Phase I Drug Trial

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Phase I Drug Trials Used Foster Care children in Violation of 45 CFR 46.409 and 21 CFR 50.56 ALLIANCE FOR HUMAN RESEARCH PROTECTION Tel. 212-595-8974                (AHRP)                 Fax: 212-595-9086 142 West End Ave. Suite 28P New York, NY 10023 March 10, 2004 Dr. Michael Carome Chief of Compliance Office of […]

Complaint: Phase I AIDS Drug/Vaccine Experiment on Foster Children

RE: Phase I Drug trials used foster children in violation of 45 CFR 46.409 and 21 CFR 50.56

The Alliance for Human Research Protection (AHRP) has reason to believe that federal regulations for the protection of children as research subjects have been seriously violated in federally funded HIV research.

We have learned that a series of Phase I and Phase II drug experiments were conducted on infants and children who were under the guardianship of the New York City Agency for Children's Services (ACS), and living at Incarnation Children's Center, a foster care facility under contract with ACS.

AHRP Calls for Federal Investigation of Drug Trials Using Children ...