Stakeholders in the Medical research enterprise, in the European Union and in the U.S., claim that clinical trials conducted on human subjects adhere to strict safety standards. “One of the things that sets clinical trials apart from other scientific experiments is the obligation for care. Investigators undertaking them have obligations to ensure that patients enrolled…Read More
To view AHRP news and infomails from 2006, please visit our new site. Infomails Subscribe to AHRP’s infomails At FDA, Graham is still the whistle-blower Loss of Trust: Big Drug Makers See Sales Decline With Their Image War hero’s death in clinical trial follows years of FDA neglect European perspective: Bird Flu / Rumsfeld Tamiflu…Read More
AHRP Speaks Out AHRP Press Briefing 9/14/04: Antidepressants & suicide-related risks for children Open Letter to NIMH re Prozac & Concealed Suicide Attempts Open Letter to Officials at NIMH AHRP Briefing 2/2/04: Scientists present suicide evidence Conflicts of Interest policy – New York Times Phase I Drug Trials Used Foster Care children in Violation of…Read More
The Phase I trial–the first in humans–was set up by US drug research company Parexel International Corp on behalf of German pharmaceutical company TeGenero.Read More
ALLIANCE FOR HUMAN RESEARCH PROTECTION Homepage 142 West End Ave. Suite 28P New York, NY 10023 March 10, 2004 Dr. Michael Carome Chief of Compliance Office of Human Research Protections David Horowitz Director, Office of Compliance Food & Drug Administration Dept. of Health and Human Services cc: Dr. Bernard Schwetz, Director, OHRP Dr. David Lepay,…Read More
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.Read More