AHRP - New York Post - COLUMBIA CHANGES POLICY ON 'GUINEA PIG' KIDS

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Fri, 24 Feb 2006 22:28:11 -0500

[sSRI-Research] AHRP - New York Post - COLUMBIA CHANGES

POLICY ON 'GUINEA PIG' KIDS

 

 

 

 

 

 

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION

 

 

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

 

FYI

 

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 indication of head in the sand oversight.

 

 

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

 

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

 

 

http://www.nypost.com/news/nationalnews/62323.htm

 

COLUMBIA CHANGES POLICY ON 'GUINEA PIG' KIDS

 

By IAN BISHOP Post Correspondent

 

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. "