New York–Following an extensive review of New York City foster children’s participation in clinical trials related to HIV/AIDS from the early 1980s through 2005, the Vera Institute of Justice has issued its final report and policy recommendations. The Experiences of New York City Foster Children in HIV/AIDS Clinical Trials is based on a multi-year study initiated by the NYC Administration for Children’s Services in response to allegations that African American and Latino children in foster care had been inappropriately enrolled into unnecessary and dangerous medical experiments.

Vera reviewers found that 532 children in foster care participated in 88 clinical trials, including 65 trials of new medications, between 1985 and 2005. The findings dispel some of the allegations that led to the study and confirm others. The examination of the children’s child welfare files found, for example, that no children were removed from their families to participate in the trials and no children died because of clinical trials medications.

Vera reviewers also found that while the child welfare agency had developed a policy in the late 1980s, the regulations were not always followed. For example, some children participated in trials that were not approved by the child welfare commissioner, files were poorly managed and often incomplete, and informed consent documents were often missing or filled out incorrectly. In some cases, child welfare files described deviations from the processes required by federal regulations and Children’s Services policy, and Vera reviewers found that three children had been enrolled in a Phase 1 trial that had not been approved by the child welfare commissioner.

“This report comes from a painstaking review of thousands of boxes of documents,” said Timothy Ross, who directed Vera’s study along with his colleague, Anne Lifflander. “We have done our best to provide as much information as possible to inform the debate on these complex issues. It is important for the public, child welfare, and the medical community to know what happened.”

To ensure objectivity, the project was overseen by an independent advisory board chaired by Richard Dudley, a member of Vera’s board of trustees and a founding member of the National Black Leadership Commission on AIDS. “A major focus of our policy recommendations is for the future, but the importance of those recommendations will never be fully understood without a clear understanding of what happened in the past,” Dudley said. “ACS has a responsibility to protect children, a significant majority of whom are of color. The agency has had difficulty convincing people that it has the type of understanding, respect, and overall consideration for people of color that is required to really protect such children. We hope our recommendations will put them on a path to build greater trust.”

Without taking a position on whether or not foster children should be able to enroll in clinical trials, based on their findings Vera staff and its Clinical Trials Advisory Board assembled a list of recommendations designed to help policymakers pursuing this option avoid similar lapses. For example, the report recommends that only medical staff, not child welfare staff, be authorized to obtain consent for a child’s participation. The full list of recommendations, along with an expanded list of findings, is available in the Executive Summary, which is also available in Spanish. The Executive Summary and the full report, which includes a detailed discussion of the findings and recommendations, are available on Vera’s web site, www.vera.org.

“In the 1980s, the onset of pediatric AIDS and other problems combined to create many challenges for New York City, especially for the African American and Latino communities and the government agencies that serve those communities.” said Michael Jacobson, Vera’s director. “In good and bad times, it is important that everyone works to protect and provide the highest quality of care possible to the most vulnerable among us—and that includes foster children.”

Biographies:

Richard G. Dudley, MD, Chair, Vera Institute of Justice Clinical Trials Advisory Board Richard Dudley has a private practice in psychiatry that includes a clinical practice, a forensic practice, and consultation/education. He is a former deputy commissioner of the New York City Department of Mental Health, Mental Retardation, and Alcoholism Services and an original member of the National Black Leadership Commission on AIDS. Dudley has also served as the medical director of the Washington Heights-West Harlem Community Mental Health Center. He currently teaches at New York University School of Law and at the City University of New York Medical School.

Timothy Ross, PhD, Project Director Timothy Ross served as Vera's research director from 2002 to 2006 and is the founder and director of Vera’s Child Welfare, Health and Justice Program. Since joining Vera in 1999, he has led child welfare research projects such as studies of the overlap between child welfare and juvenile justice, the prevalence of children in foster care whose parents are incarcerated, and how the police and child protective workers coordinate responses to allegations of severe child maltreatment. He is the author of the forthcoming Child Welfare: The Challenge of Collaboration and has taught at Hunter and Baruch Colleges. Ross has undergraduate degrees in political science from Williams College and the University of Kent at Canterbury and a PhD in government and politics from the University of Maryland.

Anne Lifflander, MD, MPH, Senior Research Associate Before joining Vera in September 2005, Anne Lifflander worked as a primary care physician and public health practitioner in underserved communities in New York City and Central America. She received an M.D. in 1980 from SUNY Stony Brook. She completed her post-graduate medical training at the Residency Program in Social Medicine-Internal Medicine Track, at Montefiore Medical Center. She received an MPH in 2001 from the Rollins School of Public Health at Emory University.