In early 2005, New York City's Administration for Children's Services asked Vera to explore issues related to the enrollment of approximately 465 foster children in clinical trials of HIV and AIDS treatments during the late 1980s and 1990s. In conducting this work, Vera staff will identify the processes established to enroll and monitor these children, determine whether those procedures were followed, and report on the condition of those children today.
The enrollment of foster children in clinical trials is a national issue. Some states, like New York and Illinois, have enrolled hundreds of children in clinical trials; others, including South Dakota, Oklahoma, Kentucky, Kansas, and Hawaii, do not include foster children in medical research. According to a survey by the federal Department of Health and Human Services, many other states have not developed policies concerning foster children and clinical trials.
Opponents of involving foster children in clinical trials—where the risks and benefits are often unknown—worry that this highly vulnerable population may be too easily neglected or even exploited. When it comes to children of color, in particular, they point to historic examples where the health care system has acted in discriminatory and prejudicial ways.
On the other hand, those who favor including foster children in clinical trials argue that enrollment can provide high quality care and cutting-edge medicine to children who otherwise would receive only routine medical services. In this view, excluding foster children unfairly bars them from the best the medical profession has to offer.
Nowhere has this controversy been more intense than in New York City. Some community advocates and media have alleged that children of color were inappropriately removed from their families and enrolled in the HIV/AIDS clinical trials, primarily during the late '80s and early '90s, without proper consent or monitoring. They have also raised concerns about the effects of the medications used, how children receiving the medicine were monitored, and responses to requests to remove children from trials. Medical professionals, including those who conducted the trials, have responded that they were medically appropriate and saved lives.
Given the controversy surrounding this issue, Vera is assembling an advisory board of medical, child welfare, legal, and community experts to review our findings and assure the public of the independence of our research. This work is part of Vera's mission to improve government systems. We hope that the information we provide will contribute to the public debate that will help shape future policies regarding clinical trials and children in government custody.