Late last week, the Vera Institute of Justice released its 500-page detailed report regarding New York City's foster children and their participation in HIV/AIDS clinical trials from the late 1980's through 2001. These trials tested medications for treating the symptoms of HIV/AIDS in children. http://www.vera.org/publication_pdf/clinicaltrials-appendix.pdf
The report provides us with an opportunity to catalogue the numerous deficiencies in NYC's efforts to protect foster children during these clinical trials, and it exposes the lack of adequate data available to us today as we seek to understand and correct these deficiencies.
The New York Times suggested in its January 27, 2009 article that allegations about poor procedures and a lack of protection of foster children in clinical trials have been refuted by the Vera report. http://www.nytimes.com/2009/01/28/nyregion/28foster.html?_r=1&scp=1&sq=foster%20childen%20hiv&st=cse The New York Times clearly misunderstood the report.
Alarming Failure to Protect Our Children
Based on information available to it, Vera states in its report that of the 25 children who died while participating in the medication clinical trials none died as a result of the medication provided to them in those trials. But, Vera's lack of access to the medical records of the deceased foster children raises questions about their ability to accurately determine the causes of death of these children. See Page 225 of the report.
The report reviewed the experiences of 532 foster children, but there are another 264 foster children for whom Vera received insufficient information to determine whether those 264 children were or were not participants in clinical trials. Moreover, for twenty-two of the foster children who participated in the trials, Vera hasn't received adequate information to determine whether these children were ever even infected with HIV. See Page 203 of the report.
Of the 532 foster children, 98 participated in the clinical trials without the approval of the Commissioner of the NYC Administration for Children's Services. The Commissioner's approval was required for the participation of foster children in any clinical trials. See Page 239 of the report.
Twenty-one percent of the children, or 112 children, participated in clinical trials despite the fact that their parents had not signed the required informed consent documents. For at least seven children, the person who signed an informed consent form was not legally authorized to do so. Kinship foster parents, parents without parental rights, and child welfare staff signed the forms in contradiction of the policies in place to protect the children. Even when forms were signed by legally authorized individuals, those individuals likely were often confused about the nature of the trials to which they were consenting. Many informed consent forms contained technical language difficult for people without a medical background to understand. Often, the informed consents from legally authorized individuals were obtained in violation of federal rules for obtaining such consents. These violations include handwritten notes for informed consent in lieu of official documents, consent accepted over the phone, coercive tactics used to obtain consent, and consent sought or obtained from parents who may not have been competent to provide it. See Pages viii to ix of the report.
Three of these children were enrolled in a phase I clinical trial even though Children’s Services’ policy barred participation in phase I trials. Phase I trials are the first stage of testing in human subjects. These trials are designed to assess the safety and tolerability of a drug. Approximately half of the trials could have been phase I (32 of 65 treatment trials). Vera was unable to identify any phase for 18 of the 65 treatment trials, and they could not determine whether the foster children participated in the phase I or the phase II aspect of 14 phase I/II trials. See Pages 355 to 357 of the report.
For 30 percent of the foster children, some part of the child welfare file was lost or destroyed. Records often did not contain documentation required by state regulations. See Page ix of the report.
Only the New York State Department of Health (NYSDOH) has the right to conduct or authorize a review of medical and clinical trial records of foster children who participated in HIV/AIDS trials—even when hospitals agree to have the files reviewed. NYC Administration for Children’s Services asked NYSDOH to permit it to review this information. The NYSDOH refused those requests. See Page xii of the report.
Because Vera was not permitted to review Internal Review Board (IRB) minutes from the hospitals where clinical trials were conducted, Vera was unable to determine whether or not independent advocates were required for compliance with federal regulations and Children’s Services policy in many trials. See Page 257 of the report. The federal government reviewed the IRB minutes from Columbia University Medical Center's IRB and determined that Columbia failed to follow federal regulations with regard to determining the need for independent advocates. See Page 127 of the report.
Preventing Future Failures
Our city and our state must make the protection of our foster children a high priority, while aggressively undertaking efforts to treat the symptoms of AIDS and prevent the spread of HIV amongst our children. We must demand that New York City and New York State work together to correct the alarming deficiencies discovered and revealed in the Vera report. Our children deserve better protection.