AHRP Complaint Validated: Columbia “Changes Policy” on ‘Guinea Pig’ Kids

The New York Post and the Associated Press report that the federal Office of
Human Research Protection issued its final letter of determination to
Columbia University Medical Center (CUMC) New York /Presbyterian Hospital
(Feb 17)  following its investigation of a series of AIDS drug and vaccine
experiments conducted on children in foster care.  

The investigation was prompted by a complaint filed by AHRP on March 10,
2004  [See: http://www.ahrp.org/ahrpspeaks/HIVkids0304.php ]

OHRP determined that  the University institutional review board (IRB) had
failed to ensure that essential federal safeguards were followedcarry–as is
its federally mandated responsibility:

"CUMC/ IRB failed to obtain sufficient information to make the
determinations required for approval of research under 45 CFR 46.111:"

Re: "the selection of wards of the state and foster children as research
subjects;"
Re: "the process for obtaining permission of parents or guardians for wards
of the state or foster children;"
Re: "safeguards with respect to the enrollment of wards of  the state or
foster children."

After the finding of non-compliance with federal requirements, AP and the
Post report, "the University says it will institute mandatory training for
faculty members whose research involves children so it complies with federal
rules protecting vulnerable youths."

AP reports: "Columbia faculty members were notified of the training
requirement on Tuesday in an e-mail from David Hirsh, the university’s
executive vice president for research.  Columbia spokeswoman Marilyn
Castaldi said Wednesday in a statement that all investigators at the
university who conduct pediatric research "will now be required to undergo
training specifically geared to participation of children in research."

"The e-mail to faculty says that effective March 1 approval for research
involving children as subjects "will be contingent upon receipt of
documentation that the Research with Minors module has been completed by the
investigators."

It is not clear what the self-imposed requirements under Columbia’s "module"
are–and whether they afford children real protections.
Furthermore, given that similar violations have been documented at equally
prestigious institutions–OHRP’s failure to issue requirements for universal
safety standards for research involving vulnerable children is an
indicagtion of head in the sand oversight.

See OHRP letter at: http://www.hhs.gov/ohrp/detrm_letrs/YR06/feb06a.pdf

Contact: Vera Hassner Sharav
veracare@ahrp.org
 New York Post <http://www.nypost.com>  

NEW YORK POST
COLUMBIA CHANGES POLICY ON ‘GUINEA PIG’ KIDS

By IAN BISHOP

WASHINGTON — Columbia University says it will institute mandatory training
for faculty members whose research involves children so it complies with
federal rules protecting vulnerable youngsters from becoming "guinea pigs."

But a final federal review lets Columbia off with little more than a
reprimand despite the finding that drug experiments were done on
AIDS-stricken foster kids without proper safeguards.

The federal probe came after The Post, following research by journalist and
health advocate Liam Scheff, reported that foster kids were being used as
"guinea pigs" at a Catholic-charity home affiliated with
Columbia-Presbyterian Medical Center.

Columbia said then it didn’t have to provide advocates for the children
because the experiments held the promise of improved health for them.

Medical ethicists disagreed.

Under the university’s new policy, all investigators who conduct pediatric
research "will now be required to undergo training specifically geared to
participation of children in research."

Columbia-Presbyterian, which was at risk of losing its federal research
funding, satisfied regulators that it had increased training for the
in-house oversight boards that monitor the ethics and safety of all human
experiments.

"So what’s the incentive to comply?" wondered Alliance for Human Research
Protection honcho Vera Hassner Sharav.

"That’s the usual way [the government] gives a pass to any institution
violates federal regs."

ian.bishop@nypost.com
  _____  

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Associated Press
2-22-2006
^BC-NY–AIDS-Foster Children,0495<
^Columbia to institute mandatory training for child research<
^By KAREN MATTHEWS=

¶ NEW YORK (AP) _ Columbia University says it will institute mandatory
training for faculty members whose research involves children so it complies
with federal rules protecting vulnerable youths.
¶ The training plan was filed with the federal Office for Human Research
Protections, which determined last year that Columbia researchers had tested
AIDS drugs on foster children without providing the children with
independent advocates to protect their interests.
¶ Columbia faculty members were notified of the training requirement on
Tuesday in an e-mail from David Hirsh, the university’s executive vice
president for research.
¶ Columbia spokeswoman Marilyn Castaldi said Wednesday in a statement that
all investigators at the university who conduct pediatric research "will now
be required to undergo training specifically geared to participation of
children in research."

¶ The e-mail to faculty says that effective March 1 approval for research
involving children as subjects "will be contingent upon receipt of
documentation that the Research with Minors module has been completed by the
investigators."

¶ OHRP, a division of the Department of Health and Human Services,
determined last May that researchers at the Columbia University Medical
Center and the affiliated NewYork-Presbyterian Hospital failed to obtain
proper consent, information and safeguards for foster children on whom AIDS
drugs were tested in the 1980s and ’90s.
¶ Columbia officials said at the time they did not believe they needed to
provide the advocates because their experiments held the promise of improved
health for the children. Medical ethicists disagreed, saying the foster
children were vulnerable and required the protection.
¶ There are no foster children involved in any of Columbia’s current
research.
¶ A Feb. 17 letter from OHRP addressed to Columbia University Medical Center
and NewYork-Presbyterian Hospital said that their Dec. 8, 2005, response to
an OHRP query indicated there were no foster children or wards of the state
enrolled in any of 17 current studies.

¶ The letter says corrective actions taken by Columbia and
NewYork-Presbyterian "adequately address OHRP’s findings, questions and
concerns" and "there should be no need for further involvement of OHRP in
this matter."
¶ Castaldi said, "We are pleased that OHRP’s questions about our pediatric
research have been fully answered."

¶ The Associated Press reported May 4, 2005, that researchers in New York,
Illinois and several other states funded by the National Institutes of
Health had tested AIDS drugs on hundreds of foster children since the 1980s,
often without providing the children with independent advocates.

¶ AP’s story prompted a congressional hearing at which experts testified
that the standards for enrolling foster children in medical experiments
varied widely across the country.

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