June 17, 2005
Pediatric Research Rules Allegedly Violated
DHHS' Office of Human Research Protection (OHRP) has concluded that "some AIDS drug experiments [at Columbia University Medical Center/New York Presbyterian Hospital] involving foster children violated federal rules designed to ensure vulnerable youths were protected from the risks of medical research," according to this morning's Washington Post. (Our earlier posts on this subject were on May 4 and May 24.)
The government cited Columbia Presbyterian in a letter dated May 23 with violating rules in at least four AIDS studies involving foster children, including:
Failing to "obtain sufficient information regarding the selection of wards of the state and foster children as research subjects."
- Failing to "obtain sufficient information regarding the process for obtaining permission of parents or guardians for wards of the state or foster children."
- Failing to have enough information to ensure the selection of patients for the studies was "equitable" . . . .
[An AP news story on May 4] prompted a congressional hearing, at which experts testified that the standards for enrolling foster children in medical experiments varied widely across the country. Some lawmakers complained that the foster kids had fewer protections than prisoners.
The OHRP's determination letter is here. [tm]
June 17, 2005 | Permalink
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