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AHRP Calls for Federal Investigation of Drug Trials Using Children in Foster Care
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 Position Statement on Mental Health Screening – FDA Hearing Re: Drug Advertising
AHRP Position Statement on Mental Health Screening – FDA Hearing Re: Drug Advertising Wed, 02 Nov 2005 FDA is holding public hearings (Nov 1, 2) Re:Â Direct-to-Consumer Promotion of Medical Products at: National Transportation Safety Board Boardroom and Conference Center 429 L’Enfant Plaza, SW., Washington, DC 2 Time: 9:00 –5:00….
Separating Science from Promotion, Evidence from Propaganda WCSJ 2009
Click here for Separating Science from Promotion, Evidence from Propaganda
AHRP Comments on Landmark Decision by the Court of Appeals of Maryland
A landmark decision by Maryland’s highest court, the Court of Appeals of Maryland, is a victory for the human rights of children. The decision affirms the responsibility of parents, the government, researchers and institutional review boards (IRB) to protect children from non-therapeutic experiments that may put their health at risk.
NIH Rule change Re: Whistle blowers – Comments due before June 15
A request for comment about NIH proposed new research misconduct rule
See Fed Register:
http://ori.dhhs.gov/multimedia/acrobat/42CFRParts50and93.pdfThe new rule, I believe is meant to protect research institutions from the effective sting of a knowledgeable whistle blower.
The new rule would redefine whistle-blower as “complainant” and would limit the role of the complainant. Under the old rule, the whistle-blower participated in the process helping investigators by leading them to the evidence, etc.
Statement by Vera Hassner Sharav, Anthrax Band Reunion Press Conference
My name is Vera Hassner Sharav, and I am president of The Alliance for Human Research Protection: a national human rights organization that exposes unethical research practices which undermine the dignity, rights, and safety of human subjects.
In 1947, an American military tribunal sat in judgment of the Nazi doctors at Nuremberg, and laid down ten essential principles that define “permissible medical experiments” in a civilized society. Those principles are enshrined in the Nuremberg Code which is the cornerstone of all medical research ethics. The nations of the world adopted the Code as a safeguard to prevent future medical atrocities.
