Two N.Y. Hospitals Violated Federal Regulations in NIH-Sponsored AIDS Drug Trials Involving Foster Children, HHS Says

Two New York City hospitals violated federal regulations in NIH-funded AIDS drug trials involving HIV-positive foster children, the HHS Office of Human Research Protections said last month in a letter to the hospitals, the AP/Long Island Newsday reports. In a letter dated May 23 and sent to Columbia University Medical Center and New York Presbyterian Hospital, OHRP said that the institutions violated federal regulations in at least four drug studies involving foster children. The violations include failing to obtain adequate information on the selection of foster children as research participants and the process of acquiring consent from parents or guardians and failure to ensure unbiased selection of trial participants (Solomon, AP/Long Island Newsday, 6/17). The letter gives CUMC and NYPH until June 30 to develop corrective plans to increase protections for children participating in drug trials (Hemel, New York Sun, 6/17).

Background, Federal Regulations
The hospitals' trials were a part of larger NIH-funded studies involving hundreds of HIV-positive foster children in at least seven states that often did not appoint independent advocates for the children, according to an Associated Press investigation. The research among foster children was conducted mainly in the 1990s in at least seven states, including Illinois, Louisiana, Maryland, New York, North Carolina, Colorado and Texas. Since 1983, the government has required that researchers and oversight boards appoint independent advocates for foster children enrolled in a certain type of study that involves "greater-than-minimal risk" and lacks the "promise of direct benefit." However, child advocates were not appointed for most of the NIH-funded AIDS-related studies, despite written promises from research institutions that guardians would be assigned (Kaiser Daily HIV/AIDS Report, 5/5). OHRP is withholding its decision on whether CUMC and NYPH should have provided the children with independent advocates until it receives further information (AP/Long Island Newsday, 6/17).

Reaction, Further Investigation
CUMC spokesperson Marilyn Castaldi said that the trials were "instrumental in extending lifesaving HIV treatments to children," adding, "We stand behind the clinical aspects of these trials. It's not an issue of safety or harm" (Scott, New York Times, 6/17). Both hospitals in correspondence with government officials said they currently are developing plans to improve safeguards for children, particularly foster children, in drug trials (AP/Long Island Newsday, 6/17). New York City's Administration for Children's Services has hired the Vera Institute of Justice to investigate the charge that the city inappropriately allowed foster children to participate in the trials (New York Times, 6/17).

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