Federal investigators have concluded that Columbia University Medical Center and New York-Presbyterian Hospital violated protocol on the use of human research subjects between 1988 and 2001, when doctors at the center administered experimental AIDS drugs to foster-care children.

In a letter dated May 23, the Department of Health and Human Services gave Columbia and New York Presbyterian until June 30 to develop a “corrective action plan” to bolster safeguards protecting children in clinical trials.

According to the HHS investigators, the medical center’s institutional review board – which vets experiments involving human subjects – failed to determine whether it had proper consent to administer cutting-edge treatments to foster-care children.

The city’s Administration for Children’s Services acknowledged in April that approximately 465 HIV positive and AIDS-infected foster children received treatments that had not yet been approved by the Food and Drug Administration. The experiments at the Manhattan hospitals were funded by the National Institutes of Health, which has conducted pediatric AIDS drug tests on more than 13,000 children in at least seven states. An estimated 5-10% of patients in these trials were wards of the foster-care system.

“These studies … were instrumental in extending lifesaving HIV treatments to children,” a Columbia medical center spokeswoman, Marilyn Castaldi, said in a statement yesterday. She said that since the center is currently formulating a response to the HHS letter, “it would not be appropriate to comment further at this point.”

In previous correspondence with the HHS, Columbia and New York-Presbyterian officials argued that researchers did not have to appoint special advocates to represent the foster children’s interests because the treatments carried “the prospect of direct benefit” for patients with HIV and AIDS.

But federal investigators said that the review board didn’t gather enough information to make such an assessment.

Bioethics experts told The New York Sun yesterday that institutions conducting medical trials should never be the only judges of questions regarding young patients in clinical trials.

“The researchers obviously have a conflict of interest that would prevent them from being the sole protector of the child,” said the director of the Stanford University Center for Biomedical Ethics, David Magnus.

The fact that many of the patients in the Manhattan hospitals’ trials were foster children should have prompted the institutional review board to consider “extra precautions,” the editor of the journal IRB: Ethics & Human Research, Karen Maschke, said.

“These are by definition vulnerable subjects,” Ms. Maschke said.

According to Ms. Maschke, the HHS investigators “dodged” a central issue in the inquiry: whether the research would have been permissible even with advocacy oversight. “If the answer is no, then the ‘advocate’ question is moot,” Ms. Maschke said.

Several of the drugs administered in the NIH-funded studies were in the first phase of development. Mr. Magnus said that Phase 1 research seeks to determine a drug’s “maximum tolerable dosage,” and he said it is “dubious” that such trials are ever in the best interests of child patients.

Meanwhile, local politicians are demanding to know how the ACS allowed infants and youngsters under its watch to be enrolled in drug trials.

The ACS has also weathered criticism for failing to stem alleged abuses at the Incarnation Children’s Center in Harlem. According to a BBC documentary that aired last November, HIV-infected children at the center allegedly received potentially lethal doses of anti-AIDS medicines, sometimes being force-fed the drugs through stomach tubes.

Council Member William Perkins, a Democrat who represents Harlem, said the HHS letter “confirms a shocking disregard for the rights and well-being of foster care children by the ACS.”

Mr. Perkins called on the ACS to conduct a “vigorous investigation” into the use of foster children in medical experiments. But according to ACS officials, the agency has already contracted the Vera Institute for Justice, a Manhattan-based nonprofit group, to review city’s practices regarding medical experiments that use foster children as subjects.

The ACS said it “intends to make all of Vera’s findings fully available to the public.”

Officials at the ACS told the Sun yesterday that none of the city’s foster children are currently enrolled in drug experiments. But NIH officials yesterday could not confirm or deny that foster children are still being used in ongoing federally funded medical experiments.

“It is likely” that foster care children currently being treated in federally funded AIDS drug trials, NIH spokesman John Burklow told the Sun, but he added, “the decisions about who can enroll into a clinical trial are made at the local IRB level.”

Officials at Columbia and New York-Presbyterian told the HHS last August that they were taking several steps to protect young patients in clinical trials – including a mandatory training program for staff on the use of children in research.

Last month’s letter requires officials at the hospitals to turn over troves of documents to the HHS so that investigators can scrutinize the hospitals’ institutional review boards.