NYC Commissioned Investigation Absolves NYC of 532 Deaths Foster Children AIDS Trials

[Guest guest]

ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIThe final report of the VERA Institute investigation commissioned in 2005 bythe NYC Administration of Child Services will hardly put to rest thecontroversy surrounding a 20-year period during which children in fostercare were subjected to toxic Phase I and Phase II AIDS drug and vaccineexperiments--mostly without parental consent and without the protection ofan independent advocate--as mandated by federal regulations in force thenand now.The VERA Institute report findings:532 children in NYC foster care were enrolled in the AIDS clinical trials orobservational studies. 80 of the 532 children who participated in clinical trials or observationalstudies 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 aspecial medical advisory panel, as the city's policy required. And 21 children participated in trials that the panel had REVIEWED BUT hadNOT RECOMMENDED. (In both cases, 13 of the enrollments occurred before the children wereplaced in foster care.)The authors of the report "concluded" that the deaths were "not a directresult of the medications."http://www.vera.org/publication_pdf/clinicaltrials-noappendix.pdfHowever the validity of that conclusion is highly questionable inasmuch asthe VERA Institute reached that "conclusion" on the basis of (admittedly)incomplete, therefore unreliable records.  MOST IMPORTANT: The VERA Institute acknowledges that its staff never gainedaccess to the children's primary medical clinical trial records--which thehospitals conducting the trials kept sealed under a shield ofconfidentiality.  "citing confidentiality laws, the New York State Department of Health(NYSDOH) refused multiple requests from Children's Services that it use itssupervisory authority to allow Vera Institute of Justice staff from Vera orChildren's Services to review clinical trial research or medical records.This limited Vera's review in several ways, including the ability to fullydocument the frequency and severity of toxicity (side effects), theindividual outcomes of trial participation for the children in the review,and the existence of valid, signed informed consent documents."  [ExecutiveSummary] http://www.vera.org/publication_pdf/clinicaltrials-noappendix.pdfNeither did the Vera Institute have access to minutes from medical centerresearch review boards where the trials were conducted."Vera could not identify the trials in which an IRB approved a trial under45 CFR 46.406 or .407.  HRA/Children's Services' policy required that eachinstitutionproduce proof of IRB approval, but the policy did not require that theinstitution identify the category under which the IRB approved the research"DENIAL OF ACCESS TO THE PRIMARY RECORDS EFFECTIVELY UNDERMINED THE VALIDITYOF THE VERA INSTITUTE INVESTIGATION which was charged with fact-finding about these highly controversialexperiments.The foster children in the experiments--94% children of color--wereenrolled, mostly in violation of federal informed consent requirements. The VERA Institute relied on secondary, child welfare files and PediatricAIDS Unit (PAU) records both of which are notoriously incomplete.  "Although state regulations mandated that Children's Services ensure theretention 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 waslost, destroyed, or otherwise unavailable." "the records of the Pediatric AIDS Unit (PAU) were incomplete, especiallyafter 1995. Problems with the PAU's record keeping after 1995, includingdefectsin the unit's electronic database, were noted in the unit's quarterlyreports to supervisors and state officials, including the AIDS Institute."Even those incomplete welfare files provide a hint of the adverse effectssuffered by children who had been subjected to the experimental trials: "The child welfare files contained information indicating that some childrenexperienced serious toxicities, or side effects, from trial medications,such as reduced liver function or severe anemia. These toxicities wereconsistent with toxicities described in published articles about thetrials."Background: In 2004, after ascertaining that there were legitimate issues of concern andthe possibility of child abuse--some of which were enumerated in a report byLiam Scheff, The House that AIDS Built,http://www.altheal.org/toxicity/house.htmthe Alliance for Human Research Protection filed a complaint with thefederal Office of Human Research Protection (OHRP). The AHRP complaintfocused on the enrollment of particularly vulnerable foster children in AIDSdrug / vaccine experiments and system wide institutional failure to protectthe individual child's best interest in accordance with Federal regulationsmandating an independent advocate for each child. The foster children enrolled in the AIDS trials were denied their humanright: they were enrolled in the trial in accordance with New York City ACSguidelines which waive a foster child's right to individual consent. ACSguidelines stated: "Separate consent need not be obtained for each child."This waiver, we believe, denies these children their basic human dignity andascribes to them the status of guinea pigs. http://www.ahrp.org/ahrpsp The VERA Institute report confirms that the AHRP letter of complaint was thecornerstone for OHRP's investigation of Columbia University Medical Center'sHIV-AIDS clinical trials, followed by a nationwide investigation:"OHRP issued determination letters to 19 institutions across the country forviolations related to the enrollment of foster children in the HIV/AIDSclinical trials originallycited in the AHRP letter.366 The 19 institutions included the New York Citymedical centers Bronx-Lebanon and Bellevue Hospital Centers. 367 The SUNYHealth Science Center at Stony Brook had also received a determinationletter in February 2006 regarding two of the clinical trials cited.368 Eachof these letters refers to an IRB's apparent failure to categorize theresearch as 404, 405, 406, or 407 studies and/or to obtain sufficientinformation regarding the selection of foster children as participants inthe trials. At each of the 19 other sites that received the June 2006determination letters, OHRP approved corrective action plans aimed atpreventing futureviolations." Links to the 19 letters at:http://www.hhs.gov/ohrp/compliance/letters/2006.html The VERA Institute report makes some cogent critical observations about theshortcomings of the OHRP investigation:" The OHRP investigations indicate that IRBs at many institutions across thecountry did not properly document their activities and did not take thespecial circumstances of children in foster care into consideration. As isits mandate, OHRP focused its activities on compliance with federalregulations. The investigation at CUMC, however, left many other questionsunanswered. OHRP did not seek to make determinations on how many children infoster care participated in clinical trials or whether the person who signedthe consent form had the legal authority to do so, nor did it examine whatadverse events or benefits occurred to the children, if any, due to trialparticipation. The investigation did not examine whether foster childrenmade up a disproportionate number of children in HIV/AIDS clinical trials orspecify the policy of New York City's child welfare agency for enrolling andmonitoring foster children in clinical trials."Evidence previously uncovered by the Associated Press, confirmed AHRP'sconcerns: most of the foster children in the AIDS trials were denied theprotection of an independent advocate charged with ensuring that a fosterchild's best interest is served by participating in a research project--asmandated by federal regulations. Because the facts do not refute our complaint about the failure to provideNYC foster children the protection of an independent advocate--who may haverefused consent for the AIDS drug / vaccine trials in which 80 children areconfirmed to have died, the VERA report attempts to whitewash the violationsby claiming that:"The role and requirements of the independent advocate described in federalresearch regulations were not well understood by clinical trials researchersand, in some cases, child welfare staff...." It boggles the imagination that institutional review boards at premiermedical research centers could claim ignorance about a glaring conflict ofinterest:"In at least six instances where Vera reviewers found that an independentadvocate had been appointed, the person appointed had relationships to theinstitution conducting the trial or a child welfare agency that the federalregulations specifically bar."The ACS Press Release claimed: "evidence that child welfare officialsfollowed then-current written policies to obtain parental consent for nearly80 percent of children participating in the trials" when in fact, the childwelfare agency changed its enrollment policy to speed up the enrollmentprocess.  The New York City ACS guidelines waived a foster child's right toindividual consent in direct violation of federal regulations: "Separate consent need not be obtained for each child." This waiver, we believe, denied foster children their basic human dignityand cast them to the status of guinea pigs. Oddly, The New York Times did not consider 80 children's deaths worthy ofmention in its news report!  See: AHRP complaint: http://www.ahrp.org/ahrpspSee:The Associated Press report, "Researchers Tested AIDS Drugs on Children"by John Solomon, May 5, 2004, whose investigation found that less than athird of the children in the AIDS trials :http://www.ahrp.org/infomail/05/05/04.phpSee: Testimony http://www.ahrp.org/cms/content/view/219/140/Contact: Vera Hassner Sharavveracare212-595-8974http://www.vera.org/publication_pdf/clinicaltrials-execsum.pdfTHE VERA INSTITUTE OF JUSTICETHE EXPERIENCES OF NEW YORK CITYFOSTER CHILDREN IN HIV/AIDS CLINICAL TRIALS EXECUTIVE SUMMARYEXCERPTThe Vera review also found evidence that supported some concerns about theparticipation offoster children and their families in clinical trials. This evidenceincludes violations of stateregulations, Children's Services' own policies for clinical trial review andenrollment, andfederal regulations for protecting human subjects.1. Child welfare agency policy after 1991 called for a review of clinicaltrials by a MedicalAdvisory Panel and approval by the commissioner. However,. Twenty-one children participated in three medication trials that the MAPreviewedand did not recommend and the commissioner did not approve. Thirteen oftheseenrollments took place before the children entered foster care.. Thirteen children participated in four medication trials that the MAP hadreviewedbut for which no recommendation had been forwarded to the commissioner. Twoofthese enrollments took place before the children entered foster care.. Sixty-four children participated in 30 medication trials that were notreviewed by theMAP. Thirteen of these enrollments took place before the children enteredfoster care.2. Regulations and policy required the child welfare agency to retain signedinformed consentforms, commissioner approval documents, and other documentation for eachtrial and eachenrollment. For 21 percent of enrollments in medication trials that tookplace while thechildren were in foster care, signed informed consent forms were not foundin the childwelfare files.3. Trials sponsored by the National Institutes of Health were monitored byan organizationcharged with ensuring that an informed consent document was present in theresearch recordsfor each enrolled child. Without access to clinical trial research records,Vera cannot saywhether or not a valid informed consent document existed in every case.4. In at least 16 cases, Vera staff found that children in foster careappeared to have beenenrolled in trials prior to the commissioner's approval of the trial. Insome instances,HRA/ACS took several months to approve a trial.5. In at least seven enrollments, the person who signed an informed consentform was notlegally authorized to do so. Kinship foster parents, parents withoutparental rights, and childwelfare staff signed the consents in these cases.6. Federal regulations required informed consent forms to be written inaccessible language.Many informed consent forms contained technical language difficult forpeople without amedical background to understand.7. The role and requirements of the independent advocate described infederal researchregulations were not well understood by clinical trials researchers and, insome cases, childwelfare staff. In at least six instances where Vera reviewers found that anindependentadvocate had been appointed, the person appointed had relationships to theinstitutionconducting the trial or a child welfare agency that the federal regulationsspecifically bar.8. In several situations, child welfare files described deviations from theprocesses required byfederal regulations and Children's Services policy. These includehandwritten notes forinformed consent in lieu of official documents, consent accepted over thephone, and consentsought or obtained from parents who may not have been competent to provideit. In at leasttwo instances, the files indicate that parents' wishes were ignored. Inother situations, consentwas requested in ways that parents might have perceived as coercive.9. Although state regulations mandated that Children's Services ensure theretention of most ofthe child welfare files that Vera was asked to review, for 30 percent of thechildren, somepart of the child welfare file was lost, destroyed, or otherwiseunavailable.10. Available records often did not contain documentation required by stateregulations.11. Though required to collect information related to HIV testing,HIV-related medical care, andclinical 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 defectsin the unit's electronic database, were noted in the unit's quarterlyreports to supervisors andstate officials, including the AIDS Institute.12. Foster care agency staff approved at least 14 enrollments of childrenwho were in the jointguardianship of the commissioner and the foster care agency. Althoughconforming to thetechnical requirements of the policy, this resulted in the enrollment ofseveral foster childrenin trials the commissioner had not approved. Three of these children wereenrolled in a phaseI clinical trial even though Children's Services' policy barredparticipation in phase I trials.~~~~~~~~~http://www.nytimes.com/2009/01/28/nyregion/28foster.html?_r=1 & pagewanted=printTHE NEW YORK TIMESJanuary 28, 2009Study Refutes Claims on AIDS Drug TrialsBy LISA W. FODERAROAn investigation into the participation of New York City foster children inclinical drug trials for H.I.V. and AIDS over a nearly 20-year period hasfound no evidence that any children died as a result of the trials or thatthe foster children were selected because of their race.In the late 1980s, as the AIDS epidemic intensified, the city'schild-welfare agency developed a policy to allow foster children to enrollin drug trials at a time when there were no approved treatments for childreninfected with H.I.V. and AIDS. Hundreds of children received medication inscores of trials conducted from the late 1980s to 2005.But after charges by a freelance journalist that children were put in trialswithout their parents' knowledge and given medications known to cause death,some civil rights activists and City Council members expressed angryconcern.As a result, in 2005 the city commissioned the Vera Institute of Justice, anindependent nonprofit group, to investigate the claims. That study, which isto be released on Wednesday, determined that city officials had acted ingood faith and in the interests of the children, many of whom were seriouslyill.But it also found that the agency had not always followed its own protocolsand kept poor records.After interviewing dozens of people involved in the trials and reviewinghundreds of thousands of pages of case files, documents and correspondence,the Vera Institute concluded that none of the 532 children in the trialsdied as a direct result of the medications. (Twenty-five children receivingtreatment as part of the trials died during the trial years.)The report also found that foster children were not removed from theirfamilies by the city because a parent had refused to consent to a child'streatment, as some had alleged.In addition, the study said that researchers did not specifically selectfoster children for enrollment in the trials. And while the foster childrenwere overwhelmingly black and Hispanic, as some critics emphasized, thatprofile mirrored the demographics of children with H.I.V. infection in thecity at the time."When we read through an amazing volume of material, we found thatChildren's Services were aware that this was a very sensitive issue for alot of important historic reasons," said Timothy A. Ross, the co-director ofthe 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 standardfor enrolling kids in foster care that the child welfare agency used washigher than the federal standard."However, the institute also discovered problems. "There were clearlybreakdowns in the implementation of this policy," Dr. Ross said.Sixty-four children participated in 30 medication trials that were notreviewed by a special medical advisory panel, as the city's policy required.And 21 children participated in trials that the panel had reviewed but hadnot recommended. (In both cases, 13 of the enrollments occurred before thechildren were placed in foster care.)Moreover, the informed consent forms from biological parents or guardianswere missing from the child-welfare files in 21 percent of cases, eventhough 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 toreview medical records, which might have included some additional consents."We found a disturbing lack of medical consent forms," he said. "In somecases we found handwritten consents instead of the official consent forms."Mr. Ross added that such makeshift permissions violated both city policy andfederal regulations.The commissioner of the Administration for Children's Services, John B.Mattingly, said in an interview about the report: "In very general terms, itputs to rest the most egregious charges that were being made by a few peoplethree or four years ago. No children were yanked from their homes. That isall completely false."Liam Scheff, the journalist in Boston who first made the alarming chargesabout the trials, questioned that finding."Now they admit that the children died, but, oh, it couldn't have been thedrugs," Mr. Scheff said in an e-mail message. "How do they know? How do theytell the difference?"He said that the drugs in question had Food and Drug Administration warningson them and that they had "caused permanent injury and painful death inadults who have taken the exact same drugs at normal prescribed doses. Thesechildren 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 thatpolicies are properly enforced in any future clinical trials involvingfoster children. Today, no children are involved in medication trials.One change involved the revamping of the way the agency catalogues andmaintains archived case records; an electronic system established in 2004allows for prompt retrieval of all case files. Another new policy calls formore review by Family Court when a parent is not available to provideconsent.Copyright 2009 The New York Times CompanyFAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. Suchmaterial is made available for educational purposes, to advanceunderstanding of human rights, democracy, scientific, moral, ethical, andsocial justice issues, etc. It is believed that this constitutes a 'fairuse' of any such copyrighted material as provided for in Title 17 U.S.C.section 107 of the US Copyright Law. This material is distributed withoutprofit. _____________Infomail1 mailing listto send a message to Infomail1-leave =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.

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ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIThe final report of the VERA Institute investigation commissioned in 2005 bythe NYC Administration of Child Services will hardly put to rest thecontroversy surrounding a 20-year period during which children in fostercare were subjected to toxic Phase I and Phase II AIDS drug and vaccineexperiments--mostly without parental consent and without the protection ofan independent advocate--as mandated by federal regulations in force thenand now.The VERA Institute report findings:532 children in NYC foster care were enrolled in the AIDS clinical trials orobservational studies. 80 of the 532 children who participated in clinical trials or observationalstudies 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 aspecial medical advisory panel, as the city's policy required. And 21 children participated in trials that the panel had REVIEWED BUT hadNOT RECOMMENDED. (In both cases, 13 of the enrollments occurred before the children wereplaced in foster care.)The authors of the report "concluded" that the deaths were "not a directresult of the medications."http://www.vera.org/publication_pdf/clinicaltrials-noappendix.pdfHowever the validity of that conclusion is highly questionable inasmuch asthe VERA Institute reached that "conclusion" on the basis of (admittedly)incomplete, therefore unreliable records. MOST IMPORTANT: The VERA Institute acknowledges that its staff never gainedaccess to the children's primary medical clinical trial records--which thehospitals conducting the trials kept sealed under a shield ofconfidentiality. "citing confidentiality laws, the New York State Department of Health(NYSDOH) refused multiple requests from Children's Services that it use itssupervisory authority to allow Vera Institute of Justice staff from Vera orChildren's Services to review clinical trial research or medical records.This limited Vera's review in several ways, including the ability to fullydocument the frequency and severity of toxicity (side effects), theindividual outcomes of trial participation for the children in the review,and the existence of valid, signed informed consent documents." [ExecutiveSummary] http://www.vera.org/publication_pdf/clinicaltrials-noappendix.pdfNeither did the Vera Institute have access to minutes from medical centerresearch review boards where the trials were conducted."Vera could not identify the trials in which an IRB approved a trial under45 CFR 46.406 or .407. HRA/Children's Services' policy required that eachinstitutionproduce proof of IRB approval, but the policy did not require that theinstitution identify the category under which the IRB approved the research"DENIAL OF ACCESS TO THE PRIMARY RECORDS EFFECTIVELY UNDERMINED THE VALIDITYOF THE VERA INSTITUTE INVESTIGATION which was charged with fact-finding about these highly controversialexperiments.The foster children in the experiments--94% children of color--wereenrolled, mostly in violation of federal informed consent requirements. The VERA Institute relied on secondary, child welfare files and PediatricAIDS Unit (PAU) records both of which are notoriously incomplete. "Although state regulations mandated that Children's Services ensure theretention 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 waslost, destroyed, or otherwise unavailable.the records of the Pediatric AIDS Unit (PAU) were incomplete, especiallyafter 1995. Problems with the PAU's record keeping after 1995, includingdefectsin the unit's electronic database, were noted in the unit's quarterlyreports to supervisors and state officials, including the AIDS Institute."Even those incomplete welfare files provide a hint of the adverse effectssuffered by children who had been subjected to the experimental trials: "The child welfare files contained information indicating that some childrenexperienced serious toxicities, or side effects, from trial medications,such as reduced liver function or severe anemia. These toxicities wereconsistent with toxicities described in published articles about thetrials."Background: In 2004, after ascertaining that there were legitimate issues of concern andthe possibility of child abuse--some of which were enumerated in a report byLiam Scheff, The House that AIDS Built,http://www.altheal.org/toxicity/house.htmthe Alliance for Human Research Protection filed a complaint with thefederal Office of Human Research Protection (OHRP). The AHRP complaintfocused on the enrollment of particularly vulnerable foster children in AIDSdrug / vaccine experiments and system wide institutional failure to protectthe individual child's best interest in accordance with Federal regulationsmandating an independent advocate for each child. The foster children enrolled in the AIDS trials were denied their humanright: they were enrolled in the trial in accordance with New York City ACSguidelines which waive a foster child's right to individual consent. ACSguidelines stated: "Separate consent need not be obtained for each child."This waiver, we believe, denies these children their basic human dignity andascribes to them the status of guinea pigs. http://www.ahrp.org/ahrpsp The VERA Institute report confirms that the AHRP letter of complaint was thecornerstone for OHRP's investigation of Columbia University Medical Center'sHIV-AIDS clinical trials, followed by a nationwide investigation:"OHRP issued determination letters to 19 institutions across the country forviolations related to the enrollment of foster children in the HIV/AIDSclinical trials originallycited in the AHRP letter.366 The 19 institutions included the New York Citymedical centers Bronx-Lebanon and Bellevue Hospital Centers. 367 The SUNYHealth Science Center at Stony Brook had also received a determinationletter in February 2006 regarding two of the clinical trials cited.368 Eachof these letters refers to an IRB's apparent failure to categorize theresearch as 404, 405, 406, or 407 studies and/or to obtain sufficientinformation regarding the selection of foster children as participants inthe trials. At each of the 19 other sites that received the June 2006determination letters, OHRP approved corrective action plans aimed atpreventing futureviolations." Links to the 19 letters at:http://www.hhs.gov/ohrp/compliance/letters/2006.html The VERA Institute report makes some cogent critical observations about theshortcomings of the OHRP investigation:" The OHRP investigations indicate that IRBs at many institutions across thecountry did not properly document their activities and did not take thespecial circumstances of children in foster care into consideration. As isits mandate, OHRP focused its activities on compliance with federalregulations. The investigation at CUMC, however, left many other questionsunanswered. OHRP did not seek to make determinations on how many children infoster care participated in clinical trials or whether the person who signedthe consent form had the legal authority to do so, nor did it examine whatadverse events or benefits occurred to the children, if any, due to trialparticipation. The investigation did not examine whether foster childrenmade up a disproportionate number of children in HIV/AIDS clinical trials orspecify the policy of New York City's child welfare agency for enrolling andmonitoring foster children in clinical trials."Evidence previously uncovered by the Associated Press, confirmed AHRP'sconcerns: most of the foster children in the AIDS trials were denied theprotection of an independent advocate charged with ensuring that a fosterchild's best interest is served by participating in a research project--asmandated by federal regulations. Because the facts do not refute our complaint about the failure to provideNYC foster children the protection of an independent advocate--who may haverefused consent for the AIDS drug / vaccine trials in which 80 children areconfirmed to have died, the VERA report attempts to whitewash the violationsby claiming that:"The role and requirements of the independent advocate described in federalresearch regulations were not well understood by clinical trials researchersand, in some cases, child welfare staff...." It boggles the imagination that institutional review boards at premiermedical research centers could claim ignorance about a glaring conflict ofinterest:"In at least six instances where Vera reviewers found that an independentadvocate had been appointed, the person appointed had relationships to theinstitution conducting the trial or a child welfare agency that the federalregulations specifically bar."The ACS Press Release claimed: "evidence that child welfare officialsfollowed then-current written policies to obtain parental consent for nearly80 percent of children participating in the trials" when in fact, the childwelfare agency changed its enrollment policy to speed up the enrollmentprocess. The New York City ACS guidelines waived a foster child's right toindividual consent in direct violation of federal regulations: "Separate consent need not be obtained for each child." This waiver, we believe, denied foster children their basic human dignityand cast them to the status of guinea pigs. Oddly, The New York Times did not consider 80 children's deaths worthy ofmention in its news report! See: AHRP complaint: http://www.ahrp.org/ahrpspSee:The Associated Press report, "Researchers Tested AIDS Drugs on Children"by John Solomon, May 5, 2004, whose investigation found that less than athird of the children in the AIDS trials :http://www.ahrp.org/infomail/05/05/04.phpSee: Testimony http://www.ahrp.org/cms/content/view/219/140/Contact: Vera Hassner Sharavveracare212-595-8974http://www.vera.org/publication_pdf/clinicaltrials-execsum.pdfTHE VERA INSTITUTE OF JUSTICETHE EXPERIENCES OF NEW YORK CITYFOSTER CHILDREN IN HIV/AIDS CLINICAL TRIALS EXECUTIVE SUMMARYEXCERPTThe Vera review also found evidence that supported some concerns about theparticipation offoster children and their families in clinical trials. This evidenceincludes violations of stateregulations, Children's Services' own policies for clinical trial review andenrollment, andfederal regulations for protecting human subjects.1. Child welfare agency policy after 1991 called for a review of clinicaltrials by a MedicalAdvisory Panel and approval by the commissioner. However,. Twenty-one children participated in three medication trials that the MAPreviewedand did not recommend and the commissioner did not approve. Thirteen oftheseenrollments took place before the children entered foster care.. Thirteen children participated in four medication trials that the MAP hadreviewedbut for which no recommendation had been forwarded to the commissioner. Twoofthese enrollments took place before the children entered foster care.. Sixty-four children participated in 30 medication trials that were notreviewed by theMAP. Thirteen of these enrollments took place before the children enteredfoster care.2. Regulations and policy required the child welfare agency to retain signedinformed consentforms, commissioner approval documents, and other documentation for eachtrial and eachenrollment. For 21 percent of enrollments in medication trials that tookplace while thechildren were in foster care, signed informed consent forms were not foundin the childwelfare files.3. Trials sponsored by the National Institutes of Health were monitored byan organizationcharged with ensuring that an informed consent document was present in theresearch recordsfor each enrolled child. Without access to clinical trial research records,Vera cannot saywhether or not a valid informed consent document existed in every case.4. In at least 16 cases, Vera staff found that children in foster careappeared to have beenenrolled in trials prior to the commissioner's approval of the trial. Insome instances,HRA/ACS took several months to approve a trial.5. In at least seven enrollments, the person who signed an informed consentform was notlegally authorized to do so. Kinship foster parents, parents withoutparental rights, and childwelfare staff signed the consents in these cases.6. Federal regulations required informed consent forms to be written inaccessible language.Many informed consent forms contained technical language difficult forpeople without amedical background to understand.7. The role and requirements of the independent advocate described infederal researchregulations were not well understood by clinical trials researchers and, insome cases, childwelfare staff. In at least six instances where Vera reviewers found that anindependentadvocate had been appointed, the person appointed had relationships to theinstitutionconducting the trial or a child welfare agency that the federal regulationsspecifically bar.8. In several situations, child welfare files described deviations from theprocesses required byfederal regulations and Children's Services policy. These includehandwritten notes forinformed consent in lieu of official documents, consent accepted over thephone, and consentsought or obtained from parents who may not have been competent to provideit. In at leasttwo instances, the files indicate that parents' wishes were ignored. Inother situations, consentwas requested in ways that parents might have perceived as coercive.9. Although state regulations mandated that Children's Services ensure theretention of most ofthe child welfare files that Vera was asked to review, for 30 percent of thechildren, somepart of the child welfare file was lost, destroyed, or otherwiseunavailable.10. Available records often did not contain documentation required by stateregulations.11. Though required to collect information related to HIV testing,HIV-related medical care, andclinical 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 defectsin the unit's electronic database, were noted in the unit's quarterlyreports to supervisors andstate officials, including the AIDS Institute.12. Foster care agency staff approved at least 14 enrollments of childrenwho were in the jointguardianship of the commissioner and the foster care agency. Althoughconforming to thetechnical requirements of the policy, this resulted in the enrollment ofseveral foster childrenin trials the commissioner had not approved. Three of these children wereenrolled in a phaseI clinical trial even though Children's Services' policy barredparticipation in phase I trials.~~~~~~~~~http://www.nytimes.com/2009/01/28/nyregion/28foster.html?_r=1 & pagewanted=printTHE NEW YORK TIMESJanuary 28, 2009Study Refutes Claims on AIDS Drug TrialsBy LISA W. FODERAROAn investigation into the participation of New York City foster children inclinical drug trials for H.I.V. and AIDS over a nearly 20-year period hasfound no evidence that any children died as a result of the trials or thatthe foster children were selected because of their race.In the late 1980s, as the AIDS epidemic intensified, the city'schild-welfare agency developed a policy to allow foster children to enrollin drug trials at a time when there were no approved treatments for childreninfected with H.I.V. and AIDS. Hundreds of children received medication inscores of trials conducted from the late 1980s to 2005.But after charges by a freelance journalist that children were put in trialswithout their parents' knowledge and given medications known to cause death,some civil rights activists and City Council members expressed angryconcern.As a result, in 2005 the city commissioned the Vera Institute of Justice, anindependent nonprofit group, to investigate the claims. That study, which isto be released on Wednesday, determined that city officials had acted ingood faith and in the interests of the children, many of whom were seriouslyill.But it also found that the agency had not always followed its own protocolsand kept poor records.After interviewing dozens of people involved in the trials and reviewinghundreds of thousands of pages of case files, documents and correspondence,the Vera Institute concluded that none of the 532 children in the trialsdied as a direct result of the medications. (Twenty-five children receivingtreatment as part of the trials died during the trial years.)The report also found that foster children were not removed from theirfamilies by the city because a parent had refused to consent to a child'streatment, as some had alleged.In addition, the study said that researchers did not specifically selectfoster children for enrollment in the trials. And while the foster childrenwere overwhelmingly black and Hispanic, as some critics emphasized, thatprofile mirrored the demographics of children with H.I.V. infection in thecity at the time."When we read through an amazing volume of material, we found thatChildren's Services were aware that this was a very sensitive issue for alot of important historic reasons," said Timothy A. Ross, the co-director ofthe 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 standardfor enrolling kids in foster care that the child welfare agency used washigher than the federal standard."However, the institute also discovered problems. "There were clearlybreakdowns in the implementation of this policy," Dr. Ross said.Sixty-four children participated in 30 medication trials that were notreviewed by a special medical advisory panel, as the city's policy required.And 21 children participated in trials that the panel had reviewed but hadnot recommended. (In both cases, 13 of the enrollments occurred before thechildren were placed in foster care.)Moreover, the informed consent forms from biological parents or guardianswere missing from the child-welfare files in 21 percent of cases, eventhough 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 toreview medical records, which might have included some additional consents."We found a disturbing lack of medical consent forms," he said. "In somecases we found handwritten consents instead of the official consent forms."Mr. Ross added that such makeshift permissions violated both city policy andfederal regulations.The commissioner of the Administration for Children's Services, John B.Mattingly, said in an interview about the report: "In very general terms, itputs to rest the most egregious charges that were being made by a few peoplethree or four years ago. No children were yanked from their homes. That isall completely false."Liam Scheff, the journalist in Boston who first made the alarming chargesabout the trials, questioned that finding."Now they admit that the children died, but, oh, it couldn't have been thedrugs," Mr. Scheff said in an e-mail message. "How do they know? How do theytell the difference?"He said that the drugs in question had Food and Drug Administration warningson them and that they had "caused permanent injury and painful death inadults who have taken the exact same drugs at normal prescribed doses. Thesechildren 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 thatpolicies are properly enforced in any future clinical trials involvingfoster children. Today, no children are involved in medication trials.One change involved the revamping of the way the agency catalogues andmaintains archived case records; an electronic system established in 2004allows for prompt retrieval of all case files. 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