The final report of the VERA Institute investigation commissioned in 2005 by the NYC Administration of Child Services will hardly put to rest the controversy surrounding a 20-year period during which children in foster care were subjected to toxic Phase I and Phase II AIDS drug and vaccine experiments--mostly without parental consent and without the protection of an independent advocate--as mandated by federal regulations in force then and now.

The VERA Institute report findings:

532 children in NYC foster care were enrolled in the AIDS clinical trials or observational studies.

80 of the 532 children who participated in clinical trials or observational studies died while in foster care;  25 of them died while enrolled in a medication trial.

64 children participated in 30 medication trials that were NOT REVIEWED by a special medical advisory panel, as the city's policy required.

And 21 children participated in trials that the panel had REVIEWED BUT had NOT RECOMMENDED.
(In both cases, 13 of the enrollments occurred before the children were placed in foster care.)

The authors of the report "concluded" that the deaths were "not a direct result of the medications."

However the validity of that conclusion is highly questionable inasmuch as the VERA Institute reached that "conclusion" on the basis of (admittedly) incomplete, therefore unreliable records.  

MOST IMPORTANT: The VERA Institute acknowledges that its staff never gained access to the children's primary medical clinical trial records--which the hospitals conducting the trials kept sealed under a shield of confidentiality.  

"citing confidentiality laws, the New York State Department of Health (NYSDOH) refused multiple requests from Children's Services that it use its supervisory authority to allow Vera Institute of Justice staff from Vera or Children's Services to review clinical trial research or medical records.

This limited Vera's review in several ways, including the ability to fully document the frequency and severity of toxicity (side effects), the individual outcomes of trial participation for the children in the review, and the existence of valid, signed informed consent documents."  [Executive Summary ]

The Vera Institute did not have access to minutes from medical center research review boards where the trials were conducted.

"Vera could not identify the trials in which an IRB approved a trial under 5 CFR 46.406 or .407.  HRA/Children's Services' policy required that each institution produce proof of IRB approval, but the policy did not require that the institution identify the category under which the IRB approved the research"

DENIAL OF ACCESS TO THE PRIMARY RECORDS EFFECTIVELY UNDERMINED THE VALIDITY OF THE VERA INSTITUTE INVESTIGATION  which was charged with fact-finding about these highly controversial experiments.
The foster children in the experiments--94% children of color--were enrolled, mostly in violation of federal informed consent requirements.

The VERA Institute relied on secondary, child welfare files and Pediatric AIDS Unit (PAU) records both of which are notoriously incomplete.  

"Although state regulations mandated that Children's Services ensure the retention of most of the child welfare files that Vera was asked to review, for 30 percent of the children, some part of the child welfare file was lost, destroyed, or otherwise unavailable."

"the records of the Pediatric AIDS Unit (PAU) were incomplete, especially after 1995. Problems with the PAU's record keeping after 1995, including defects in the unit's electronic database, were noted in the unit's quarterly reports to supervisors and state officials, including the AIDS Institute."

Even those incomplete welfare files provide a hint of the adverse effects suffered by children who had been subjected to the experimental trials:

"The child welfare files contained information indicating that some children experienced serious toxicities, or side effects, from trial medications, such as reduced liver function or severe anemia. These toxicities were consistent with toxicities described in published articles about the trials."

Background:
In 2004, after ascertaining that there were legitimate issues of concern and the possibility of child abuse--some of which were enumerated in a report by Liam Scheff, The House that AIDS Built, the Alliance for Human Research Protection filed a complaint with the federal Office of Human Research Protection (OHRP). The AHRP complaint focused on the enrollment of particularly vulnerable foster children in AIDS drug / vaccine experiments and system wide institutional failure to protect the individual child's best interest in accordance with Federal regulations mandating an independent advocate for each child.

The foster children enrolled in the AIDS trials were denied their human ight: they were enrolled in the trial in accordance with New York City ACS guidelines which waive a foster child's right to individual consent. ACS guidelines stated: "Separate consent need not be obtained for each child."
This waiver, we believe, denies these children their basic human dignity and ascribes to them the status of guinea pigs .

The VERA Institute report confirms that the AHRP letter of complaint was the cornerstone for OHRP's investigation of Columbia University Medical Center's HIV-AIDS clinical trials, followed by a nationwide investigation:

"OHRP issued determination letters to 19 institutions across the country for violations related to the enrollment of foster children in the HIV/AIDS clinical trials originally cited in the AHRP letter.366 The 19 institutions included the New York City medical centers Bronx-Lebanon and Bellevue Hospital Centers. 367 The SUNY Health Science Center at Stony Brook had also received a determination letter in February 2006 regarding two of the clinical trials cited.368 Each of these letters refers to an IRB's apparent failure to categorize the research as 404, 405, 406, or 407 studies and/or to obtain sufficient information regarding the selection of foster children as participants in the trials. At each of the 19 other sites that received the June 2006 determination letters, OHRP approved corrective action plans aimed at preventing future violations." Links to the 19 letters .

The VERA Institute report makes some cogent critical observations about the shortcomings of the OHRP investigation:

" The OHRP investigations indicate that IRBs at many institutions across the country did not properly document their activities and did not take the special circumstances of children in foster care into consideration. As is its mandate, OHRP focused its activities on compliance with federal regulations. The investigation at CUMC, however, left many other questions unanswered."

"OHRP did not seek to make determinations on how many children in foster care participated in clinical trials or whether the person who signed the consent form had the legal authority to do so, nor did it examine what adverse events or benefits occurred to the children, if any, due to trial participation.

"The investigation did not examine whether foster children made up a disproportionate number of children in HIV/AIDS clinical trials or specify the policy of New York City's child welfare agency for enrolling and monitoring foster children in clinical trials."

Evidence previously uncovered by the Associated Press, confirmed AHRP's oncerns: most of the foster children in the AIDS trials were denied the protection of an independent advocate charged with ensuring that a foster child's best interest is served by participating in a research project--as mandated by federal regulations.

Because the facts do not refute our complaint about the failure to provide NYC foster children the protection of an independent advocate--who may have refused consent for the AIDS drug / vaccine trials in which 80 children are confirmed to have died, the VERA report attempts to whitewash the violations by claiming that:
 
"The role and requirements of the independent advocate described in federal research regulations were not well understood by clinical trials researchers and, in some cases, child welfare staff...."

It boggles the imagination that institutional review boards at premier medical research centers could claim ignorance about a glaring conflict of interest:

"In at least six instances where Vera reviewers found that an independent advocate had been appointed, the person appointed had relationships to the institution conducting the trial or a child welfare agency that the federal regulations specifically bar."

The ACS Press Release claimed: "evidence that child welfare officials followed then-current written policies to obtain parental consent for nearly 80 percent of children participating in the trials" when in fact, the child welfare agency changed its enrollment policy to speed up the enrollment process. 

The New York City ACS guidelines waived a foster child's right to individual consent in direct violation of federal regulations:
"Separate consent need not be obtained for each child."

This waiver denied foster children their basic human dignity and cast them to the status of guinea pigs.

Oddly, The New York Times did not consider 80 children's deaths worthy of mention in its news report!  

See: AHRP complaint: http://www.ahrp.org/ahrpsp

See:The Associated Press report, "Researchers Tested AIDS Drugs on Children"
by John Solomon, May 5, 2004, whose investigation found that less than a third of the children in the AIDS trials :

See: AHRP Testimony

posted by Vera Hassner Sharav


THE VERA INSTITUTE OF JUSTICE
THE EXPERIENCES OF NEW YORK CITY
FOSTER CHILDREN IN HIV/AIDS CLINICAL TRIALS

 EXECUTIVE SUMMARY ---EXCERPT

The Vera review also found evidence that supported some concerns about the participation of foster children and their families in clinical trials. This evidence includes violations of state regulations, Children's Services' own policies for clinical trial review and enrollment, and federal regulations for protecting human subjects.

1. Child welfare agency policy after 1991 called for a review of clinical trials by a Medical Advisory Panel and approval by the commissioner. However, twenty-one children participated in three medication trials that the MAP reviewed and did not recommend and the commissioner did not approve. Thirteen of these enrollments took place before the children entered foster care.

• Thirteen children participated in four medication trials that the MAP had reviewed but for which no recommendation had been forwarded to the commissioner. Two of these enrollments took place before the children entered foster care.

• Sixty-four children participated in 30 medication trials that were not reviewed by the MAP. Thirteen of these enrollments took place before the children entered foster care.

2. Regulations and policy required the child welfare agency to retain signed informed consent forms, commissioner approval documents, and other documentation for each trial and each enrollment. For 21 percent of enrollments in medication trials that took place while the children were in foster care, signed informed consent forms were not found in the child welfare files.

3. Trials sponsored by the National Institutes of Health were monitored by an organization charged with ensuring that an informed consent document was present in the research records for each enrolled child. Without access to clinical trial research records, Vera cannot say whether or not a valid informed consent document existed in every case.

4. In at least 16 cases, Vera staff found that children in foster care appeared to have been enrolled in trials prior to the commissioner's approval of the trial. In some instances, HRA/ACS took several months to approve a trial.

5. In at least seven enrollments, 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 consents in these cases.

6. Federal regulations required informed consent forms to be written in accessible language.
Many informed consent forms contained technical language difficult for people without a medical background to understand.

7. The role and requirements of the independent advocate described in federal research regulations were not well understood by clinical trials researchers and, in some cases, child welfare staff. In at least six instances where Vera reviewers found that an independent advocate had been appointed, the person appointed had relationships to the institution conducting the trial or a child welfare agency that the federal regulations specifically bar.

8. In several situations, child welfare files described deviations from the processes required by federal regulations and Children's Services policy. These include handwritten notes for informed consent in lieu of official documents, consent accepted over the phone, and consent sought or obtained from parents who may not have been competent to provide it. In at least two instances, the files indicate that parents' wishes were ignored. In other situations, consent was requested in ways that parents might have perceived as coercive.

9. Although state regulations mandated that Children's Services ensure the retention of most of the child welfare files that Vera was asked to review, for 30 percent of the children, some part of the child welfare file was lost, destroyed, or otherwise unavailable.

10. Available records often did not contain documentation required by state regulations.

11. Though required to collect information related to HIV testing, HIV-related medical care, and clinical trials enrollment, the records of the Pediatric AIDS Unit (PAU) were incomplete, especially after 1995. Problems with the PAU's record keeping after 1995, including defects in the unit's electronic database, were noted in the unit's quarterly reports to supervisors and state officials, including the AIDS Institute.

12. Foster care agency staff approved at least 14 enrollments of children who were in the joint guardianship of the commissioner and the foster care agency. Although conforming to the technical requirements of the policy, this resulted in the enrollment of several foster children in trials the commissioner had not approved. Three of these children were enrolled in a phase I clinical trial even though Children's Services' policy barred participation in phase I trials.
~~~~~~~~~


THE NEW YORK TIMES
January 28, 2009
Study Refutes Claims on AIDS Drug Trials

By LISA W. FODERARO

An investigation into the participation of New York City foster children in clinical drug trials for H.I.V. and AIDS over a nearly 20-year period has found no evidence that any children died as a result of the trials or that the foster children were selected because of their race.

In the late 1980s, as the AIDS epidemic intensified, the city's child-welfare agency developed a policy to allow foster children to enroll in drug trials at a time when there were no approved treatments for children infected with H.I.V. and AIDS. Hundreds of children received medication in scores of trials conducted from the late 1980s to 2005.

But after charges by a freelance journalist that children were put in trials without their parents' knowledge and given medications known to cause death, some civil rights activists and City Council members expressed angry concern.

As a result, in 2005 the city commissioned the Vera Institute of Justice, an independent nonprofit group, to investigate the claims. That study, which is to be released on Wednesday, determined that city officials had acted in good faith and in the interests of the children, many of whom were seriously ill.

But it also found that the agency had not always followed its own protocols and kept poor records.

After interviewing dozens of people involved in the trials and reviewing hundreds of thousands of pages of case files, documents and correspondence, the Vera Institute concluded that none of the 532 children in the trials died as a direct result of the medications. (Twenty-five children receiving treatment as part of the trials died during the trial years.)

The report also found that foster children were not removed from their families by the city because a parent had refused to consent to a child's treatment, as some had alleged.

In addition, the study said that researchers did not specifically select foster children for enrollment in the trials. And while the foster children were overwhelmingly black and Hispanic, as some critics emphasized, that profile mirrored the demographics of children with H.I.V. infection in the city at the time.

"When we read through an amazing volume of material, we found that Children's Services were aware that this was a very sensitive issue for a lot of important historic reasons," said Timothy A. Ross, the co-director of the project at Vera.

"Children's Services did research on the rules and regulations that applied, and developed a reasoned policy in the late 1980s," he added. "The standard for enrolling kids in foster care that the child welfare agency used was higher than the federal standard."

However, the institute also discovered problems. "There were clearly breakdowns in the implementation of this policy," Dr. Ross said.

Sixty-four children participated in 30 medication trials that were not reviewed by a special medical advisory panel, as the city's policy required.
And 21 children participated in trials that the panel had reviewed but had not recommended. (In both cases, 13 of the enrollments occurred before the children were placed in foster care.)

Moreover, the informed consent forms from biological parents or guardians were missing from the child-welfare files in 21 percent of cases, even though regulations and the city's own policies mandated that they be kept, Mr. Ross said. The state's Department of Health refused Vera's request to review medical records, which might have included some additional consents.

"We found a disturbing lack of medical consent forms," he said. "In some cases we found handwritten consents instead of the official consent forms."
Mr. Ross added that such makeshift permissions violated both city policy and federal regulations.

The commissioner of the Administration for Children's Services, John B.
Mattingly, said in an interview about the report: "In very general terms, it puts to rest the most egregious charges that were being made by a few people three or four years ago. No children were yanked from their homes. That is all completely false."

Liam Scheff, the journalist in Boston who first made the alarming charges about the trials, questioned that finding.
"Now they admit that the children died, but, oh, it couldn't have been the drugs," Mr. Scheff said in an e-mail message. "How do they know? How do they tell the difference?"

He said that the drugs in question had Food and Drug Administration warnings on them and that they had "caused permanent injury and painful death in adults who have taken the exact same drugs at normal prescribed doses. These children died, and countless others were made sick while taking these drugs, because of a diagnosis that is itself overly harsh, overly deterministic"
and, he said, based on faulty H.I.V. testing technology.

Mr. Mattingly said the agency had already taken steps to ensure that policies are properly enforced in any future clinical trials involving foster children. Today, no children are involved in medication trials.

One change involved the revamping of the way the agency catalogues and maintains archived case records; an electronic system established in 2004 allows for prompt retrieval of all case files. Another new policy calls for more review by Family Court when a parent is not available to provide consent.

Copyright 2009 The New York Times Company