enrolling foster children in clinical trials. Each point on this continuum contains a different set of risks and potential benefits. 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 not in their parents’ care.

The knowledge gathered in this study provided a basis for Vera and its Clinical Trials Advisory Board to make recommendations that can serve as benchmarks for child welfare staff, elected representatives, and community advocates to measure progress in addressing these and other concerns. The recommendations appear in the final report, The Experiences of New York City Foster Children in HIV/AIDS Clinical Trials.

For more information, contact Allon Yaroni.